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Preparation process and evaluation method of tussilago farfara formula granules

A technology of formula granules and evaluation methods, which is applied in pharmaceutical formulas, medical preparations containing active ingredients, plant raw materials, etc., can solve the problem of not having the best process parameters of coltsfoot formula granules, achieve high consistency and reduce material changes The magnitude of the effect

Active Publication Date: 2022-03-01
BEIJING KANGRENTANG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] Therefore, the technical problem to be solved in the present invention is to overcome the problem that there is no optimal process parameter that can obtain the coltsfoot flower formula granules more quickly in the prior art, and then the coltsfoot flower formula granules prepared by it can meet the quality standard; thus providing A process evaluation method that can effectively and quickly obtain the optimal process and ensure that the formula granules prepared by the optimal process meet the quality standards

Method used

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  • Preparation process and evaluation method of tussilago farfara formula granules
  • Preparation process and evaluation method of tussilago farfara formula granules
  • Preparation process and evaluation method of tussilago farfara formula granules

Examples

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Embodiment 1

[0033] A process evaluation method for Coltsfoot flower formula granules, specifically, the present embodiment adopts the similarity coefficient S of key quality attributes cqa The products of Bupleurum chinensis decoction pieces obtained by different process steps are evaluated successively, and the process of this process evaluation is as follows:

[0034] 1. Determine the preparation process of standard decoction:

[0035] Withdraw the decoction pieces of winter flowers, put them in a casserole, soak them for 30 minutes, decoct twice, add 12 times the amount of water for the first decoction, boil with high heat, simmer for 30 minutes, filter while hot, cool quickly, and set aside; The amount of the decoction pieces is 10 times the amount of water, boiled with high heat, simmered for 20 minutes, filtered while hot, and quickly cooled for later use; the filtrate was combined and it was obtained.

[0036] Preparation of freeze-dried powder: take an appropriate amount of stand...

Embodiment 2

[0087] The present embodiment is used to verify the process condition parameters obtained in the large production verification example 1, and the details are as follows:

[0088] Take three batches of Coltsfoot decoction pieces, numbered 1, 2 and 3 respectively, carry out production verification according to the best process selected in Example 1, collect the samples prepared by each process link, and detect according to the method in Example 1, Analyze the delivery of quality indicators in each link.

[0089] 1. The transmission of the paste rate

[0090] Due to the addition of auxiliary materials in the granulation process, the paste yield of granules is not used as a reference. cqa As shown in Table 8 below.

[0091] Table 8. Large-scale production verification of Donghua formula granules cqa

[0092]

[0093] Summary: From the results in the above table, it can be seen that the paste production rate is S cqa From the standard frying to the end of the drying process...

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Abstract

The invention provides a preparation process and an evaluation method of tussilago farfara formula granules. A key quality attribute similarity coefficient Scqa of an evaluation index is adopted to evaluate a product generated in any step in the preparation process of traditional Chinese medicine formula granules. The Scqa of the evaluation index at least comprises the Scqa of the S peak area and the Scqa of the atlas; the evaluation process comprises the following steps: firstly, selecting a process of which the Scqa value of the S peak area is within the range of 1 + / -15%, and then selecting a process of which the Scqa value of the atlas is most within the range of 1 + / -30% from the screened processes as an optimal process. Through the Scqa value, the difference between the material basis contained in the product prepared by different production process steps and the material basis contained in the standard decoction can be effectively evaluated, and the consistency of the product and the standard decoction is ensured.

Description

technical field [0001] The invention relates to the field of preparation of traditional Chinese medicines, in particular to a preparation process and an evaluation method of a Coltsfoot flower formula granule. Background technique [0002] The traditional Chinese medicine formula granules are made of decoction pieces, extracted by water, concentrated, dried and granulated. It maintains the material basis of traditional Chinese medicine decoction decoction and extraction, and eliminates the decoction link before clinical use. It is the development of traditional Chinese medicine decoction. important practice. Coltsfoot flower formula granules are formula granules made from the dried flower buds of Asteraceae Tussilago farfara L.. [0003] The "Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules" clearly stipulates that the standard decoction is the material benchmark for measuring whether a single traditional C...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/86A61K36/28A61K9/16A61K133/00
CPCG01N30/8634G01N30/8686A61K36/28A61K9/16A61K2236/331A61K2236/39A61K2236/51Y02P90/30
Inventor 张志强董晨虹沈建梅贾扬花张伟娜付静
Owner BEIJING KANGRENTANG PHARMA
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