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Process evaluation method for traditional Chinese medicine formula granules

A technology of traditional Chinese medicine formula granules and evaluation methods, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., to achieve high consistency and reduce the magnitude of material changes

Pending Publication Date: 2022-03-04
BEIJING KANGRENTANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Therefore, the technical problem to be solved in the present invention is to overcome the problem in the prior art that the optimal process parameters can not be obtained more quickly, so that the formula granules prepared by the optimal process parameters meet the quality standards; thereby providing an effective and rapid A process evaluation method to 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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  • Process evaluation method for traditional Chinese medicine formula granules
  • Process evaluation method for traditional Chinese medicine formula granules
  • Process evaluation method for traditional Chinese medicine formula granules

Examples

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Embodiment 1

[0038] A process evaluation method for traditional Chinese medicine formula granules. The traditional Chinese medicine formula granules in this example are Bei Bupleurum formula granules. Specifically, this embodiment adopts the key quality attribute similarity coefficient S cqa The products of Bei Bupleurum decoction pieces obtained by different process steps are evaluated sequentially. The process of this process evaluation is as follows:

[0039] 1. Determine the preparation process of the standard decoction:

[0040] Take Beibupleurum decoction pieces, put them in a casserole, soak for 30 minutes, add 9 times the amount of water to the decoction pieces for the first decoction, boil with a strong fire (500w), simmer for 20 minutes, filter while it is hot, cool quickly, and set aside; add decoction pieces for the second decoction Measure 6 times of water, boil with high fire, decoct with slow fire (200w) for 15 minutes, filter while it is hot, and cool down quickly for late...

Embodiment 2

[0088] This embodiment is used to verify the process condition parameters obtained in the large-scale production verification embodiment 1, specifically as follows:

[0089] Three batches of Bupleurum decoction pieces were taken, numbered 1, 2 and 3 respectively, and production verification was carried out according to the process selected in Example 1 above, samples prepared in each process were collected, and tested according to the method in Example 1. Due to the addition of excipients in the production process of Bei Bupleurum formula granules, the paste yield cannot directly reflect the transfer of the substance’s value. Therefore, the content transfer rate of saikosaponin a and the S of the characteristic map cqa Analyze the delivery of quality indicators in each link. Among them, the S of saikosaponin a content transfer rate cqa as in Table 7 and image 3 As shown, the peak area of ​​S peak is S cqa And the S of each characteristic peak of the characteristic map cqa...

Embodiment 3

[0099] A process evaluation method for traditional Chinese medicine formula granules. The traditional Chinese medicine formula granules in this embodiment are ebony formula granules. Specifically, this embodiment adopts the key quality attribute similarity coefficient S cqa The products of the ebony decoction pieces obtained by different process steps are evaluated successively. The process of this process evaluation is as follows:

[0100] 1. Determine the preparation process of the standard decoction:

[0101] Take the ebony decoction pieces of batch 180627-611300-13, put them in a casserole, soak for 30 minutes, add 6 times the amount of water to the decoction pieces after decocting, boil with a strong fire (500w), decoct with a slow fire for 30 minutes, filter while hot, and cool quickly. Set aside; add 4 times the amount of water to the decoction pieces for the second decoction, boil with strong fire, then decoct with slow fire (200w) for 20 minutes, filter while hot, an...

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Abstract

The invention provides a process evaluation method of traditional Chinese medicine formula granules. A key quality attribute similarity coefficient Scqa of an evaluation index is adopted to evaluate a product generated in any step in a preparation process of the traditional Chinese medicine formula granules. The Scqa at least comprises the Scqa of the peak area of an S peak and the Scqa of a characteristic spectrum or a fingerprint spectrum; the process for performing process evaluation by adopting the Scqa of the characteristic spectrum or the fingerprint spectrum comprises the following steps: calculating the ratio of the maximum value to the minimum value in the Scqa of the same characteristic peak of all products, selecting the Scqa of the characteristic peak of which the ratio is greater than or equal to 2 to perform evaluation screening, and if the ratios of all the characteristic peaks are less than 2, selecting the Scqa of all the characteristic peaks to perform evaluation screening; and screening out the process corresponding to the Scqa of the characteristic spectrum or the fingerprint spectrum with the maximum number and the value closer to 1. 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 traditional Chinese medicine preparation, in particular to a process evaluation method for traditional Chinese medicine formula granules. Background technique [0002] Traditional Chinese medicine formula granules are made of decoction pieces, extracted with water, concentrated, dried, and granulated. It maintains the material basis of traditional Chinese medicine decoction and decoction extraction, and avoids the decoction before clinical use. It is the development of traditional Chinese medicine decoction. important practice. It is well known in the industry that standard decoction is a standard reference to measure whether the traditional Chinese medicine formula granules are basically consistent with clinical decoction, and its material components are closely related to clinical efficacy. Usually, in the standard of traditional Chinese medicine formula granules, three parameters are used to characterize the qu...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/86
CPCG01N30/02G01N30/8686G01N30/8631G01N2030/027Y02P90/30
Inventor 张志强沈建梅杜微波董晨虹付静
Owner BEIJING KANGRENTANG PHARMA
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