Tablet containing fresh dendrobium officinale lyophilized powder and preparation method
Patent Information
- Application Number
- CN202611511080.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-09-28
- Publication Date
- 2026-10-30
AI Technical Summary
[0019]然而,即使将铁皮石斛的药材干燥粉末压制成片剂,由于此药材粉末中纤维素含量高、粉末疏松、粉末流动性较差、难以压片成形、此药材中含粉量高易吸湿造成片剂贮藏过程中容易松片等制剂问题,将铁皮石斛的药材干燥粉末压制成片剂仍然在药剂学工业规模生产中存在巨大挑战
[0096]本发明制备铁皮石斛片剂时使用的麦芽糊精是以淀粉为原料,经酶法水解、精制、喷雾干燥制成的淀粉衍生物,是一种常用的片剂填充剂(亦有称赋型剂)。本发明制备铁皮石斛片剂时使用的山梨糖醇具有有清凉的甜味,是蔗糖甜度的60%,是生产无糖糖果和各种防龋齿食品的重要原料。代谢过程中的山梨糖醇不受胰岛素的控制,对血糖值无影响。本发明制备铁皮石斛片剂时使用的异麦芽酮糖醇(英文名:Isomalt)又称帕拉金糖醇、益寿糖,是一种甜味剂,通常呈白色结晶状,无气味,甜度为蔗糖的50%~60%。山梨糖醇和异麦芽酮糖醇基于其甜度能够替代蔗糖等容易引起血糖突然变化的辅料,用于片剂制备可适用于血糖异常患者。本发明制备铁皮石斛片剂时使用的柠檬酸基于其酸性常用于口服制剂调节口感。本发明制备铁皮石斛片剂时使用的WS-23(西安拉维亚)是一种调节口感的凉味剂,WS23是一种人工合成的有机化合物,化学名称为N,2,3-三甲基-2-异丙基丁酰胺,具有类似薄荷的清凉香味且无刺激性辣味。作为新一代凉味剂,其清凉效果持久稳定,适用温度范围广。相较于传统薄荷醇,WS23解决了黏膜刺激性和苦味残留问题。本发明制备铁皮石斛片剂时使用的硬脂酸镁是固体制剂尤其是片剂常用的润滑剂。上述辅料均是国家药品监督管理局公布的可食用辅料,它们用于本发明片剂具有优良的安全冗余。
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Abstract
Description
Technical Field
[0001] This invention belongs to the field of life sciences and relates to a Dendrobium officinale product, particularly a tablet made from freeze-dried fresh Dendrobium officinale powder, and more particularly to a tablet prepared from freeze-dried fresh Dendrobium officinale directly pulverized and then used as a raw material. This invention also relates to a method for preparing this tablet. The Dendrobium officinale tablets of this invention have several advantages that are incomparable to existing Dendrobium officinale processed products, and as a Dendrobium officinale product that can be taken orally or chewed, especially chewed, it maximizes the biological efficacy of Dendrobium officinale. Background Technology
[0002] The inventors of this application disclosed a freeze-dried powder made from fresh Dendrobium officinale in Chinese Patent No. ZL2015101544892 (CN104758257B). This product exhibits excellent performance in maintaining the optimal composition of active ingredients in Dendrobium officinale. This application is the result of further in-depth development of Dendrobium officinale products based on this.
[0003] Dendrobium officinale Kimura et Migo, also known as black-jointed grass, Yunnan Dendrobium, and Dendrobium officinale, is a perennial epiphytic herb belonging to the order Microsperms and the family Orchidaceae. The stem is erect, cylindrical, 9-35 cm long and 2-4 mm thick. The sepals and petals are yellowish-green, nearly similar, oblong-lanceolate, about 1.8 cm long and 4-5 mm wide. Flowering occurs from March to June. It is mainly distributed in Anhui, Zhejiang, and Fujian provinces of China. The stem is used medicinally, belonging to the category of yin-tonifying herbs.
[0004] Dendrobium officinale is a perennial herb that is widely distributed in Guangxi, Yunnan, Zhejiang, Fujian and other places. It is usually found on rocks in semi-shaded and damp mountainous areas.
[0005] Morphological characteristics of Dendrobium officinale: The stem is erect, cylindrical, 9-35 cm long and 2-4 mm thick, unbranched, with many nodes, the internodes are 1-3-1.7 cm long, and usually 3-5 leaves are alternately arranged above the middle; the leaves are distichous, papery, oblong-lanceolate, 3-4(-7) cm long and 9-11(-15) mm wide, the apex is obtuse and somewhat hooked, the base is decurrent into a sheath clasping the stem, the margin and midrib are often tinged with pale purple; the leaf sheath often has purple spots, and when old, its upper margin loosens from the stem and opens, leaving a ring-shaped bluish gap with the node.
[0006] The racemes usually emerge from the upper part of leafless old stems, bearing 2-3 flowers; the peduncle is 5-10 mm long, with 2-3 short sheaths at the base; the rachis is folded and curved, 2-4 cm long; the floral bracts are dry and membranous, pale white, ovate, 5-7 mm long, with a slightly obtuse apex; the pedicels and ovary are 2-2.5 cm long; the sepals and petals are yellowish-green, nearly similar, oblong-lanceolate, about 1.8 cm long and 4-5 mm wide, with an acute apex and 5 veins; the lateral sepals are wider at the base, about 1 cm wide; the calyx sac is conical, about 5 mm long. The apex is rounded; the lip is white with a green or yellow callus at the base, ovate-lanceolate, slightly shorter than the sepals, reflexed in the middle, acute at the apex, unlobed or indistinctly 3-lobed, with purplish-red stripes on both sides below the middle, and the margin is somewhat wavy; the lip disc is densely covered with fine papillate hairs and has a purplish-red patch above the middle; the column is yellowish-green, about 3 mm long, with a purple dot on each side of the apex; the column foot is yellowish-green with purplish-red stripes, sparsely hairy; the anther cap is white, oblong-triangular, about 2.3 mm long, with a nearly acute apex and 2-lobed. Flowering period: March to June.
[0007] In terms of growth habits, Dendrobium officinale thrives in cool, humid, and well-ventilated environments. It typically grows on semi-shaded, damp rocks at altitudes up to 1600 meters, preferring warm, humid climates and semi-shaded environments, and is not cold-hardy.
[0008] In terms of geographical distribution, Dendrobium officinale is widely distributed in southwestern Anhui (Dabie Mountains), eastern Zhejiang (Yinxian, Tiantai, Xianju), western Fujian (Ninghua), northwestern Guangxi (Tian'e), Sichuan, and southeastern Yunnan (Shiping, Wenshan, Malipo, Xichou).
[0009] In terms of propagation methods, there are methods such as organized rapid propagation and propagation by division and cuttings.
[0010] Tissue culture rapid propagation method: Before planting, tissue culture seedlings should be hardened off for 14 to 21 days. The specific measure is to move the tissue culture seedlings to a hardening-off room so that they can gradually adapt to the natural environment in an open and changing environment. When the leaves of the tissue culture seedlings are dark green, they can be removed from the bottle for planting.
[0011] Before removing the seedlings from the jar, open the cap and allow them to acclimatize to natural temperature and humidity for 2-3 days. Then, wash the seedlings, gently removing those still containing the culture medium and placing them in a basin for cleaning. Contaminated seedlings and bare-root or sparsely rooted seedlings should be kept separate. First, rinse the tissue culture seedlings with tap water, primarily to remove the agar to prevent mold growth and root rot. Then, rinse them thoroughly with clean water. Ideally, the seedlings should be graded according to size and quality during washing to facilitate cultivation and management, improve survival rates, and promote uniform growth.
[0012] Propagation by division and cuttings: When dividing, select 1- or 2-year-old plants that are tender green, robust, have many sprouts, well-developed root systems, and are free from pests and diseases as seed plants. Cut off dead branches, broken branches, old branches, and excessively long fibrous roots. Cut the plant into small clumps, each with 5-7 stems with leaves, which can then be planted.
[0013] In terms of cultivation techniques, the cultivation time for Dendrobium officinale is generally in spring and autumn each year, with spring being superior to autumn. In Zhejiang Province, the optimal cultivation time for Dendrobium officinale is from mid-April to late June, when the temperature is between 12 and 25℃ and the air humidity is relatively high, resulting in a higher survival rate and longer growth period for transplanted seedlings after they have been removed from the culture vessel. The second best time is from mid-September to late October, during which special attention should be paid to cold resistance and frost protection when transplanting. The cultivation substrate is crucial for high-quality and efficient cultivation of Dendrobium officinale. The biological characteristics of Dendrobium officinale require the cultivation substrate to have both good water retention and good ventilation. Large-scale production requires that the raw materials for the cultivation substrate be readily available and easy to handle. The substrates reported include sphagnum moss, gravel, peanut shells, moss, coconut husks, pine bark, sawdust, charcoal, and wood blocks. In production, bark and sawdust are mainly used, or a mixture of bark, sawdust, gravel, and organic fertilizer, with the bark crushed into particles smaller than 2-3 cm. Dendrobium officinale cultivation requires greenhouses. Greenhouse construction must ensure ventilation, shade, rain protection, and insect-proof netting. The location's natural factors, such as light, temperature, humidity, and ventilation, must be considered based on the growth habits of Dendrobium officinale. The suitable temperature for Dendrobium officinale growth is 15-30℃. In Zhejiang province, where summers are hot, 80% shade netting is typically used, with the plastic film partially uncovered to facilitate cooling. In cold winters, double-layered plastic film is used for insulation under 30-50% shading. Dendrobium officinale requires consistently moist substrate and an air humidity of over 80%, but waterlogging must be avoided. Sprinkler or drip irrigation is best; flushing is prohibited. The amount of water required varies depending on the season and region.
[0014] Dendrobium officinale is included in the Chinese Pharmacopoeia from 2010 to 2025. Dendrobium officinale is the dried stem of the orchid Dendrobium officinale Kimura et Migo. The plant is harvested from November to March of the following year. After removing impurities and trimming some of the fibrous roots, it is heated and twisted into a spiral or spring shape before drying. This is what is commonly known as "Dendrobium officinale" (earring-shaped Dendrobium). Alternatively, it can be cut into sections and dried or dried at low temperature, which is what is commonly known as "Dendrobium officinale". It is evident that there are three names for this: first, the fresh plant *Dendrobium officinale* Kimura et Migo, an orchid; second, the dried stem of this fresh plant, twisted into a spiral or spring shape, known as "Tiepi Fengdou" (Iron Skin Fennel); and third, the fresh plant, cut into sections and dried, also known as "Tiepi Shihu" (Iron Skin Dendrobium). The aforementioned pharmacopoeia clearly records the processing methods for *Dendrobium officinale*, as well as the final product form of *Dendrobium officinale* commonly available in the market. Therefore, the classic methods of processing and using *Dendrobium officinale* all require drying the fresh orchid.
[0015] Given the morphological characteristics of fresh Dendrobium officinale plants, such as erect stems, 9-35 cm long, and 2-4 mm thick, processing them into spiral or spring-shaped "Dendrobium officinale capsules" or cutting them into sections and drying them into "Dendrobium officinale" requires a significant amount of manual labor and may result in substantial material loss due to stem breakage. Therefore, directly freeze-drying the harvested fresh Dendrobium officinale plant stems as described above (ZL2015101544892 (CN104758257B)) and then pulverizing them into powder can eliminate the cumbersome processing steps of spiral or spring-shaped or section-dried products, while also avoiding material loss associated with such processing methods.
[0016] Therefore, directly drying fresh Dendrobium officinale and processing it into powdered Dendrobium officinale slices would be of great value. For example, freeze-dried fresh Dendrobium officinale powder can fully retain the effective components, and the absorption rate of active ingredients is greatly improved.
[0017] As described in ZL2015101544892(CN104758257B), while ensuring the complete preservation of effective components and significantly improving the absorption rate of active ingredients, the physical properties of this freeze-dried Dendrobium officinale powder need improvement. For example, due to the loose texture of the powder, its flowability is poor without any additives, which causes significant technical problems when accurately packaging the freeze-dried Dendrobium officinale powder. To address this, ZL2015101544892(CN104758257B) employs a special two-part freeze-drying process, with a small portion undergoing deep freezing and the majority of the material undergoing conventional freezing, resulting in freeze-dried Dendrobium officinale powder with excellent physical properties.
[0018] ZL2015101544892 (CN104758257B), when used as a drug dosage form in the form of lyophilized powder, presents several inconveniences. For example, the powder is uncompressed, occupies a large volume, and is inconvenient for dosage dispensing. As dried powder of medicinal plants, it is advantageous to further process it into tablets, as such powders typically have a low bulk density, resulting in low drug volume when formulated into capsules or other conventional dosage forms.
[0019] However, even if the dried powder of Dendrobium officinale is compressed into tablets, there are still significant challenges in the pharmaceutical industry for large-scale production due to the high cellulose content, loose texture, poor flowability, difficulty in tableting, and the tendency of the high powder content to absorb moisture, which can cause the tablets to loosen during storage.
[0020] Therefore, those skilled in the art still look forward to providing a tablet made from Dendrobium officinale powder that can be easily produced on an industrial scale. Summary of the Invention
[0021] The purpose of this invention is to provide a tablet containing freeze-dried fresh Dendrobium officinale powder, which exhibits excellent properties and can be easily produced in industrial-scale production facilities. The inventors unexpectedly discovered that the tablets containing freeze-dried fresh Dendrobium officinale powder produced using the method of this invention possess desirable and desirable characteristics. This invention is thus accomplished.
[0022] Therefore, the first aspect of the present invention provides the use of the combination of isomaltitol and citric acid in the preparation of Dendrobium officinale tablets with improved performance using fresh Dendrobium officinale freeze-dried powder as raw material.
[0023] According to the use described in the first aspect of the invention, said property is the physical strength property of the tablet, namely its resistance to abrasion and breakage. According to the use described in the first aspect of the invention, said property is the physical strength property of the tablet, characterized by its friability and resistance to abrasion and breakage. According to the use described in the first aspect of the invention, the tablet comprises the following components: Dendrobium officinale, sorbitol, maltodextrin, isomaltitol, citric acid, cooling agent WS-23, and magnesium stearate.
[0024] According to the use described in the first aspect of the invention, the Dendrobium officinale in the tablets is added in the form of Dendrobium officinale powder, which is made by freeze-drying fresh Dendrobium officinale and then pulverizing it. For example, the powder is a powder that can pass through an 80-mesh sieve.
[0025] According to the use described in the first aspect of the invention, the tablet comprises the following components in parts by weight: 115-125 parts by weight of Dendrobium officinale powder, for example, 120 parts by weight; 300-400 parts by weight of sorbitol, for example, 310-370 parts by weight; 30-100 parts by weight of maltodextrin, for example, 40-85 parts by weight; 40-80 parts by weight of isomaltitol, for example, 50-75 parts by weight; 5-20 parts by weight of citric acid, for example, 10-15 parts by weight; 0.2-1 parts by weight of cooling agent WS-23, for example, 0.3-0.7 parts by weight; and 2-10 parts by weight of magnesium stearate, for example, 5-8 parts by weight.
[0026] According to the first aspect of the invention, the Dendrobium officinale in the tablets is fed in the form of Dendrobium officinale powder, which is made by freeze-drying fresh Dendrobium officinale and then pulverizing it. The powder is prepared by a method comprising the following steps: removing impurities from fresh Dendrobium officinale harvested from the orchid family, cutting it into small segments (1-2 cm in length), pre-freezing it in a freeze dryer at -35°C or below for 3 hours, and then freeze-drying it according to a conventional freeze-drying process to reduce the moisture content of the material to below 12% to obtain the segmented freeze-dried material; then pulverizing the freeze-dried material with a pulverizer until the powder particle size is less than 80 mesh to obtain Dendrobium officinale powder.
[0027] According to the use described in the first aspect of the invention, the tablet comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 340 parts by weight of sorbitol, 61.5 parts by weight of maltodextrin, 60 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0028] According to the use described in the first aspect of the invention, the tablet comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 370 parts by weight of sorbitol, 41.5 parts by weight of maltodextrin, 50 parts by weight of isomaltitol, 15 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 5 parts by weight of magnesium stearate.
[0029] According to the use described in the first aspect of the invention, the tablet comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 310 parts by weight of sorbitol, 81.5 parts by weight of maltodextrin, 70 parts by weight of isomaltitol, 10 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 8 parts by weight of magnesium stearate.
[0030] According to the use described in the first aspect of the invention, the tablet comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 355 parts by weight of sorbitol, 51.5 parts by weight of maltodextrin, 55 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.7 parts by weight of cooling agent WS-23, and 7 parts by weight of magnesium stearate.
[0031] According to the use described in the first aspect of the invention, the tablet comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 330 parts by weight of sorbitol, 71.5 parts by weight of maltodextrin, 65 parts by weight of isomaltitol, 10 parts by weight of citric acid, 0.3 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0032] According to the use described in the first aspect of the invention, the tablet comprises the following components in parts by weight: 118.8 parts by weight of Dendrobium officinale powder, 344.4 parts by weight of sorbitol, 58.8 parts by weight of maltodextrin, 59.7 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.3 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0033] According to the use described in the first aspect of the invention, the tablet comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 340 parts by weight of sorbitol, 61.5 parts by weight of maltodextrin, 60 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0034] According to the use described in the first aspect of the invention, the tablet is prepared by a method comprising the steps of: (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (e.g., 7-9% of the total weight of the solid materials) of ethanol (e.g., 45-55% ethanol) for use as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to a mixing device in sequence and mix thoroughly (e.g., 30-40 minutes) for later use; (3) First, spray a small amount (e.g., 3-5% of the total weight of solid materials) of ethanol (e.g., 90-98% ethanol) into the mixed powder obtained in step (2), mix (e.g., 10-18 min), then add the prescribed amount of isomaltitol, mix (e.g., 10-15 min), then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing (e.g., 20-30 min), to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet particles obtained in step (3) to a fluidized bed dryer (e.g., 55~65℃) and dry (e.g., 2.7~3.5h) until the moisture content drops to below 3%. Then, sieve the dry particles through a 14-mesh sieve to obtain dry particles for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (e.g., mix for 15 min) to obtain the final mixed granules for later use. (6) The final mixed granules are compressed into tablets on a rotary tablet press (for example, with a hardness of 40~50N) according to the designed tablet weight to obtain Dendrobium officinale tablets.
[0035] According to the use described in the first aspect of the invention, each tablet weighs 0.2g to 1.0g, for example, 0.4g to 0.8g, for example, 0.6g.
[0036] Furthermore, a second aspect of the present invention provides a Dendrobium officinale tablet comprising the following components: Dendrobium officinale, sorbitol, maltodextrin, isomaltitol, citric acid, cooling agent WS-23, and magnesium stearate.
[0037] According to the tablets of the second aspect of the present invention, the Dendrobium officinale is added in the form of Dendrobium officinale powder, which is made by freeze-drying fresh Dendrobium officinale and then pulverizing it. For example, the powder is a powder that can pass through an 80-mesh sieve.
[0038] The tablet according to the second aspect of the present invention comprises the following components in parts by weight: 115-125 parts by weight of Dendrobium officinale powder, for example, 120 parts by weight; 300-400 parts by weight of sorbitol, for example, 310-370 parts by weight; 30-100 parts by weight of maltodextrin, for example, 40-85 parts by weight; 40-80 parts by weight of isomaltitol, for example, 50-75 parts by weight; 5-20 parts by weight of citric acid, for example, 10-15 parts by weight; 0.2-1 parts by weight of cooling agent WS-23, for example, 0.3-0.7 parts by weight; and 2-10 parts by weight of magnesium stearate, for example, 5-8 parts by weight.
[0039] According to the tablets of the second aspect of the present invention, the Dendrobium officinale is fed in the form of Dendrobium officinale powder, which is made by freeze-drying fresh Dendrobium officinale and then pulverizing it. The powder is prepared by a method comprising the following steps: removing impurities from fresh Dendrobium officinale harvested from the orchid family, cutting it into small segments (1-2 cm in length), pre-freezing it in a freeze dryer at -35°C or below for 3 hours, and then freeze-drying it according to a conventional freeze-drying process to reduce the moisture content of the material to below 12% to obtain the segmented freeze-dried material; then pulverizing the freeze-dried material with a pulverizer until the powder particle size is less than 80 mesh to obtain Dendrobium officinale powder.
[0040] The tablet according to the second aspect of the present invention comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 340 parts by weight of sorbitol, 61.5 parts by weight of maltodextrin, 60 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0041] The tablet according to the second aspect of the present invention comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 370 parts by weight of sorbitol, 41.5 parts by weight of maltodextrin, 50 parts by weight of isomaltitol, 15 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 5 parts by weight of magnesium stearate.
[0042] The tablet according to the second aspect of the present invention comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 310 parts by weight of sorbitol, 81.5 parts by weight of maltodextrin, 70 parts by weight of isomaltitol, 10 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 8 parts by weight of magnesium stearate.
[0043] The tablet according to the second aspect of the present invention comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 355 parts by weight of sorbitol, 51.5 parts by weight of maltodextrin, 55 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.7 parts by weight of cooling agent WS-23, and 7 parts by weight of magnesium stearate.
[0044] The tablet according to the second aspect of the present invention comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 330 parts by weight of sorbitol, 71.5 parts by weight of maltodextrin, 65 parts by weight of isomaltitol, 10 parts by weight of citric acid, 0.3 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0045] The tablet according to the second aspect of the present invention comprises the following components in parts by weight: 118.8 parts by weight of Dendrobium officinale powder, 344.4 parts by weight of sorbitol, 58.8 parts by weight of maltodextrin, 59.7 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.3 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0046] The tablet according to the second aspect of the present invention comprises the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 340 parts by weight of sorbitol, 61.5 parts by weight of maltodextrin, 60 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0047] The tablet according to the second aspect of the present invention is prepared by a method comprising the following steps: (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (e.g., 7-9% of the total weight of the solid materials) of ethanol (e.g., 45-55% ethanol) for use as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to a mixing device in sequence and mix thoroughly (e.g., 30-40 minutes) for later use; (3) First, spray a small amount (e.g., 3-5% of the total weight of solid materials) of ethanol (e.g., 90-98% ethanol) into the mixed powder obtained in step (2), mix (e.g., 10-18 min), then add the prescribed amount of isomaltitol, mix (e.g., 10-15 min), then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing (e.g., 20-30 min), to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet particles obtained in step (3) to a fluidized bed dryer (e.g., 55~65℃) and dry (e.g., 2.7~3.5h) until the moisture content drops to below 3%. Then, sieve the dry particles through a 14-mesh sieve to obtain dry particles for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (e.g., mix for 15 min) to obtain the final mixed granules for later use. (6) The final mixed granules are compressed into tablets on a rotary tablet press (for example, with a hardness of 40~50N) according to the designed tablet weight to obtain Dendrobium officinale tablets.
[0048] According to the second aspect of the invention, each tablet weighs 0.2g to 1.0g, for example, 0.4g to 0.8g, for example, 0.6g.
[0049] Furthermore, a third aspect of the present invention provides a method for preparing Dendrobium officinale tablets, the tablets comprising the following components: Dendrobium officinale, sorbitol, maltodextrin, isomaltitol, citric acid, cooling agent WS-23, and magnesium stearate.
[0050] The method according to a third aspect of the present invention includes the following steps: (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (e.g., 7-9% of the total weight of the solid materials) of ethanol (e.g., 45-55% ethanol) for use as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to a mixing device in sequence and mix thoroughly (e.g., 30-40 minutes) for later use; (3) First, spray a small amount (e.g., 3-5% of the total weight of solid materials) of ethanol (e.g., 90-98% ethanol) into the mixed powder obtained in step (2), mix (e.g., 10-18 min), then add the prescribed amount of isomaltitol, mix (e.g., 10-15 min), then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing (e.g., 20-30 min), to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet particles obtained in step (3) to a fluidized bed dryer (e.g., 55~65℃) and dry (e.g., 2.7~3.5h) until the moisture content drops to below 3%. Then, sieve the dry particles through a 14-mesh sieve to obtain dry particles for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (e.g., mix for 15 min) to obtain the final mixed granules for later use. (6) The final mixed granules are compressed into tablets on a rotary tablet press (for example, with a hardness of 40~50N) according to the designed tablet weight to obtain Dendrobium officinale tablets.
[0051] According to the method described in the third aspect of the present invention, the tablets produced therefrom have a tablet weight of 0.2g to 1.0g, for example 0.4g to 0.8g, for example 0.6g.
[0052] According to the method of the third aspect of the present invention, the Dendrobium officinale in the tablets is added in the form of Dendrobium officinale powder, which is made by freeze-drying fresh Dendrobium officinale and then pulverizing it. For example, the powder is a powder that can pass through an 80-mesh sieve.
[0053] According to the method of the third aspect of the present invention, the tablet comprises the following components in parts by weight: 115-125 parts by weight of Dendrobium officinale powder, for example, 120 parts by weight; 300-400 parts by weight of sorbitol, for example, 310-370 parts by weight; 30-100 parts by weight of maltodextrin, for example, 40-85 parts by weight; 40-80 parts by weight of isomaltitol, for example, 50-75 parts by weight; 5-20 parts by weight of citric acid, for example, 10-15 parts by weight; 0.2-1 parts by weight of cooling agent WS-23, for example, 0.3-0.7 parts by weight; and 2-10 parts by weight of magnesium stearate, for example, 5-8 parts by weight.
[0054] According to the method of the third aspect of the present invention, the Dendrobium officinale in the tablets is fed in the form of Dendrobium officinale powder, which is made by freeze-drying fresh Dendrobium officinale and then pulverizing it. The powder is prepared by a method comprising the following steps: removing impurities from fresh Dendrobium officinale harvested from the orchid family, cutting it into small segments (1-2 cm in length), pre-freezing it in a freeze dryer at -35°C or below for 3 hours, and then freeze-drying it according to conventional freeze-drying process to reduce the moisture content of the material to below 12% to obtain the segmented freeze-dried material; then pulverizing the freeze-dried material with a pulverizer until the powder particle size is less than 80 mesh to obtain Dendrobium officinale powder.
[0055] According to the method of the third aspect of the present invention, the tablet contains the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 340 parts by weight of sorbitol, 61.5 parts by weight of maltodextrin, 60 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0056] According to the method of the third aspect of the present invention, the tablet contains the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 370 parts by weight of sorbitol, 41.5 parts by weight of maltodextrin, 50 parts by weight of isomaltitol, 15 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 5 parts by weight of magnesium stearate.
[0057] According to the method of the third aspect of the present invention, the tablet contains the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 310 parts by weight of sorbitol, 81.5 parts by weight of maltodextrin, 70 parts by weight of isomaltitol, 10 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 8 parts by weight of magnesium stearate.
[0058] According to the method of the third aspect of the present invention, the tablet contains the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 355 parts by weight of sorbitol, 51.5 parts by weight of maltodextrin, 55 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.7 parts by weight of cooling agent WS-23, and 7 parts by weight of magnesium stearate.
[0059] According to the method of the third aspect of the present invention, the tablet contains the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 330 parts by weight of sorbitol, 71.5 parts by weight of maltodextrin, 65 parts by weight of isomaltitol, 10 parts by weight of citric acid, 0.3 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0060] According to the method of the third aspect of the present invention, the tablet contains the following components in parts by weight: 118.8 parts by weight of Dendrobium officinale powder, 344.4 parts by weight of sorbitol, 58.8 parts by weight of maltodextrin, 59.7 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.3 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0061] According to the method of the third aspect of the present invention, the tablet contains the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 340 parts by weight of sorbitol, 61.5 parts by weight of maltodextrin, 60 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
[0062] Although the specific steps described in the preparation method of the present invention differ in some details or language from the steps described in the preparation examples in the detailed embodiments section below, those skilled in the art can fully summarize the above-described method steps based on the detailed disclosure of the entire present invention.
[0063] Any embodiment of any aspect of the present invention may be combined with other embodiments, provided that they do not contradict each other. Furthermore, any technical feature in any embodiment of any aspect of the present invention may be applied to the same technical feature in other embodiments, provided that they do not contradict each other.
[0064] The present invention will now be described in further detail.
[0065] All references cited in this invention are incorporated herein by reference in their entirety, and in the event of any inconsistency between the meanings expressed in these references and those expressed herein, the meanings expressed herein shall prevail. Furthermore, the various terms and phrases used in this invention have their general meanings known to those skilled in the art; however, this invention still seeks to provide a more detailed explanation and interpretation of these terms and phrases, and in the event of any inconsistency between the mentioned terms and their known meanings and those expressed herein, the meanings expressed herein shall prevail.
[0066] The water content in the freeze-dried powder of fresh Dendrobium officinale is generally below 12%, preferably below 10%. Moisture content can be controlled by appropriately adjusting the freeze-drying process. The moisture content in the freeze-dried powder can be determined using many known methods, such as loss on drying. Tablets prepared from the freeze-dried powder of fresh Dendrobium officinale exhibit some of the excellent effects described in the context of this invention.
[0067] The *Shennong Bencao Jing* (Shennong's Classic of Materia Medica), written during the Qin and Han dynasties, records that *Dendrobium officinale* "treats internal injuries, eliminates numbness, regulates qi, nourishes the five internal organs, treats weakness and emaciation, strengthens yin, and with prolonged use, thickens the intestines and stomach." The *Daozang* (Taoist Canon), a classic of Taoist medicine compiled over a thousand years ago, lists *Dendrobium officinale* as the first of the "Nine Great Immortal Herbs of China." Li Shizhen, in his *Compendium of Materia Medica*, praises *Dendrobium officinale* for "strengthening yin and replenishing essence, thickening the intestines and stomach, replenishing internal deficiencies, regulating stomach qi, building muscle, improving intelligence, relieving fright, and promoting longevity." It is popularly known as the "life-saving immortal herb." Modern *Dendrobium officinale* stems can clear heat and generate fluids, reduce inflammation and relieve pain, and soothe the throat, showing good efficacy in treating hoarseness. *Dendrobium* also has good anti-fatigue and hypoxia-resistance effects. Pharmacies sell a wide variety of Dendrobium officinale at low prices, often using aquatic plants as substitutes. Only a few major domestic brands offer genuine Dendrobium officinale, with Fulimen and Tongrentang being the most authentic. Tongrentang is the most expensive and has the most attractive packaging, making it suitable for gifting.
[0068] Regarding the efficacy of Dendrobium officinale in treating stomach yin deficiency and febrile diseases with fluid depletion: This herb excels at nourishing stomach yin, promoting fluid production and quenching thirst, and also clearing stomach heat. It is primarily used to treat febrile diseases with fluid depletion, characterized by thirst, dry tongue with a black coating, and is often used in combination with Trichosanthes kirilowii, fresh Rehmannia glutinosa, and Ophiopogon japonicus, as described in the "Treatise on Seasonal Diseases" for clearing heat and preserving fluids. For stomach pain, swollen gums, and oral ulcers due to stomach heat and yin deficiency, it can be used in combination with Rehmannia glutinosa, Ophiopogon japonicus, and Scutellaria baicalensis.
[0069] Regarding the efficacy of Dendrobium officinale for kidney yin deficiency: This herb nourishes kidney yin and reduces deficiency fire, making it suitable for symptoms such as blurred vision, weakness of muscles and bones, and yin deficiency with fire excess, including steaming bone fever. For those with kidney yin deficiency and blurred vision, it is often used in combination with Lycium barbarum, Rehmannia glutinosa, and Cuscuta chinensis, as in the Dendrobium Nobile Brightening Pill (from *Yuanji Qiwei*). For those with kidney yin deficiency and weakness of muscles and bones, it is often used in combination with Rehmannia glutinosa, Cornus officinalis, Eucommia ulmoides, and Achyranthes bidentata, which tonify the liver and kidneys and strengthen muscles and bones. For those with kidney deficiency with fire excess, including steaming bone fever, it is suitable to use in combination with Rehmannia glutinosa, Lycium barbarum, Phellodendron chinense, and Coptis chinensis, which nourish kidney yin and reduce deficiency fire.
[0070] Dendrobium officinale has a sweet taste and slightly cold nature. It nourishes Yin, clears heat, benefits the stomach, and promotes the production of body fluids. Dendrobium officinale contains alkaloids such as dendrobine, mucilage, starch, polysaccharides, and mannose. It has certain antipyretic and analgesic effects, promotes gastric juice secretion, aids digestion, enhances metabolism, and has anti-aging effects. Clinically, Dendrobium officinale can be used for heat-induced fluid depletion, low-grade fever with thirst, red tongue with little coating; stomach Yin deficiency, thirst and dry throat, nausea and vomiting, poor appetite, dull stomach pain, smooth tongue with little coating; and kidney Yin deficiency, blurred vision.
[0071] There are many ways to consume Dendrobium officinale. For example, in tea: Take 20-30 grams of fresh Dendrobium officinale, wash, peel, and slice thinly or cut into sections and crack. Add a few red dates or some goji berries, and enough water (depending on your drinking capacity). Bring to a boil over high heat, then simmer over low heat for at least 30 minutes before drinking. Alternatively, steep in boiling water. After eating, remove the Dendrobium officinale and consume it. In dishes: Take 30-50 grams of fresh Dendrobium officinale, wash, slice, or cut into sections and crack. It can be used to cook chicken, duck, or bones, depending on personal preference. Cook for a slightly longer time than usual. In alcohol: Take 500 grams of fresh Dendrobium officinale, rinse thoroughly, and combine with goji berries, American ginseng, and 1000 grams of white wine. Soak for two months, then consume in appropriate amounts morning and evening. Juicing: Wash the product and use a juicer to add water at a ratio of 10:1 to make juice. Adding honey will enhance the flavor. Drinking this before or after drinking alcohol can help sober you up, protect your liver, and relieve headaches. The effects are noticeable.
[0072] The health benefits of Dendrobium officinale are well-known. For example... Regarding the nourishing yin and fluid effects of Dendrobium officinale, the *Chinese Pharmacopoeia* states that Dendrobium officinale "specifically nourishes the qi and fluids of the lungs and stomach; when qi and fluids are abundant, kidney water is naturally generated," indicating its effectiveness in nourishing yin and generating fluids, treating various symptoms of yin deficiency and fluid depletion. Traditional Chinese medicine believes that yin fluid is the material basis of human life activities, possessing the functions of nourishing the body, internal organs, brain, marrow, and bones, inhibiting excessive yang and fire, and maintaining normal growth, development, and reproductive functions. If the body's yin fluid is insufficient, symptoms such as lethargy, dull complexion, dry eyes, sluggishness, lower back and knee weakness, dizziness, fatigue, dry mouth and throat, sore throat, and constipation may occur. Dendrobium officinale is an essential medicine for nourishing yin; taking it can fundamentally solve the problem of insufficient yin fluid in the body.
[0073] Regarding the body-strengthening effects of Dendrobium officinale: Dendrobium has the function of nourishing yin and blood. The Qing Dynasty medical text *Treatise on the Properties of Medicinal Herbs* states that Dendrobium can replenish kidney essence, nourish stomach yin, and boost energy. Dendrobium contains abundant polysaccharides. Experiments have shown that Dendrobium polysaccharides can enhance immune function and increase the phagocytic ability of peritoneal macrophages on chicken erythrocytes.
[0074] Regarding the spleen-tonifying effects of Dendrobium officinale: The spleen and stomach play a vital role in digesting food and absorbing nutrients to nourish the whole body; they are the source of nutrition, and therefore, adequate nutrition depends primarily on the function of the spleen and stomach. Dendrobium officinale is a stomach-tonifying and fluid-generating herb, recorded in both the *Shennong Bencao Jing* and *Bencao Zai Xin*. It is commonly known as a "gastrointestinal medicine" and is a frequently used remedy for stomach pain and upper abdominal distension. Modern experiments have confirmed that Dendrobium officinale has a good inhibitory effect on Helicobacter pylori, a common pathogen in spleen and stomach diseases, and is helpful in treating Helicobacter pylori-positive conditions such as atrophic gastritis, superficial gastritis, and duodenal ulcers. Furthermore, oral administration of Dendrobium officinale decoction can promote gastric juice secretion, enhance gastric emptying, and aid digestion.
[0075] Regarding the hepatoprotective and choleretic effects of Dendrobium officinale: Dendrobium officinale has a good choleretic effect. Physicians throughout history have believed that "Dendrobium officinale" nourishes liver yin and is an essential medicine for treating various liver and gallbladder disorders, including hepatitis, cholecystitis, and gallstones. It also clears deficiency heat. Deficiency heat manifests as a group of symptoms such as fatigue, dizziness, flushed face, palpitations, cough with little phlegm, insomnia, forgetfulness, dark yellow urine, red tongue, and thready pulse. The *Compendium of Materia Medica Supplement* and *Extended Meaning of Materia Medica* respectively record that it "clears stomach deficiency heat" and "relieves deficiency heat in the stomach and hemorrhoids." Compared with ordinary heat-clearing drugs, the deficiency heat cleared by Dendrobium officinale is specifically a type of deficiency heat characterized by yin deficiency and excessive heat. Pharmacological experiments show that Dendrobium officinale can significantly reduce the peak fever and body temperature response index in rabbits with excessive heat, and shorten the duration of fever.
[0076] Regarding the bone-strengthening effects of Dendrobium officinale: As people enter middle age, "the body's yin energy diminishes by half" (Zhu Danxi), meaning the body's yin fluids begin to weaken, and the function of muscles and bones gradually declines. Dendrobium officinale can nourish yin fluids, which can lubricate joints, thus achieving the effects of strengthening muscles and bones, improving joint mobility, and enhancing resistance to rheumatism. Modern pharmacological research shows that Dendrobium officinale can improve stress response and has good anti-fatigue and hypoxia tolerance effects. In terms of promoting circulation, Dendrobium officinale nourishes yin, moistens the blood vessels, and dilates blood vessels, thereby promoting blood circulation. Experimental results show that Dendrobium officinale can significantly improve blood stasis symptoms, lower blood cholesterol and triglycerides, and increase high-density lipoprotein cholesterol levels, and can treat cardiovascular and cerebrovascular diseases.
[0077] Regarding the hypoglycemic effect of Dendrobium officinale: Traditional Chinese medicine believes that the occurrence of diabetes mellitus is mainly due to kidney yin deficiency and lung and stomach heat, with qi and yin deficiency as its pathological characteristics. Dendrobium officinale nourishes yin, clears heat and moistens dryness, and has been a specific medicine for treating diabetes since ancient times. Clinical studies have shown that Dendrobium officinale can not only enhance insulin activity, but also significantly lower blood sugar levels, restoring blood sugar to normal.
[0078] Regarding the anti-tumor effects of Dendrobium officinale: Dendrobium officinale has a killing effect on certain cells of human lung cancer, ovarian cancer, and promyelocytic leukemia, exhibiting strong anti-tumor activity. Clinical studies have shown that Dendrobium officinale, when used as an adjunct therapy for malignant tumors, can improve the symptoms of cancer patients, reduce the side effects of radiotherapy and chemotherapy, enhance immunity, improve quality of life, and prolong survival time.
[0079] Regarding the eye-brightening effects of Dendrobium officinale: Traditional Chinese medicine believes that the essence of the five internal organs and six bowels flows through the meridians to the eyes, and the liver "opens into the eyes." The physiology and pathology of the eyes are closely related to the abundance of Yin essence in the liver. Dendrobium officinale has the function of nourishing Yin and benefiting the eyes, and has been regarded as a superior product for eye care by physicians throughout history. Modern pharmacological studies have confirmed that Dendrobium officinale not only has a delaying effect on the prevention and treatment of cataracts, a common eye disease in the elderly, and can maintain the transparency of the lens by 36.8%, but also inhibits or corrects abnormal changes in enzyme activity caused by galactose.
[0080] Regarding the skin-nourishing effects of Dendrobium officinale: As people enter middle age, the body's yin fluid gradually decreases, accelerating skin aging and causing it to darken or wrinkle. Dendrobium officinale contains a large amount of mucilage, which has a moisturizing and nourishing effect on human skin.
[0081] Regarding the longevity-promoting effects of Dendrobium officinale, the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica) lists it as a commercial medicine with the effect of "lightening the body and prolonging life." Modern research shows that Dendrobium officinale contains a variety of trace elements, which are closely related to human health and longevity. The anti-aging effects of Dendrobium officinale on the human body are broader and more comprehensive than those of ordinary drugs.
[0082] Furthermore, various classic Chinese medicine treatises provide detailed records of the efficacy of Dendrobium officinale. For example, the *Compendium of Materia Medica* records that Dendrobium officinale: relieves numbness and lowers qi, nourishes the five internal organs for weakness and emaciation, strengthens yin and benefits essence. Long-term use thickens the intestines and stomach, replenishes internal deficiencies, regulates stomach qi, promotes muscle growth, expels pathogenic heat and prickly heat from the skin, relieves pain, coldness, numbness, and weakness in the feet and knees, calms the mind, eliminates fright, lightens the body, and prolongs life. It also benefits qi and clears heat, strengthens yang, expels wind-dampness from the skin, treats long-term coldness in the bones, and tonifies the kidneys and strengthens the body. It treats fever with spontaneous sweating, and carbuncles with internal pus drainage. The *Shennong's Classic of Materia Medica* records that Dendrobium officinale: treats internal injuries, relieves numbness, lowers qi, nourishes the five internal organs for weakness and emaciation, and strengthens yin. Long-term use thickens the intestines and stomach, lightens the body, and prolongs life. The *Shennong's Classic of Materia Medica* records that Dendrobium officinale is sweet and neutral in nature. It treats internal injuries, relieves numbness, lowers qi, nourishes the five internal organs for weakness and emaciation, strengthens yin, and long-term use thickens the intestines and stomach. The Compendium of Materia Medica states: It is sweet, bland, and slightly salty, and treats fever with spontaneous sweating, carbuncles, and internal blockages requiring pus drainage. The Supplement to the Compendium of Materia Medica records that Dendrobium officinale clears stomach heat, generates fluids to relieve fatigue, and can be used as a tea substitute to improve appetite and strengthen the spleen. It also calms the nerves, treats wind-related ailments, suppresses phlegm, and has a sweet and fragrant flavor that lowers qi.
[0083] The methods of consuming Dendrobium officinale are already well known.
[0084] 1. Fresh consumption. In the past, before antibiotics were available for reducing fever, fresh Dendrobium officinale was highly effective for treating fever in children without the side effects of antibiotics. For fever caused by various reasons, simply crush fresh Dendrobium officinale and swallow it with boiled water, or chew it directly, or decoct it in boiled water and drink it to reduce fever. It can also be used to treat toothache caused by deficiency heat in adults.
[0085] 2. Tea Infusion: Grind Lao Yan Shan Dendrobium officinale into powder, take 3-5 grams per person per day, and steep in boiling water. Continue for 30 days for noticeable effects. Alternatively, boil Dendrobium officinale in water for at least 30 minutes. It can be reused, consuming the entire amount on the same day, including the residue. It can clear heat, nourish yin, and combat fatigue.
[0086] 3. Dietary Use. Dendrobium officinale can be added to daily meals, such as in stewed chicken or pigeon. Here are two examples for reference: 1) Dendrobium officinale porridge: 5 grams of Dendrobium officinale, 50 grams of glutinous rice, and appropriate amount of rock sugar. 2) Cordyceps and Dendrobium officinale soup: One pair of raw gecko, 5 pieces of Cordyceps sinensis, 5 grams of Dendrobium officinale, 200 grams of lean pork, and one piece of dried tangerine peel. (Therapeutic Effects) Nourishes Yin, generates fluids, and tonifies the liver and kidneys; suitable for all ages.
[0087] 4. Dendrobium Officinale Stomach-Clearing Drink. [Ingredients] 10g Dendrobium officinale from Laoyanshan, 12g bamboo shavings, 30g reed rhizome, 15g dandelion, 10g immature bitter orange peel, 15g ophiopogon japonicus, 6g peppermint, 12g white peony root, 6g licorice root. [Usage] Decocted in water to 200ml, taken twice daily, morning and evening, warm before meals. [Efficacy] Mildly cooling and soothing, regulates qi and relieves pain. Suitable for those with chronic superficial gastritis or gastric ulcers with a heat-prone constitution.
[0088] 5. Infuse in alcohol for drinking. Longevity-Promoting Dendrobium Officinale Wine: 250g Dendrobium Officinale, 60g Rehmannia glutinosa, 30g Achyranthes bidentata, 20g Eucommia ulmoides, 20g Salvia miltiorrhiza, 10 liters of white wine. [Efficacy] Relieves lower back and leg pain, fatigue, rheumatism, etc. Tonifies the kidneys, strengthens muscles and bones, and eliminates fatigue.
[0089] 6. Yin-Nourishing and Kidney-Tonifying Soup (Serves 1) Ingredients: 15g each of Cordyceps sinensis, Dendrobium officinale, white peony root, and Cornus officinalis; 25g each of mulberry fruit, privet fruit, eclipta prostrata, and Rehmannia glutinosa. Preparation: Simmer in 4 bowls of water until reduced to 1 bowl. Benefits: Cordyceps sinensis nourishes both the kidneys and liver. Combined with Dendrobium officinale, white peony root, mulberry fruit, and Cornus officinalis, all yin-nourishing herbs, this soup is ideal for those with yin deficiency to tonify the liver and kidneys.
[0090] 7. American Ginseng and Dendrobium Tea: [Ingredients] 5g American ginseng, 30g Dendrobium officinale from Laoyanshan. [Preparation] First, remove impurities from the American ginseng, wash it, sun-dry or oven-dry it, cut it into slices, and place it in a large container for later use. Place the Dendrobium officinale from Laoyanshan in a clay pot, add 200ml of water, bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter with clean gauze to remove the residue, collect the filtrate, and pour it into the container with the American ginseng slices. Cover and steep for 15 minutes before drinking. (Alternatively, grind the American ginseng and Dendrobium officinale into a fine powder, steep in hot water, and drink as tea. Take 3-5g each time, 1-2 times daily.) [Dosage] Drink as tea, twice a day, morning and afternoon, frequently. Consume the entire amount on the same day. [Efficacy] Nourishes Yin and stomach, promotes fluid production and relieves cough. This formula is suitable for patients with leukemia complicated by stomatitis of the stomach Yin deficiency and excess heat type. [Review] American ginseng is cool in nature, sweet and slightly bitter in taste, and excels at replenishing qi and nourishing yin, clearing heat and promoting body fluids. Modern pharmacological research has proven that American ginseng can enhance the body's disease resistance and inhibit the growth of cancer cells. Dendrobium nobile nourishes stomach yin and promotes body fluids. Clinical research data shows that Dendrobium nobile is effective for thirst, dry throat and tongue, and constipation caused by yin deficiency and fluid depletion after chemotherapy and radiotherapy for cancer. The combination of these two herbs in a dietary tea has significant effects in nourishing yin and stomach, promoting body fluids and relieving cough. It has a good adjuvant therapeutic effect on patients with leukemia complicated by stomatitis due to stomach yin deficiency and heat, and is especially suitable for adolescents, children, and elderly leukemia patients.
[0091] 8. Steamed Dendrobium and Snail: Ingredients: 1500g river snails (snails), 9g pork loin, 6g Dendrobium. Seasoning: A pinch of salt. Method: 1) Clean the river snails, removing any mud, and blanch them in boiling water. Reserve the broth after filtering. 2) Remove the snail meat, wash it with lightly salted water, drain, and place it in a stewing pot. Cut the pork loin into chunks and blanch in boiling water to remove impurities. 3) Simmer the snail broth and Dendrobium in a small pot for about 20 minutes, then remove the dregs and filter the broth. 4) Pour the broth into the stewing pot, place the pork loin on top of the snail meat, and stew for about 1 hour. Season with salt before serving. Characteristics: Fresh and slightly sweet flavor. Efficacy: Stewing Dendrobium with snails and pork can nourish yin and moisten dryness, promote urination, quench thirst and promote diuresis. It is effective for diabetes, emaciation, constipation, dry cough and drunkenness.
[0092] 9. Yin-Nourishing and Thirst-Clearing Soup: Ingredients: 6-9 grams of Dendrobium, 12 grams each of Asparagus cochinchinensis, Polygonatum odoratum, Adenophora stricta, Polygonatum sibiricum, Rehmannia glutinosa, Dioscorea opposita, and Poria cocos, and 5 grams of dried tangerine peel. Instructions: Add lean pork or chicken as desired, add eight bowls of boiling water, and simmer for three hours. Season with salt before serving. Efficacy: Highly effective for diabetes mellitus and symptoms of liver and stomach yin deficiency caused by excessive smoking and drinking.
[0093] 10. Dendrobium and Cassia Seed Granules: Ingredients: 30-50g each of Dendrobium and American ginseng; 60g each of Lycium barbarum, chrysanthemum, Cuscuta chinensis, Astragalus complanatus, Ligustrum lucidum, Cassia tora, and Plantago asiatica; 60-80g of Salvia miltiorrhiza. Usage: Grind all the above ingredients into a fine powder. Take 3-5g twice daily, dissolved in boiling water. Continuous use for more than three months will yield better results. Efficacy: Effective for hypertension, glaucoma, and cataracts caused by liver and kidney yin deficiency.
[0094] 11. Tea Beverage: 15 grams each of Polygonatum odoratum, Adenophora stricta, Dendrobium nobile, and Ophiopogon japonicus, plus five dried plums. Decoct in water, add an appropriate amount of rock sugar, and drink as tea. This can treat yin deficiency caused by febrile diseases, or dry mouth and thirst caused by excessive sweating in summer, and constipation. 12. 15 grams of Adenophora stricta, 10 grams each of Rehmannia glutinosa, Ophiopogon japonicus, and Dendrobium nobile, plus an appropriate amount of rock sugar. Decoct in water and drink. This is suitable for symptoms such as lack of body fluids after high fever, dry throat and mouth, loss of appetite, constipation, and difficulty urinating.
[0095] The common methods and dosages for using Dendrobium officinale are as follows: 1. Low-temperature cell wall breaking grinding method: Grind into a fine powder of 200 mesh or finer (do not use a high-speed heating type ordinary grinder, as the high temperature generated during the crushing process will destroy the medicinal molecules). Take 3 grams of Dendrobium officinale powder daily, divided into two doses in the morning and evening, taken with warm water. [If you need to replenish Qi, you can also add a small amount of American ginseng or ginseng powder to take together]. This method is recommended for the best effect and is suitable for long-term use. 2. Traditional method of long decoction: Take 5-6 grams of Dendrobium officinale raw material (two days' worth), add 1.5 liters of water and simmer in a clay pot. Take it after the first decoction for 24 hours, the second decoction for 8 hours, the third decoction for 8 hours, and the fourth decoction for 8 hours, then take the soup and Dendrobium officinale residue together. Good Dendrobium officinale, after boiling, is fragrant, tender, has little residue, high viscosity, and a clear and non-greasy taste. It can be drunk directly without adding any seasonings. Suitable for long-term use. [If you need to replenish Qi, you can also add a small amount of American ginseng or ginseng]. 3. Take 3-5 grams of Dendrobium officinale raw material, simmer it with chicken or duck over low heat for 100 minutes, and eat it along with the residue.
[0096] The maltodextrin used in the preparation of Dendrobium officinale tablets in this invention is a starch derivative produced from starch through enzymatic hydrolysis, purification, and spray drying. It is a commonly used tablet filler (also known as an excipient). The sorbitol used in the preparation of Dendrobium officinale tablets in this invention has a refreshing sweetness, 60% the sweetness of sucrose, and is an important raw material for the production of sugar-free candies and various anti-caries foods. Sorbitol in its metabolism is not controlled by insulin and has no effect on blood glucose levels. The isomalt used in the preparation of Dendrobium officinale tablets in this invention, also known as palatinitol or longevity sugar, is a sweetener, usually white crystalline, odorless, and with a sweetness of 50%–60% of sucrose. Sorbitol and isomalt, based on their sweetness, can replace excipients such as sucrose that easily cause sudden changes in blood glucose, making them suitable for patients with abnormal blood glucose levels in tablet preparation. The citric acid used in the preparation of Dendrobium officinale tablets in this invention, due to its acidity, is commonly used in oral preparations to adjust the taste. The WS-23 (Xi'an Lavia) used in the preparation of Dendrobium officinale tablets in this invention is a cooling agent to adjust the taste. WS23 is a synthetic organic compound with the chemical name N,2,3-trimethyl-2-isopropylbutyramide, which has a minty-like refreshing aroma without any irritating spiciness. As a new generation of cooling agent, its cooling effect is long-lasting and stable, and it has a wide applicable temperature range. Compared with traditional menthol, WS23 solves the problems of mucosal irritation and bitter residue. The magnesium stearate used in the preparation of Dendrobium officinale tablets in this invention is a commonly used lubricant in solid dosage forms, especially tablets. All the above excipients are edible excipients published by the National Medical Products Administration, and they have excellent safety redundancy when used in the tablets of this invention.
[0097] To better preserve the efficacy of Dendrobium officinale, this invention employs freeze-drying technology to process fresh Dendrobium officinale, removing moisture, drying it, and pulverizing it into a fine powder. Freeze-drying technology offers the following advantages: freeze-drying is carried out at low temperatures, which is beneficial for preserving heat-sensitive active substances; the freeze-drying process inhibits the growth of microorganisms and enzyme activity; the volume and shape of the sample remain almost unchanged during freeze-drying, maintaining its original structure and preventing shrinkage; the dried material is loose and porous, resembling a sponge, and drying typically removes more than 90% of the moisture, which is beneficial for long-term product preservation. Furthermore, Dendrobium officinale tablets prepared using fresh Dendrobium officinale powder can be directly chewed and taken, offering convenient consumption and extremely high utilization of active ingredients, surpassing some existing commercially available products in certain aspects.
[0098] The tablets of this invention exhibit some of the superior properties described in the context herein. Attached Figure Description
[0099] Figure 1 The liquid chromatogram of Dendrobium officinale powder shows that peak 1 is mannose, peak 2 is glucosamine hydrochloride (internal standard), and peak 3 is glucose. Detailed Implementation
[0100] The invention will be further described through the following embodiments; however, the scope of the invention is not limited to the embodiments described below. Those skilled in the art will understand that various changes and modifications can be made to the invention without departing from its spirit and scope. The invention provides a general and / or specific description of the materials and methods used in the experiments. Although many materials and methods of operation used to achieve the objectives of the invention are well known in the art, the invention is still described in as much detail as possible herein. The following embodiments further illustrate the invention, but are not intended to limit it.
[0101] The preparation steps described below are for illustrative purposes and are specifically described based on the comparability of the examples. Those skilled in the art can fully understand the method for preparing Dendrobium officinale tablets of the present invention from these examples based on their existing knowledge.
[0102] The production and quality control equipment used in this invention are conventional pharmaceutical industry equipment. For example, some of the instruments and equipment used in this invention include: DSC 8000 (PerkinElmer, Inc., USA), LABCONCO FREEZONE 6L freeze dryer (LABCONCO, Inc., USA), QRZG-300BC linear reciprocating drug cutter (Zhejiang Haishan Pharmaceutical Equipment Co., Ltd.), 20B pulverizer (Nanjing Dahao Drying Equipment Factory), and LYO-3000 freeze dryer (Shanghai Dongfulong Technology Co., Ltd.).
[0103] Raw material preparation example 1: Preparation and quality testing of Dendrobium officinale powder This preparation example describes the process of preparing Dendrobium officinale dry powder and its quality testing, as the raw material for preparing the Dendrobium officinale tablets of the present invention.
[0104] 1. Preparation of freeze-dried powder of fresh Dendrobium officinale: The applicant removed impurities from fresh Dendrobium officinale Kimura et Migo orchids grown at its planting base in Dafang County, Guizhou Province, and harvested them in December 2023. The pieces were cut into small segments (1-2 cm in length) and pre-frozen at -35°C for 3 hours in a freeze dryer. Then, the pieces were freeze-dried according to conventional freeze-drying processes (basically referring to freeze-drying curve A of CN104758257B, with a vacuum degree <0.5mba) to reduce the moisture content of the material to below 12%, resulting in freeze-dried segments. The freeze-dried material was then pulverized using a pulverizer until the powder particle size was less than 80 mesh, thus obtaining fresh Dendrobium officinale freeze-dried powder. The powder was then sealed and packaged, yielding a batch of 186 kg of freeze-dried powder.
[0105] In early small-scale studies, the inventors found that when pulverized to 100 mesh, 80 mesh, 60 mesh, and 40 mesh, the powder yield was in the range of 65-90%, and the smaller the particle size, the lower the powder yield. The 80 mesh and 100 mesh powders had no granular texture. To facilitate subsequent tablet preparation, considering the powder yield, powder properties, and compressibility, 80 mesh was chosen as the raw material for tablet preparation. This powder size is also a conventional particle size for tablet preparation materials in the art. It was stored in a well-ventilated, dry place to prevent moisture. Unless otherwise stated, this batch of freeze-dried Dendrobium officinale powder was used in all experiments of this invention.
[0106] 2. Quality testing of Dendrobium officinale powder: Referring to the items and methods under the Dendrobium officinale section of the 2025 edition of the Chinese Pharmacopoeia, the quality of the freeze-dried Dendrobium officinale powder prepared in this embodiment was tested. The Dendrobium officinale listed in the 2025 edition of the Chinese Pharmacopoeia is obtained by drying fresh plants by baking or low-temperature drying. The freeze-dried powder of this invention is obtained by freeze-drying. Since they are essentially dried products obtained by different methods, the pharmacopoeia standards are theoretically applicable to the freeze-dried powder prepared in this embodiment.
[0107] (1) Identification: Take 1g of the powder, add 15ml of chloroform-methanol (9:1) mixed solution, sonicate for 20 minutes, filter, and use the filtrate as the test solution; separately take 1g of Dendrobium officinale reference material (purchased from the China National Institutes for Food and Drug Control), and prepare a reference material solution using the same method; perform thin-layer chromatography (General Rule 0502), take 2~5μl of each of the above two solutions, spot them separately on the same silica gel G thin-layer plate, use toluene-ethyl formate-formic acid (6:3:1) as the developing solvent, develop, remove, dry, spray with 10% sulfuric acid ethanol solution, heat at 95℃ for about 3 minutes, and examine under ultraviolet light (365nm); in the chromatogram of the test sample, at the corresponding position of the chromatogram of the reference material, the pharmacopoeia requires that fluorescent spots of the same color appear. Result: In the chromatogram of the test sample, fluorescent spots of the same color appear at the corresponding position of the chromatogram of the reference material.
[0108] (2) Moisture content: Determined according to Method II of General Chapter 0832, Part IV of the 2025 Chinese Pharmacopoeia. The pharmacopoeia stipulates that the moisture content of this variety shall not exceed 12.0%. The actual measured results were 8.16%, 7.83%, and 8.04%, with an average of 8.01%.
[0109] (3) Total ash content: According to the 2025 edition of the Chinese Pharmacopoeia, Part IV, General Chapter 2302, the total ash content of this variety shall not exceed 6.0%. The actual measured results were 3.87%, 3.76%, and 3.89%, with an average of 3.84%.
[0110] (4) Extractives: The extractives were determined by hot extraction method under the "Determination of Alcohol-soluble Extractives" section 2201 of the General Chapter IV of the 2025 edition of the Chinese Pharmacopoeia, using ethanol as the solvent. The pharmacopoeia stipulates that the extractives of this variety shall not be less than 6.5%. The actual results were 13.13%, 12.47%, and 13.32%, with an average of 12.97%.
[0111] (5) Polysaccharide content determination Preparation of reference solution: Take an appropriate amount of anhydrous glucose reference standard, accurately weigh it, add water to make a solution containing 90 μg per ml.
[0112] Preparation of standard curve: Accurately measure 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml, and 1.0 ml of the reference solution and place them into 10 ml stoppered test tubes respectively. Add water to each tube to bring the volume to 1.0 ml. Accurately add 1 ml of 5% phenol solution (prepare immediately before use), shake well, and then accurately add 5 ml of sulfuric acid. Shake well, heat in a boiling water bath for 20 minutes, remove, and cool in an ice bath for 5 minutes. Using the corresponding reagents as blanks, measure the absorbance at a wavelength of 488 nm using ultraviolet-visible spectrophotometry (General Chapter 0401, Part IV of the 2025 Chinese Pharmacopoeia). Plot the standard curve with absorbance as the ordinate and concentration as the abscissa.
[0113] Preparation of the test solution: Accurately weigh about 0.3g of the powder, add 200ml of water, heat under reflux for 2 hours, cool, transfer to a 250ml volumetric flask, wash the container several times with a small amount of water, combine the washings in the same volumetric flask, add water to the mark, shake well, filter, accurately measure 2ml of the filtrate, place it in a 15ml centrifuge tube, accurately add 10ml of anhydrous ethanol, shake well, refrigerate for 1 hour, take it out, centrifuge (4000 rpm) for 20 minutes, discard the supernatant (filter if necessary), wash the precipitate twice with 80% ethanol, 8ml each time, centrifuge, discard the supernatant, dissolve the precipitate in hot water, transfer to a 25ml volumetric flask, cool, add water to the mark, shake well, and the test solution is ready.
[0114] Assay: Accurately measure 1 ml of the test solution and place it in a 10 ml stoppered test tube. Following the method under the preparation of the standard curve, starting from "accurately add 1 ml of 5% phenol solution", measure the absorbance according to the method. Read the amount of anhydrous glucose in the test solution from the standard curve and calculate the result.
[0115] According to the pharmacopoeia, the content of Dendrobium officinale polysaccharide in this product, calculated as anhydrous glucose (C6H12O6), shall not be less than 25.0% when calculated on a dried basis.
[0116] In this study, a standard curve was plotted using absorbance versus anhydrous glucose concentration (mg / ml), showing a good linear relationship. The equation is A = 11.315C - 0.0036(R). 2 =0.9998), indicating that anhydrous glucose showed good linearity in the range of 18.5 μg-92.5 μg. The measured results were 48.57%, 47.38%, and 49.43%, with a mean of 48.46%.
[0117] (6) Determination of mannose content Determined by high performance liquid chromatography (General Chapter 0512, Part IV, Chinese Pharmacopoeia, 2025).
[0118] Chromatographic conditions and system suitability test: Octadecylsilane-bonded silica gel was used as the packing material; acetonitrile-0.02 mol / L ammonium acetate solution (20:80) was used as the mobile phase; the detection wavelength was 250 nm. The theoretical plate number, calculated based on the mannose peak, should not be less than 4000. Shimadzu LC-10A series high-performance liquid chromatograph, Yuexu column (C18 column, 4.6 mm × 250 mm, 5 μm).
[0119] Correction factor determination: Accurately weigh an appropriate amount of glucosamine hydrochloride (purchased from West Asia Reagent), add water to prepare a solution containing 12 mg per ml, as the internal standard solution. Separately, accurately weigh approximately 10 mg of mannose reference standard (China National Institutes for Food and Drug Control), place it in a 100 ml volumetric flask, accurately add 1 ml of the internal standard solution, add an appropriate amount of water to dissolve and dilute to the mark, shake well, pipette 400 μl, add 400 μl each of 0.5 mol / L PMP (1-phenyl-3-methyl-5-pyrazolone, purchased from West Asia Reagent) methanol solution and 0.3 mol / L sodium hydroxide solution, mix well, and react in a 70℃ water bath for 100 minutes. Then add 500 μl of 0.3 mol / L hydrochloric acid solution, mix well, wash three times with 2 ml of chloroform each time, discard the chloroform solution, centrifuge the aqueous layer, take 10 μl of the supernatant, inject it into the liquid chromatograph, determine the value, and calculate the correction factor.
[0120] A standard curve was plotted with mannose concentration (mg / ml) as the X-axis and the peak area ratio of the reference standard to the internal standard (Areference / Ainternal) as the Y-axis. The linear regression equation was Areference / Ainternal = 10.471 × C + 0.0094 (R2 = 0.9998), indicating that mannose exhibits good linearity in the range of 10.03 μg / ml to 200.6 μg / ml. Within this linear range, the correction factor f was 0.7842 ± 0.0141 (n = 6).
[0121] Assay: Accurately weigh approximately 0.12 g of the powder, place it in a Soxhlet extractor, add an appropriate amount of 80% ethanol, heat under reflux for 4 hours, discard the ethanol solution, evaporate the ethanol from the residue, disassemble the filter paper tube and place it in a beaker, add 100 ml of water, then accurately add 2 ml of internal standard solution, decoct for 1 hour while stirring constantly, cool, add water to make up to approximately 100 ml, mix well, centrifuge, take 1 ml of the supernatant, place it in an ampoule or headspace vial, add 0.5 ml of 3.0 mol / L hydrochloric acid solution, seal, mix well, hydrolyze at 110℃ for 1 hour, cool, adjust the pH to neutral with 3.0 mol / L sodium hydroxide solution, take 400 μl, and follow the correction factor determination method, starting from "add 0.5 mol / L PMP methanol solution", operate according to the method, take 10 μl of the supernatant, inject it into the liquid chromatograph, and determine the result.
[0122] Based on the dry weight, the pharmacopoeia stipulates that this product should contain 13.0%~38.0% mannose (C6H12O6). The actual measured results were 31.34%, 29.71%, and 30.86%, with an average of 30.64%.
[0123] (7) Peak area ratio of mannose to glucose: Take an appropriate amount of glucose reference standard (China National Institutes for Food and Drug Control), accurately weigh it, and add water to prepare a solution containing 50 μg per ml, which is used as the reference solution. Accurately pipette 0.4 ml and determine the mannose content according to the method under "(6) Determination of mannose content" above. The pharmacopoeia stipulates that the peak area ratio of mannose to glucose should be 2.4~8.0. The actual results are 3.24, 3.47, and 3.38, with an average of 3.36. A typical liquid chromatogram is shown below. Figure 1 As shown in the figure, 1 is mannose, 2 is the internal standard glucosamine hydrochloride, and 3 is the glucose peak.
[0124] The above results indicate that the main quality control items of the fresh Dendrobium officinale freeze-dried powder prepared in this example meet the requirements of the Dendrobium officinale section in the current edition of the Chinese Pharmacopoeia.
[0125] Unless otherwise stated, the Dendrobium officinale powder used in the preparation of Dendrobium officinale tablets below is the freeze-dried powder of fresh Dendrobium officinale obtained in Example 1. Examples of tablets with excellent properties made from freeze-dried fresh Dendrobium officinale powder are provided below.
[0126] Example 1: Preparation of Dendrobium officinale tablets Prescription (per tablet): Dendrobium officinale powder: 120mg, sorbitol: 340mg, maltodextrin: 61.5mg, isomaltitol: 60mg, citric acid: 12mg, cooling agent WS-23: 0.5mg, magnesium stearate: 6mg; Manufacturing method (based on a batch size of 10,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (8% of the total weight of solid materials) of 50% ethanol as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (35 min). Set aside for later use. (3) First spray a small amount (4% of the total weight of solid materials) of 95% ethanol into the mixed powder obtained in step (2), mix for 10 minutes, then add the prescribed amount of isomaltitol, mix for 15 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 25 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 60°C for 3 hours until the moisture content drops to below 3%. Then, granulate the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed granules are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets. These tablets are then packaged in HDPE plastic bottles, with 50 tablets per bottle.
[0127] The tablets of this invention weigh approximately 0.6g. Unless otherwise specified, they are pressed using a capsule-shaped mold, with a long axis of 14mm and a short axis of 7mm. Since the tablets of this invention are relatively large, and the recommended daily dosage is 3-6 tablets, it is advantageous to package them in high-density polyethylene (HDPE) plastic bottles. This does not significantly increase costs, and while this type of packaging has a large capacity, although it is a commonly used packaging material in the pharmaceutical industry, tablets are still susceptible to wear and tear and breakage during long-term storage and transportation. Therefore, it is beneficial to examine the physical strength properties of the tablets in this invention, such as evaluating tablet friability, as a parameter.
[0128] Example 2: Preparation of Dendrobium officinale tablets Prescription (per tablet): Dendrobium officinale powder: 120mg, sorbitol: 370mg, maltodextrin: 41.5mg, isomaltitol: 50mg, citric acid: 15mg, cooling agent WS-23: 0.5mg, magnesium stearate: 5mg; Manufacturing method (based on a batch size of 10,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (9% of the total weight of solid materials) of 45% ethanol as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (30 min). Set aside for later use. (3) First, spray a small amount (3% of the total weight of solid materials) of 97% ethanol into the mixed powder obtained in step (2), mix for 18 minutes, then add the prescribed amount of isomaltitol, mix for 12 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 25 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 60°C for 3.3 hours until the moisture content drops to below 3%. Then, sieve the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0129] Example 3: Preparation of Dendrobium officinale tablets Prescription (per tablet): Dendrobium officinale powder: 120mg, sorbitol: 310mg, maltodextrin: 81.5mg, isomaltitol: 70mg, citric acid: 10mg, cooling agent WS-23: 0.5mg, magnesium stearate: 8mg; Manufacturing method (based on a batch size of 10,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (7% of the total weight of solid materials) of 55% ethanol as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (40 min). Set aside for later use. (3) First spray a small amount (5% of the total weight of solid materials) of 90% ethanol into the mixed powder obtained in step (2), mix for 15 minutes, then add the prescribed amount of isomaltitol, mix for 15 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 30 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 55°C for 3.5 hours until the moisture content drops to below 3%. Then, sieve the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0130] Example 4: Preparation of Dendrobium officinale tablets Prescription (per tablet): Dendrobium officinale powder: 120mg, sorbitol: 355mg, maltodextrin: 51.5mg, isomaltitol: 55mg, citric acid: 12mg, cooling agent WS-23: 0.7mg, magnesium stearate: 7mg; Manufacturing method (based on a batch size of 10,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (8% of the total weight of solid materials) of 45% ethanol as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (35 min). Set aside for later use. (3) First, spray a small amount (4% of the total weight of solid materials) of 96% ethanol into the mixed powder obtained in step (2), mix for 12 minutes, then add the prescribed amount of isomaltitol, mix for 15 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 20 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 65°C for 2.8 hours until the moisture content drops to below 3%. Then, granulate the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0131] Example 5: Preparation of Dendrobium officinale tablets Prescription (per tablet): Dendrobium officinale powder: 120mg, sorbitol: 330mg, maltodextrin: 71.5mg, isomaltitol: 65mg, citric acid: 10mg, cooling agent WS-23: 0.3mg, magnesium stearate: 6mg; Manufacturing method (based on a batch size of 10,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (8% of the total weight of solid materials) of 55% ethanol as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (40 min). Set aside for later use. (3) First spray a small amount (4% of the total weight of solid materials) of 95% ethanol into the mixed powder obtained in step (2), mix for 10 minutes, then add the prescribed amount of isomaltitol, mix for 15 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 25 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 65°C for 2.7 hours until the moisture content drops to below 3%. Then, sieve the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0132] Example 6: Preparation of Dendrobium officinale tablets Prescription (per tablet): Dendrobium officinale powder: 118.8mg, sorbitol: 344.4mg, maltodextrin: 58.8mg, isomaltitol: 59.7mg, citric acid: 12mg, cooling agent WS-23: 0.3mg, magnesium stearate: 6mg.
[0133] Manufacturing method (based on a batch size of 10,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (8% of the total weight of solid materials) of 50% ethanol as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (30 min). Set aside for later use. (3) First spray a small amount (4% of the total weight of solid materials) of 95% ethanol into the mixed powder obtained in step (2), mix for 12 minutes, then add the prescribed amount of isomaltitol, mix for 15 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 20 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 55°C for 3.5 hours until the moisture content drops to below 3%. Then, sieve the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0134] Example 7: Preparation of Dendrobium officinale tablets Prescription (per tablet): Dendrobium officinale powder: 118.8mg, sorbitol: 344.4mg, maltodextrin: 58.8mg, isomaltitol: 59.7mg, citric acid: 12mg, cooling agent WS-23: 0.3mg, magnesium stearate: 6mg.
[0135] Manufacturing method (based on a batch size of 50,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (8% of the total weight of solid materials) of 50% ethanol as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (35 min). Set aside for later use. (3) First, spray a small amount (4% of the total weight of solid materials) of 98% ethanol into the mixed powder obtained in step (2), mix for 12 minutes, then add the prescribed amount of isomaltitol, mix for 10 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 25 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 60°C for 3 hours until the moisture content drops to below 3%. Then, granulate the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0136] Example 8: Preparation of Dendrobium officinale tablets Prescription (per tablet): Dendrobium officinale powder: 120mg, sorbitol: 340mg, maltodextrin: 61.5mg, isomaltitol: 60mg, citric acid: 12mg, cooling agent WS-23: 0.5mg, magnesium stearate: 6mg; Manufacturing method (based on a batch size of 100,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (8% of the total weight of solid materials) of 50% ethanol as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (35 min). Set aside for later use. (3) First spray a small amount (4% of the total weight of solid materials) of 90% ethanol into the mixed powder obtained in step (2), mix for 10 minutes, then add the prescribed amount of isomaltitol, mix for 15 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 25 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 60°C for 3 hours until the moisture content drops to below 3%. Then, granulate the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0137] Experimental Example 1: Determination of Tablet Friability The fragility of tablets was determined according to the equipment and methods described in Tablet Friability Test Method 0923 of Part IV of the 2025 edition of the Chinese Pharmacopoeia.
[0138] The test was conducted at a temperature of 20–23°C and a relative humidity of 50%. Twelve tablets were taken, the powder that had detached was blown off, and the tablets were accurately weighed. They were then placed in a cylinder and rotated 300 times. The tablets were removed, the powder was blown off again, and the tablets were accurately weighed. The percentage weight loss was calculated, and any broken, cracked, or pulverized tablets were inspected. It should be noted that the pharmacopoeia typically stipulates that the weight loss of a tablet after 100 rotations in a cylinder should not exceed 1.0%, and no broken, cracked, or pulverized tablets should be detected. Based on this pharmacopoeia stipulation, the inventors discovered in early research that some formulations produced tablets with poor friability. To amplify this defect and facilitate observation of tablet performance, this test example uses a method of rotating the tablets in a cylinder 300 times to test the friability.
[0139] The initial weight loss of the tablets obtained in Examples 1 to 8 was measured to be 0.34%, 0.28%, 0.41%, 0.30%, 0.33%, 0.36%, 0.35%, and 0.39%, respectively. Furthermore, no broken, cracked, or pulverized tablets were detected in any of the eight batches of tablets in all tests. This indicates that these tablets still have excellent performance with low weight loss even under enhanced friability rotation conditions.
[0140] The tablets of Examples 1 to 8 were placed open in an environment with a temperature of 20 to 23°C and a relative humidity of 30% for 3 weeks. The friability of the tablets was determined by the same method as above. The weight loss was in the range of 0.31% to 0.42%. For example, the weight loss of the tablet of Example 1 was 0.33%, and no broken, cracked or pulverized tablets were detected. The results were basically the same as those of the initial tablets.
[0141] The tablets of Examples 1 to 8 were placed open in an environment with a temperature of 20 to 23°C and a relative humidity of 60% for 3 weeks. The friability of the tablets was determined by the same method as above. The weight loss was in the range of 0.29% to 0.44%. For example, the weight loss of the tablet of Example 1 was 0.40%, and no broken, cracked or pulverized tablets were detected. The results were basically the same as those of the initial tablets.
[0142] The tablets of Examples 1 to 8 were placed open in an environment with a temperature of 20 to 23°C and a relative humidity of 85% for 3 weeks. The friability of the tablets was determined by the same method as above. The weight loss was all in the range of 0.34% to 0.40%. For example, the weight loss of the tablet of Example 1 was 0.36%, and no broken, cracked or pulverized tablets were detected. The results were basically the same as those of the initial tablets.
[0143] The above results indicate that, under room temperature conditions, exposure of the tablets in Examples 1-8 to different humidity conditions has no effect on the physical strength of the tablets in terms of abrasion resistance and breakage resistance, and they exhibit excellent brittleness performance.
[0144] The tablets of Examples 1 to 8 were placed open in an environment with a temperature of 50 to 55°C and a relative humidity of 30% for 3 weeks. The friability of the tablets was determined by the same method as above. The weight loss was in the range of 0.38% to 0.51%. For example, the weight loss of the tablet of Example 1 was 0.47%, and no broken, cracked or pulverized tablets were detected. The results were basically the same as those of the initial tablets.
[0145] The tablets of Examples 1 to 8 were placed open in an environment with a temperature of 50 to 55°C and a relative humidity of 60% for 3 weeks. The friability of the tablets was determined by the same method as above. The weight loss was in the range of 0.41% to 0.52%. For example, the weight loss of the tablet of Example 1 was 0.46%, and no broken, cracked or pulverized tablets were detected. The results were basically the same as those of the initial tablets.
[0146] The tablets of Examples 1 to 8 were placed open in an environment with a temperature of 50 to 55°C and a relative humidity of 85% for 3 weeks. The friability of the tablets was determined by the same method as above. The weight loss was in the range of 0.46% to 0.55%. For example, the weight loss of the tablet of Example 1 was 0.49%, and no broken, cracked or pulverized tablets were detected. The results were basically the same as those of the initial tablets.
[0147] The tablets of Examples 1 to 8 were placed open in an environment with a temperature of 70 to 75°C and a relative humidity of 30% for 3 weeks. The friability of the tablets was determined by the same method as above. The results showed that the weight loss was in the range of 0.47% to 0.61%. For example, the weight loss of the tablet of Example 1 was 0.49%, and no broken, cracked or pulverized tablets were detected. The results were basically the same as those of the initial tablets.
[0148] The tablets of Examples 1 to 8 were placed open in an environment with a temperature of 70 to 75°C and a relative humidity of 60% for 3 weeks. The friability of the tablets was determined by the same method as above. The weight loss was in the range of 0.44% to 0.59%. For example, the weight loss of the tablet of Example 1 was 0.54%, and no broken, cracked or pulverized tablets were detected. The results were basically the same as those of the initial tablets.
[0149] The tablets of Examples 1 to 8 were placed open in an environment with a temperature of 70 to 75°C and a relative humidity of 85% for 3 weeks. The friability of the tablets was determined by the same method as above. The weight loss was in the range of 0.49% to 0.65%. For example, the weight loss of the tablet of Example 1 was 0.61%, and no broken, cracked or pulverized tablets were detected. The results were basically the same as those of the initial tablets.
[0150] The above results indicate that, under higher temperature conditions, exposure of the tablets in Examples 1-8 to different humidity conditions has a slight impact on the physical strength of the tablets in terms of abrasion resistance and breakage resistance, but overall they still exhibit excellent brittleness performance.
[0151] The inventors of this application discovered in their initial research work that the excellent abrasion and breakage resistance of the tablets in Examples 1-8 is related to the combined use of citric acid and isomaltitol. While it is well known in the field of solid dosage forms that citric acid is typically used as an acidic flavoring agent and isomaltitol as a sweetener to replace sucrose or other sweeteners that may affect blood sugar, the combination of citric acid and isomaltitol in the formulation of this invention imparts excellent abrasion and breakage resistance to the tablets, a property not previously taught in the prior art. These initial research works are detailed below.
[0152] Example 9: Preparation of Dendrobium officinale tablets (without citric acid) Prescription (per tablet): Dendrobium officinale powder: 120mg, sorbitol: 352mg, maltodextrin: 61.5mg, isomaltitol: 60mg, cooling agent WS-23: 0.5mg, magnesium stearate: 6mg; Manufacturing method (based on a batch size of 10,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; the cooling agent WS-23 is dissolved in an appropriate amount (8% of the total weight of the solid materials) of 50% ethanol and used as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (35 min). Set aside for later use. (3) First spray a small amount (4% of the total weight of solid materials) of 95% ethanol into the mixed powder obtained in step (2), mix for 10 minutes, then add the prescribed amount of isomaltitol, mix for 15 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 25 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 60°C for 3 hours until the moisture content drops to below 3%. Then, granulate the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0153] The friability properties of the tablets in this embodiment were examined using the same research and testing methods as in Experimental Example 1. Results: Initially, the weight loss was 0.38% and there was no breakage, cracking, or pulverization. After being placed in an open environment at 20-23°C with relative humidity of 30%, 60%, and 85% for 3 weeks, the weight loss was 0.42%, 0.46%, and 0.68%, respectively, and none of them showed any breakage, cracking, or pulverization. After being placed in an open environment at 50-55°C with relative humidity of 30%, 60%, and 85% for 3 weeks, the weight loss was 0.48%, 0.66%, and 0.93%, respectively, and none of them showed any breakage, cracking, or pulverization. After being placed in an open environment at 70-75°C with relative humidity of 30%, 60%, and 85% for 3 weeks, the weight loss was 0.65%, 0.97%, and 1.34%, respectively. Only two pieces in the high humidity group showed tortoise-like cracks, while the other two groups showed no abnormalities.
[0154] The above results indicate that under higher temperature and humidity conditions, the brittleness performance of the tablets in this embodiment, which reflects the physical strength of abrasion and breakage resistance, deteriorates, and the performance worsens with higher temperature or humidity.
[0155] Example 10: Preparation of Dendrobium officinale tablets (without isomaltitol) Prescription (per tablet): Dendrobium officinale powder: 120mg, sorbitol: 380mg, maltodextrin: 81.5mg, citric acid: 12mg, cooling agent WS-23: 0.5mg, magnesium stearate: 6mg; Manufacturing method (based on a batch size of 10,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (8% of the total weight of solid materials) of 50% ethanol as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (35 min). Set aside for later use. (3) First spray a small amount (4% of the total weight of solid materials) of 95% ethanol into the mixed powder obtained in step (2), mix for 10 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 25 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use. (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 60°C for 3 hours until the moisture content drops to below 3%. Then, granulate the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0156] The friability properties of the tablets in this embodiment were examined using the same research and testing methods as in Experimental Example 1. Results: Initially, the weight loss was 0.43% and there was no breakage, cracking, or pulverization. After being placed in an open environment at 20-23°C with relative humidity of 30%, 60%, and 85% for 3 weeks, the weight loss was 0.74%, 1.45%, and 1.84%, respectively, and 1-2 pieces in each group were broken or cracked. After being placed in an open environment at 50-55°C with relative humidity of 30%, 60%, and 85% for 3 weeks, the weight loss was 0.92%, 1.92%, and 2.48%, respectively. In each group, 1-3 pieces were broken or cracked, and 1 piece in the high humidity group was pulverized. After being placed in an open environment at 70-75°C with relative humidity of 30%, 60%, and 85% for 3 weeks, the weight loss was 1.36%, 2.27%, and 2.94%, respectively. In each group, 2-4 pieces were broken or cracked, while 1 piece and 2 pieces were crushed in the medium humidity group and the high humidity group, respectively.
[0157] The above results indicate that under higher temperature and humidity conditions, the brittleness performance of the tablets in this embodiment, which reflects the physical strength of abrasion and breakage resistance, deteriorates significantly, and the performance worsens with higher temperature or humidity.
[0158] Example 11: Preparation of Dendrobium officinale tablets (without isomaltitol and citric acid) Prescription (per tablet): Dendrobium officinale powder: 120mg, sorbitol: 385mg, maltodextrin: 88.5mg, cooling agent WS-23: 0.5mg, magnesium stearate: 6mg; Manufacturing method (based on a batch size of 10,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; the cooling agent WS-23 is dissolved in an appropriate amount (8% of the total weight of the solid materials) of 50% ethanol and used as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (35 min). Set aside for later use. (3) First spray a small amount (4% of the total weight of solid materials) of 95% ethanol into the mixed powder obtained in step (2), mix for 10 minutes, then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing for 25 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use. (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 60°C for 3 hours until the moisture content drops to below 3%. Then, granulate the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0159] The friability properties of the tablets in this embodiment were examined using the same research and testing methods as in Experimental Example 1. Results: Initially, the weight loss was 0.42% and there was no breakage, cracking, or pulverization. After being placed in an open environment at 20-23°C with relative humidity of 30%, 60%, and 85% for 3 weeks, the weight loss was 0.97%, 1.74%, and 2.23%, respectively, and 1-2 pieces in each group were broken or cracked. After being placed in an open environment at 50-55°C with relative humidity of 30%, 60%, and 85% for 3 weeks, the weight loss was 1.28%, 2.06%, and 2.83%, respectively. In each group, 2-3 pieces were broken or cracked, and 2 pieces in the high humidity group were pulverized. After being placed in an open environment at 70-75°C with relative humidity of 30%, 60%, and 85% for 3 weeks, the weight loss was 1.54%, 2.63%, and 3.31%, respectively. In each group, 2-3 pieces were broken or cracked, while 3 pieces and 2 pieces were crushed in the medium humidity group and the high humidity group, respectively.
[0160] The above results indicate that, under higher temperature and humidity conditions, the brittleness performance of the tablets in this embodiment, which reflects the physical strength of abrasion and breakage resistance, becomes significantly worse, and the performance deteriorates with higher temperature or humidity.
[0161] Example 12: Preparation of Dendrobium officinale tablets (without isomaltitol and citric acid, and using other binders instead) (drug) Unsatisfactory tablet friability is often related to improper use of adhesives. This example attempts to investigate some commonly used adhesives.
[0162] Prescription (per tablet): Dendrobium officinale powder: 120mg, sorbitol: 385mg, maltodextrin: 88.5mg, cooling agent WS-23: 0.5mg, magnesium stearate: 6mg, binder: 20mg; Manufacturing method (based on a batch size of 10,000 tablets): (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; the adhesive and cooling agent WS-23 are dissolved in an appropriate amount (9% of the total weight of the solid materials) of 50% ethanol and used as an adhesive for later use. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to the mixing equipment in sequence and mix thoroughly (35 min). Set aside for later use. (3) Spray a small amount (3% of the total weight of solid materials) of 95% ethanol into the mixed powder obtained in step (2), mix for 10 minutes, then spray the binder obtained in step (1) into the mixed powder, continue mixing for 25 minutes to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), and then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use. (4) Transfer the wet granules obtained in step (3) to a fluidized bed dryer and dry at 60°C for 3 hours until the moisture content drops to below 3%. Then, granulate the dry granules through a 14-mesh sieve to obtain dry granules for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (mixing for 15 min) to obtain the final mixed granules for later use. (6) Based on the designed tablet weight, the final mixed particles are pressed into tablets on a rotary tablet press with a hardness of 40~50N to obtain Dendrobium officinale tablets.
[0163] The adhesives used were prepared by dissolving the following in 50% ethanol (they could be dissolved in water or high-concentration ethanol first and then diluted to this ethanol concentration): sodium carboxymethyl cellulose (Example 12a), hydroxypropyl methyl cellulose (50 mPa·s, Example 12b), highly substituted hydroxypropyl cellulose (50 mPa·s, Example 12c), copovidone (S630, Example 12d), and polyethylene glycol 6000 (Example 12e).
[0164] The friability properties of the tablets in this embodiment were examined using the same research and testing methods as in Experimental Example 1. Results: Initially, the weight loss of the five types of tablets was within the range of 0.36% to 0.44%, and there was no breakage, cracking, or pulverization. Under open conditions of 20-23°C and 30% relative humidity for 3 weeks, the weight loss of the five types of tablets was in the range of 0.67-0.83%; under 60% relative humidity for 3 weeks, the weight loss of the five types of tablets was in the range of 1.19-1.38%; and under 85% relative humidity for 3 weeks, the weight loss of the five types of tablets was in the range of 1.51-1.68%. In addition, 1-3 tablets in each group were broken or cracked. Under open conditions of 50-55°C and 30% relative humidity for 3 weeks, the weight loss of the five types of tablets was in the range of 0.94-1.18%; under 60% relative humidity for 3 weeks, the weight loss of the five types of tablets was in the range of 1.58-1.72%; and under 85% relative humidity for 3 weeks, the weight loss of the five types of tablets was in the range of 1.87-1.98%. In addition, 1-4 tablets in each group were broken or cracked. Under open conditions of 70-75°C and 30% relative humidity for 3 weeks, the weight loss of the five types of tablets was in the range of 1.21-1.38%. Under 60% relative humidity for 3 weeks, the weight loss of the five types of tablets was in the range of 1.76-1.93%. Under 85% relative humidity for 3 weeks, the weight loss of the five types of tablets was in the range of 2.16-2.37%. In addition, 2-4 tablets in each group were broken, cracked, or pulverized.
[0165] In addition, referring to Example 12a, but replacing 120 mg of Dendrobium officinale powder with 80 mg of sorbitol and 40 mg of maltodextrin, tablets weighing approximately 600 mg per tablet were prepared. The tablets initially lost 0.39% of their weight and did not break, crack, or crumble. The weight losses at open relative humidity of 85% and temperatures of 20-23°C, 50-55°C, and 70-75°C were 0.54%, 0.66%, and 0.64%, respectively.
[0166] The above results indicate that under higher temperature and humidity conditions, the friability performance of the tablets in this embodiment, which reflects the physical strength of abrasion and breakage resistance, deteriorates significantly, and the higher the temperature or humidity, the worse the performance. It also shows that when fresh Dendrobium officinale freeze-dried powder is used to prepare tablets, the resulting tablets do not have ideal physical strength of abrasion and breakage resistance. From the example without the addition of fresh Dendrobium officinale freeze-dried powder, it can be seen that the physical strength of abrasion and breakage resistance of various tablets reflected by the friability performance mentioned above is mainly related to the special fresh Dendrobium officinale freeze-dried powder of this invention.
[0167] In some supplementary embodiments, referring to Example 1, but with the isomaltitol dosage reduced to 10 mg, 20 mg, and 30 mg, the resulting tablets showed unsatisfactory friability. After 3 weeks of open storage at 70-75°C and 85% relative humidity, the weight losses were 2.63%, 2.38%, and 1.87%, respectively, indicating that insufficient isomaltitol dosage resulted in unsatisfactory friability. In some additional tests, it was found that isomaltitol dosages exceeding 90 mg did not cause a deterioration in friability or were significantly better than in Example 1. The reason why it is unnecessary to further increase the isomaltitol dosage within the range of Examples 1-8 is that there is no greater benefit.
[0168] In some supplementary embodiments, referring to Example 1 but reducing the citric acid dosage to 2 mg and 5 mg, the resulting tablets showed unsatisfactory friability. After 3 weeks of open storage at 70-75°C and 85% relative humidity, the weight losses were 1.15% and 0.97%, respectively, indicating that insufficient citric acid resulted in unsatisfactory friability. In some additional tests, it was found that citric acid dosages exceeding 20 mg did not cause a deterioration in friability or were significantly better than in Example 1, but excessive acidity led to a poorer taste. Within the dosage range of Examples 1-8, there was no need to further increase the citric acid dosage because there was no greater benefit.
[0169] Experimental Example 2: Long-term stability study of tablets The tablets prepared according to Examples 1-8 of this invention were packaged in high-density polyethylene (HDPE) plastic bottles, 50 tablets per bottle. The bottle openings were sealed with aluminum-plastic composites and stored in the dark for 24 months at a temperature of 20-25°C and a relative humidity of 50-55%. Samples were taken at 0, 12, and 24 months to determine the mannose content, the mannose to glucose peak area ratio, and the friability (obtained by rotating the tablets 100 times in a conventional cylinder). The mannose content was calculated as the relative percentage content at 0 months, which was taken as 100%. The relative percentage content of mannose at 12 and 24 months was also calculated. Results: Mannose relative content in December: All 8 batches of tablets were in the range of 98% to 101%. For example, the percentage content of mannose in the tablets of Example 1 in December relative to October was 99.27%. Mannose content relative to 0 months: All 8 batches of tablets were in the range of 98%~102%. For example, the percentage content of mannose in tablets of Example 2 was 101.14% relative to 0 months. The peak area ratio of mannose to glucose in 8 batches of tablets was in the range of 3.1 to 3.5 at 0 months, for example, 3.28 for tablet of Example 1; in 12 months, it was in the range of 3.2 to 3.5, for example, 3.33 for tablet of Example 1; and in 24 months, it was in the range of 3.2 to 3.6, for example, 3.25 for tablet of Example 1. The friability (after 100 rotations in a drum) of 8 batches of tablets was within the range of 0.13% to 0.21% at 0 months (e.g., 0.156% for tablets in Example 1), within the range of 0.11% to 0.23% at 12 months (e.g., 0.182% for tablets in Example 1), and within the range of 0.17% to 0.25% at 24 months (e.g., 0.177% for tablets in Example 1). No broken, cracked, or pulverized tablets were found in any of the 8 batches at any of the 3 testing time points.
[0170] The above results indicate that some tablets prepared according to the present invention have excellent stability.
[0171] In additional tests, the 24-month friability (100 revolutions in a cylinder) stability of the three tablets of Examples 9-11 and the five tablets of Example 12 were examined in parallel with the above-mentioned 24-month stability. The results showed that the weight loss of each batch of tablets was in the range of 1.28% to 2.43%, and all batches showed varying degrees / numbers of breakage, cracking or pulverization. For example, the weight loss of the tablets in Example 12d was 2.16%, and breakage occurred.
[0172] This invention employs freeze-drying technology to prepare freeze-dried powder of fresh Dendrobium officinale, which is then used as raw material to prepare Dendrobium officinale tablets. Freeze-drying is a process where, after freezing the sample, it is kept frozen and then sublimated into vapor under vacuum conditions, which is then released, thereby removing excess moisture from the sample. This drying method is carried out at low temperatures, which, compared to conventional sun-drying, oven-drying, and spray-drying, effectively preserves the original color, aroma, flavor, and active ingredients of the sample to the greatest extent. Freeze-drying does not alter the physical structure of the product, keeping its shape and size essentially unchanged before and after drying. Compared to samples dried and rehydrated using other methods, the resulting product is closer to a fresh product, and freeze-dried fresh samples are easier to preserve and transport. Therefore, this invention uses freeze-drying to dry fresh Dendrobium officinale into freeze-dried powder, and then produces Dendrobium officinale tablets, effectively ensuring the quality of Dendrobium officinale.
[0173] The embodiments described herein are merely illustrative of the composition and effects of the present invention and are not intended to limit the patent scope of the present invention. Therefore, those skilled in the art can make similar modifications without departing from the structure of the present invention, and all such modifications fall within the patent scope of the present invention. These modifications should also be considered within the protection scope of the present invention and will not affect the effectiveness of the implementation of the present invention or the practicality of the patent.
Claims
1. The use of the combination of isomaltitol and citric acid in the preparation of Dendrobium officinale tablets with improved performance using fresh Dendrobium officinale freeze-dried powder as raw material.
2. The use according to claim 1, wherein the property is the physical strength property of the tablet in terms of abrasion and breakage resistance; or, the property is the physical strength property of the tablet in terms of abrasion and breakage resistance characterized by friability.
3. The use according to claim 1, wherein the tablet comprises the following components: Dendrobium officinale, sorbitol, maltodextrin, isomaltitol, citric acid, cooling agent WS-23, and magnesium stearate.
4. According to claim 1, the Dendrobium officinale in the tablets is added in the form of Dendrobium officinale powder made from fresh Dendrobium officinale after freeze-drying; or, the Dendrobium officinale in the tablets is added in the form of Dendrobium officinale powder made from fresh Dendrobium officinale after freeze-drying, and the powder is prepared by a method comprising the following steps: removing impurities from fresh Dendrobium officinale harvested from the Orchidaceae family, cutting it into small segments (1-2 cm in length), pre-freezing it in a freeze dryer at -35°C or below for 3 hours, and then freeze-drying it according to conventional freeze-drying process to reduce the moisture content of the material to below 12% to obtain the segmented freeze-dried material; then pulverizing the freeze-dried material with a pulverizer until the powder particle size is less than 80 mesh to obtain Dendrobium officinale powder.
5. The use according to claim 1, wherein the tablet comprises the following components in parts by weight: 115-125 parts by weight of Dendrobium officinale powder, for example, 120 parts by weight; 300-400 parts by weight of sorbitol, for example, 310-370 parts by weight; 30-100 parts by weight of maltodextrin, for example, 40-85 parts by weight; 40-80 parts by weight of isomaltitol, for example, 50-75 parts by weight; 5-20 parts by weight of citric acid, for example, 10-15 parts by weight; 0.2-1 parts by weight of cooling agent WS-23, for example, 0.3-0.7 parts by weight; and 2-10 parts by weight of magnesium stearate, for example, 5-8 parts by weight; or, The tablets contain the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 340 parts by weight of sorbitol, 61.5 parts by weight of maltodextrin, 60 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate; or, The tablets contain the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 370 parts by weight of sorbitol, 41.5 parts by weight of maltodextrin, 50 parts by weight of isomaltitol, 15 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 5 parts by weight of magnesium stearate; or, The tablets contain the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 310 parts by weight of sorbitol, 81.5 parts by weight of maltodextrin, 70 parts by weight of isomaltitol, 10 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 8 parts by weight of magnesium stearate; or, The tablets contain the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 355 parts by weight of sorbitol, 51.5 parts by weight of maltodextrin, 55 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.7 parts by weight of cooling agent WS-23, and 7 parts by weight of magnesium stearate; or, The tablets contain the following components in the indicated weight proportions: 120 parts by weight of Dendrobium officinale powder, 330 parts by weight of sorbitol, 71.5 parts by weight of maltodextrin, 65 parts by weight of isomaltitol, 10 parts by weight of citric acid, 0.3 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate; or, The tablets contain the following components in the indicated weight proportions: 118.8 parts by weight of Dendrobium officinale powder, 344.4 parts by weight of sorbitol, 58.8 parts by weight of maltodextrin, 59.7 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.3 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate; or, The tablets contain the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 340 parts by weight of sorbitol, 61.5 parts by weight of maltodextrin, 60 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate; or, The tablet is prepared by a method comprising the following steps: (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (e.g., 7-9% of the total weight of the solid materials) of ethanol (e.g., 45-55% ethanol) for use as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to a mixing device in sequence and mix thoroughly (e.g., 30-40 minutes) for later use; (3) First, spray a small amount (e.g., 3-5% of the total weight of solid materials) of ethanol (e.g., 90-98% ethanol) into the mixed powder obtained in step (2), mix (e.g., 10-18 min), then add the prescribed amount of isomaltitol, mix (e.g., 10-15 min), then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing (e.g., 20-30 min), to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet particles obtained in step (3) to a fluidized bed dryer (e.g., 55~65℃) and dry (e.g., 2.7~3.5h) until the moisture content drops to below 3%. Then, granulate the dry particles through a 14-mesh sieve to obtain dry particles for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (e.g., mix for 15 min) to obtain the final mixed granules for later use. (6) The final mixed granules are compressed into tablets on a rotary tablet press (e.g., with a hardness of 40-50N) according to the designed tablet weight, thus obtaining Dendrobium officinale tablets; for example, the tablet weight of each tablet is 0.2g-1.0g, e.g., 0.4g-0.8g, e.g., 0.6g.
6. A Dendrobium officinale tablet comprising the following components: Dendrobium officinale, sorbitol, maltodextrin, isomaltitol, citric acid, cooling agent WS-23, and magnesium stearate.
7. The tablet according to claim 6, wherein the Dendrobium officinale is fed in the form of Dendrobium officinale powder made from fresh Dendrobium officinale freeze-dried and then pulverized; or, wherein the Dendrobium officinale is fed in the form of Dendrobium officinale powder made from fresh Dendrobium officinale freeze-dried and then pulverized, the powder being prepared by a method comprising the following steps: removing impurities from fresh Dendrobium officinale harvested from the Orchidaceae family, cutting it into small segments (1-2 cm in length), pre-freezing it in a freeze dryer at -35°C or below for 3 hours, and then freeze-drying it according to a conventional freeze-drying process to reduce the moisture content of the material to below 12%, thereby obtaining the cut freeze-dried material; then pulverizing the freeze-dried material with a pulverizer until the powder particle size is less than 80 mesh, thereby obtaining Dendrobium officinale powder.
8. The tablet according to claim 6, comprising the following components in parts by weight: 115-125 parts by weight of Dendrobium officinale powder, for example, 120 parts by weight; 300-400 parts by weight of sorbitol, for example, 310-370 parts by weight; 30-100 parts by weight of maltodextrin, for example, 40-85 parts by weight; 40-80 parts by weight of isomaltitol, for example, 50-75 parts by weight; 5-20 parts by weight of citric acid, for example, 10-15 parts by weight; 0.2-1 parts by weight of cooling agent WS-23, for example, 0.3-0.7 parts by weight; and 2-10 parts by weight of magnesium stearate, for example, 5-8 parts by weight; or, It contains the following components in parts by weight: 120 parts Dendrobium officinale powder, 340 parts sorbitol, 61.5 parts maltodextrin, 60 parts isomaltitol, 12 parts citric acid, 0.5 parts cooling agent WS-23, and 6 parts magnesium stearate; or, It contains the following components in parts by weight: 120 parts Dendrobium officinale powder, 370 parts sorbitol, 41.5 parts maltodextrin, 50 parts isomaltitol, 15 parts citric acid, 0.5 parts cooling agent WS-23, and 5 parts magnesium stearate; or, It contains the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 310 parts by weight of sorbitol, 81.5 parts by weight of maltodextrin, 70 parts by weight of isomaltitol, 10 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 8 parts by weight of magnesium stearate; or, It contains the following components in the indicated weight proportions: 120 parts by weight of Dendrobium officinale powder, 355 parts by weight of sorbitol, 51.5 parts by weight of maltodextrin, 55 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.7 parts by weight of cooling agent WS-23, and 7 parts by weight of magnesium stearate; or, It contains the following components in parts by weight: 120 parts by weight of Dendrobium officinale powder, 330 parts by weight of sorbitol, 71.5 parts by weight of maltodextrin, 65 parts by weight of isomaltitol, 10 parts by weight of citric acid, 0.3 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate; or, It contains the following components in parts by weight: 118.8 parts by weight of Dendrobium officinale powder, 344.4 parts by weight of sorbitol, 58.8 parts by weight of maltodextrin, 59.7 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.3 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate; or, It contains the following components in the following weight proportions: 120 parts by weight of Dendrobium officinale powder, 340 parts by weight of sorbitol, 61.5 parts by weight of maltodextrin, 60 parts by weight of isomaltitol, 12 parts by weight of citric acid, 0.5 parts by weight of cooling agent WS-23, and 6 parts by weight of magnesium stearate.
9. The tablet according to claim 6, which is prepared by a method comprising the steps of: (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (e.g., 7-9% of the total weight of the solid materials) of ethanol (e.g., 45-55% ethanol) for use as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to a mixing device in sequence and mix thoroughly (e.g., 30-40 minutes) for later use; (3) First, spray a small amount (e.g., 3-5% of the total weight of solid materials) of ethanol (e.g., 90-98% ethanol) into the mixed powder obtained in step (2), mix (e.g., 10-18 min), then add the prescribed amount of isomaltitol, mix (e.g., 10-15 min), then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing (e.g., 20-30 min), to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet particles obtained in step (3) to a fluidized bed dryer (e.g., 55~65℃) and dry (e.g., 2.7~3.5h) until the moisture content drops to below 3%. Then, granulate the dry particles through a 14-mesh sieve to obtain dry particles for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (e.g., mix for 15 min) to obtain the final mixed granules for later use. (6) The final mixed granules are compressed into tablets on a rotary tablet press (e.g., with a hardness of 40~50N) according to the designed tablet weight to obtain Dendrobium officinale tablets; for example, the weight of each tablet is 0.2g~1.0g, e.g., 0.4g~0.8g, e.g., 0.6g.
10. A method for preparing Dendrobium officinale tablets according to any one of claims 6 to 9, comprising the following steps: (1) Each material is pre-crushed into powder that can pass through an 80-mesh sieve; citric acid and cooling agent WS-23 are dissolved in an appropriate amount (e.g., 7-9% of the total weight of the solid materials) of ethanol (e.g., 45-55% ethanol) for use as a wetting agent. (2) Add the prescribed amounts of Dendrobium officinale powder, sorbitol, and maltodextrin to a mixing device in sequence and mix thoroughly (e.g., 30-40 minutes) for later use; (3) First, spray a small amount (e.g., 3-5% of the total weight of solid materials) of ethanol (e.g., 90-98% ethanol) into the mixed powder obtained in step (2), mix (e.g., 10-18 min), then add the prescribed amount of isomaltitol, mix (e.g., 10-15 min), then spray the wetting agent obtained in step (1) into the mixed powder, continue mixing (e.g., 20-30 min), to obtain a soft material (which can be formed into a ball when squeezed and dispersed when pinched), then make all the material pass through a 14-mesh sieve to granulate, and obtain wet granules for later use; (4) Transfer the wet particles obtained in step (3) to a fluidized bed dryer (e.g., 55~65℃) and dry (e.g., 2.7~3.5h) until the moisture content drops to below 3%. Then, granulate the dry particles through a 14-mesh sieve to obtain dry particles for later use. (5) The above dry granules are finally mixed with the prescribed amount of magnesium stearate in a motion mixer (e.g., mix for 15 min) to obtain the final mixed granules for later use. (6) The final mixed particles are pressed into tablets on a rotary tablet press (e.g., with a hardness of 40-50N) according to the designed tablet weight to obtain Dendrobium officinale tablets; for example, the Dendrobium officinale in the tablets is fed in the form of Dendrobium officinale powder made from fresh Dendrobium officinale after freeze-drying; for example, the Dendrobium officinale in the tablets is fed in the form of Dendrobium officinale powder made from fresh Dendrobium officinale after freeze-drying, and the powder is prepared by a method including the following steps: removing impurities from fresh Dendrobium officinale harvested from the orchid family, cutting it into small segments (1-2cm in length), pre-freezing it in a freeze dryer at -35℃ or below for 3 hours, and then freeze-drying it according to the conventional freeze-drying process to reduce the moisture content of the material to below 12% to obtain the cut freeze-dried material; then the freeze-dried material is pulverized by a pulverizer until the powder particle size is less than 80 mesh to obtain Dendrobium officinale powder.
Citation Information
Patent Citations
Freeze-dried powder of fresh Dendrobium officinale and its preparation method
CN104758257B
