A stomach-strengthening and digestion-promoting orally disintegrating tablet and a preparation method thereof

Abstract

The present invention relates to the technical field of food or health care products, and in particular to a stomach-strengthening and digestion-promoting orally disintegrating tablet and a preparation method thereof. The present invention selects Chinese medicinal raw materials that are both medicinal and edible: hawthorn, roasted malt, chicken gizzard lining, Poria cocos, tangerine peel and white hyacinth bean to extract a Chinese medicinal combination extract, which has the effect of strengthening the stomach and digestion; the Chinese medicinal combination dry paste powder obtained after drying the Chinese medicinal combination extract is then combined with a specific auxiliary material combination to prepare a stomach-strengthening and digestion-promoting orally disintegrating tablet, which can be quickly disintegrated in the oral cavity, and no water is required after taking it, and it is easy to take and carry. Compared with the general traditional extraction process, the extraction process of the Chinese medicinal raw materials provided by the present invention has a simplified process, lower energy consumption, and clear filtrate; the Chinese medicinal combination dry paste powder prepared by the present invention is used for tableting, and has the advantages of low hygroscopicity, uniform and fine particle size, and good taste.

Description

Technical Field

[0001] The invention relates to the technical field of food or health products, and in particular to a stomach-strengthening and digestion-promoting orally disintegrating tablet and a preparation method thereof. Background Art

[0002] In recent years, with the continuous improvement of living standards and the increasing frequency of social activities, more and more people have begun to ignore dietary issues, which has brought about a series of negative effects. Indigestion is one of the serious problems.

[0003] Jianweixiaoshi tablets belong to the second national high-quality Chinese patent medicine selection variety. Its prescription is composed of tangerine peel, hawthorn, Pseudostellaria heterophylla, fried malt, and yam, which has the effect of strengthening the stomach and digestion. Its preparation process mainly includes Chinese medicine extraction, granulation, tableting, coating, aluminum-plastic packaging, etc. The product quality standard is included in Part 1 of the Pharmacopoeia of the People's Republic of China (2020 edition). It is mainly used clinically for food accumulation caused by weak spleen and stomach, with symptoms such as loss of appetite, belching, sour and smelly smell, and abdominal distension. According to data from the State Food and Drug Administration, there are a total of 56 approval numbers for Jianweixiaoshi tablets.

[0004] Zhao Yunge found through retrieval and screening in the article "Exploring the Medication Rules of Anorexia in Children (Spleen Deficiency and Food Accumulation Syndrome) and the Efficacy Observation of the Spleen-Strengthening and Digestion-Promoting Prescription Based on the Study of Ancient and Modern Literature" that 45 Chinese medicines were available in the prescriptions recorded in ancient literature, with a total frequency of use of 138 times, and 93 Chinese medicines were obtained from the prescriptions used in modern literature, with a total frequency of use of 603 times. The drugs recorded in ancient literature were summarized, and according to the statistical results, the commonly used combination drugs were: ginseng-Atractylodes macrocephala-Poria cocos-Chenpi-Roasted Licorice; the commonly used combination drugs in modern times are: Poria cocos-Atractylodes macrocephala-Scorched Malt-Scorched Shenqu-Scorched Hawthorn-Chicken's Gizzard.

[0005] The 2020 edition of the "Chinese Pharmacopoeia" (Volume IV) added the "orodisintegrating tablets" sub-dosage form to the "0101 Tablets" item, and defined orodisintegrating tablets as "tablets that can disintegrate or dissolve rapidly in the mouth without the need for water. They are generally suitable for small doses of raw materials and are often used for patients with dysphagia or who do not cooperate with medication. They can be prepared by direct compression and freeze-drying."

[0006] At present, there are many difficulties in the preparation and production process of orally disintegrating tablets, mainly:

[0007] (1) High cost: The tablets obtained by freeze-drying technology have good disintegration properties, so the first technology developed for preparing orally disintegrating tablets is freeze-drying technology. However, industrial production requires large-scale freeze-drying equipment, which greatly increases the production cost. Although the direct tableting method is simple in process and low in cost, it has high requirements on the properties of drugs and excipients, especially Chinese herbal medicine extracts have many impurities and high viscosity, which are difficult to operate in practice. The wet granulation tableting process has relatively low requirements on production equipment, preparation process and other conditions, and the production is easy to control, which is in line with the actual situation of most domestic pharmaceutical manufacturers. However, this method has many steps and is time-consuming. In particular, since this type of preparation collapses when exposed to water, the environmental moisture must be controlled below 50% during the production, packaging and storage process, and the production cost will also increase accordingly.

[0008] (2) Difficulty in tableting: The pressure during the tableting process of orally disintegrating tablets has a great influence on the disintegration performance of the tablets. Selecting the appropriate pressure is the key to the tableting process of orally disintegrating tablets. The hardness of orally disintegrating tablets prepared by direct tableting has a great relationship with the disintegration time. Within a certain pressure range, the greater the pressure, the greater the hardness and the longer the disintegration time, which cannot meet the disintegration requirements of orally disintegrating tablets; if the pressure is too small, the tablet cannot be formed.

[0009] (3) Difficulty in packaging. Since orodisintegrating tablets are easy to absorb moisture and break easily, they are not conducive to transportation and storage. In particular, orodisintegrating tablets prepared by freeze-drying have low hardness, great brittleness, and are very easy to break. The inner and outer packaging of orodisintegrating tablets must have good waterproof and shockproof properties, which puts higher requirements on the packaging process. If conventional blister packaging is used, orodisintegrating tablets will absorb moisture from the air, causing quality problems during the shelf life or breakage during transportation. Therefore, after the blister is sealed, consider using another layer of double aluminum packaging. In addition, due to the fragility of orodisintegrating tablets, the blister packaging should adopt a back-opening design instead of conventional extrusion to avoid damage to the tablets during administration.

[0010] (4) Disintegration time: The disintegration of orally disintegrating tablets is strictly required and must be completed within 1 minute. Screening out the appropriate disintegrant combination requires a great deal of work. During production, it is particularly important to properly handle the relationship between the tablet press pressure and the tablet's hardness, friability, and disintegration time.

[0011] (5) Taste problem: For Chinese herbal extracts, direct tableting requires the addition of a large amount of excellent disintegrants and flavor correctors, which may cause the tablet weight to be too large, prolong the disintegration time, and place high requirements on the purification and refining of Chinese herbal medicine. The amount of excipients used is large, and the orodisintegrating tablets still have a gritty feel after oral disintegration.

[0012] Therefore, it is necessary to improve the extraction and preparation process in order to find an orally disintegrating tablet with good taste and rapid disintegration. Summary of the invention

[0013] The purpose of the present invention is to overcome the shortcomings of the prior art and provide a stomach-strengthening and digestion-promoting orally disintegrating tablet, which is convenient for consumers to take quickly without water and improves the compliance of taking.

[0014] To achieve the above object, the technical solution adopted by the present invention is:

[0015] In a first aspect, the present invention provides a stomach-strengthening and digestion-promoting orally disintegrating tablet, comprising a Chinese medicine combination dry paste powder and auxiliary materials;

[0016] The Chinese medicine combination dry paste powder comprises the following raw material components: hawthorn, roasted malt, chicken gizzard lining, poria, tangerine peel and white hyacinth bean;

[0017] The auxiliary materials include lubricants, fillers, and disintegrants;

[0018] The mass ratio of the filler to the disintegrant is (69-78.5):(1-10); the filler includes at least one of mannitol, sorbitol, erythritol, and glucose; the disintegrant includes at least one of microcrystalline cellulose, dry starch, sodium carboxymethyl starch, baking soda, and citric acid.

[0019] Considering that Jianweixiaoshi tablets can better serve enterprises and the public, and enter the market in the form of health food or ordinary food rather than medicine, the present invention uses medicinal materials with the same origin as medicine and food to extract and prepare Jianweixiaoshi orodisintegrating tablets. The present invention uses six kinds of medicinal materials, hawthorn, Poria, chicken gizzard lining, tangerine peel, roasted malt, and white hyacinth bean, to obtain a Chinese medicine combination extract that has the effect of strengthening the stomach and digesting food; the obtained Chinese medicine combination extract is made into a Chinese medicine combination dry paste powder and then combined with a specific auxiliary material combination to obtain a Jianweixiaoshi orodisintegrating tablet. The present invention adjusts the composition of auxiliary materials, especially conducts a lot of research on the selection of fillers and disintegrants, so that the prepared orodisintegrating tablets can be quickly disintegrated in the mouth (within 60s), and no water is required after taking it, which is convenient to take and easy to carry.

[0020] Among the Chinese medicinal raw materials used in the present invention, charred hawthorn tastes sour and sweet, is slightly warm in nature, and enters the spleen, stomach, and liver meridians. The effects of hawthorn recorded in Chinese medicine prescriptions include digestion and stomachic invigoration, turbidity removal and lipid reduction, and are often used to treat meat stagnation, stomach distension, hyperlipidemia, etc. It can promote the digestion of fat, enhance the activity of gastric digestive enzymes, and has a strong effect of digestion and stagnation. It has the effects of appetizing and digesting food, removing stagnation and eliminating accumulation, promoting blood circulation and dispersing blood stasis, and removing phlegm and promoting qi. Hawthorn can stimulate the appetite and digest food, especially for eliminating meat stagnation.

[0021] Poria: It tastes sweet and light, and is neutral in nature. It enters the heart, spleen, kidney, lung and other meridians. It has the effect of strengthening the spleen and can be used to treat symptoms such as anorexia, spleen deficiency, poor appetite, loose stools and diarrhea.

[0022] Tangerine peel: pungent, bitter, warm in nature, enters the spleen meridian, stomach meridian, and lung meridian, and has the effects of regulating qi and strengthening the spleen, regulating the middle, drying dampness, and resolving phlegm. In this recipe, it mainly acts on the spleen and helps the spleen to transport and transform.

[0023] Chicken gizzard lining: After killing the chicken, take out the gizzard, peel off the inner wall, wash and dry it. It tastes sweet and is neutral in nature. It enters the spleen, stomach, small intestine and bladder meridians. It has the effect of strengthening the stomach and digesting food. It can be used for food stagnation and infantile malnutrition. Chicken gizzard lining contains gastric hormones and trace amounts of pepsin, which can increase gastric juice secretion, acidity and digestion, and accelerate gastric emptying.

[0024] Roasted malt: sweet in taste, neutral in nature, enters the spleen, stomach, and liver meridians. It has the effects of promoting qi and digestion, strengthening the spleen and stimulating appetite, and relieving milk and swelling. Malt is good at eliminating the stagnation of rice, flour, and yam, and can promote the digestion of starchy foods; it can also soothe the liver and relieve depression, regulate liver qi, and prevent spleen deficiency and liver attack.

[0025] White lentil: sweet, slightly warm in nature. Enters the spleen and stomach meridians; has the effects of strengthening the spleen and eliminating dampness, harmonizing the middle and relieving heat.

[0026] Among the excipients used in the present invention, fillers (also called diluents) can increase the mass or volume of tablets; they can be used as diluents for the active ingredients of the raw materials to reduce dosage deviations; and they can improve the formability of the raw materials. Disintegrants can shorten the disintegration time and accelerate the dissolution of the active ingredients. Lubricants can increase fluidity, reduce the difficulty of tableting, and improve the appearance of tablets.

[0027] Preferably, the stomach-strengthening and digestion-promoting orally disintegrating tablet comprises the following components in parts by weight: 20-25 parts of Chinese medicine combination dry paste powder, 0.5-1 part of lubricant, 69-78.5 parts of filler, and 1-10 parts of disintegrant.

[0028] The present invention has found through extensive research that when the components contained in the stomach-strengthening and digestion-promoting orodisintegrating tablets are in the above ratio, the prepared orodisintegrating tablets can not only disintegrate rapidly in the oral cavity, but also have the advantages of sweet and sour taste, good flavor, and no bad flavor.

[0029] Preferably, the lubricant includes at least one of magnesium stearate and silicon dioxide.

[0030] Preferably, the filler is erythritol or mannitol; and / or the disintegrant is sodium carboxymethyl starch, or a combination of baking soda and citric acid.

[0031] Preferably, when the disintegrant is sodium carboxymethyl starch, the amount of the disintegrant is 1-1.5 parts; when the disintegrant is a combination of baking soda and citric acid, the amount of the disintegrant is 10 parts.

[0032] Preferably, the Chinese medicine combination dry paste powder comprises the following raw material components in parts by weight: 10 parts of hawthorn, 6-10 parts of roasted malt, 6-10 parts of chicken gizzard lining, 3-10 parts of Poria cocos, 2-10 parts of tangerine peel, and 2-6 parts of white hyacinth bean.

[0033] More preferably, the Chinese medicine combination dry paste powder comprises the following raw material components in parts by weight: 10 parts of hawthorn, 6 parts of roasted malt, 6 parts of chicken gizzard lining, 3 parts of Poria cocos, 2.5 parts of tangerine peel, and 2.5 parts of white hyacinth bean.

[0034] Preferably, the Chinese medicine combination dry paste powder is prepared by the following method:

[0035] (I) mixing hawthorn and tangerine peel, adding water, heating for extraction, and filtering to obtain filtrate A;

[0036] (II) Mix chicken gizzard lining and Poria cocos, add water, heat and extract, and filter to obtain filtrate B;

[0037] (III) mixing roasted malt and white lentil, crushing, adding water, heating for extraction, cooling, adding amylase for hydrolysis, and filtering to obtain filtrate C;

[0038] (IV) combining the filtrate A, filtrate B and filtrate C obtained in steps (I) to (III), heating and then standing to cool, filtering, concentrating and removing impurities, adding whey protein isolate and stirring, shearing and dispersing to obtain a uniform suspension, and drying to obtain a Chinese medicine combination dry paste powder.

[0039] The present invention takes into account the different characteristics of medicinal materials and extracts them in groups, so that the active components of Chinese medicine raw materials can be extracted to the maximum extent. The yield of separate extraction is higher than that of combined extraction of medicinal materials, and the appearance of the extract is good; the extraction rate of separate extraction can reach more than 20%, and the extraction rate of combined extraction is about 15%. In addition, the starch content in malt and white lentils is relatively high. The present invention adds α-amylase in the extraction to degrade part of the starch, reduce the viscosity of the system, facilitate the dissolution of effective substances, and reduce the difficulty of filtering. If α-amylase is not added, the crushed material will become porridge-like after long-term heating, and it is difficult to filter. Compared with the general traditional extraction process, the extraction process of Chinese medicine raw materials provided by the present invention has a simplified process, lower energy consumption, and clear filtrate; the Chinese medicine combination dry paste powder prepared by the present invention is used for tableting, and has the advantages of low hygroscopicity, uniform and fine particle size, and good taste.

[0040] The present invention has found that the whey protein isolate is the best spray drying carrier. The present invention attempts to use dextrin or starch as a spray drying carrier, but the suspension system is unstable and will settle. The spray drying process causes serious wall adhesion and loss. The spray drying temperature is too high, which destroys the flavor of the extract.

[0041] Preferably, in the step (III), 0.01-0.02% α-amylase is used for hydrolysis, and the hydrolysis condition is hydrolysis at 80-90° C. for 1 hour.

[0042] Preferably, in steps (I) to (III), the amount of water added is 6 times the total weight of the medicinal materials.

[0043] Preferably, in the steps (I) to (III), the extraction time is 0.5-2 h.

[0044] Preferably, in step (IV), the amount of whey protein isolate added is 6%.

[0045] Preferably, in step (IV), the shear dispersion condition is: dispersion at 8000 rpm for 10 min.

[0046] Preferably, the stomach-strengthening and digestion-promoting orally disintegrating tablet has a tablet weight of 0.25-0.30 g and a hardness of 1-3 kg.

[0047] In a second aspect, the present invention provides a method for preparing the stomach-strengthening and digestion-promoting orally disintegrating tablet, comprising the following steps:

[0048] (1) mixing the Chinese medicine combination dry paste powder and a portion of auxiliary materials to obtain a mixture A;

[0049] (2) The remaining auxiliary materials and the mixture A are mixed evenly, and tabletted to obtain the stomach-strengthening and digestion-promoting orally disintegrating tablets.

[0050] Preferably, the tableting conditions are: temperature 15-25°C, relative humidity below 45%;

[0051] And / or, the mass ratio of a portion of the auxiliary materials in step (1) to the remaining auxiliary materials in step (2) is (2-65):(15-78).

[0052] Preferably, the process of steps (1)-(2) is:

[0053] (a) grinding and sieving the disintegrant and the filler, and uniformly mixing the dry paste powder and a portion of the filler to obtain a mixture A;

[0054] (b) mixing the remaining filler and disintegrant with the lubricant to obtain a mixture B;

[0055] (c) mixing the mixture A and the mixture B uniformly, and compressing the mixture into tablets to obtain the stomach-strengthening and digestion-promoting orally disintegrating tablets.

[0056] The orally disintegrating tablet should disintegrate or dissolve rapidly in the oral cavity, have a good taste, be easy to swallow, be non-irritating to the oral mucosa, and should be subjected to a disintegration time limit inspection (need to disintegrate within 60 seconds). The stomach-strengthening and digestion-promoting orally disintegrating tablet prepared by the present invention is prepared by a direct tablet compression method, has a sweet and sour taste, has no bad flavor, and disintegrates rapidly in the oral cavity. The friability can meet the requirements for tablets in the pharmacopoeia.

[0057] The beneficial effects of the present invention are:

[0058] The invention selects Chinese medicinal raw materials which are both medicinal and edible: hawthorn, roasted malt, chicken gizzard lining, poria, tangerine peel and white hyacinth bean to extract a Chinese medicinal combination extract, which has the effects of invigorating the stomach and promoting digestion; the Chinese medicinal combination dry paste powder obtained by drying the Chinese medicinal combination extract is combined with a specific auxiliary material combination to prepare a stomach-strengthening and digestion-promoting orally disintegrating tablet, which can be quickly disintegrated in the oral cavity, does not need to drink water after taking, and has the characteristics of being easy to take and easy to carry.

[0059] Compared with the general traditional extraction process, the raw material extraction process provided by the present invention has a simplified process, lower energy consumption and clear filtrate; the Chinese medicine combination dry paste powder prepared by the present invention is used for tableting and has the advantages of low hygroscopicity, uniform and fine particle size and good taste. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figure 1 This is a comparison of the hygroscopicity of orally disintegrating tablets after being placed for 2 hours.

[0061] Figure 2 Comparison of process filtrates extracted with / without α-amylase.

[0062] Figure 3 The present invention is used to compare the process filtrate / dry paste powder prepared by the extraction process of the present invention and the traditional extraction process. DETAILED DESCRIPTION

[0063] In order to better illustrate the purpose, technical solutions and advantages of the present invention, the present invention will be further described below in conjunction with specific embodiments.

[0064] In the technical scheme of the present invention, hawthorn, roasted malt, chicken gizzard lining, Poria, dried orange peel, and white hyacinth bean are Chinese herbal medicine pieces that meet the technical requirements of the pharmacopoeia. The experimental methods used in the present invention are conventional methods unless otherwise specified, and the materials, reagents, etc. used can be obtained from commercial channels unless otherwise specified.

[0065] Embodiment 1:

[0066] An embodiment of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention comprises the following components in parts by weight: 20 parts of Chinese medicine combination dry paste powder, 78.5 parts of erythritol, 1 part of sodium carboxymethyl starch, and 0.5 parts of magnesium stearate.

[0067] The Chinese medicine combination dry paste powder comprises the following raw material components in parts by weight: 10 parts of hawthorn, 6 parts of roasted malt, 6 parts of chicken gizzard lining, 3 parts of poria, 2.5 parts of tangerine peel, and 2.5 parts of white hyacinth bean.

[0068] The Chinese medicine combination dry paste powder is prepared by the following method:

[0069] (1) Mix hawthorn and tangerine peel, add water at a material-water ratio of 1:6, and soak for 1 hour; heat to a low boiling temperature for 1.5 hours, and filter to remove residue to obtain filtrate A;

[0070] (2) Mix chicken gizzard lining and Poria cocos, add water at a material-water ratio of 1:6, and soak for 1.5 hours; heat with slightly boiling water for 2 hours, filter and remove residue to obtain filtrate B;

[0071] (3) Mix the roasted malt and white lentils, crush them into large particles, add water at a material-water ratio of 1:6, boil for 0.5 h, cool to 90-95° C., add 0.01-0.02% thermostable α-amylase and hydrolyze at 80-90° C. for 1 h; and coarsely filter to obtain filtrate C;

[0072] (4) The filtrate A, filtrate B and filtrate C obtained in steps (1) to (3) are combined, boiled for 5-10 minutes, and allowed to stand to cool naturally to room temperature; the filtrate is filtered twice with a 200-300 mesh filter cloth to obtain a filtrate, and concentrated at 85° C. to 1-1.2 times the weight of the medicinal materials in an open air at 85° C. to 95° C.; the obtained concentrated solution is filtered through diatomaceous earth to remove impurities to obtain a clarified solution, 6% whey protein isolate is added, the solution is stirred evenly, and then dispersed by high-speed shearing (8000 rpm, 10 minutes) to obtain a uniform suspension.

[0073] (5) The suspension is spray-dried at an air inlet temperature of 160° C. and an air outlet temperature of 95-97° C. to obtain a spray-dried powder of the Chinese medicinal material extract, that is, the Chinese medicinal material combination dry paste powder.

[0074] The preparation method of the stomach-strengthening and digestion-promoting orally disintegrating tablet comprises the following steps:

[0075] S1: crush erythritol through a 100-mesh sieve for later use;

[0076] S2: Mix the Chinese medicine combination dry paste powder and 65 parts of erythritol evenly to obtain a mixture A;

[0077] S3: Evenly mix the remaining erythritol, sodium carboxymethyl starch and magnesium stearate to obtain a mixture B;

[0078] S4: Mixing mixture A and mixture B uniformly to obtain mixture C;

[0079] S5: tabletting the mixture C to obtain the stomach-strengthening and digestion-promoting orally disintegrating tablets, with the tablet weight controlled to be 0.26-0.28 g and the hardness to be 2-3 kg; the tablets are sealed in a 10-wire aluminum foil bag for storage.

[0080] Embodiment 2:

[0081] An embodiment of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention comprises the following components in parts by weight: 20 parts of Chinese medicine combination dry paste powder, 78 parts of (spray-dried) mannitol, 1 part of sodium carboxymethyl starch, 0.5 parts of magnesium stearate, and 0.5 parts of silicon dioxide.

[0082] The Chinese medicine combination dry paste powder comprises the following raw material components in parts by weight: 10 parts of hawthorn, 10 parts of roasted malt, 10 parts of chicken gizzard lining, 10 parts of poria, 2 parts of tangerine peel, and 2 parts of white hyacinth bean.

[0083] The preparation of the Chinese medicine combination dry paste powder is the same as in Example 1.

[0084] The preparation method of the stomach-strengthening and digestion-promoting orally disintegrating tablet comprises the following steps:

[0085] S1: Mix the Chinese medicine combination dry paste powder with magnesium stearate, silicon dioxide and sodium carboxymethyl starch to obtain a mixture A;

[0086] S2: Mixing mixture A and (spray-dried) mannitol uniformly to obtain mixture B;

[0087] S3: tabletting the mixture B to obtain the stomach-strengthening and digestion-promoting orally disintegrating tablets, with the tablet weight controlled to be 0.26-0.28 g and the hardness to be 2-3 kg; the tablets are sealed in a 10-wire aluminum foil bag for storage.

[0088] Embodiment 3:

[0089] An embodiment of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention comprises the following components in parts by weight: 20 parts of Chinese medicine combination dry paste powder, 78 parts of sorbitol, 1 part of sodium carboxymethyl starch, and 1 part of magnesium stearate.

[0090] The Chinese medicine combination dry paste powder comprises the following raw material components in parts by weight: 10 parts of hawthorn, 6 parts of roasted malt, 6 parts of chicken gizzard lining, 3 parts of poria, 10 parts of tangerine peel, and 6 parts of white hyacinth bean.

[0091] The preparation of the Chinese medicine combination dry paste powder is the same as in Example 1.

[0092] The preparation method of the stomach-strengthening and digestion-promoting orally disintegrating tablets described in this embodiment is different from that in Embodiment 1 only in that erythritol is replaced by sorbitol.

[0093] Embodiment 4:

[0094] An embodiment of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention comprises the following components in parts by weight: 25 parts of Chinese medicine combination dry paste powder, 72.5 parts of erythritol, 1.5 parts of sodium carboxymethyl starch, and 1 part of magnesium stearate.

[0095] The composition and preparation of the Chinese medicine combination dry paste powder are the same as those in Example 1.

[0096] The preparation method of the stomach-strengthening and digestion-promoting orally disintegrating tablet comprises the following steps:

[0097] S1: crush erythritol and pass through a 100-mesh sieve;

[0098] S2: Mix the Chinese medicine combination dry paste powder and 60 parts of erythritol evenly to obtain a mixture A;

[0099] S3: Evenly mix the remaining erythritol, sodium carboxymethyl starch and magnesium stearate to obtain a mixture B;

[0100] S4: Mixing mixture A and mixture B uniformly to obtain mixture C;

[0101] S5: tabletting the mixture C to obtain the stomach-strengthening and digestion-promoting orally disintegrating tablets, with the tablet weight controlled to be 0.26-0.28 g and the hardness to be 2-3 kg; the tablets are sealed in a 10-wire aluminum foil bag for storage.

[0102] Embodiment 5:

[0103] An embodiment of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention comprises the following components in parts by weight: 20 parts of Chinese medicine combination dry paste powder, 74 parts of erythritol, 5 parts of microcrystalline cellulose, and 1 part of magnesium stearate.

[0104] The composition and preparation of the Chinese medicine combination dry paste powder are the same as those in Example 1.

[0105] The preparation method of the stomach-strengthening and digestion-promoting orally disintegrating tablet comprises the following steps:

[0106] S1: crush erythritol through a 100-mesh sieve;

[0107] S2: Mix the Chinese medicine combination dry paste powder and 45 parts of erythritol evenly to obtain a mixture A;

[0108] S3: uniformly mixing the remaining erythritol, microcrystalline cellulose and magnesium stearate to obtain a mixture B;

[0109] S4: Mixing the mixture A and the mixture B uniformly to obtain a mixture C;

[0110] S5: tabletting the mixture C to obtain the stomach-strengthening and digestion-promoting orally disintegrating tablets, with the tablet weight controlled to be 0.26-0.28 g and the hardness to be 2-3 kg; the tablets are sealed in a 10-wire aluminum foil bag for storage.

[0111] Embodiment 6:

[0112] An embodiment of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention comprises the following components in parts by weight: 20 parts of Chinese medicine combination dry paste powder, 73 parts of glucose, 5 parts of sorbitol, 1 part of dry starch, and 1 part of magnesium stearate.

[0113] The composition and preparation of the Chinese medicine combination dry paste powder are the same as those in Example 1.

[0114] The preparation method of the stomach-strengthening and digestion-promoting orally disintegrating tablets described in this example is different from that in Example 2 only in that mannitol is replaced by glucose and sorbitol, and sodium carboxymethyl starch is replaced by dry starch.

[0115] Embodiment 7:

[0116] An embodiment of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention comprises the following components in parts by weight: 20 parts of Chinese medicine combination dry paste powder, 69 parts of erythritol, 6 parts of baking soda, 4 parts of citric acid, and 0.5 parts of magnesium stearate.

[0117] The composition and preparation of the Chinese medicine combination dry paste powder are the same as those in Example 1.

[0118] The preparation method of the stomach-strengthening and digestion-promoting orally disintegrating tablet comprises the following steps:

[0119] S1: crush erythritol and pass through a 100-mesh sieve, crush citric acid and pass through a 100-mesh sieve for later use;

[0120] S2: Mix the Chinese medicine combination dry paste powder, 34 parts of erythritol and baking soda to obtain a mixture A;

[0121] S3: Evenly mix the remaining erythritol and citric acid to obtain a mixture B;

[0122] S4: adding magnesium stearate to mixture A and mixing evenly, and finally adding mixture B and mixing evenly to obtain mixture C;

[0123] S5: tabletting the mixture C to obtain the stomach-strengthening and digestion-promoting orally disintegrating tablets, with the tablet weight controlled to be 0.26-0.28 g and the hardness to be 2-3 kg; the tablets are sealed in a 10-wire aluminum foil bag for storage.

[0124] Comparative Example 1:

[0125] A comparative example of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention comprises the following components in parts by weight: 20 parts of Chinese medicine combination dry paste powder, 74 parts of erythritol, 5 parts of sodium carboxymethyl cellulose, and 1 part of magnesium stearate.

[0126] The composition and preparation of the Chinese medicine combination dry paste powder are the same as those in Example 1.

[0127] The preparation method of the stomach-strengthening and digestion-promoting orally disintegrating tablets described in this comparative example is different from that in Example 5 only in that microcrystalline cellulose is replaced by sodium carboxymethyl cellulose.

[0128] Comparative Example 2:

[0129] A comparative example of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention comprises the following components in parts by weight: 20 parts of Chinese medicine combination dry paste powder, 79 parts of maltodextrin, and 1 part of magnesium stearate.

[0130] The composition and preparation of the Chinese medicine combination dry paste powder are the same as those in Example 1.

[0131] The preparation method of the stomach-strengthening and digestion-promoting orally disintegrating tablets described in this comparative example is:

[0132] S1: Mix the dry paste powder and 64 parts of maltodextrin to obtain a mixture A;

[0133] S2: uniformly mixing the remaining maltodextrin and magnesium stearate to obtain a mixture B;

[0134] S3: Mixing mixture A and mixture B uniformly to obtain mixture C;

[0135] S4: tabletting the mixture C to obtain the stomach-strengthening and digestion-promoting orally disintegrating tablets, with the tablet weight controlled to be 0.26-0.28 g and the hardness to be 2-3 kg; the tablets are sealed in a 10-wire aluminum foil bag for storage.

[0136] Comparative Example 3:

[0137] A comparative example of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention; the difference between this comparative example and Example 1 is only that in the preparation of the Chinese medicine combination dry paste powder, the extract of roasted malt and white lentil hydrolyzed by thermostable α-amylase is not added in step (3), and the rest is the same as Example 1.

[0138] Comparative Example 4:

[0139] A comparative example of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention; the difference between this comparative example and Example 1 is only that in the preparation of the Chinese medicine combination dry paste powder, the whey protein isolate is replaced with maltodextrin in step (4), and the rest is the same as Example 1.

[0140] Comparative Example 5:

[0141] A comparative example of the stomach-strengthening and digestion-promoting orally disintegrating tablets of the present invention; the difference between this comparative example and Example 1 is only that this comparative example adopts the traditional extraction and extract preparation process to extract the Chinese medicine combination extract to prepare a dry paste powder, and the rest is the same as Example 1.

[0142] The specific preparation method of the Chinese medicine combination dry paste powder is:

[0143] (1) Weigh the Chinese medicinal materials by weight, add 8 times the amount of purified water as the total weight of the raw materials, soak for 30 minutes, and then boil for 2 hours; filter and collect the filtrate, add 8 times the amount of water to the residue and boil for a second time for 2 hours, filter, and discard the residue; combine the two filtrates and set aside.

[0144] (2) Concentration: The combined filtrate is concentrated under reduced pressure to a relative density of 1.05-1.10 and refrigerated for 24 hours. The upper layer of the drug solution is filtered through a 200-mesh filter, and the filtrate is further concentrated to a thick paste with a relative density of 1.18-1.25. An appropriate amount of starch is added to obtain a thick extract. The thick extract is dried under reduced pressure and vacuum to obtain a dry extract, which is crushed and filtered through a 100-mesh sieve to obtain a dry paste powder of the Chinese medicine combination.

[0145] Comparative Example 6:

[0146] A comparative example of the stomach-strengthening and digestion-promoting orodisintegrating tablets of the present invention; the difference between this comparative example and Example 1 is that the stomach-strengthening and digestion-promoting orodisintegrating tablets of this comparative example include the following components by weight: 20 parts of Chinese medicine combination dry paste powder, 68.5 parts of erythritol, 10 parts of sodium carboxymethyl starch, and 0.5 parts of magnesium stearate. The rest is the same as Example 1. Test Example 1: Comparison of disintegration time and taste of orodisintegrating tablets

[0147] The test samples are: the stomach-strengthening and digestion-promoting orally disintegrating tablets prepared in Examples 1-7, Comparative Examples 1-2, and Comparative Example 6.

[0148] Table 1 Comparison of disintegration time of orally disintegrating tablets

[0149] Test samples Oral disintegration time Example 1 30s Example 2 20s Example 3 41s Example 4 34s Example 5 35s Example 6 40s Example 7 29s Comparative Example 1 103s Comparative Example 2 107s Comparative Example 6 147s

[0150] The disintegration time of the orodisintegrating tablets taken by the subjects for stomachic and sedative digestion was compared, and the results are shown in Table 1. Comparative Example 1 combines erythritol and sodium carboxymethyl cellulose, resulting in the prepared orodisintegrating tablets not dispersing in the oral cavity and dissolving slowly. Comparative Example 2 uses maltodextrin as a filler excipient, and the orodisintegrating tablets will clump in the oral cavity, not dispersing, and dissolving slowly. The ratio of the filler and disintegrant in Comparative Example 6 exceeds the scope of the present invention, resulting in increased viscosity and prolonged disintegration time. After a lot of exploration, the embodiments of the present invention adjusted the selection and combination of fillers and disintegrants in the excipients, and the prepared orodisintegrating tablets for stomachic and sedative digestion can all disintegrate rapidly within 60s, among which Example 2 can disintegrate rapidly in about 20s at the fastest.

[0151] In the taste evaluation results, in general, the Jianwei Xiaoshi orodisintegrating tablets prepared in the embodiments of the present invention have a sweet and sour taste, good flavor, and no bad flavor; the quality appearance and hardness of the tablets are generally good and non-hygroscopic. Among them, the Jianwei Xiaoshi orodisintegrating tablets of Example 1 have good mouth feel fluidity, a cool feeling, good instant solubility, and a characteristic flavor of medicinal materials. The Jianwei Xiaoshi orodisintegrating tablets of Example 2 melt in the mouth, have moderate sweetness, a cool feeling, and a good experience. The Jianwei Xiaoshi orodisintegrating tablets of Example 3 are relatively sweet, and the flavor of medicinal materials is prominent. The Jianwei Xiaoshi orodisintegrating tablets of Example 4 have an acceptable taste and a slight starchy taste. The Jianwei Xiaoshi orodisintegrating tablets of Example 5 are relatively sweet, with a slight sense of gravel and powder. The Jianwei Xiaoshi orodisintegrating tablets of Example 6 have a relatively rough taste compared to other embodiments, and the sweetness is heavier than the flavor of the medicinal materials. The astringent feeling brought by the acid and alkali of the Jianwei Xiaoshi orodisintegrating tablets of Example 7 is acceptable, and has a characteristic flavor of medicinal materials. The Jianweixiaoshi orodisintegrating tablets of Comparative Example 1 have poor hardness and good sweetness, but the tablets do not disperse in the oral cavity and dissolve slowly. The Jianweixiaoshi orodisintegrating tablets of Comparative Example 2 are not sweet and have no characteristic flavor; they clump in the oral cavity, do not disperse, and dissolve slowly.

[0152] Test Example 2: Hygroscopicity comparison

[0153] The stomach-strengthening and digestion-promoting orally disintegrating tablets prepared in Example 1 and Comparative Example 4 were left open for 2 hours to observe their hygroscopicity.

[0154] The results are as follows Figure 1 The hygroscopicity of the orodisintegrating tablets after being placed for 2 hours was compared. In Example 1, whey protein isolate was used as a spray-dried carrier and the orodisintegrating tablets were left open for 2 hours, and the surface of the orodisintegrating tablets was still dry; in Comparative Example 4, maltodextrin was used as a spray-dried carrier and the orodisintegrating tablets were left open for 2 hours, and the orodisintegrating tablets had absorbed a lot of moisture.

[0155] Test Example 3: Extraction Process Comparison

[0156] The process filtrate / dry paste powder prepared in Example 1 and Comparative Examples 3-5 were observed.

[0157] The comparison results of Example 1 and Comparative Example 3 are as follows Figure 2 As shown, malt and white lentil have high starch content. In Example 1, α-amylase is added during extraction to degrade part of the starch, reduce the viscosity of the system, facilitate the dissolution of effective substances, and reduce the difficulty of filtration. In Comparative Example 3, α-amylase is not added, and the crushed material becomes porridge-like after long-term heating, which is difficult to filter.

[0158] Comparative Example 4 uses maltodextrin as a spray-drying carrier, but the spray-drying results in serious wall adhesion and large losses, and the spray-drying temperature is too high, which destroys the flavor of the extract. Example 1 uses whey protein isolate as a spray-drying carrier, which has the best effect.

[0159] Comparison of Example 1 and Comparative Example 5 is as follows Figure 3 As shown, the extraction process of the Chinese medicine raw materials provided by the present invention is simplified in process, lower in energy consumption, and clear in filtrate compared with the general traditional extraction process; the Chinese medicine combination dry paste powder prepared by the present invention is used for tableting, and has the advantages of low hygroscopicity, uniform and fine particle size, and good taste.

[0160] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the essence and scope of the technical solution of the present invention.

Claims

1. A stomach-strengthening and digestion-promoting orodisintegrating tablet, characterized in that: Including Chinese medicine combination dry paste powder and auxiliary materials; The Chinese medicine combination dry paste powder comprises the following raw material components: hawthorn, roasted malt, chicken gizzard lining, poria, tangerine peel and white hyacinth bean; The auxiliary materials include lubricants, fillers, and disintegrants; The mass ratio of the filler to the disintegrant is (69-78.5):(1-10); the filler includes at least one of mannitol, sorbitol, erythritol, and glucose; the disintegrant includes at least one of microcrystalline cellulose, dry starch, sodium carboxymethyl starch, baking soda, and citric acid.

2. The stomach-strengthening and digestion-promoting orally disintegrating tablet according to claim 1, characterized in that: The stomach-strengthening and digestion-promoting orally disintegrating tablet comprises the following components in parts by weight: 20-25 parts of Chinese medicine combination dry paste powder, 0.5-1 part of lubricant, 69-78.5 parts of filler, and 1-10 parts of disintegrant.

3. The stomach-strengthening and digestion-promoting orally disintegrating tablet according to claim 1, characterized in that: The lubricant includes at least one of magnesium stearate and silicon dioxide.

4. The stomach-strengthening and digestion-promoting orally disintegrating tablet according to claim 1, characterized in that The filler is erythritol or mannitol; And / or, the disintegrant is sodium carboxymethyl starch, or a combination of baking soda and citric acid.

5. The stomach-strengthening and digestion-promoting orally disintegrating tablet according to claim 4, characterized in that: When the disintegrant is sodium carboxymethyl starch, the amount of the disintegrant is 1-1.5 parts; when the disintegrant is a combination of baking soda and citric acid, the amount of the disintegrant is 10 parts.

6. The stomach-strengthening and digestion-promoting orally disintegrating tablet according to claim 1, characterized in that: The Chinese medicine combination dry paste powder comprises the following raw material components in parts by weight: 10 parts of hawthorn, 6-10 parts of roasted malt, 6-10 parts of chicken gizzard lining, 3-10 parts of poria, 2-10 parts of tangerine peel, and 2-6 parts of white hyacinth bean.

7. The stomach-strengthening and digestion-promoting orally disintegrating tablet according to claim 1, characterized in that: The Chinese medicine combination dry paste powder is prepared by the following method: (I) mixing hawthorn and tangerine peel, adding water, heating for extraction, and filtering to obtain filtrate A; (II) Mix chicken gizzard lining and Poria cocos, add water, heat and extract, and filter to obtain filtrate B; (III) mixing roasted malt and white lentil, crushing, adding water, heating for extraction, cooling, adding amylase for hydrolysis, and filtering to obtain filtrate C; (IV) combining the filtrate A, filtrate B and filtrate C obtained in steps (I) to (III), heating and then standing to cool, filtering, concentrating and removing impurities, adding whey protein isolate and stirring, shearing and dispersing to obtain a uniform suspension, and drying to obtain a Chinese medicine combination dry paste powder.

8. The stomach-strengthening and digestion-promoting orally disintegrating tablet according to claim 7, characterized in that: In the step (III), 0.01-0.02% α-amylase is used for hydrolysis, and the hydrolysis condition is hydrolysis at 80-90° C. for 1 hour.

9. A method for preparing the stomach-strengthening and digestion-promoting orally disintegrating tablet according to any one of claims 1 to 8, characterized in that: The steps include: (1) mixing the Chinese medicine combination dry paste powder and a portion of auxiliary materials to obtain a mixture A; (2) The remaining auxiliary materials and the mixture A are mixed evenly, and tabletted to obtain the stomach-strengthening and digestion-promoting orally disintegrating tablets.

10. The method for preparing the stomach-strengthening and digestion-promoting orally disintegrating tablet according to claim 9, characterized in that: The tableting conditions in step (2) are: temperature 15-25° C., relative humidity below 45%; And / or, the mass ratio of a portion of the auxiliary materials in step (1) to the remaining auxiliary materials in step (2) is (2-65):(15-78).

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