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Quality control method of pulse-invigorating and heart-nourishing pill

A quality control method, the technology of Tongmai Yangxin Pill, is applied in the field of quality control of Tongmai Yangxin Pill, and can solve the problems of simple product quality inspection, difficult quality control, affecting the internal quality of products, etc.

Active Publication Date: 2009-04-01
津药达仁堂集团股份有限公司乐仁堂制药厂
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although Tongmai Yangxin Pills have been widely used clinically, the current quality control method used in the production of Tongmai Yangxin Pills is WS3-B- The 2027-95 ministerial standard, many years of production practice, found that there are the following defects in the quality inspection process: first, there is no qualitative and quantitative control method, and the product quality inspection is too simple; second, there is a lack of targeted active ingredients. Therefore, it brings great difficulties to the quality control of the production process, which directly affects the inherent quality of the product.

Method used

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  • Quality control method of pulse-invigorating and heart-nourishing pill
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  • Quality control method of pulse-invigorating and heart-nourishing pill

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Effect test

Embodiment 1

[0176] Tongmai Yangxin pill quality control of the present invention: comprise identification, inspection and assay; Wherein for identification method, the steps are as follows:

[0177] Identification of Radix Polygoni Multiflori Radix by Thin Layer Chromatography

[0178] (1) Preparation of the test solution: take 1.5g of the powder of this product, pass through an 80 mesh sieve, add 25mL of methanol, heat and reflux for 1 hour, filter, evaporate the filtrate to dryness, add 10ml of 8% hydrochloric acid, heat and reflux for 1 hour, and let it cool , put in a separatory funnel, extract three times with 0.0% diethyl ether, 10ml each time, combine the extracts, evaporate to dryness, add 1ml chloroform to the residue to dissolve, and use it as the test solution;

[0179] (2) Preparation of Polygonum multiflorum medicinal material solution: take 0.25 g of medicinal material powder, pass through an 80 mesh sieve, add 25 mL of methanol, heat and reflux for 0.5 hour, filter, evapora...

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Abstract

The invention discloses a quality control method of a pulse-invigorating and heart-nourishing pill. The method comprises the following steps: the contents prepared tuber fleece flower and Chinese magnolia vine fruit are identified, and the contents are tested according to the method described in the pharmacopoeia, and liquoric root in the contents is assayed. The quality of the related drugs can be guaranteed more accurately by the assay of the active component liquoric root in the pulse-invigorating and heart-nourishing pill to effectively ensure safety, uniformity, stability, effectiveness and controllability of the pulse-invigorating and heart-nourishing pill. The new quality control method is simple and convenient, gives accurate result and better reproducibility, and can achieve the purpose of quality control.

Description

technical field [0001] The invention relates to a quality control method of pharmaceutical preparations, in particular to a quality control method of Tongmai Yangxin Pills. Background technique [0002] Relevant studies have shown that most patients with coronary heart disease are middle-aged and elderly people. From the perspective of the occurrence and development of the disease, there are many reasons, but generally speaking, there are solid aspects such as blood stasis, phlegm turbidity, stagnation of qi, and cold coagulation, and there are also virtual aspects. one side. Some people are tired from working for a long time, and some people are old and frail, which leads to the deficiency of internal organs, imbalance of yin and yang, deficiency of qi and blood, such as deficiency of vitality, deficiency of qi and yin, etc., which lead to coronary heart disease; It will damage the qi, blood, yin and yang of the human body and aggravate the weak state of the body. Studies...

Claims

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Application Information

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IPC IPC(8): A61K36/8968A61K9/20A61P9/10G01N30/02G01N30/90A61K35/36A61K35/56A61K35/586
Inventor 李林
Owner 津药达仁堂集团股份有限公司乐仁堂制药厂
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