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Preparation process and quality control method of meridian-warming decoction

A technology of preparation process and quality control method, which is applied to the preparation process of Wenjing Decoction and its quality control field, can solve the problems of inconsistent material basis and the inability to guarantee the consistency of clinical efficacy, and achieves avoiding differences, saving costs, and ensuring The effect of consistency

Active Publication Date: 2021-12-07
BEIJING KANGRENTANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the material basis contained in the product obtained from the existing disclosed Wenjing Decoction preparation process and its clinical standard decoction is usually not consistent, and thus the consistency of clinical efficacy cannot be guaranteed.

Method used

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  • Preparation process and quality control method of meridian-warming decoction
  • Preparation process and quality control method of meridian-warming decoction
  • Preparation process and quality control method of meridian-warming decoction

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] A quality control method for the preparation process of Wenjing Decoction. In this embodiment, the stability research of the standard decoction process and the determination of chromatographic conditions are carried out, and the influence of the concentration step on the material basis of Wenjing Decoction is also investigated. Specifically as follows:

[0049] 1. Study on the process stability of standard decoction

[0050] 1.1 Chromatographic conditions

[0051] 1.1.1 Wenjing Decoction HPLC Fingerprint / Characteristic Map Method

[0052] Chromatographic conditions and system suitability test use Waters CORTECS UPLC T3 (column length is 150mm, internal diameter is 2.1mm, particle diameter is 1.7μm) chromatographic column, with acetonitrile as mobile phase A, with 0.1% phosphoric acid aqueous solution as mobile phase B, press Gradient elution was carried out according to the provisions in Table 1 below; the flow rate was 0.3ml per minute, the injection volume was 3μl, ...

Embodiment 2

[0138] This example provides the detection of the standard substances of Wenjingtang prepared under different preparation process conditions, including Examples 1 to 8, and according to the test results, the evaluation of the preparation process of Wenjingtang can be realized simply and effectively, and then screened out The best preparation process conditions.

[0139] Among them, the S of the characteristic map or fingerprint map cqa The method of detection and the detection method of the transfer rate of effective index components are the same as the method recorded in Example 1, all adopting the high performance liquid phase fingerprint detection method to detect, and the detection conditions are also exactly the same as in Example 1, the difference is only for the The samples are different.

example 1

[0140] Example 1: Weigh the thick powder of Wenjingtang decoction pieces according to the prescription ratio, add 1080 / 60 times of water (that is, when the coarse powder of Wenjingtang decoction pieces is 60g, add 1080ml of water), soak for 0 minutes, boil with strong fire, keep slightly boiled with slow fire, decoct until The amount of the liquid medicine was 80% of the amount of water added, filtered, concentrated under reduced pressure at 50°C to a relative density of 1.02 (50°C), and dried under normal pressure at 60°C to obtain sample 1.

[0141] The test results of sample 1 are: the cream yield is 46.28%, the powder collection rate is 47.23%, the transfer rate of ammonium glycyrrhizinate is 55.36%, the transfer rate of paeoniflorin is 104.50%, the transfer rate of ferulic acid is 81.83%, and the transfer rate of β-ecdysteroid The transfer rate of ketone is 92.97%, the transfer rate of paeonifloride is 87.98%, the transfer rate of cinnamon aldehyde is 4.02%, the transfer r...

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Abstract

The invention provides a preparation process and a quality control method of a meridian-warming decoction, and the preparation process comprises the following steps: obtaining a characteristic spectrum or a fingerprint spectrum of a standard decoction and a test sample, the standard decoction being an ancient decoction of the meridian-warming decoction, and the test sample being a material reference object or a compound preparation of the meridian-warming decoction prepared by adopting corresponding process parameters; obtaining a key quality attribute similarity coefficient Scqa of the characteristic spectrum or the fingerprint spectrum, wherein the Scqa value = the relative peak area of the S peak corresponding to each characteristic peak in the test sample / the relative peak area of the S peak corresponding to each characteristic peak in the standard decoction; and carrying out quality control on the test sample according to the Scqa result, wherein the preparation process of the test sample corresponding to the characteristic spectrum or the fingerprint spectrum with the most Scqa value closer to the numerical value 1 is screened as a preferred process. According to the method, the process corresponding to the product which is more consistent with the material basis contained in the clinical standard decoction can be screened out more simply, conveniently and accurately, and the material basis of the product is kept consistent with that of the clinical standard decoction, so that the consistency of the curative effect is ensured.

Description

technical field [0001] The invention relates to the field of traditional Chinese medicines, in particular to a preparation process of Wenjing decoction and a quality control method thereof. Background technique [0002] Wenjing decoction comes from "Women's Encyclopedia of Good Prescriptions" (Song·Chen Ziming). The decoction method recorded in the prescription is: Angelica, Chuanxiong, Paeoniae Alba, Guixin, Moutan Cortex, Curcuma, half and half, ginseng, licorice, and Achyranthes bidentata. One or two. right Ju, five qian per serving. One and a half cups of water, decoct to eight minutes, remove the dregs and serve warm. According to literature research and ancient weighing apparatus (quantity) accounting, the dosage conversion ratio of the Song Dynasty (one coin = 4.13g, one cup = 300ml), the traditional decoction preparation method of Wenjingtang is obtained: each herb is crushed into coarse powder, 1 part by weight of Angelica sinensis, Rhizoma Chuanxiong 1 part by...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679Y02P90/02
Inventor 张志强周海凤韩妮娜刘利娟李默影张蓓栾仲欣梁勇满付静
Owner BEIJING KANGRENTANG PHARMA