Method for homogenizing raw materials of traditional Chinese medicine preparation

Abstract

The present invention relates to the technical field of traditional Chinese medicine preparations, and particularly to a method for homogenizing the raw materials of traditional Chinese medicine preparations. In addition to the single homogenization treatment of the drugs from which the target components of the traditional Chinese medicine preparations are derived, this homogenization treatment method further simplifies the homogenization treatment of other key components that affect the fluctuation of the target components. By adopting this homogenization treatment method, the problem that the optimization of production processes and direct raw material differences cannot further effectively improve the consistency of the preparation quality is effectively solved. At the same time, the problems of cumbersome process flow and long detection cycle during the homogenization treatment of the key raw materials that affect the target components in the existing batch products are avoided. The homogenization treatment of medicinal materials can be simply realized, the quality differences of raw medicinal materials between different batches are preferably reduced, and the quality stability of traditional Chinese medicine preparations in the industry is guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, and particularly to a method for homogenizing raw materials of traditional Chinese medicine preparations. Background Art

[0002] Most traditional Chinese medicine preparations are produced by directly feeding cut pieces of Chinese herbal medicines. The quality fluctuations of the cut pieces are directly introduced into the preparations, which becomes an important reason for the large quality differences among different batches of traditional Chinese medicine preparations, and to a certain extent affects the stable exertion of the clinical efficacy of traditional Chinese medicine. Traditional Chinese medicine has characteristics such as particularity, complexity, and large quality fluctuations. Currently, there are limitations in the homogenization treatment of the medicinal flavors under the quality standards of traditional Chinese medicine preparations, including cut pieces, extracts, etc., and sometimes it is difficult to achieve the expected purpose.

[0003] Taking the medicinal materials of Compound Phellodendron Chinense Liquid as an example, based on the production process, the differences in direct raw materials often affect the judgment of the quality differences of Chinese patent medicines. The production process and feeding that have requirements in the Pharmacopoeia and affect the content difference of berberine hydrochloride, which affects the quality of Compound Phellodendron Chinense Liquid Coated Agent, are studied. Berberine hydrochloride in Compound Phellodendron Chinense Liquid Coated Agent mainly comes from Phellodendron amurense in the raw materials. Therefore, the quality differences of Phellodendron amurense can be directly transmitted to the finished Compound Phellodendron Chinense Liquid Coated Agent. After researchers homogenized the raw materials of Phellodendron amurense using the batch mixing and blending technology with berberine hydrochloride as the index, it was found that the transfer rate relationship of berberine hydrochloride in Compound Phellodendron Chinense Liquid Coated Agent was still unstable. It was considered that it might be related to the production process. However, under the original process of Compound Phellodendron Chinense Liquid Coated Agent, several batches of Phellodendron amurense raw materials were analyzed and calculated. According to the transfer rate data of berberine hydrochloride, the analysis results showed that the original production process was stable and would not cause differences in the transfer rate relationship of berberine hydrochloride.

[0004] In view of the technical limitation that "it is impossible to significantly and effectively improve the quality consistency of preparations from the perspectives of the production process and direct raw material differences", the present invention is proposed. Summary of the Invention

[0005] The present invention provides a method for homogenizing raw materials of traditional Chinese medicine preparations, which effectively solves the problem that the optimization of the production process and direct raw material differences cannot further effectively improve the quality consistency of preparations. At the same time, it avoids the problems of cumbersome process flow and long detection cycle when homogenizing the key raw materials that affect the index components of existing batch products. It can simplify the realization of the homogenization treatment of medicinal materials, preferably reduce the quality differences of raw medicinal materials between different batches, ensure the quality stability of traditional Chinese medicine preparations in the industry, and solve the problems existing in the prior art.

[0006] The technical solution adopted by the present invention is as follows:

[0007] A method for homogenizing raw materials of traditional Chinese medicine preparations includes the following operating steps:

[0008] (1) For each raw material of the traditional Chinese medicine preparation, collect the raw medicinal materials / sliced pieces that have passed the inspection according to the legal standards. The number of batches of each medicinal material / sliced piece is ≥2, and fix one batch of medicinal materials / sliced pieces that meet the enterprise's internal control standards as the reference medicine;

[0009] (2) Identify the quality index components of the traditional Chinese medicine preparation and the main source medicinal materials / sliced pieces of the quality index components of the traditional Chinese medicine preparation;

[0010] (3) Identify the key raw materials other than the source medicinal materials / sliced pieces in step (2) that have an impact on the stability of the quality index components of the traditional Chinese medicine preparation;

[0011] (4) Conduct separate treatment on the main source medicinal materials / sliced pieces of the quality index components of the traditional Chinese medicine preparation in step (2):

[0012] For the feedstock that meets the enterprise's internal control standards, use it directly; or, conduct high-low mixing and blending treatment on the main source medicinal materials / sliced pieces of the quality index components of the traditional Chinese medicine preparation; reserve for use;

[0013] (5) For the key raw materials in step (3), select any one for treatment: For the feedstock that meets the enterprise's internal control standards, use it directly; otherwise, conduct homogenization treatment on the key raw materials. The steps of the homogenization treatment are as follows:

[0014] S1: Weigh the medicinal materials / sliced pieces of the aforementioned key raw materials according to the raw material composition ratio of the traditional Chinese medicine preparation, and use the other raw material components of the traditional Chinese medicine preparation as the reference medicinal materials, reserve for use;

[0015] S2: Preparation of the test solution: Mix the key raw materials described in S1 with the reference medicinal materials, add reagents for extraction treatment to obtain the extracted medicinal materials, which is the test solution; Measure the content of the quality index components of the traditional Chinese medicine preparation in the test solution, denoted as x1;

[0016] S3: Preparation of the negative solution:

[0017] Prepare according to the test solution in S2, remove the key raw materials therein, and prepare the negative solution in the same method; Measure the content of the quality index components of the traditional Chinese medicine preparation in the negative solution, denoted as x2;

[0018] S4: According to the above index contents of the test products and negative solutions of different batches obtained in S2 and S3, formulate and calculate the homogenization standard s to obtain the homogenization ratio of the medicinal materials / sliced pieces of the aforementioned key raw materials of different batches; Among them,

[0019] s = a1f1 + a2f2 + …… a n f n

[0020] 1 = a1 + a2 + …… a n ;

[0021] The above-mentioned homogenization standard s is determined by the internal control standard of the enterprise;

[0022] a is the homogenization ratio of the aforementioned key raw materials in different batches;

[0023] f n is the influencing factor of the aforementioned key raw materials in different batches; influencing factor = x1 divided by x2.

[0024] S5: According to the homogenization ratio of the aforementioned key raw materials in different batches obtained in S4, feed the corresponding batches of this key raw material.

[0025] Furthermore, the operation steps further include:

[0026] (6) Continue to sequentially select other key raw materials, repeat step (5), and perform homogenization treatment.

[0027] Furthermore, the selection of the reagent in step S2 refers to the reagent solution used in the production process of preparing the corresponding traditional Chinese medicine preparation according to the raw materials of the traditional Chinese medicine preparation.

[0028] Furthermore, the traditional Chinese medicine preparation includes a traditional Chinese medicine preparation in which the pairing of preparation components will affect the quality index components in the traditional Chinese medicine preparation, and / or a traditional Chinese medicine preparation in which the quality difference of the preparation components in the pairing will cause a significant fluctuation in the content of the quality index components in the traditional Chinese medicine preparation.

[0029] Furthermore, the traditional Chinese medicine preparation is the medicinal materials of compound huangbai liquid, and the medicinal materials of compound huangbai liquid are used for the preparation of compound huangbai liquid liniment.

[0030] Furthermore, the raw material composition of the medicinal materials of compound huangbai liquid includes phellodendron amurense, honeysuckle flower, dandelion, forsythia suspensa, and scolopendra; the homogenization treatment includes the following operation steps:

[0031] (1) Collect the raw medicinal materials / sliced medicinal materials that have passed the legal standard inspection, with the number of batches of each medicinal material / sliced medicinal material ≥ 2, and fix a batch of medicinal materials / sliced medicinal materials that meet the internal control standard of the enterprise as the reference medicine;

[0032] (2) Identify the quality index component of the medicinal materials of compound huangbai liquid - berberine hydrochloride, and the main source medicinal material / sliced medicinal material of berberine hydrochloride - phellodendron amurense;

[0033] According to the internal control standard of the enterprise, select to perform or not perform high-low mixing and blending treatment, and preferably perform high-low mixing and blending treatment on it alone; reserve for use;

[0034] (3) Identify the key raw materials other than phellodendron amurense that have an impact on the stability of berberine hydrochloride - honeysuckle flower, dandelion; optionally perform one of the following treatments: for the feedstock that meets the internal control standard of the enterprise, use it directly; otherwise, perform homogenization treatment on this key raw material; the steps of this homogenization treatment are as follows:

[0035] ① Preparation of test solution: According to the weight composition of the components of the Compound Huangbai Liquid medicinal materials, weigh the medicinal material powder of Flos Lonicerae or Herba Taraxaci, and mix it with the reference medicine in (1) in a bottle. Precisely add Reagent 1 - ethanol aqueous solution for extraction treatment to obtain the ethanol - extracted medicinal materials. Concentrate to an appropriate amount, dilute with ethanol, and filter; take an appropriate amount of the filtered ethanol - extracted medicinal materials, dilute with water, refrigerate and filter, and take the continuous filtrate; add Reagent 2 - methanol for dilution and filter to obtain the test solution; determine the content of berberine hydrochloride in the solution and record it as x1;

[0036] ② Preparation of negative solution

[0037] Prepare according to ① for the test solution, remove the key raw materials therein, and prepare the negative solution in the same method; determine the content of berberine hydrochloride in the negative solution and record it as x2;

[0038] (4) According to the index contents of the test solutions and negative solutions of different batches obtained above in ① and ②, formulate and calculate the homogenization standard s to obtain the homogenization ratio of the key raw materials of different batches; among them,

[0039] s = a1f1 + a2f2 + …… a n f n

[0040] 1 = a1 + a2 + …… a n ;

[0041] The above - mentioned homogenization standard s is determined by the enterprise's internal control standard;

[0042] a is the homogenization ratio of the key raw materials of different batches - Flos Lonicerae or Herba Taraxaci;

[0043] f n is the influencing factor of the key raw materials of different batches - Flos Lonicerae or Herba Taraxaci; influencing factor = x1 divided by x2;

[0044] (5) According to the homogenization ratio of the key raw materials of different batches obtained in (4), feed the corresponding batches of the key raw materials.

[0045] Furthermore, the Reagent 1 - ethanol aqueous solution in S3 is 0% - 100% ethanol aqueous solution; the extraction treatment is: ultrasonic extraction at 20 - 75 °C for 15 min - 30 min.

[0046] Furthermore, the dosages of each component of the Compound Huangbai Liquid medicinal materials are: Cortex Phellodendri Chinensis 30 - 60 parts, Forsythia suspensa 60 - 120 parts, Flos Lonicerae 30 - 80 parts, Herba Taraxaci 30 - 60 parts, Scolopendra 1.5 - 5.0 parts.

[0047] Further, the enterprise internal control standard value is represented by an influence factor. If the influence factor is equal to the enterprise internal control standard value, it is directly retained. When the influence factor is different from the enterprise internal control standard value, high-low mixing and blending treatment is carried out.

[0048] Further, the enterprise internal control standard for Phellodendron amurense is as follows: calculated on the basis of the dried product, the content of berberine calculated as berberine hydrochloride is 3.5% - 4.5%; the enterprise internal control standard for Lonicera japonica Thunb. is: calculated on the basis of the dried product, the influence factor evaluating the dissolution of berberine hydrochloride is 0.4 ± 0.05 or 40% ± 5%; the enterprise internal control standard for Taraxacum mongolicum Hand.-Mazz. is: calculated on the basis of the dried product, the influence factor evaluating the dissolution of berberine hydrochloride is 0.6 ± 0.05 or 60% ± 5%.

[0049] Further, the key raw materials other than Phellodendron amurense that have an impact on the stability of berberine hydrochloride in step (3) are subjected to homogenization treatment in sequence.

[0050] Advantages of the present invention:

[0051] 1. The present invention adopts more scientific and standardized steps to analyze and homogenize the raw materials of traditional Chinese medicine preparations before feeding, which preferably avoids the problems of cumbersome technological processes and long detection cycles for the homogenization treatment of traditional Chinese medicine raw materials in order to ensure the quality stability of traditional Chinese medicine preparations. It can simplify the process of homogenizing medicinal materials, preferably reduce the quality differences of raw medicinal materials between different batches, and improve the quality of traditional Chinese medicine preparations.

[0052] 2. The present invention specifically examines the problem that the quality of the raw materials of Compound Phellodendron amurense Liquid is unstable between different batches and affects the quality of the final liniment product. The homogenization treatment method of the present invention is used to homogenize the raw materials of Compound Phellodendron amurense Liquid. The results show that on the basis of ensuring the homogenization of the main source raw materials of the index components of the raw materials of Compound Phellodendron amurense Liquid, continuing the homogenization treatment of other single key raw materials (Lonicera japonica Thunb., Taraxacum mongolicum Hand.-Mazz.), the volatility of the index components in the medicinal materials is significantly reduced, which is beneficial to controlling and reducing the influence of the quality differences of raw medicinal materials between different batches on the quality and stability of the medicinal materials.

[0053] 3. The present invention is suitable for use before the preparation of traditional Chinese medicine preparations where the components interact with each other and extraction (of active ingredients) operations are required, and can achieve the beneficial effects of the aforementioned analysis and homogenization treatment before feeding. Specific embodiments

[0054] To clearly illustrate the technical features of the present invention, the present invention will be elaborated in detail through specific embodiments below. The scope of the present invention is not limited to the following embodiments. Professionals in the field can understand that various changes and modifications can be made to the present invention without departing from the spirit and scope of the present invention.

[0055] For the instruments, reagents, materials, etc. involved in the following examples, unless otherwise specified, they are all conventional instruments, reagents, materials, etc. existing in the prior art and can be obtained through regular commercial channels. For the experimental methods, detection methods, etc. involved in the following examples, unless otherwise specified, they are all conventional experimental methods, detection methods, etc. existing in the prior art. For the parts, percentages, etc. involved in the following examples, unless otherwise specified, they are all in weight units.

[0056] In the embodiments of the present invention, the medicinal materials of Compound Huangbai Liquid are taken as an example for illustration.

[0057] Example 1 (Huangbai, Flos Lonicerae, and Herba Taraxaci are not homogenized)

[0058]

Prescription

[0059]

Preparation method

[0060] Take Flos Lonicerae (J01, J02, J04, J05, J07, J08), Phellodendron amurense Rupr. (H01, H02, H03, H04, H05, H07), and Herba Taraxaci (P01, P03, P04, P05, P06, P09) that meet the pharmacopoeia standards in quality, and randomly combine them to prepare 6 batches of Compound Huangbai Liquid liniment. Taking the relative standard deviation of the berberine hydrochloride content as the evaluation index, evaluate the influence of the non-uniformity control of Flos Lonicerae, Herba Taraxaci, and Phellodendron amurense Rupr. on the fluctuation (RSD%) of berberine hydrochloride in Compound Huangbai Liquid liniment. See Table 1. The results show that the fluctuation of berberine hydrochloride in Compound Huangbai Liquid liniment (RSD% = 38.15%) is significantly higher.

[0061] Table 1 Evaluation table of the content fluctuation of berberine hydrochloride in Compound Huangbai Liquid liniment when Huangbai, Flos Lonicerae, and Herba Taraxaci are not homogenized

[0062]

[0063]

[0064] Example 2 (Homogenize Phellodendron amurense Rupr. according to the medicinal material that is the main source of the quality index component - berberine hydrochloride content)

[0065] Homogenization of Phellodendron amurense Rupr.:

[0066] The Pharmacopoeia has requirements for the content of berberine hydrochloride in Compound Huangbai Liquid Liniment, so the quality index component of the medicinal materials for Compound Huangbai Liquid is determined to be berberine hydrochloride, in order to stably achieve the quality control of the medicinal materials for Compound Huangbai Liquid. Since the main source of the medicinal materials is Phellodendron amurense Rupr., therefore, Phellodendron amurense Rupr. is first subjected to separate single homogenization.

[0067] Chinese Pharmacopoeia standard: Calculated on the dried basis, Phellodendron amurense Rupr. contains not less than 3.0% of berberine calculated as berberine hydrochloride. According to the internal control standard of the enterprise: Calculated on the dried basis, Phellodendron amurense Rupr. contains 3.5% - 4.5% of berberine calculated as berberine hydrochloride. The following different batches of Phellodendron amurense Rupr. are homogenized.

[0068] Table 2 Calculation Table for Homogenization of Phellodendron amurense Rupr.

[0069]

[0070] Table 3 Evaluation Table for the Influence after Homogenization of Phellodendron amurense Rupr.

[0071]

[0072]

[0073] For the 6 batches of Compound Huangbai Liquid Liniment prepared by feeding after homogenization of Phellodendron amurense Rupr., with the relative standard deviation of the berberine hydrochloride content as the evaluation index, compared with Example 1, the volatility (RSD%) of berberine hydrochloride in Compound Huangbai Liquid Liniment has decreased (24.94% < 38.15%), but the overall fluctuation is still relatively high.

[0074] Example 3 (Identifying Indirect Key Raw Materials)

[0075]

Prescription

[0076]

Preparation Method

[0077] The content of berberine hydrochloride in the samples is detected respectively, and the results show that Taraxacum mongolicum Hand.-Mazz. and Lonicera japonica Thunb. in the formula have an inhibitory effect on the content of berberine hydrochloride in Compound Huangbai Liquid Liniment. To improve the batch-to-batch uniformity of the finished product, in addition to the medicinal flavor of the index component source - Phellodendron amurense Rupr., the screening and homogenization research of other key raw material medicinal flavors are also quite necessary. Therefore, the identified key raw materials - Taraxacum mongolicum Hand.-Mazz. and Lonicera japonica Thunb. are continuously homogenized and investigated.

[0078] Table 4 Research and Analysis Table of Key Raw Materials

[0079]

[0080] Example 4 (Homogenization of Honeysuckle and Its Influence)

[0081] On the basis of the steps in Example 2, continue the homogenization treatment of honeysuckle. The step operations are as follows:

[0082] Homogenization treatment of honeysuckle:

[0083] 1. Chinese Pharmacopoeia standard for honeysuckle: Calculated on the dried basis, the total amount of phenolic acids, calculated as chlorogenic acid, 3,5-di-O-caffeoylquinic acid and 4,5-di-O-caffeoylquinic acid, shall not be less than 3.8%.

[0084] 2. Enterprise internal control standard: For honeysuckle calculated on the dried basis, the influence factor (or called recovery rate) on the dissolution of berberine hydrochloride is evaluated according to the following test sample method and denoted as f. The standard is tentatively set as 0.4 ± 0.05 or 40% ± 5%, denoted as f JS 。

[0085] 2.1 Preparation of test sample solution

[0086] Precisely weigh 2 portions of forsythia (reference), 1 portion of phellodendron (reference), 1 portion of honeysuckle, 1 portion of dandelion (reference), and 0.06 portion of centipede (reference) powders, place them in a stoppered conical flask, mix, precisely add an appropriate amount of 70% ethanol, weigh, ultrasonicate for 30 minutes, cool, weigh again, make up the lost weight with 70% ethanol, shake well, and filter. Take 2.00 g of the filtrate, dilute it with water to 10.00 g, shake well, refrigerate for 12 - 24 hours, filter off the precipitate, take 1.00 g of the continued filtrate, dilute it with methanol to 10 ml to obtain; determine the content of berberine hydrochloride in the solution and denote it as x1;

[0087] 2.2 Preparation of honeysuckle negative solution

[0088] Precisely weigh 2 portions of forsythia, 1 portion of phellodendron, 0 portion of honeysuckle, 1 portion of dandelion, and 0.06 portion of centipede powders, place them in a stoppered conical flask, mix, precisely add an appropriate amount of 70% ethanol, weigh, ultrasonicate for 30 minutes, cool, weigh again, make up the lost weight with 70% ethanol, shake well, and filter. Take 2.00 g of the filtrate, dilute it with water to 10.00 g, shake well, refrigerate for 12 - 24 hours, filter off the precipitate, take 1.00 g of the continued filtrate, dilute it with methanol to 10 ml to obtain; determine the content of berberine hydrochloride in the solution and denote it as x2;

[0089] 2.3 Calculation of honeysuckle homogenization

[0090] Calculation example:

[0091] Lonicera japonica batch number Influence factors of each batch J1 <![CDATA[f1 = 0.2]]> J2 <![CDATA[f2 = 0.3]]>

[0092] For the honeysuckle of the above different batches, x1 is divided by x2, that is, the influence factor f of the honeysuckle of this batch n ;

[0093] According to the influence factor results of the honeysuckle of different batches, calculate the homogenization mixing ratios a1 and a2 of different batches. The calculation method is as follows: s = 0.4 = a1f1 + a2f2; 1 = a1 + a2;

[0094] a is the homogenization ratio of the two batches of honeysuckle; according to f1 and f2, the obtained a1 is 0.333; a2 is 0.667, that is, 0.333 parts of the honeysuckle of batch J1 and 0.667 parts of the honeysuckle of batch J2 are taken and mixed to obtain the honeysuckle with an influence factor of 0.4.

[0095] Verification of the effect after the homogenization treatment of honeysuckle:

[0096] Verification method:

[0097]

Prescription

[0098]

Preparation method

[0099] Table 5 Honeysuckle homogenization calculation table

[0100]

[0101] Table 6 Influence evaluation table after the homogenization of honeysuckle

[0102]

[0103] According to the above influence factor evaluation method, the test solution and negative solution of the raw materials of the honeysuckle of each batch are prepared, the influence factor is calculated, and according to the foregoing formula, the mixing ratio of any two batches of raw materials for mixed batching is calculated. At the same time, 6 batches of Compound Phellodendron Chinense Liquid Liniment are prepared to evaluate the influence of the homogenization of honeysuckle on the fluctuation (RSD%) of berberine hydrochloride in the Compound Phellodendron Chinense Liquid Liniment. The results show that compared with Example 2, the fluctuation (RSD%) of berberine hydrochloride in the Compound Phellodendron Chinense Liquid Liniment after the homogenization of honeysuckle is significantly reduced (24.94% > 18.15%)

[0104] Example 5 (Effect after the homogenization of Taraxacum mongolicum)

[0105] Based on the steps of Example 4, continue the homogenization treatment of dandelion.

[0106] Homogenization treatment of dandelion:

[0107] 1. Enterprise internal control standard: For dandelion calculated as the dried product, the influence factor (or recovery rate) on the dissolution of berberine hydrochloride is evaluated by the following test sample method and denoted as f. The standard is tentatively set as 0.6 ± 0.05 or 60% ± 5%; the enterprise internal control standard of dandelion is denoted as f PS ;

[0108] 1.1 Preparation of test sample solution

[0109] Precision weigh 2 portions of forsythia (reference), 1 portion of phellodendron bark (reference), 1 portion of honeysuckle flower (reference), 1 portion of dandelion, and 0.06 portion of centipede (reference) powder, place them in a stoppered conical flask, mix, precisely add an appropriate amount of 70% ethanol, weigh, ultrasonicate for 30 minutes, cool, weigh again, make up the lost weight with 70% ethanol, shake well, and filter. Take 2.00 g of the filtrate, dilute it to 10.00 g with water, shake well, refrigerate for 12 - 24 hours, filter off the precipitate, take 1.00 g of the continued filtrate, dilute it to 10 ml with methanol to obtain; determine the content of berberine hydrochloride in the solution and denote it as x1;

[0110] 1.2 Preparation of dandelion negative solution

[0111] Precision weigh 2 portions of forsythia, 1 portion of phellodendron bark, 1 portion of honeysuckle flower, 0 portion of dandelion, and 0.06 portion of centipede powder, place them in a stoppered conical flask, mix, precisely add an appropriate amount of 70% ethanol, weigh, ultrasonicate for 30 minutes, cool, weigh again, make up the lost weight with 70% ethanol, shake well, and filter. Take 2.00 g of the filtrate, dilute it to 10.00 g with water, shake well, refrigerate for 12 - 24 hours, filter off the precipitate, take 1.00 g of the continued filtrate, dilute it to 10 ml with methanol to obtain; determine the content of berberine hydrochloride in the solution and denote it as x2;

[0112] 1.3 The homogenization calculation of dandelion is the same as the homogenization calculation method of honeysuckle in the aforementioned Example 3.

[0113] Verification of the effect after the homogenization treatment of dandelion:

[0114] Verification method:

[0115]

Prescription

[0116]

Preparation Method

[0117] Table 7 Dandelion Homogenization Calculation Table

[0118]

[0119] Table 8 Evaluation Table of the Influence after Dandelion Homogenization

[0120]

[0121] For the raw materials of dandelion in each batch, the test solution and negative solution are prepared according to the above-mentioned influence factor evaluation method, the influence factors are calculated, and according to the aforementioned formula, the mixing ratio of any two mixed batches of raw materials is calculated. At the same time, 6 batches of Compound Huangbai Liquid Liniment are prepared to evaluate the influence of dandelion homogenization on the fluctuation (RSD%) of berberine hydrochloride in Compound Huangbai Liquid Liniment. The results show that compared with Example 3, the fluctuation (RSD%) of berberine hydrochloride in Compound Huangbai Liquid Liniment after dandelion homogenization is significantly reduced (18.15% > 7.94%), meeting the expected requirement of being lower than 10%.

[0122] As described above, only the embodiments of the present application are given. The protection scope of the present application is not limited by these specific embodiments, but is determined by the claims of the present application. For those skilled in the art, various changes and modifications can be made to the present application. Any modification, equivalent replacement, improvement, etc. made within the technical idea and principle of the present application shall be included within the protection scope of the present application.

Claims

1. A method for homogenizing the raw materials of a traditional Chinese medicine preparation, characterized in that, The raw materials of the traditional Chinese medicine preparation are the medicinal materials of Compound Huangbai Liquid, and the medicinal materials of Compound Huangbai Liquid are used for the preparation of Compound Huangbai Liquid Coated Agent; the raw material composition of the medicinal materials of Compound Huangbai Liquid includes Phellodendron chinense, Lonicera japonica, Taraxacum mongolicum, Forsythia suspensa and Scolopendra subspinipes; the homogenization treatment includes the following operation steps: (1) Collect raw medicinal materials / sliced medicinal materials that have passed the inspection according to the legal standards. The number of batches of each medicinal material / sliced medicinal material is ≥2, and one batch of medicinal materials / sliced medicinal materials that meet the enterprise's internal control standards is fixed as the reference medicine; (2) Identify the quality index component of the medicinal materials of Compound Huangbai Liquid - berberine hydrochloride, and the main source medicinal material / sliced medicinal material of berberine hydrochloride - Phellodendron chinense; According to the enterprise's internal control standards, if the raw materials of Phellodendron chinense do not meet the enterprise's internal control standards, conduct high-low mixing and blending treatment on them separately; reserve for later use; (3) Identify the key raw materials other than Phellodendron chinense that have an impact on the stability of berberine hydrochloride - Lonicera japonica and Taraxacum mongolicum. Select any one for treatment, or conduct homogenization treatment in sequence: conduct homogenization treatment on the feedstock that does not meet the enterprise's internal control standards; the steps of this homogenization treatment are as follows: ① Preparation of test solution: Weigh the powdered medicinal materials of Lonicera japonica or Taraxacum mongolicum according to the component weight composition of the medicinal materials of Compound Huangbai Liquid. Mix them with the other reference medicines except Lonicera japonica or Taraxacum mongolicum in (1) in a bottle. Precisely add reagent 1 - 70% ethanol aqueous solution for extraction treatment to obtain the ethanol-extracted medicinal materials. Concentrate to an appropriate amount, dilute with ethanol, and filter; take an appropriate amount of the filtered ethanol-extracted medicinal materials, dilute with water, refrigerate and filter, and take the continuous filtrate; add reagent 2 - methanol for dilution and filter to obtain the test solution; determine the content of berberine hydrochloride in the solution and record it as x1; ② Preparation of negative solution Prepare according to ① the test solution, remove the key raw materials therein, and prepare the negative solution in the same method; determine the content of berberine hydrochloride in the negative solution and record it as x2; (4) According to the index contents of the test samples and negative solutions of different batches obtained in ① and ② above, formulate and calculate the homogenization standard s to obtain the homogenization ratio of the key raw materials of different batches mentioned above; among them, s = a1f1 + a2f2 + …… a n f n 1 = a1 + a2 + …… a n ; The above homogenization standard s is determined by the enterprise's internal control standards; a is the homogenization ratio of the key raw materials of Lonicera japonica or Taraxacum mongolicum of different batches mentioned above; f n is the influencing factor for the aforementioned key raw materials, honeysuckle or dandelion, in different batches; influencing factor = x1 divided by x2; (5) According to the homogenization ratio of the key raw materials of different batches obtained in (4), feed the corresponding batches of the key raw materials.

2. The homogenization treatment method for traditional Chinese medicine preparation raw materials according to claim 1, wherein, The extraction treatment in S3 is: ultrasonic extraction at 20 - 75°C for 15 min - 30 min.

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