A method for preparing a homogenized substantially enhanced all-purpose capsule

CN122894437APending Publication Date: 2026-10-13CHENGDU YANGTIAN WANYING PHARM CO LTD
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Patent Information

Application Number
CN202611040222.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-07-14
Publication Date
2026-10-13

AI Technical Summary

Technical Problem

[0004]CN115192652A制成的万应胶囊虽然具有良好的清热效果,同时也具有解毒及镇惊的作用,特别是针对有牙龈咽喉肿痛及烦躁易惊的状态有良好的治疗效果,特别是在高热的状态下缓解高热下带来的口舌生疮的问题;但是,一方面,CN115192652A制成的万应胶囊产品的均质化程度较低,甚至会出现花粒现象(即胶囊内含物出现色斑),从而导致产品不合格,且即使产品合格,由于均质化程度较低,从而出现不同胶囊颗粒药效之间的差异,从而影响产品质量;另一方面,体外培育牛黄作为贵重药材,且为热敏性物质,虽然现有的工艺牛黄的均匀性尚可,但制粒后需将乙醇、水等溶剂通过干燥去除,从而导致一部分牛黄有效成分的缺失

Benefits of technology

本发明发明人在实践中令人惊讶地发现,色斑现象的发生是因为香墨粉在现有工艺的制备过程中容易出现卫星团聚体,因此,本发明中,通过儿茶粉、香墨粉、糖粉形成复合颗粒A,与胡黄连、黄连形成初始混合物混合的方式,不但解决了色斑现象,且还提高了胡黄连、黄连及儿茶粉的均质性。

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Abstract

This invention discloses a method for preparing Wanying Capsules with significantly improved homogenization, belonging to the field of traditional Chinese medicine preparation technology. The method includes the following steps: S1, taking all catechu powder, all or part of the ink powder, and 110-140 parts by weight of sugar powder, mixing them in a high-speed mixer to obtain composite particles A; mixing the initial mixture formed by all of *Picrorhiza scrophulariiflora* and all of *Coptis chinensis* with composite particles A to form mixture one; S2, mixing mixture one with the remaining ingredients to obtain Wanying Capsules. This invention solves the problem of uneven particle formation and also improves the homogenization of *Picrorhiza scrophulariiflora*, *Coptis chinensis*, and catechu powder.
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Description

Technical Field

[0001] This invention relates to the field of preparation of traditional Chinese medicine preparations, and in particular to a method for preparing Wanying Capsules with significantly improved homogenization. Background Technology

[0002] Wanying Capsules are made from Coptis chinensis, Coptis chinensis, catechu, cinnamon, ox bile, bezoar, bear bile powder, borneol, and artificial musk. They have the effects of clearing heat, detoxifying, and calming the nerves. They are used for oral ulcers, swollen gums and throat, high fever in children, and irritability caused by internal accumulation of pathogenic toxins.

[0003] CN115192652A discloses a method for preparing Wanying Capsules, comprising the following steps: S1, mixing and pulverizing Coptis chinensis, Coptis chinensis, catechu, and cinnamon to obtain mixture one; S2, mixing in vitro cultured bezoar with the mixed powder in S1 to obtain mixture two; adding sugar powder to mixture two and mixing evenly to obtain mixture three; boiling and dissolving bear bile powder with purified water to obtain bear bile powder solution; concentrating and filtering ox bile to obtain ox bile paste; adding an appropriate amount of purified water to ox bile paste and bear bile powder solution and mixing to obtain mixture four; mixing mixture four, mixture three, and an ethanol aqueous solution to form granules through a granulator, drying, sizing, and sieving; grinding borneol and artificial musk into fine powder and mixing with the sieved granules to obtain product granules, which are then filled into empty capsules to obtain Wanying Capsules.

[0004] While the Wanying Capsules made under CN115192652A have good heat-clearing effects, as well as detoxifying and calming effects, they are particularly effective in treating conditions such as swollen and sore gums and throat, and irritability, especially in relieving mouth ulcers caused by high fever. However, on the one hand, the homogenization of Wanying Capsules made under CN115192652A is low, and even the phenomenon of "speckled grains" (i.e., discolored spots appearing in the capsule contents) may occur, leading to product substandardness. Even if the product is qualified, the low homogenization results in differences in efficacy between different capsule particles, thus affecting product quality. On the other hand, since in vitro cultured bezoar is a precious medicinal material and a heat-sensitive substance, although the current process can achieve a relatively good uniformity of bezoar, solvents such as ethanol and water need to be removed through drying after granulation, resulting in the loss of some of the effective components of bezoar. Summary of the Invention

[0005] To address the aforementioned deficiencies, this invention provides a method for preparing a universal capsule with significantly improved homogenization, which aims to improve at least one of the problems mentioned in the background art.

[0006] The technical solution is: a method for preparing a universal capsule with significantly improved homogenization, wherein the formula of the universal capsule is as follows: 50-65 parts by weight of Coptis chinensis, 50-65 parts by weight of Picrorhiza scrophulariiflora, 50-65 parts by weight of catechu, 105-125 parts by weight of cinnamon, 10.2-12 parts by weight of bear bile powder, 2-3.5 parts by weight of bezoar, 80-98 parts by weight of ox bile, 3-4 parts by weight of borneol, 2-3.5 parts by weight of artificial musk, and 600-700 parts by weight of sugar powder as an excipient. The preparation method includes the following steps: S1, take all the catechu powder, all or part of the ink powder, and 110-140 parts by weight of sugar powder, mix them in a high-speed mixer to obtain composite particles A, and mix the initial mixture formed by all the Coptis chinensis and all the Coptis chinensis with composite particles A to form mixture one; S2, Mixture 1 is mixed with the remaining ingredients to obtain Wanying Capsules; The mass fraction is one of grams, kilograms, thousand kilograms, or ten thousand kilograms.

[0007] The present invention also provides a method for preparing a universal capsule with significantly improved homogenization.

[0008] The technical solution is: a method for preparing a universal capsule with significantly improved homogenization, wherein the formula of the universal capsule is as follows: 50-65 parts by weight of Coptis chinensis, 50-65 parts by weight of Picrorhiza scrophulariiflora, 50-65 parts by weight of catechu, 105-125 parts by weight of cinnamon, 10.2-12 parts by weight of bear bile powder, 2-3.5 parts by weight of bezoar, 80-98 parts by weight of ox bile, 3-4 parts by weight of borneol, 2-3.5 parts by weight of artificial musk, and 600-700 parts by weight of sugar powder as an excipient. The method is characterized by the following steps: S1, take all the catechu powder, 100-110 parts by weight of ink powder, and 110-140 parts by weight of sugar powder, mix them in a high-speed mixer to obtain composite particles A, and mix the initial mixture formed by mixing all the Coptis chinensis and all the Coptis chinensis with composite particles A to form mixture one; S2, Mixture 1 is mixed with the remaining ingredients to obtain the Wan Ying Capsule, including the following steps: S22, add the remaining powdered sugar to mixture one and mix well to form mixture three; S23, All bear bile powder and all ox bile are mixed to form mixture four; S24. Mixture 3 and Mixture 4 are mixed and then granulated, dried, sized, and sieved using a granulator. S25. Mix all borneol, all artificial musk and 10 to 25 parts by weight of ink powder, grind them into a fine powder, sieve them, mix them with the sieved granules from S24 and all bezoar to obtain product granules, and fill them into empty capsules to obtain Wanying Capsules. The mass fraction is one of grams, kilograms, thousand kilograms, or ten thousand kilograms.

[0009] Furthermore, before S1, there is also S0. The initial mixture is formed by mixing and crushing Coptis chinensis and Coptis chinensis, sieving, and obtaining the initial mixture. The initial mixture is a mixture that has passed through an 80-100 mesh sieve. All catechu powder, all ink powder, and all sugar powder are each powder that has passed through an 80-100 mesh sieve.

[0010] Furthermore, in S1, the high-speed mixer operates at a speed of 8 rpm to 20 rpm, and the mixing time is 10 min to 30 min.

[0011] Furthermore, S23 includes the following steps: S231. Boil and dissolve all the bear bile powder in purified water to obtain bear bile powder solution. The amount of purified water is 1 to 2 times the mass of the bear bile powder. S232. Concentrate and filter all the ox bile to obtain ox bile extract, the specific gravity of which is 1.1 g / mL to 1.3 g / mL; S233. Add an appropriate amount of purified water to the ox bile paste and bear bile powder solution and mix to obtain mixture four. The amount of purified water added is appropriate.

[0012] Furthermore, in S24, the drying temperature is 50℃~55℃, granulation is carried out by a gyratory pellet mill with a 10-mesh stainless steel screen, and sieving is carried out by a gyratory pellet mill with 10-mesh and 80-mesh stainless steel screens; in the mixed granulation, an ethanol aqueous solution is also added, in which the volume fraction of ethanol is 75%~85%, and the amount is 230 parts by mass~245 parts by mass.

[0013] Compared with the prior art, the principles and beneficial effects of the present invention are as follows: The inventors of this invention have surprisingly discovered in practice that the occurrence of discoloration is due to the easy formation of satellite agglomerates in the preparation process of ink powder using existing processes. Therefore, in this invention, by forming composite particles A from catechu powder, ink powder, and sugar powder, and mixing them with Coptis chinensis and Coptis chinensis to form an initial mixture, not only is the discoloration phenomenon solved, but the homogeneity of Coptis chinensis, Coptis chinensis, and catechu powder is also improved.

[0014] The inventors further improved the utilization rate of bezoar by adding bezoar and preserved ink in the final production stage, while ensuring that the effective ingredient RSD of bezoar is less than 5%. Attached Figure Description

[0015] Figure 1 This is a process flow diagram of Comparative Example 1 of the present invention; Figure 2 This is a process flow diagram of Embodiment 1 of the present invention; Figure 3 This is a process flow diagram of Comparative Example 2 of the present invention; Figure 4 This is a process flow diagram of Embodiment 4 of the present invention; Figure 5 This is a process flow diagram of Embodiment 5 of the present invention. Detailed Implementation

[0016] As used in this article: "Prepared from" is synonymous with "comprising". The terms "comprising", "including", "having", "containing", or any other variations thereof as used herein are intended to cover non-exclusive inclusion. For example, a composition, step, method, article, or apparatus that includes the listed elements is not necessarily limited to those elements, but may include other elements not expressly listed or elements inherent to such composition, step, method, article, or apparatus.

[0017] When a quantity, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper and lower preferred values, this should be understood as specifically disclosing all ranges formed by any pair of any upper or preferred value with any lower or preferred value, regardless of whether the range is disclosed individually. For example, when the range “1–5” is disclosed, the described range should be interpreted as including ranges “1–4”, “1–3”, “1–2”, “1–2 and 4–5”, “1–3 and 5”, etc. When numerical ranges are described herein, unless otherwise stated, the range is intended to include its endpoints and all integers and fractions within that range.

[0018] The technical solution of the present invention will be clearly and completely described below with reference to embodiments and comparative examples. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] Those skilled in the art will understand that the following embodiments are for illustrative purposes only and should not be construed as limiting the scope of this application. Unless otherwise specified in the embodiments and comparative examples, specific conditions were applied under conventional conditions or conditions recommended by the manufacturer. Materials or instruments used without a specified manufacturer are all commercially available products. All materials used in the following embodiments and comparative examples were purchased from the same batch.

[0020] In these embodiments, unless otherwise specified, the portions and percentages are all by weight.

[0021] "Parts by mass" refers to the basic unit of measurement that expresses the mass ratio of multiple components. One part can represent any unit mass, such as 1g or 2.689g. If we say that component A has "a" parts by mass and component B has "b" parts by mass, it means the ratio of the mass of component A to the mass of component B is a:b. Alternatively, it can mean that the mass of component A is aK and the mass of component B is bK (K is any number representing a multiplier). It is important to understand that, unlike the number of parts by mass, the sum of the mass parts of all components is not limited to 100 parts.

[0022] "And / or" is used to indicate that one or both of the described situations may occur, for example, A and / or B includes (A and B) and (A or B).

[0023] In the following examples and comparative examples, the formula of Wanying Capsules is as follows: 60 parts by weight of Coptis chinensis, 60 parts by weight of Picrorhiza scrophulariiflora, 60 parts by weight of catechu, 120 parts by weight of cinnamon ink, 3.6 parts by weight of borneol, 12 parts by weight of bear bile powder, 3 parts by weight of artificial musk, 3 parts by weight of in vitro cultured bezoar, and 96 parts by weight of ox bile.

[0024] In the following examples and comparative examples, the amount of powdered sugar used was 675 parts by mass; the volume fraction of ethanol in the ethanol aqueous solution was 80%, and the amount of ethanol aqueous solution used was 238 parts by mass.

[0025] Comparative Example 1 A method for preparing a universal capsule, the process flow is as follows: Figure 1 This includes the following steps:

[0026] S1, mix and pulverize Coptis chinensis, Coptis chinensis, catechu and sesame oil, and pass through a 100-mesh sieve to obtain mixture one.

[0027] S2. This step includes the following steps: S21, mix the in vitro cultured bezoar that has passed through an 80-mesh sieve with the mixed powder in S1 to obtain mixture two.

[0028] S22. Add the sugar powder that has passed through a 100-mesh sieve to mixture two and mix well to form mixture three.

[0029] S23, Bear bile powder is mixed with ox bile to form mixture four, including the following steps: S231, bear bile powder is boiled and dissolved in purified water to obtain bear bile powder solution, wherein the amount of purified water is 1.5 times the mass of bear bile powder.

[0030] S232, concentrate and filter ox bile to obtain ox bile paste, the specific gravity of which is 1.2 g / mL.

[0031] S233, add an appropriate amount of purified water to the ox bile paste and bear bile powder solution to mix and obtain mixture four. The amount of purified water added is appropriate, depending on the state in actual production where the ox bile paste and bear bile powder solution can be prepared into a wetting agent.

[0032] S24. Mixture 3 and Mixture 4 and the ethanol aqueous solution are mixed and granulated by a granulator, dried, sized, and sieved. The drying temperature is 55℃. The granulation is carried out by a gyratory granulator with a 10-mesh stainless steel screen. The sieving is carried out by a gyratory granulator with 10-mesh and 80-mesh stainless steel screens.

[0033] S25. Mix borneol and artificial musk, grind them into a fine powder, sieve them through a 60-mesh sieve, and then mix them with the sieved particles from S24 to obtain product particles. Fill empty capsules to obtain Wanying Capsules.

[0034] In steps S21, S22, S23, and S25, a three-dimensional motion mixer is used for each mixing step, with a rotation speed of 20 rpm and a mixing time of 15 min.

[0035] Example 1 A method for preparing a universal capsule with significantly improved homogenization, the process flow is as follows: Figure 2 This includes the following steps: S0, mix and grind Coptis chinensis and Coptis chinensis, pass through a 100-mesh sieve to obtain an initial mixture; grind catechu and ink separately, pass through a 100-mesh sieve to obtain catechu powder and ink powder; pass sugar powder through a 100-mesh sieve.

[0036] S1, take catechu powder, ink powder and 135 parts by weight of sugar powder from S0, mix them in a high-speed mixer at 1000 rpm for 10 minutes to obtain composite particles A. Mix the initial mixture with composite particles A to form mixture one.

[0037] S2, This step includes the following steps: S21, Mix the in vitro cultured bezoar that has passed through an 80-mesh sieve with Mixture 1 to form Mixture 2.

[0038] S22, add the remaining powdered sugar to mixture two and mix well to form mixture three.

[0039] S23, Bear bile powder is mixed with ox bile to form mixture four, including the following steps: S231. The bear bile powder is boiled and dissolved in purified water to obtain a bear bile powder solution, wherein the amount of purified water is 1.5 times the mass of the bear bile powder.

[0040] S232. Concentrate and filter ox bile to obtain ox bile extract, the specific gravity of which is 1.2 g / mL.

[0041] S233. Add an appropriate amount of purified water to the ox bile paste and bear bile powder solution and mix to obtain mixture four. The amount of purified water added is appropriate, depending on the state in actual production where the ox bile paste and bear bile powder solution can be prepared into a wetting agent.

[0042] S24. Mixture 4 and Mixture 3 and ethanol aqueous solution are mixed and granulated by a granulator, dried, sized and sieved; the drying temperature is 55℃, granulation is carried out by a gyratory granulator with a 10-mesh stainless steel screen, and sieving is carried out by a gyratory granulator with 10-mesh and 80-mesh stainless steel screens.

[0043] S25. Mix borneol and artificial musk, grind them into a fine powder, sieve them through a 60-mesh sieve, and then mix them with the sieved particles from S24 to obtain product particles. Fill empty capsules to obtain Wanying Capsules.

[0044] In S1, S21, S22, S23, and S25, a three-dimensional motion mixer is used for each mixing step, with a rotation speed of 20 rpm and a mixing time of 15 min.

[0045] Comparative Example 2 The difference compared to Example 1 is as follows: S0 is: mix and pulverize Coptis chinensis, Coptis chinensis and 135 parts by weight of sugar powder, and pass through a 100-mesh sieve to obtain an initial mixture; catechu and ink powder are pulverized separately and passed through a 100-mesh sieve to obtain catechu powder and ink powder; sugar powder is passed through a 100-mesh sieve.

[0046] S1 is: Take the catechu powder and ink powder of S0, mix them in a high-speed mixer at 1000 rpm for 10 minutes to obtain composite particles A. The initial mixture is mixed with composite particles A to form mixture one.

[0047] The comparative process flow is as follows: Figure 3 .

[0048] Two batches of each of Comparative Example 1, Example 1, and Comparative Example 2 were produced, and 2000 capsules of each were made. The weight of the contents (product particles) of one capsule was 0.3g.

[0049] Color spot detection: 200 capsules each of Comparative Example 1, Example 1 and Comparative Example 2 were randomly selected. Under standard light (1000 Lux, bright office environment), the contents of the capsules (product particles) were poured onto a white cardboard. Judgment criteria: at a distance of 30cm, any area with a color that is clearly visible to the naked eye and is significantly different from the surrounding area was judged as "having a color spot". When judging, only obvious color spots that are "visible at a glance" were counted, and minor color differences that required careful searching were ignored. The results are shown in Table 1 below.

[0050] Content content detection: Ten capsules of each of Comparative Example 1, Example 1 and Comparative Example 2 were randomly selected and the effective content of Coptis chinensis and Calculus bovis was detected. The results are shown in Table 1.

[0051] Table 1. Detection of pigmentation spots and inclusions As shown in Table 1, the improvement of the existing process in Example 1, especially the method of forming composite particles A from catechu powder, ink powder, and sugar powder, solved the problem of color spots, improved product quality, and increased the homogenization of Coptis chinensis and bezoar. Table 1 also shows that while solving the color spot problem, it also improved the homogenization of Coptis chinensis, Coptis chinensis, and bezoar. However, Comparative Example 2 not only failed to solve the color spot problem, but also made the problem more serious, with more severe satellite aggregation, and the improvement of Coptis chinensis and bezoar was not significant.

[0052] Example 2 The difference compared to Example 1 is as follows: In S0, it passes through an 80-mesh sieve.

[0053] In S1, the rotation speed is 8 rpm and the time is 15 minutes.

[0054] Example 3 The difference compared to Example 1 is as follows: In S1, the rotation speed is 12 rpm and the time is 10 min.

[0055] The capsules prepared in Example 2 and Example 3 were subjected to pigmentation detection. 200 capsules of each were randomly tested. The number of pigmented particles in Example 2 was 3 and the number of pigmented particles in Example 3 was 4.

[0056] Although Examples 1-3 solved the problem of pigmentation and improved the homogeneity of some substances, the content of bezoar in the final product still needs to be increased.

[0057] Example 4 A method for preparing a universal capsule with significantly improved homogenization, the process flow is as follows: Figure 4 This includes the following steps: S0, mix and grind Coptis chinensis and Coptis chinensis, pass through a 100-mesh sieve to obtain an initial mixture; grind catechu and ink separately, pass through a 100-mesh sieve to obtain catechu powder and ink powder; pass sugar powder through a 100-mesh sieve.

[0058] S1, take catechu powder, ink powder and 135 parts by weight of sugar powder from S0, mix them in a high-speed mixer at 1000 rpm for 10 minutes to obtain composite particles A. Mix the initial mixture with composite particles A to form mixture one.

[0059] S2, This step includes the following steps: S22, add the remaining powdered sugar to mixture one and mix well to form mixture three.

[0060] S23, Bear bile powder is mixed with ox bile to form mixture four, including the following steps: S231. The bear bile powder is boiled and dissolved in purified water to obtain a bear bile powder solution, wherein the amount of purified water is 1.5 times the mass of the bear bile powder.

[0061] S232. Concentrate and filter ox bile to obtain ox bile extract, the specific gravity of which is 1.2 g / mL.

[0062] S233. Add an appropriate amount of purified water to the ox bile paste and bear bile powder solution and mix to obtain mixture four. The amount of purified water added is appropriate, depending on the state in actual production where the ox bile paste and bear bile powder solution can be prepared into a wetting agent.

[0063] S24. Mixture 4 and Mixture 3 and ethanol aqueous solution are mixed and granulated by a granulator, dried, sized and sieved; the drying temperature is 55℃, granulation is carried out by a gyratory granulator with a 10-mesh stainless steel screen, and sieving is carried out by a gyratory granulator with 10-mesh and 80-mesh stainless steel screens.

[0064] S25. Mix and grind borneol and artificial musk into a fine powder, sieve through a 60-mesh sieve, and then mix with the sieved particles from S24 and the in vitro cultured bezoar that has passed through an 80-mesh sieve to obtain product particles, which are then filled into empty capsules to obtain Wanying Capsules.

[0065] In S1, S22, S23, and S25, a three-dimensional motion mixer is used for each mixing step, with a rotation speed of 20 rpm and a mixing time of 15 min.

[0066] Two batches were produced using the process described in this embodiment, resulting in 2000 Wanying capsules. The weight of the contents (product particles) in each Wanying capsule was 0.3g.

[0067] Ten capsules of Wanying were randomly selected and their effective content of bezoar was tested. The results are shown in Table 2.

[0068] Table 2. Results of bezoar detection in Example 4 Compared with Example 1, Example 4, because the in vitro cultured bezoar was added in the final part of the production process without going through granulation, sizing, and drying equipment, reduced equipment adhesion losses and improved the utilization rate of the in vitro cultured bezoar. However, the distribution of bezoar in the product particles was uneven. The results of the bezoar effective component (bilirubin) content test in Example 4 showed that the RSD of Example 4 was significantly higher than that of Example 1, and the RSD of Example 4 was greater than 5% of the process control.

[0069] Example 5 A method for preparing a universal capsule with significantly improved homogenization, the process flow is as follows: Figure 5 This includes the following steps: S0, mix and grind Coptis chinensis and Coptis chinensis, pass through a 100-mesh sieve to obtain an initial mixture; grind catechu and ink separately, pass through a 100-mesh sieve to obtain catechu powder and ink powder; pass sugar powder through a 100-mesh sieve.

[0070] S1, take 105 parts by weight of catechu powder, 105 parts by weight of ink powder, and 135 parts by weight of sugar powder from S0, mix them in a high-speed mixer at 1000 rpm for 10 minutes to obtain composite particles A. Mix the initial mixture with composite particles A to form mixture one.

[0071] S2, This step includes the following steps: S22, add the remaining powdered sugar to mixture one and mix well to form mixture three.

[0072] S23, Bear bile powder is mixed with ox bile to form mixture four, including the following steps: S231. The bear bile powder is boiled and dissolved in purified water to obtain a bear bile powder solution, wherein the amount of purified water is 1.5 times the mass of the bear bile powder.

[0073] S232. Concentrate and filter ox bile to obtain ox bile extract, the specific gravity of which is 1.2 g / mL.

[0074] S233. Add an appropriate amount of purified water to the ox bile paste and bear bile powder solution and mix to obtain mixture four. The amount of purified water added is appropriate, depending on the state in actual production where the ox bile paste and bear bile powder solution can be prepared into a wetting agent.

[0075] S24. Mixture 4 and Mixture 3 and ethanol aqueous solution are mixed and granulated by a granulator, dried, sized and sieved; the drying temperature is 55℃, granulation is carried out by a gyratory granulator with a 10-mesh stainless steel screen, and sieving is carried out by a gyratory granulator with 10-mesh and 80-mesh stainless steel screens.

[0076] S25. Mix borneol and artificial musk, grind them into a fine powder, sieve them through a 60-mesh sieve, and then mix them with the sieved particles from S24, the in vitro cultured bezoar that has passed through an 80-mesh sieve, and the remaining ink to obtain product particles. Fill empty capsules to obtain Wanying Capsules.

[0077] In S1, S22, S23, and S25, a three-dimensional motion mixer is used for each mixing step, with a rotation speed of 20 rpm and a mixing time of 15 min.

[0078] Two batches were produced using the process described in this embodiment, resulting in 2000 Wanying capsules. The weight of the contents (product particles) in each Wanying capsule was 0.3g.

[0079] 200 capsules of Wanying Capsules were randomly selected for pigmentation detection, and the results are shown in Table 3. 10 capsules of Wanying Capsules were randomly selected for the detection of the effective content of bezoar, and the results are shown in Table 3.

[0080] Table 3 Detection results of Example 5 As shown in Table 3, the addition of 15 parts by weight of scented ink powder, due to its similar properties to borneol, artificial musk and bezoar, not only improved the homogeneity of bezoar (RSD of 4.2%, meeting the process control requirements), but also further improved the color spot phenomenon, and no polymerization phenomenon occurred.

[0081] Furthermore, those skilled in the art will understand that although some embodiments herein include certain features included in other embodiments but not others, combinations of features from different embodiments are intended to be within the scope of this application and form different embodiments. The information disclosed in this background section is intended only to enhance the understanding of the general background of this application and should not be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

Claims

1. A method for preparing a universal capsule with significantly improved homogenization, wherein, The formula for Wanying Capsules is as follows: 50-65 parts by weight of Coptis chinensis, 50-65 parts by weight of Picrorhiza scrophulariiflora, 50-65 parts by weight of catechu, 105-125 parts by weight of cinnamon, 10.2-12 parts by weight of bear bile powder, 2-3.5 parts by weight of bezoar, 80-98 parts by weight of ox bile, 3-4 parts by weight of borneol, 2-3.5 parts by weight of artificial musk, and 600-700 parts by weight of sugar powder as an excipient. The method for preparing the capsules includes the following steps: S1, take all the catechu powder, all the ink powder, and 110-140 parts by weight of sugar powder, mix them in a high-speed mixer to obtain composite particles A, and mix the initial mixture formed by mixing all the Coptis chinensis and all the Coptis chinensis with composite particles A to form mixture one; S2, Mixture 1 is mixed with the remaining ingredients to obtain the Wan Ying Capsule, including the following steps: S21, Mix bezoar with mixture one to form mixture two; S22, add the remaining powdered sugar to mixture two and mix well to form mixture three; S23, All bear bile powder and all ox bile are mixed to form mixture four; S24. Mixture 3 and Mixture 4 are mixed and then granulated, dried, sized, and sieved using a granulator. S25. Mix all borneol and all artificial musk, grind them into a fine powder, sieve them, and then mix them with the sieved particles from S24 to obtain product particles. Fill empty capsules to obtain Wanying Capsules. The mass fraction is one of grams, kilograms, thousand kilograms, or ten thousand kilograms.

2. The method for preparing the Wanying capsule with significantly improved homogenization according to claim 1, characterized in that, Before S1, there is also S0. The initial mixture is formed by mixing and crushing Coptis chinensis and Coptis chinensis, sieving, and obtaining the initial mixture. The initial mixture is a mixture that has passed through an 80-100 mesh sieve. All catechu powder, all ink powder, and all sugar powder are each powder that has passed through an 80-100 mesh sieve.

3. The method for preparing the Wanying capsule with significantly improved homogenization according to claim 1, characterized in that, In S1, the high-speed mixer operates at a speed of 8 rpm to 20 rpm and a mixing time of 10 min to 30 min.

4. The method for preparing the Wanying capsule with significantly improved homogenization according to claim 1, characterized in that, S23 includes the following steps: S231. Boil and dissolve all the bear bile powder in purified water to obtain bear bile powder solution. The amount of purified water is 1 to 2 times the mass of the bear bile powder. S232. Concentrate and filter all the ox bile to obtain ox bile extract, the specific gravity of which is 1.1 g / mL to 1.3 g / mL; S233. Add an appropriate amount of purified water to the ox bile paste and bear bile powder solution and mix to obtain mixture four. The amount of purified water added is appropriate.

5. The method for preparing the Wanying capsule with significantly improved homogenization according to claim 1, characterized in that, In S24, the drying temperature is 50℃~55℃. Granulation is carried out by a gyratory pellet mill with a 10-mesh stainless steel screen. Sieving is carried out by a gyratory pellet mill with 10-mesh and 80-mesh stainless steel screens. In the mixed granulation, an ethanol aqueous solution is also added. The volume fraction of ethanol in the ethanol aqueous solution is 75%~85%, and the amount used is 230 parts by weight~245 parts by weight.

6. A method for preparing a universal capsule with significantly improved homogenization, wherein, The formula for Wanying Capsules is as follows: 50-65 parts by weight of Coptis chinensis, 50-65 parts by weight of Picrorhiza scrophulariiflora, 50-65 parts by weight of catechu, 105-125 parts by weight of cinnamon, 10.2-12 parts by weight of bear bile powder, 2-3.5 parts by weight of bezoar, 80-98 parts by weight of ox bile, 3-4 parts by weight of borneol, 2-3.5 parts by weight of artificial musk, and 600-700 parts by weight of sugar powder as an excipient. The method for preparing the capsules includes the following steps: S1, take all the catechu powder, 100-110 parts by weight of ink powder, and 110-140 parts by weight of sugar powder, mix them in a high-speed mixer to obtain composite particles A, and mix the initial mixture formed by mixing all the Coptis chinensis and all the Coptis chinensis with composite particles A to form mixture one; S2, Mixture 1 is mixed with the remaining ingredients to obtain the Wan Ying Capsule, including the following steps: S22, add the remaining powdered sugar to mixture one and mix well to form mixture three; S23, All bear bile powder and all ox bile are mixed to form mixture four; S24. Mixture 3 and Mixture 4 are mixed and then granulated, dried, sized, and sieved using a granulator. S25. Mix all borneol, all artificial musk and 10 to 25 parts by weight of ink powder, grind them into a fine powder, sieve them, mix them with the sieved granules from S24 and all bezoar to obtain product granules, and fill them into empty capsules to obtain Wanying Capsules. The mass fraction is one of grams, kilograms, thousand kilograms, or ten thousand kilograms.

7. The method for preparing the Wanying capsule with significantly improved homogenization according to claim 6, characterized in that, Before S1, there is also S0. The initial mixture is formed by mixing and crushing Coptis chinensis and Coptis chinensis, sieving, and obtaining the initial mixture. The initial mixture is a mixture that has passed through an 80-100 mesh sieve. All catechu powder, all ink powder, and all sugar powder are each powder that has passed through an 80-100 mesh sieve.

8. The method for preparing the Wanying capsule with significantly improved homogenization according to claim 6, characterized in that, In S1, the high-speed mixer operates at a speed of 800 rpm to 1200 rpm, and the mixing time is 10 min to 30 min.

9. The method for preparing the Wanying capsule with significantly improved homogenization according to claim 6, characterized in that, S23 includes the following steps: S231. Boil and dissolve all the bear bile powder in purified water to obtain bear bile powder solution. The amount of purified water is 1 to 2 times the mass of the bear bile powder. S232. Concentrate and filter all the ox bile to obtain ox bile extract, the specific gravity of which is 1.1 g / mL to 1.3 g / mL; S233. Add an appropriate amount of purified water to the ox bile paste and bear bile powder solution and mix to obtain mixture four. The amount of purified water added is appropriate.

10. The method for preparing the Wanying capsule with significantly improved homogenization according to claim 6, characterized in that, In S24, the drying temperature is 50℃~55℃. Granulation is carried out by a gyratory pellet mill with a 10-mesh stainless steel screen. Sieving is carried out by a gyratory pellet mill with 10-mesh and 80-mesh stainless steel screens. In the mixed granulation, an ethanol aqueous solution is also added. The volume fraction of ethanol in the ethanol aqueous solution is 75%~85%, and the amount used is 230 parts by weight~245 parts by weight.

Citation Information

Patent Citations

  • Wanchu granules and preparation method thereof

    CN115192652A