Preparation method of traditional Chinese medicine granules

Abstract

The invention discloses a preparation method of traditional Chinese medicine granules. The method comprises the following steps: mixing and dissolving traditional Chinese medicine extract with a proper amount of 70-95% ethanol solution, filtering, and preparing granules with a proper amount of auxiliary materials.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a method for preparing traditional Chinese medicine granules. Background Art

[0002] Chinese herbal granules are easy to carry and take, and do not require decocting. They are particularly suitable for people who are busy at work and find it difficult to decoct Chinese medicine on their own, as well as children and other people who have difficulty swallowing.

[0003] The granulation methods of Chinese medicine granules include wet granulation, dry granulation, one-step granulation, spray granulation, etc. Among them, wet granulation is the most widely used. The obtained granules are surface moistened and have the advantages of good granule quality, beautiful appearance, and strong wear resistance.

[0004] When Chinese medicine granules are granulated by wet method, in order to reduce the amount of auxiliary materials, it is usually necessary to concentrate the Chinese medicine extract to a higher relative density. The applicant found in the early production process that some Chinese medicine extracts would produce scorch-like foreign matter after concentration, and the granules obtained after filtering with filter cloth still had scorch-like foreign matter observed during the solubility test. In order to solve this problem, the applicant tried a variety of methods, including lowering the concentration temperature, increasing the vacuum degree, and filtering with filter cloth with a higher mesh number, but the improvement in the solubility test results was not obvious.

[0005] As mentioned above, there is currently a lack of a method that can effectively solve the problem of unqualified solubility of granules made from this type of Chinese medicine extract. Summary of the invention

[0006] The invention provides a method for preparing Chinese medicine granules, which can effectively solve the problem that many Chinese medicine granules fail to meet the solubility inspection requirements.

[0007] The invention provides a method for preparing Chinese medicine granules, which comprises the steps of mixing and dissolving a Chinese medicine extract with an appropriate amount of 70%-95% ethanol solution, filtering, and then preparing granules with an appropriate amount of auxiliary materials.

[0008] Wherein, the relative density of the traditional Chinese medicine extract is 1.15~1.40.

[0009] Among them, the amount of 70%~95% ethanol solution can be optimized according to the solubility of the extract after mixed dissolution and filtration. The solubility inspection method is as follows: take an extract equivalent to 1 bag of granules in a single-dose package, add 200ml of hot water, stir for 5 minutes, the solution should be clear or slightly turbid, and there should be no charred foreign matter.

[0010] Among them, the Chinese medicine granules can be any one of Isatis Root Granules, Enteritis Ning Granules, Compound Apricot Fragrance Rabbit Ear Wind Granules, Pulse An Granules, Brain Blood Health Granules, Qinggan Lidan Granules, Qingliang Fangshu Granules, Schisandra Granules, Apricot Fragrance Rabbit Ear Wind Granules, Xuekang Granules, Motherwort Granules or Zixin Yin Granules, but are not limited to the Chinese medicine granules listed above, and can also be other Chinese medicine granules with the same problem.

[0011] Wherein, when the Chinese medicine granules are Radix Isatidis granules, the preparation method is as follows: (1) Take 1400g of Radix Isatidis, add water and boil twice, the first time for 2 hours and the second time for 1 hour, filter the decoction, combine the filtrates, and concentrate to a clear paste with a relative density of about 1.20, add ethanol to make the alcohol content reach 60%, let it stand for precipitation, take the supernatant, recover the ethanol and concentrate it to an extract with a relative density of 1.30~1.35; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

[0012] Wherein, when the Chinese medicine granules are Schisandra chinensis granules, the preparation method is as follows: (1) Take 300g of Schisandra chinensis, add water and boil twice, each time for 2 hours, filter the decoction, combine the filtrate, let it stand, separate the supernatant, concentrate it to a clear paste with a relative density of 1.16-1.22, add 2 times the amount of ethanol, stir it thoroughly, let it stand for 24 hours, filter it, wash the residue with 60% ethanol, combine the washing liquid and the filtrate, recover the ethanol and concentrate it to an extract with a relative density of about 1.36; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, add an appropriate amount of sucrose powder, make granules, dry, and make 1000 g.

[0013] Wherein, the Chinese medicine granules are Xingxiang Tuerfeng granules, and the preparation method is as follows: (1) Take 1500g of Xingxiang Tuerfeng, add 8 times the amount of water and boil for three times, each time for 2 hours, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.10-1.20, add ethanol to make the alcohol content 70%, let it stand overnight, and separate the supernatant; wash the precipitate twice with 70% ethanol, combine the washing liquid and the supernatant, recover the ethanol under reduced pressure and concentrate to an extract with a relative density of about 1.30; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

[0014] Wherein, when the Chinese medicine granules are Xuekang granules, the preparation method is as follows: (1) Take 416.7g of Radix Sarcandrae extract powder, add 6666.7ml of water, heat to boil and dissolve, concentrate to 1000ml, let cool, add ethanol to make the alcohol content reach 70%, let stand for 48 hours, take the supernatant, recover the ethanol, and concentrate to an extract with a relative density of about 1.33; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

[0015] Wherein, when the Chinese medicine granules are Leonurus japonicus granules, the preparation method is as follows: (1) Take 1350g of Leonurus japonicus, chop it, add water and boil it for 3 hours, filter the decoction, concentrate the filtrate to a clear paste with a relative density of about 1.04, let it stand, take the supernatant, and concentrate it to an extract with a relative density of 1.36-1.38; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

[0016] The preparation method provided by the invention does not require special equipment and is simple to operate and is very economical and practical.

[0017] The present invention is further described below by taking Radix Isatidis granules as an example.

[0018] Experimental Example 1 Study on the Preparation Method of Radix Isatidis Granules 1. Preparation and solubility test of Isatis root granules Take Radix Isatidis, add water and boil twice, the first time for 2 hours, the second time for 1 hour, filter the decoction, combine the filtrates, and concentrate under reduced pressure to a clear paste with a relative density of about 1.20 (50°C), add ethanol to make the alcohol content reach 60%, let it stand for precipitation, take the supernatant, recover the ethanol under reduced pressure and concentrate it to an extract with a relative density of 1.33 (56°C), filter it with a 300-mesh filter cloth, add 80% ethanol solution and stir evenly, filter it with a 300-mesh filter cloth, and set aside; Take weighed sucrose powder and dextrin, stir evenly, add the evenly mixed mixture of Isatis Radix granules fluid extract and 80% ethanol solution mentioned above, make granules, dry and granulate to obtain Isatis Radix granules.

[0019] Solubility test and results: Take 10g of granules (equivalent to 14g of the decoction piece), add 200ml of hot water, stir for 5 minutes, and there will be a small amount of charred matter at the bottom of the solution.

[0020] 2. Research on the preparation process of Isatis Radix Granules (1) Comparison of concentration temperature differences of alcohol precipitation filtrate Take 2 L of the alcohol precipitation filtrate and divide it into 2 equal parts. One part is concentrated under reduced pressure at 50°C to obtain extract ①; the other part is concentrated under reduced pressure at 70°C to obtain extract ②. The above extracts are made into granules according to the method under "1. Preparation of Isatis Root Granules and Solubility Test" to obtain Granules ① and granules ②.

[0021] Solubility test results: There was a small amount of charred matter at the bottom of both granular solutions, with no significant difference.

[0022] (2) Comparison of particle drying temperature differences Take two portions of wet granules from the item “(1) Comparison of the difference in concentration temperature of the alcohol precipitation filtrate” and dry them at 50°C and 70°C respectively to obtain granules ① and ②.

[0023] Solubility test results: There was a small amount of charred matter at the bottom of both granular solutions, with no significant difference.

[0024] 3. Study on the properties of coke Take 500g of granules under "1. Preparation of Isatis Root Granules and Solubility Test", add 5L of hot water, stir to dissolve, filter, collect the charred residue, take a small amount, add 50% ethanol, 95% ethanol, 50% methanol, and methanol ultrasonic dissolution respectively, the results: they can basically be completely dissolved.

[0025] 4. Research on the granulation process of Radix Isatidis Granules Take two portions of extract with a relative density of 1.33 (56°C), each 2.5kg, add 180ml of 80% ethanol solution to one portion, stir evenly, filter through a 300-mesh filter cloth, add to a mixture of sucrose powder and dextrin that has been evenly mixed, make granules, dry, and round to obtain Isatis Radix Granules ①; add 180ml of 80% ethanol solution to the other portion at 80°C, mix for 30 minutes, filter through a 300-mesh filter cloth, add to a mixture of sucrose powder and dextrin that has been evenly mixed, make granules, dry, and round to obtain Isatis Radix Granules ②.

[0026] Solubility test results: There is a small amount of charred matter at the bottom of the solution of particle ①, and the solution of particle ② is clear. DETAILED DESCRIPTION

[0027] The following examples are used to illustrate the present invention but are not intended to limit the scope of the present invention.

[0028] Example 1: Preparation method of Radix Isatidis granules (1) Take 1400g of Radix Isatidis, add water and boil twice, the first time for 2 hours and the second time for 1 hour, filter the decoction, combine the filtrates, and concentrate to a clear paste with a relative density of about 1.20, add ethanol to make the alcohol content reach 60%, let it stand for precipitation, take the supernatant, recover the ethanol and concentrate it to an extract with a relative density of 1.30~1.35; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

[0029] Example 2: Preparation method of Schisandra chinensis granules (1) Take 300g of Schisandra chinensis, add water and boil twice, each time for 2 hours, filter the decoction, combine the filtrate, let it stand, separate the supernatant, concentrate it to a clear paste with a relative density of 1.16-1.22, add 2 times the amount of ethanol, stir it thoroughly, let it stand for 24 hours, filter it, wash the residue with 60% ethanol, combine the washing liquid and the filtrate, recover the ethanol and concentrate it to an extract with a relative density of about 1.36; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, add an appropriate amount of sucrose powder, make granules, dry, and make 1000 g.

[0030] Example 3: Preparation method of apricot-scented rabbit ear wind granules (1) Take 1500g of Xingxiang Tuerfeng, add 8 times the amount of water and boil for three times, each time for 2 hours, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.10-1.20, add ethanol to make the alcohol content 70%, let it stand overnight, and separate the supernatant; wash the precipitate twice with 70% ethanol, combine the washing liquid and the supernatant, recover the ethanol under reduced pressure and concentrate to an extract with a relative density of about 1.30; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

[0031] Example 4: Preparation method of Xuekang granules (1) Take 416.7g of Radix Sarcandrae extract powder, add 6666.7ml of water, heat to boil and dissolve, concentrate to 1000ml, let cool, add ethanol to make the alcohol content reach 70%, let stand for 48 hours, take the supernatant, recover the ethanol, and concentrate to an extract with a relative density of about 1.33; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

[0032] Example 5: Preparation method of motherwort granules (1) Take 1350g of Leonurus japonicus, chop it, add water and boil it for 3 hours, filter the decoction, concentrate the filtrate to a clear paste with a relative density of about 1.04, let it stand, take the supernatant, and concentrate it to an extract with a relative density of 1.36-1.38; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

Claims

1. A method for preparing Chinese medicine granules, characterized in that: The preparation method comprises the steps of mixing and dissolving the Chinese medicine extract with an appropriate amount of 70%-95% ethanol solution, filtering, and then preparing granules with an appropriate amount of auxiliary materials.

2. The preparation method according to claim 1, characterized in that: The relative density of the Chinese medicine extract is 1.15-1.

40.

3. The preparation method according to claim 1, characterized in that: The Chinese medicine extract is mixed with an appropriate amount of 70%-95% ethanol solution, dissolved and filtered, and then an extract equivalent to one bag of granules in a single-dose package is taken, 200 ml of hot water is added, and stirred for 5 minutes. The solution should be clear or slightly turbid, and no burnt foreign matter should be present.

4. The preparation method according to claim 1, characterized in that The preparation method comprises the following steps: taking a Chinese medicine extract with a relative density of 1.15-1.40, mixing and dissolving it with an appropriate amount of 70%-95% ethanol solution, filtering it, and then preparing granules with an appropriate amount of auxiliary materials to obtain the product.

5. The preparation method according to any one of claims 1 to 4, characterized in that: The Chinese medicine granules are one of Isatis root granules, Changyanning granules, compound apricot-fragrant rabbit ear wind granules, Mai'an granules, Naoxuekang granules, Qingganlidan granules, Qingliangfangshu granules, Schisandra granules, apricot-fragrant rabbit ear wind granules, Xuekang granules, Leonurus granules or Zixinyin granules.

6. The preparation method according to claim 5, characterized in that: The Chinese medicine granules are Radix Isatidis granules, and the preparation method is as follows: (1) Take 1400g of Radix Isatidis, add water and boil twice, the first time for 2 hours and the second time for 1 hour, filter the decoction, combine the filtrates, and concentrate to a clear paste with a relative density of about 1.20, add ethanol to make the alcohol content reach 60%, let it stand for precipitation, take the supernatant, recover the ethanol and concentrate it to an extract with a relative density of 1.30~1.35; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

7. The preparation method according to claim 5, characterized in that: The Chinese medicine granules are Schisandra chinensis granules, and the preparation method is as follows: (1) Take 300g of Schisandra chinensis, add water and boil twice, each time for 2 hours, filter the decoction, combine the filtrate, let it stand, separate the supernatant, concentrate it to a clear paste with a relative density of 1.16-1.22, add 2 times the amount of ethanol, stir it thoroughly, let it stand for 24 hours, filter it, wash the residue with 60% ethanol, combine the washing liquid and the filtrate, recover the ethanol and concentrate it to an extract with a relative density of about 1.36; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, add an appropriate amount of sucrose powder, make granules, dry, and make 1000 g.

8. The preparation method according to claim 5, characterized in that: The Chinese medicine granules are Xingxiang Tuerfeng granules, and the preparation method is as follows: (1) Take 1500g of Xingxiang Tuerfeng, add 8 times the amount of water and boil for three times, each time for 2 hours, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.10-1.20, add ethanol to make the alcohol content 70%, let it stand overnight, and separate the supernatant; wash the precipitate twice with 70% ethanol, combine the washing liquid and the supernatant, recover the ethanol under reduced pressure and concentrate to an extract with a relative density of about 1.30; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

9. The preparation method according to claim 5, characterized in that: The Chinese medicine granules are Xuekang granules, and the preparation method is as follows: (1) Take 416.7g of Radix Sarcandrae extract powder, add 6666.7ml of water, heat to boil and dissolve, concentrate to 1000ml, let cool, add ethanol to make the alcohol content reach 70%, let stand for 48 hours, take the supernatant, recover the ethanol, and concentrate to an extract with a relative density of about 1.33; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.

10. The preparation method according to claim 5, characterized in that: The Chinese medicine granules are Leonurus japonicus granules, and the preparation method is as follows: (1) Take 1350g of Leonurus japonicus, chop it, add water and boil it for 3 hours, filter the decoction, concentrate the filtrate to a clear paste with a relative density of about 1.04, let it stand, take the supernatant, and concentrate it to an extract with a relative density of 1.36-1.38; (2) Take the extract prepared in step (1), add an appropriate amount of 70% to 95% ethanol solution, heat to dissolve, filter with filter cloth, then add an appropriate amount of sucrose powder and dextrin, make granules, dry, and make 1000 g.