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Quality control method for Chinese medicinal preparation heat clearing and blood cooling pills

A quality control method, heat-clearing and blood-clearing technology, applied in the direction of medical formula, non-central analgesics, antipyretics, etc., can solve problems such as lack and identification means, increase detection effect, promote product sales, The effect of improving controllability

Active Publication Date: 2011-05-25
津药达仁堂集团股份有限公司乐仁堂制药厂
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AI Technical Summary

Problems solved by technology

[0006] But there is following problem in above-mentioned standard: after identification method spotting thin-layer plate is unfolded and dried, put the inspection under ultraviolet light (365nm), in the chromatogram of test product, on the corresponding position with reference substance chromatogram, there are reddish-brown spots, There are problems in the identification means of non-fluorescent spots; in addition, there are no content determination items for the index components that reflect the internal quality of the drug. For the quality control standards, it is still lacking. In order to improve the product quality of traditional Chinese medicine, it is necessary to improve the product quality standards

Method used

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  • Quality control method for Chinese medicinal preparation heat clearing and blood cooling pills

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preparation example Construction

[0040] Preparation of Reference Substance Solution Take an appropriate amount of baicalin reference substance, accurately weigh it, add methanol to make a solution containing 0.1mg per 1ml, and obtain it.

[0041]Preparation of the test solution: Take 2g of the sample, grind it finely, get 0.2g of the powder, accurately weigh it, place it in a stoppered Erlenmeyer flask, accurately measure 100ml of 70% ethanol, weigh it, heat and reflux for 30 minutes, let it cool, Weigh the weight, make up the lost weight with 70% ethanol, shake well, filter, and take the filtrate to obtain the final product.

[0042] Determination method Precisely draw 5 μl each of the reference substance solution and the test solution, inject it into the liquid chromatograph, measure it, and obtain it.

[0043] This product contains not less than 24mg of baicalin per gram.

[0044] Functions and indications: nourishing yin, clearing heat, cooling blood. It is used for pregnant women with excessive upper b...

Embodiment 2

[0047] Embodiment 2 Qingreliangxue Wan Quality Standard Drafting Instructions:

[0048] In the original quality standard of Qingre Liangxue Pills, there was the identification of Scutellaria baicalensis, but there was no content determination item. This time, the TLC identification of Rehmannia glutinosa and the content determination of Scutellaria baicalensis were added to the standard. At the same time, the identification method of scutellaria baicalensis in the original standard was revised again.

[0049] 1. Identification of Scutellaria baicalensis

[0050] 1.1 Materials and reagents

[0051] Methanol, ethyl acetate, butanone, formic acid: analytically pure

[0052] Baicalin reference substance: National Institute for the Control of Pharmaceutical and Biological Products, batch number: 110715-200514

[0053] Sample of Qingreliangxue Pill: produced by Lerentang Pharmaceutical Factory of Tianjin Zhongxin Pharmaceutical Group Co., Ltd.;

[0054] Batch number: D081001

[...

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Abstract

The invention belongs to the technical field of Chinese patent medicaments, and relates to a quality control method for a Chinese medicinal preparation, namely heat clearing and blood cooling pills prepared from Chinese medicinal materials. The heat clearing and blood cooling pills consist of Chinese medicinal materials, namely scutellaria root and Rehmannia glutinosa. The quality control method comprises the following steps of: taking baicalin and catalpol as reference products, and identifying whether scutellaria root and Rehmannia glutinosa components are contained in the prescription of the heat clearing and blood cooling pills by thin-layer chromatography; and detecting the content of the baicalin in the prescription of the heat clearing and blood cooling pills by high performance liquid chromatography. A quantitative index and an inspection method thereof make the quality standard more perfect. The revised quality standard improves the quality control of medicaments.

Description

technical field [0001] The invention belongs to the technical field of Chinese patent medicines, and relates to a quality control method of a traditional Chinese medicine preparation Qingreliangxue pill made from Chinese medicinal materials. Background technique [0002] Qingreliangxue Pill is a preparation recorded on page 192 of the ninth volume of traditional Chinese medicine preparations in the "Drug Standards of the Ministry of Health". The standard WS3-B-1843-94 of the Ministry of Health records the prescription and quality standards: [0003] Prescription: Scutellaria baicalensis 500g Dihuang 500g [0004] Preparation method: The above two flavors are crushed into fine powder, sieved, mixed evenly, made into pellets with water, dried, and obtained. [0005] Identification: Take 1 g of this product, grind it, add 20 ml of methanol, heat to reflux for 2 hours, let cool, filter, and the filtrate is used as the test solution. Take another baicalin reference substance, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/804A61K9/20A61P29/00A61P43/00G01N30/02G01N30/90
Inventor 陈坚王磊杨瑾律兆荣刘志宏
Owner 津药达仁堂集团股份有限公司乐仁堂制药厂
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