Dendrobium nobile composition for tumor treatment and preparation method of suppository of dendrobium nobile composition

Abstract

The invention provides a dendrobium composition for tumor treatment and a preparation method of a dendrobium suppository, freeze-dried fresh dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitate composition are used as raw materials, and borneol and semi-synthetic fatty glyceride are added to prepare the dendrobium suppository. Compared with conventional dried dendrobium nobile powder, the composition prepared by selecting the combination of the freeze-dried fresh dendrobium nobile powder and adding the freeze-dried fresh dendrobium nobile powder alcohol precipitate can not only improve the content of active ingredients in a finished product, but also obtain higher activity, and can also solve the process problem of non-uniform dispersibility caused by independent use of the alcohol precipitate in the processing process. Therefore, when the composition prepared from the freeze-dried fresh dendrobium nobile powder and the freeze-dried fresh dendrobium nobile powder alcohol precipitate is added into products of various dosage forms, the polysaccharide content and activity are improved, and the process problem is solved.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine preparations, and mainly relates to a dendrobium composition for tumor treatment and a preparation method of a suppository thereof. Background Art

[0002] Huoshan Dendrobium (Dendrobium huoshanense CZ. Tang et SJ Cheng) is a perennial herbaceous plant of the genus Dendrobium in the Orchidaceae family. The plant is 3 to 9 cm tall, with individual nodes as short as a grain of rice, commonly known as "rice dendrobium." It is native to Huoshan, Anhui Province, and surrounding areas. First recorded in the "Famous Doctors' Prescriptions," Huoshan Dendrobium is renowned both domestically and internationally for its preciousness and rarity. The "Bai Cao Jing" (A Mirror of Herbs) states: "Recently, a type of Dendrobium has emerged that is only about an inch short, thin as a wick, greenish-yellow in color, and tastes sweet and slightly slippery when chewed. It originates from Lu'an Prefecture and Huoshan County, Yingzhou Prefecture, and is known as Huoshan Dendrobium, the best." Modern research indicates that Huoshan Dendrobium is rich in polysaccharides, alkaloids, polyphenols, amino acids, and trace elements, boasting benefits such as nourishing yin and clearing heat, benefiting the stomach and promoting fluid production, inhibiting tumor cell growth, and enhancing immunity. In the document "Study on Chemical Components and Anti-inflammatory Activity of Dendrobium Huoshanense Stems", three bibenzyl compounds were isolated from the stems of Dendrobium Huoshanense for the first time. They had significant inhibitory effects on the production of NO, TNF-α and IL-1β levels by LPS-induced macrophages RAW264.7. Studies on the mechanism of anti-inflammatory activity showed that 3′,4-dihydroxy-3,5′-dimethoxybibenzyl was an active ingredient that inhibited the LPS-induced inflammatory response of macrophages RAW264.7 by inhibiting the activation of NF-κB, MAPKs and Akt signaling pathways. The document "Structural Identification and Activity Evaluation of Anti-inflammatory Polysaccharides from Huoshan Dendrobium (Cultivated)" extracted polysaccharides from the stems of cultivated Huoshan Dendrobium and evaluated the anti-inflammatory activity of the polysaccharides using mouse RAW264.7 macrophages as a model. The results showed that 80% alcohol-precipitated polysaccharide (cDHP-W1) was obtained by ethanol precipitation of the washed polysaccharide from Huoshan Dendrobium. Pretreatment for 1 hour effectively inhibited the phosphorylation of p38, ERK, and c-Jun N-terminal kinase (JNK) activated by LPS, and the nuclear translocation of inhibitor of NF-κB (IκB) and p65, suggesting that cDHP-W1 can inhibit the release of inflammatory mediators by regulating the phosphorylation of proteins in this pathway. A study titled "Dendrobium huoshanense Polysaccharides Prevent Inflammatory Response of Ulcerative Colitis Rat through Inhibiting the NF-κB Signaling Pathway" explored the inhibitory effect of Huoshan Dendrobium polysaccharides on ulcerative colitis induced by sodium dextran sulfate and found that intervention with Huoshan Dendrobium polysaccharides could significantly reduce serum IL-1β, IL-17, TNF-α and TGF-β levels, indicating that Huoshan Dendrobium polysaccharides can inhibit ulcerative colitis.In the literature "Dendrobiumhuoshanense stem polysaccharide amelioratesrheumatoid arthritis in mice via inhibition of inflammatory signaling pathways", it was found that the protective effect of Huoshan Dendrobium polysaccharide on type II collagen-induced rheumatoid arthritis showed that Huoshan Dendrobium polysaccharide intervention can effectively alleviate joint swelling and synovial hyperplasia in arthritis mice, reshape the balance of Th17 and T cells, reduce the secretion of proinflammatory factors related to fibroblast-like synoviocyte activation, angiogenesis, articular cartilage degradation and osteoclast differentiation, and promote the release of anti-inflammatory mediators.

[0003] Dendrobium officinale (Kimura & Migo) is a valuable medicinal plant that nourishes yin and replenishes body fluids, widely used in medical treatment and daily health care. Its active ingredients include polysaccharides, amino acids, trace elements, phenanthrenes, bibenzyls, phenolic acids, and alkaloids, exhibiting pharmacological effects such as immune enhancement, anti-tumor, anti-aging, and hypoglycemic and anti-hypertensive effects. In the article "Isolation, Purification, and Anti-inflammatory Effects of Neutral Polysaccharides from Dendrobium officinale," a polysaccharide from Dendrobium officinale was isolated and purified, structurally characterized, and its anti-inflammatory effects investigated. The isolated and purified polysaccharide, DOP-1, is a homogeneous polysaccharide composed of rhamnose, mannose, glucose, and galactose. While DOP-1 showed no significant inhibitory effect on the proliferation of RAW 264.7 cells, it significantly suppressed the expression of NO, TNF-α, and IL-1β compared to the model group. The Dendrobium officinale polysaccharide obtained in this study has a clear structure and exhibits strong anti-inflammatory activity. The study "Efficacy of Dendrobium officinale on Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma and Its Regulatory Effect on the Oral Microbiome" observed the clinical efficacy of Dendrobium officinale tea in treating radiation-induced oral mucositis in patients with nasopharyngeal carcinoma. The study also investigated its regulatory effects on immune function and the oral microbiome by comparing immune-related factors and oral microbiota before and after intervention. Dendrobium officinale was found to alleviate the symptoms of radiation-induced oral mucositis, which may be related to improving salivary gland function and regulating the oral microenvironment. Dendrobium officinale may alleviate the symptoms and improve radiation-induced oral mucositis by affecting systemic cellular immunity. Dendrobium officinale may also alleviate radiation-induced oral mucositis by directly altering the oral microbiome, reducing the secretion of pro-inflammatory factors. The study "Evaluation of the Soothing Efficacy of Ultra-Low Molecular Dendrobium Officinale Polysaccharides" explored the effects of ultra-low molecular weight Dendrobium officinale polysaccharides on inflammatory factors in human keratinocytes and macrophage-like cells. This polysaccharide was found to significantly reduce pro-inflammatory factors such as IL-8, TNF-α, IL-6, and IL-1α in human keratinocytes, and to regulate the expression of IL-6 mRNA and TGF-β1 mRNA in macrophage-like cells. The article "Effects of Fresh Dendrobium Officinale Powder on Immune Function in Mice" found that fresh Dendrobium Officinale Powder can enhance the immune system in terms of cellular and humoral immunity, as well as NK cell activity. The article "Study on the Effects of Dendrobium Officinale Powder on Immune Function in Mice" found that Dendrobium Officinale promotes delayed-type hypersensitivity in mice, increases serum hemolysin levels in mice, and enhances the phagocytic rate and index of chicken red blood cells by peritoneal macrophages, demonstrating a certain immune-enhancing effect. The article "Optimization of the Extraction Process and Antioxidant Activity of Dendrobium Officinale Polysaccharides" found that Dendrobium Officinale polysaccharides have a good scavenging ability against DPPH and hydroxyl radicals, indicating that they have good antioxidant activity.

[0004] Borneol, whose main active ingredient is borneol, is described in the Chinese Pharmacopoeia as "pungent, bitter, and slightly cold. It enters the heart, spleen, and lung meridians. It has the effects of invigorating the mind, clearing heat, and relieving pain." Modern research shows that borneol, rich in volatile components, not only exerts its inherent effects of clearing heat and reducing internal heat, providing antibacterial and anti-inflammatory benefits, and providing skin care, but also has a significant permeation-enhancing effect. This is manifested by disrupting the highly ordered lipid structure of the stratum corneum, facilitating the passage of other active ingredients in the prescription through the skin. Studies have also pointed out that various new drug delivery vehicles based on borneol, combining the advantages of borneol with different drug delivery vehicles, have great application potential and research value.

[0005] Radiotherapy is one of the core methods of cancer treatment. It uses high-energy radiation to precisely kill tumor cells, but it may also cause inevitable damage to normal tissues. Radiation enteritis is a common complication during tumor radiotherapy, mainly manifested as intestinal mucosal inflammation, ulcers and functional disorders. Drugs for the treatment of radiation enteritis mainly target local intestinal inflammation and work by anti-inflammatory, mucosal repair or regulating flora. Commonly used drugs include mesalazine, sulfasalazine, budesonide, probiotic preparations, anti-TNF-α biological agents, etc. Compared with other treatment methods such as oral medications, enema solutions, and biological agents, suppositories for the treatment of radiation enteritis have the following significant advantages: (1) high local targeting and few systemic side effects; (2) wide range of indications and definite efficacy; (3) convenient use and good patient compliance; (4) applicability to special populations, such as patients with renal insufficiency, children and elderly patients. According to the data, the clinical application of suppositories has the advantages of high mucosal healing rate, high diarrhea relief rate, low incidence of side effects and high patient satisfaction.

[0006] After checking the information, there is no report on the use of freeze-dried fresh dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitation composition for the preparation of moisturizing creams, oral gels, granules, suppositories, and for the treatment of radiation enteritis. Summary of the Invention

[0007] The purpose of the present invention is to overcome the deficiencies of the prior art and to provide a dendrobium composition for tumor treatment and a method for preparing a suppository thereof.

[0008] The objective of the present invention is achieved through the following technical solutions: A dendrobium composition, comprising freeze-dried fresh dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitate uniformly mixed to obtain the composition; wherein the freeze-dried fresh dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitate are in a weight ratio of 3-8 parts:2-7 parts; the freeze-dried fresh dendrobium powder comprises one or both of freeze-dried Huoshan dendrobium fresh powder and freeze-dried Dendrobium officinale fresh powder; and the freeze-dried fresh dendrobium powder alcohol precipitate comprises one or both of freeze-dried Huoshan dendrobium fresh powder alcohol precipitate and freeze-dried Dendrobium officinale fresh powder alcohol precipitate.

[0009] Furthermore, the preparation method of the freeze-dried fresh dendrobium powder is to harvest seasonal fresh dendrobium strips, clean them, cut them into sections, freeze-dry them, remove the sheath membranes, and crush them to obtain freeze-dried fresh dendrobium, and then pass the freeze-dried fresh dendrobium through a 500-mesh sieve to obtain freeze-dried fresh dendrobium powder.

[0010] Furthermore, the preparation method of the freeze-dried fresh dendrobium powder alcohol precipitation comprises the following steps: (1) Passing the freeze-dried fresh dendrobium through a 100-mesh sieve to obtain freeze-dried fresh dendrobium powder; (2) Preparation of Dendrobium slurry: add the freeze-dried powder of Dendrobium obtained in step (1) into drinking water at a volume of 50-60 times its weight, stir and mix evenly, and process through a colloid mill to obtain Dendrobium slurry; (3) Preparation of alcohol precipitate: Add 95% ethanol by volume to the dendrobium pulp obtained in step (2), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (4) Filtration: Pass the mixture obtained in step (3) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (5) Drying: The alcohol precipitate obtained in step (4) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (6) Crushing and sieving: Crushing the alcohol precipitate obtained in step (5) and passing it through a 300-mesh sieve for later use.

[0011] The present invention also provides a method for preparing a dendrobium suppository for tumor treatment, which uses the dendrobium composition and comprises the following steps: (1) Melting of matrix: 75-90 parts by weight of semi-synthetic fatty acid glyceride and 3-6 parts by weight of borneol powder are placed in a container and stirred at 50-60°C until completely melted to obtain a molten matrix; (2) Drug mixing: Add 2-7 parts by weight of the alcohol precipitation of freeze-dried fresh dendrobium powder and 3-8 parts by weight of freeze-dried fresh dendrobium powder to the molten matrix obtained in step (1), and stir for 30-40 minutes until the mixture is uniform, to obtain a molten suppository; (3) Injection molding: Cool the molten suppository obtained in step (2) to 40-45°C and inject it into a mold; (4) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (5) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (6) Sterilization: The obtained suppositories are sterilized by irradiation.

[0012] The beneficial effects of the present invention are as follows: the present invention uses freeze-dried fresh dendrobium powder and a composition of freeze-dried fresh dendrobium powder alcohol precipitation as raw materials, adds borneol and semi-synthetic fatty acid glyceride to prepare dendrobium suppositories, which not only increases the content of the medicinal ingredient - polysaccharide in the product to ensure the therapeutic effect, but also takes into account the uniform dispersion of various raw materials during the production process to ensure the stable content of polysaccharide and stable release of medicinal effect.

[0013] (1) Freeze-dried fresh dendrobium powder is used as the main raw material. Compared with conventional dried dendrobium powder, it has the characteristics of higher active ingredient content and better antioxidant activity. The existing study "Study on the composition and antioxidant activity of fresh and dried dendrobium polysaccharides" shows that the antioxidant activity of fresh dendrobium is better than that of dried products both in vivo and in vitro, with significant differences; the reasons for the difference in activity are mainly two aspects: first, the content of polysaccharides in fresh dendrobium is significantly higher than that in dried products; second, the structure of polysaccharides in dendrobium changes during processing, resulting in reduced activity. Another study "Comparative study on the quality of fresh and dried dendrobium" found that the total alkaloid and polysaccharide content of fresh dendrobium, as well as its scavenging rate for hydroxyl free radicals and antioxidant capacity are significantly higher than those of dried products; (2) After testing, the polysaccharide content of freeze-dried fresh dendrobium powder alcohol sediment is 60% higher than that of freeze-dried fresh dendrobium powder; the polysaccharide content of freeze-dried fresh dendrobium powder alcohol sediment is 40-50% higher than that of conventional dried dendrobium powder alcohol sediment, and the mannose content is 10-15% higher; (3) Compared with conventional dried dendrobium powder, the combination of freeze-dried fresh dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitate can not only increase the content of active ingredients in the finished product and obtain higher activity, but also solve the process problem of uneven dispersion caused by using alcohol precipitate alone during processing. Therefore, the combination of freeze-dried fresh dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitate added to various dosage forms can not only increase the polysaccharide content and activity, but also solve the process problem. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art or ordinary technicians, other drawings can be obtained based on these drawings without paying any creative work.

[0015] Figure 1 Schematic diagram of the preparation route of the dendrobium suppository of the present invention. DETAILED DESCRIPTION

[0016] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0017] The present invention provides a method for preparing freeze-dried fresh dendrobium powder and a freeze-dried fresh dendrobium powder alcohol precipitation composition, comprising the following steps: (1) Preparation of freeze-dried fresh dendrobium powder: harvest seasonal fresh dendrobium strips, clean them, cut them into sections, freeze-dry them, remove the sheath membranes, crush them, take a portion of the freeze-dried fresh dendrobium powder and pass it through a 500-mesh sieve for temporary storage; take another portion of the freeze-dried fresh dendrobium powder and pass it through a 100-mesh sieve for the following steps; (2) Preparation of Dendrobium slurry: Add the freeze-dried powder of Dendrobium obtained in step (1) into drinking water at a volume of 50-60 times its weight, stir and mix evenly, and pass through a colloid mill to obtain Dendrobium slurry; (3) Preparation of alcohol precipitate: Add 95% (volume fraction) ethanol to the Dendrobium pulp obtained in step (2), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (4) Filtration: Pass the mixture obtained in step (3) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (5) Drying: The alcohol precipitate obtained in step (4) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (6) Crushing and sieving: crush the alcohol precipitate obtained in step (5) and pass it through a 300-mesh sieve for later use; (7) Compounding: Weigh the freeze-dried fresh dendrobium powder and the freeze-dried fresh dendrobium powder alcohol precipitation according to the different combined amounts shown in Table 1, and mix them evenly to obtain a composite; (8) Evaluation of composition: The polysaccharide content and dispersion uniformity of each combination were measured and evaluated, and the results were summarized in the last column of Table 1; (9) After experimental verification, the dosage of freeze-dried fresh dendrobium powder is 3-8 parts, and the dosage of freeze-dried fresh dendrobium powder alcohol precipitation is 2-7 parts, which is a more ideal combination. It can not only ensure the content of polysaccharides in the composition, but also make it have good dispersibility, which is convenient for the preparation of various dosage forms in the later stage.

[0018] Table 1 Addition ratio of freeze-dried fresh dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitation and evaluation results of each combination like Figure 1 As shown, the present invention provides a method for preparing a dendrobium suppository with a higher active ingredient content, comprising the following steps: (1) Preparation of freeze-dried fresh dendrobium powder: harvest seasonal fresh dendrobium strips, clean them, cut them into sections, freeze-dry them, remove the sheath membranes, crush them, take a portion of the freeze-dried fresh dendrobium powder and pass it through a 500-mesh sieve for temporary storage; take another portion of the freeze-dried fresh dendrobium powder and pass it through a 100-mesh sieve for the following steps; (2) Preparation of Dendrobium slurry: Add the freeze-dried powder of Dendrobium obtained in step (1) into drinking water at a volume of 50-60 times its weight, stir and mix evenly, and pass through a colloid mill to obtain Dendrobium slurry; (3) Preparation of alcohol precipitate: Add 95% (volume fraction) ethanol to the Dendrobium pulp obtained in step (2), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (4) Filtration: Pass the mixture obtained in step (3) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (5) Drying: The alcohol precipitate obtained in step (4) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (6) Crushing and sieving: crush the alcohol precipitate obtained in step (5) and pass it through a 300-mesh sieve for later use; (7) Matrix melting: Take 75-90 parts of semi-synthetic fatty acid glyceride and 3-6 parts of borneol powder, place them in a container, and stir at 50-60°C until completely melted; (8) Drug mixing: add 2-7 parts of freeze-dried fresh dendrobium powder alcohol precipitation and 3-8 parts of freeze-dried fresh dendrobium powder to the molten matrix obtained in step (7), and stir for 30-40 minutes until the mixture is uniform; (9) Injection molding: Cool the molten suppository obtained in step (8) to 40-45°C and inject it into a 1.8 g mold; (10) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (11) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (12) Sterilization: The obtained suppositories are sterilized by irradiation.

[0019] Example 1 (1) Preparation of freeze-dried fresh dendrobium powder: harvest seasonal fresh dendrobium strips, clean them, cut them into sections, freeze-dry them, remove the sheath membranes, crush them, take a portion of the freeze-dried fresh dendrobium powder and pass it through a 500-mesh sieve and store it for later use; take another portion of the freeze-dried fresh dendrobium powder and pass it through a 100-mesh sieve and proceed to the following steps; (2) Preparation of Dendrobium slurry: Add the freeze-dried powder of Dendrobium obtained in step (1) into drinking water at a volume of 50-60 times its weight, stir and mix evenly, and pass through a colloid mill to obtain Dendrobium slurry; (3) Preparation of alcohol precipitate: Add 95% (volume fraction) ethanol to the Dendrobium pulp obtained in step (2), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (4) Filtration: Pass the mixture obtained in step (3) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (5) Drying: The alcohol precipitate obtained in step (4) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (6) Crushing and sieving: crush the alcohol precipitate obtained in step (5) and pass it through a 300-mesh sieve for later use; (7) Matrix melting: Take 85 parts of semi-synthetic fatty acid glyceride and 5 parts of borneol powder, place them in a container, and stir at 50-60°C until they are completely melted; (8) Drug mixing: Add 5 parts of freeze-dried fresh dendrobium alcohol precipitation and 5 parts of freeze-dried fresh dendrobium powder to the molten matrix obtained in step (7), and stir for 30-40 minutes until the mixture is uniform; (9) Injection molding: Cool the molten suppository obtained in step (8) to 40-45°C and inject it into a 1.8 g mold; (10) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (11) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (12) Sterilization: The obtained suppositories are sterilized by irradiation.

[0020] Example 2 (1) Preparation of freeze-dried fresh dendrobium powder: harvest seasonal fresh dendrobium strips, clean them, cut them into sections, freeze-dry them, remove the sheath membranes, crush them, take a portion of the freeze-dried fresh dendrobium powder and pass it through a 500-mesh sieve for temporary storage; take another portion of the freeze-dried fresh dendrobium powder and pass it through a 100-mesh sieve for the following steps; (2) Preparation of Dendrobium slurry: Add the freeze-dried powder of Dendrobium obtained in step (1) into drinking water at a volume of 50-60 times its weight, stir and mix evenly, and pass through a colloid mill to obtain Dendrobium slurry; (3) Preparation of alcohol precipitate: Add 95% (volume fraction) ethanol to the Dendrobium pulp obtained in step (2), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (4) Filtration: Pass the mixture obtained in step (3) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (5) Drying: The alcohol precipitate obtained in step (4) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (6) Crushing and sieving: crush the alcohol precipitate obtained in step (5) and pass it through a 300-mesh sieve for later use; (7) Matrix melting: Take 82 parts of semi-synthetic fatty acid glyceride and 6 parts of borneol powder, place them in a container, and stir at 50-60°C until they are completely melted; (8) Drug mixing: Add 6 parts of freeze-dried fresh dendrobium alcohol precipitation and 6 parts of freeze-dried fresh dendrobium powder to the molten matrix obtained in step (7), and stir for 30-40 minutes until the mixture is uniform; (9) Injection molding: Cool the molten suppository obtained in step (8) to 40-45°C and inject it into a 1.8 g mold; (10) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (11) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (12) Sterilization: The obtained suppositories are sterilized by irradiation.

[0021] Example 3 (1) Preparation of freeze-dried fresh dendrobium powder: harvest seasonal fresh dendrobium strips, clean them, cut them into sections, freeze-dry them, remove the sheath membranes, crush them, take a portion of the freeze-dried fresh dendrobium powder and pass it through a 500-mesh sieve and store it for later use; take another portion of the freeze-dried fresh dendrobium powder and pass it through a 100-mesh sieve and proceed to the following steps; (2) Preparation of Dendrobium slurry: Add the freeze-dried powder of Dendrobium obtained in step (1) into drinking water at a volume of 50-60 times its weight, stir and mix evenly, and pass through a colloid mill to obtain Dendrobium slurry; (3) Preparation of alcohol precipitate: Add 95% (volume fraction) ethanol to the Dendrobium pulp obtained in step (2), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (4) Filtration: Pass the mixture obtained in step (3) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (5) Drying: The alcohol precipitate obtained in step (4) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (6) Crushing and sieving: crush the alcohol precipitate obtained in step (5) and pass it through a 300-mesh sieve for later use; (7) Matrix melting: Take 88 parts of semi-synthetic fatty acid glyceride and 4 parts of borneol powder, place them in a container, and stir at 50-60°C until they are completely melted; (8) Drug mixing: Add 4 parts of freeze-dried fresh dendrobium alcohol precipitation and 4 parts of freeze-dried fresh dendrobium powder to the molten matrix obtained in step (7), and stir for 30-40 minutes until the mixture is uniform; (9) Injection molding: Cool the molten suppository obtained in step (8) to 40-45°C and inject it into a 1.8 g mold; (10) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (11) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (12) Sterilization: The obtained suppositories are sterilized by irradiation.

[0022] Example 4 (1) Preparation of freeze-dried fresh dendrobium powder: harvest seasonal fresh dendrobium strips, clean them, cut them into sections, freeze-dry them, remove the sheath membranes, crush them, take a portion of the freeze-dried fresh dendrobium powder and pass it through a 500-mesh sieve and store it for later use; take another portion of the freeze-dried fresh dendrobium powder and pass it through a 100-mesh sieve and proceed to the following steps; (2) Preparation of Dendrobium slurry: Add the freeze-dried powder of Dendrobium obtained in step (1) into drinking water at a volume of 50-60 times its weight, stir and mix evenly, and pass through a colloid mill to obtain Dendrobium slurry; (3) Preparation of alcohol precipitate: Add 95% (volume fraction) ethanol to the Dendrobium pulp obtained in step (2), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (4) Filtration: Pass the mixture obtained in step (3) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (5) Drying: The alcohol precipitate obtained in step (4) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (6) Crushing and sieving: crush the alcohol precipitate obtained in step (5) and pass it through a 300-mesh sieve for later use; (7) Matrix melting: Take 79 parts of semi-synthetic fatty acid glyceride and 6 parts of borneol powder, place them in a container, and stir at 50-60°C until they are completely melted; (8) Drug mixing: add 7 parts of freeze-dried fresh dendrobium alcohol precipitation and 8 parts of freeze-dried fresh dendrobium powder to the molten matrix obtained in step (7), and stir for 30-40 minutes until the mixture is uniform; (9) Injection molding: Cool the molten suppository obtained in step (8) to 40-45°C and inject it into a 1.8 g mold; (10) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (11) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (12) Sterilization: The obtained suppositories are sterilized by irradiation.

[0023] Comparative Example 1 (1) Preparation of freeze-dried fresh Dendrobium powder: harvest seasonal fresh Dendrobium strips, clean them, cut them into sections, freeze-dry them, remove the sheath membrane, crush them, and pass them through a 500-mesh sieve for later use; (2) Matrix melting: Take 88 parts of semi-synthetic fatty acid glyceride and 4 parts of borneol powder, place them in a container, and stir at 50-60°C until they are completely melted; (3) Drug mixing: Add 8 parts of freeze-dried fresh dendrobium powder to the molten matrix obtained in step (7) and stir for 30-40 minutes until the mixture is uniform; (4) Injection molding: The molten suppository obtained in step (8) was cooled to 40-45°C and injected into a 1.8 g mold; (5) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (6) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (7) Sterilization: The obtained suppositories are sterilized by irradiation.

[0024] Comparative Example 2 (1) Preparation of freeze-dried fresh Dendrobium powder: harvest seasonal fresh Dendrobium strips, clean them, cut them into sections, freeze-dry them, remove the sheath membrane, crush them, and pass them through a 100-mesh sieve for later use; (2) Preparation of Dendrobium slurry: Add the freeze-dried powder of Dendrobium obtained in step (1) into drinking water at a volume of 50-60 times its weight, stir and mix evenly, and pass through a colloid mill to obtain Dendrobium slurry; (3) Preparation of alcohol precipitate: Add 95% (volume fraction) ethanol to the Dendrobium pulp obtained in step (2), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (4) Filtration: Pass the mixture obtained in step (3) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (5) Drying: The alcohol precipitate obtained in step (4) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (6) Crushing and sieving: crush the alcohol precipitate obtained in step (5) and pass it through a 300-mesh sieve for later use; (7) Matrix melting: Take 86 parts of semi-synthetic fatty acid glyceride and 4 parts of borneol powder, place them in a container, and stir at 50-60°C until they are completely melted; (8) Drug mixing: add 10 parts of freeze-dried fresh dendrobium alcohol precipitation to the molten matrix obtained in step (7) and stir for 30-40 minutes until the mixture is uniform; (9) Injection molding: Cool the molten suppository obtained in step (8) to 40-45°C and inject it into a 1.8 g mold; (10) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (11) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (12) Sterilization: The obtained suppositories are sterilized by irradiation.

[0025] Comparative Example 3 (1) Preparation of conventional dried dendrobium powder: harvest seasonal fresh dendrobium strips, clean them, cut them into sections, dry them with hot air, crush them, take a portion and pass them through a 500-mesh sieve for temporary storage; take another portion and pass it through a 100-mesh sieve for the following steps; (2) Preparation of dendrobium slurry: adding the conventional dried dendrobium powder obtained in step (1) into drinking water at a weight of 50-60 times the weight of the conventional dried dendrobium powder, stirring and mixing the mixture uniformly, and then passing the mixture through a colloid mill to obtain dendrobium slurry; (3) Preparation of alcohol precipitate: Add 95% (volume fraction) ethanol to the Dendrobium pulp obtained in step (2), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (4) Filtration: Pass the mixture obtained in step (3) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (5) Drying: The alcohol precipitate obtained in step (4) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (6) Crushing and sieving: crush the alcohol precipitate obtained in step (5) and pass it through a 300-mesh sieve for later use; (7) Matrix melting: Take 88 parts of semi-synthetic fatty acid glyceride and 4 parts of borneol powder, place them in a container, and stir at 50-60°C until they are completely melted; (8) Drug mixing: Add 4 parts of conventional dried dendrobium alcohol precipitation and 4 parts of conventional dried dendrobium powder to the molten matrix obtained in step (7), and stir for 30-40 minutes until the mixture is uniform; (9) Injection molding: Cool the molten suppository obtained in step (8) to 40-45°C and inject it into a 1.8 g mold; (10) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (11) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (12) Sterilization: The obtained suppositories are sterilized by irradiation.

[0026] Comparative Example 4 (1) Preparation of freeze-dried fresh Dendrobium powder: harvest seasonal fresh Dendrobium strips, clean them, cut them into sections, freeze-dry them, remove the sheath membrane, crush them, and pass them through a 100-mesh sieve for later use; (2) Preparation of conventional dried dendrobium powder: harvest seasonal fresh dendrobium strips, clean them, cut them into sections, dry them with hot air, crush them, and pass them through a 500-mesh sieve. The sieved dendrobium powder is temporarily stored and will be used in step (9); (3) Preparation of Dendrobium slurry: Add the freeze-dried powder of Dendrobium obtained in step (1) into drinking water at a volume of 50-60 times its weight, stir and mix evenly, and pass through a colloid mill to obtain Dendrobium slurry; (4) Preparation of alcohol precipitate: Add 95% (volume fraction) ethanol to the dendrobium pulp obtained in step (3), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (5) Filtration: Pass the mixture obtained in step (4) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (6) Drying: The alcohol precipitate obtained in step (5) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (7) Crushing and sieving: crush the alcohol precipitate obtained in step (6) and pass it through a 300-mesh sieve for later use; (8) Matrix melting: Take 88 parts of semi-synthetic fatty acid glyceride and 5 parts of borneol powder, place them in a container, and stir at 50-60°C until they are completely melted; (9) Drug mixing: Add 3 parts of freeze-dried fresh dendrobium alcohol precipitation and 4 parts of conventional dried dendrobium powder to the molten matrix obtained in step (8), and stir for 30-40 minutes until the mixture is uniform; (10) Injection molding: The molten suppository obtained in step (9) was cooled to 40-45°C and injected into a 1.8 g mold; (11) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (12) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (13) Sterilization: The obtained suppositories are sterilized by irradiation.

[0027] Comparative Example 5 (1) Preparation of freeze-dried fresh dendrobium powder: harvest seasonal fresh dendrobium strips, clean them, cut them into segments, freeze-dry them, remove the sheath membrane, crush them, and pass them through a 500-mesh sieve. The sieved freeze-dried fresh dendrobium powder is temporarily stored and will be used in step (9); (2) Preparation of conventional dried dendrobium powder: harvest seasonal fresh dendrobium strips, clean them, cut them into sections, dry them with hot air, crush them, and pass them through a 100-mesh sieve for later use; (3) Preparation of dendrobium slurry: adding the dendrobium powder obtained in step (2) into drinking water at a volume of 50-60 times its weight, stirring and mixing, and then passing through a colloid mill to obtain dendrobium slurry; (4) Preparation of alcohol precipitate: Add 95% (volume fraction) ethanol to the dendrobium pulp obtained in step (3), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (5) Filtration: Pass the mixture obtained in step (4) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (6) Drying: The alcohol precipitate obtained in step (5) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (7) Crushing and sieving: crush the alcohol precipitate obtained in step (6) and pass it through a 300-mesh sieve for later use; (8) Matrix melting: Take 88 parts of semi-synthetic fatty acid glyceride and 5 parts of borneol powder, place them in a container, and stir at 50-60°C until they are completely melted; (9) Drug mixing: Add 3 parts of conventional dried dendrobium alcohol precipitation and 4 parts of freeze-dried fresh dendrobium powder to the molten matrix obtained in step (8), and stir for 30-40 minutes until the mixture is uniform; (10) Injection molding: The molten suppository obtained in step (9) was cooled to 40-45°C and injected into a 1.8 g mold; (11) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (12) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (13) Sterilization: The obtained suppositories are sterilized by irradiation.

[0028] The test results of all the above embodiments and comparative examples are shown in Table 2 below: Table 2 Evaluation results of suppositories in various examples and comparative examples Example Traits Content uniformity Transformation time limit Polysaccharide content Microbial limits Example 1 Dark yellow-green, complete and smooth appearance, appropriate hardness, uniform internal structure without pores Comply with regulations 19min09s 4.21% qualified Example 2 Dark yellow-green, complete and smooth appearance, appropriate hardness, uniform internal structure without pores Comply with regulations 18 minutes 55 seconds 4.88% qualified Example 3 Dark yellow-green, complete and smooth appearance, appropriate hardness, uniform internal structure without pores Comply with regulations 19 minutes and 21 seconds 3.42% qualified Example 4 Dark yellow-green, complete and smooth appearance, appropriate hardness, uniform internal structure without pores Comply with regulations 18min17s 5.40% qualified Comparative Example 1 Dark yellow-green, complete and smooth appearance, appropriate hardness, uniform internal structure without pores Comply with regulations 19min16s 2.90% qualified Comparative Example 2 Milky white, rough surface, deformation, varying hardness, uneven internal structure Not in compliance with regulations —— —— —— Comparative Example 3 Light brown, complete and smooth appearance, appropriate hardness, uniform internal structure without pores Comply with regulations 19 minutes and 36 seconds 2.78% qualified Comparative Example 4 Light brown, complete and smooth appearance, appropriate hardness, uniform internal structure without pores Comply with regulations 18 minutes and 49 seconds 2.84% qualified Comparative Example 5 Light yellow-green, complete and smooth appearance, appropriate hardness, uniform internal structure without pores Comply with regulations 19min09s 2.65% qualified As can be seen from the table above: Comparative Example 1: Suppositories prepared using freeze-dried fresh dendrobium powder as raw material exhibited excellent appearance, content uniformity that met regulatory requirements, a melting time of <30 minutes, a polysaccharide content of 2.40%, and qualified microbial limit indicators. This demonstrates that suppositories can be prepared using only freeze-dried fresh dendrobium powder as raw material. However, preparations with higher polysaccharide contents are limited by the polysaccharide content of the available raw materials.

[0029] Comparative Example 2, in which freeze-dried fresh dendrobium powder alcohol precipitation powder was used as raw material to prepare suppositories, had poor appearance and poor content uniformity, indicating that using only freeze-dried fresh dendrobium powder alcohol precipitation as raw material to prepare suppositories cannot solve the problem of uniform dispersion of raw materials during the production process.

[0030] Comparative Example 3: Suppositories prepared using conventional dried dendrobium powder and conventional dried dendrobium powder alcohol precipitation as raw materials. The results showed good appearance, content uniformity meeting regulations, a melting time of <30 min, a polysaccharide content of 2.40%, and a qualified microbial limit index. This indicates that using conventional dried dendrobium powder and conventional dried dendrobium powder alcohol precipitation to prepare suppositories is an alternative approach. However, the polysaccharide content of the suppositories obtained in this case was lower than that of Examples 1-3 and close to that of Comparative Example 1. Therefore, evaluating this preparation method solely based on polysaccharide content would increase preparation costs due to the added alcohol precipitation step; selecting appropriate raw materials is essential in this case.

[0031] Comparative Example 4, using conventional dried dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitation powder as raw materials to prepare suppositories, showed good appearance and properties, met the requirements for content uniformity, a melting time of <30 minutes, a polysaccharide content of 2.44%, and a qualified microbial limit index. This indicates that using conventional dried dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitation powder to prepare suppositories is an alternative solution, but the polysaccharide content of the suppositories obtained in this case was lower than that of Examples 1-3 and close to that of Comparative Example 1. Therefore, considering the high and low polysaccharide content of the suppositories, this method is not the optimal solution.

[0032] Comparative Example 5, using freeze-dried fresh dendrobium powder and conventional dried dendrobium powder alcohol precipitation powder as raw materials to prepare suppositories, showed good appearance and properties, met the requirements for content uniformity, a melting time of <30 minutes, a polysaccharide content of 2.25%, and a qualified microbial limit index. This indicates that using freeze-dried fresh dendrobium powder and conventional dried dendrobium powder alcohol precipitation powder to prepare suppositories is also an alternative solution, but the polysaccharide content of the suppositories obtained in this case was lower than that of the other groups. Therefore, considering the high and low polysaccharide content of the suppositories, this method is not the best solution.

[0033] In Examples 1-4, suppositories prepared using freeze-dried fresh dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitate as raw materials exhibited excellent appearance, content uniformity that met regulatory requirements, a melting time of <30 minutes, a high polysaccharide content of 3.12-4.68%, and qualified microbial limit indices. Overall, using freeze-dried fresh dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitate as raw materials for suppository preparation not only increased the polysaccharide content of the suppositories but also addressed the uneven dispersion problem associated with using alcohol precipitate alone during processing.

[0034] Anything not described in detail in the present invention is well known to those skilled in the art.

[0035] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the scope of the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. A dendrobium composition, characterized in that: The composition is obtained by uniformly mixing freeze-dried fresh dendrobium powder and freeze-dried fresh dendrobium powder alcohol precipitate; wherein the weight ratio of the freeze-dried fresh dendrobium powder and the freeze-dried fresh dendrobium powder alcohol precipitate is 3-8 parts:2-7 parts.

2. The dendrobium composition according to claim 1, wherein: The preparation method of the freeze-dried fresh dendrobium powder comprises the following steps: harvesting seasonal fresh dendrobium strips, cleaning, cutting into segments, freeze-drying, removing the sheath membrane, and crushing to obtain freeze-dried fresh dendrobium; and passing the freeze-dried fresh dendrobium through a 500-mesh sieve to obtain the freeze-dried fresh dendrobium powder.

3. The dendrobium composition according to claim 2, wherein: The preparation method of the freeze-dried fresh dendrobium powder alcohol precipitation comprises the following steps: (1) Passing the freeze-dried fresh dendrobium through a 100-mesh sieve to obtain freeze-dried fresh dendrobium powder; (2) Preparation of Dendrobium slurry: add the freeze-dried powder of Dendrobium obtained in step (1) into drinking water at a volume of 50-60 times its weight, stir and mix evenly, and process through a colloid mill to obtain Dendrobium slurry; (3) Preparation of alcohol precipitate: Add 95% ethanol by volume to the dendrobium pulp obtained in step (2), stirring thoroughly while adding until the alcohol precipitate precipitates. Stop adding when the ethanol concentration in the liquid reaches 70%, and let it stand for 4-8 hours; (4) Filtration: Pass the mixture obtained in step (3) through a 300-mesh sieve and collect the alcohol precipitate retained on the sieve; (5) Drying: The alcohol precipitate obtained in step (4) is transferred to an oven and dried at 60°C for 14-20 hours until the moisture content is less than 3%; (6) Crushing and sieving: Crushing the alcohol precipitate obtained in step (5) and passing it through a 300-mesh sieve for later use.

4. A method for preparing a dendrobium suppository for tumor treatment, characterized in that: The dendrobium composition according to any one of claims 1 to 3 comprises the following steps: (1) Melting of matrix: 75-90 parts by weight of semi-synthetic fatty acid glyceride and 3-6 parts by weight of borneol powder are placed in a container and stirred at 50-60°C until completely melted to obtain a molten matrix; (2) Drug mixing: Add 2-7 parts by weight of the alcohol precipitation of freeze-dried fresh dendrobium powder and 3-8 parts by weight of freeze-dried fresh dendrobium powder to the molten matrix obtained in step (1), and stir for 30-40 minutes until the mixture is uniform, to obtain a molten suppository; (3) Injection molding: Cool the molten suppository obtained in step (2) to 40-45°C and inject it into a mold; (4) Cooling and demolding: After the suppository is completely cooled and solidified, remove it from the mold; (5) Packaging: Use pharmaceutical packaging materials to package suppositories according to specifications; (6) Sterilization: The obtained suppositories are sterilized by irradiation.

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