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Quality controlling method for pulse restoring injection

A quality control method and injection technology, which can be used in medical preparations containing active ingredients, pharmaceutical formulations, antiviral agents, etc., and can solve problems such as slow onset of action

Inactive Publication Date: 2006-09-27
北京六盛合医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Shengmai Injection is made from ginseng, Ophiopogon japonicus, and Schisandra chinensis. It has the effects of nourishing qi and nourishing yin, and recovering the pulse. , cardiogenic shock, and septic shock, and is currently clinically used to treat angina pectoris of coronary heart disease, weakness of the spleen and stomach, acute viral myocarditis, malignant tumors, severe pneumonia in children, viral pneumonia, viral hepatitis, optic atrophy, diabetes, Cervical spondylosis, psoriasis, sudden deafness and other diseases; it is made from traditional Shengmaisan modified agent, which overcomes the shortcomings of traditional preparations with slow onset of action, and many inventors and pharmaceutical companies have done a lot of research on it Work, such as: the patent application number is "93110807.1", the name is "Shengmai Injection and its preparation process", the patent application number is "96117457.9", the name is "A Shengmai Injection and its preparation method" application; the applicant Yu Wenyong also applied to the Chinese Patent Office for an invention patent titled: "A pharmaceutical composition for treating cardiovascular and cerebrovascular diseases and its preparation method" and the patent application number is 02153312.1, but the pharmaceutical preparation must be in the On the basis of ensuring stable, controllable and safe product quality, we can continue to update and develop. In order to better control the quality of the preparation, ensure the safety of medication, better guide production, and make process control more strict and reasonable, so that consumers To be able to fully understand the product texture, it is necessary to study the method of controlling the quality of the injection; at present, in the related pharmaceutical preparations of Shengmai preparation, generally only ginsenoside Re, Rb 1 It is a detection index, but it cannot fully reflect the quality of the product at all, and it is not very reasonable to use it to control the quality of the injection; if other indicators are used for control, because there is no ready-made detection scheme, detection conditions, etc. Difficult to implement

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0508] Example 1: Using liquid chromatography to measure the fingerprints of red ginseng or ginseng and Ophiopogon japonicus as the main component characteristics:

[0509] (1) Preparation of the test solution: accurately weigh an appropriate amount of the freeze-dried powder to be tested, add water to make a solution containing 50mg per 1ml, filter it with a 0.45μm microporous membrane, and take the additional filtrate as the test solution ;

[0510] (2) Preparation of reference solution: accurately weigh ginsenoside Rg 1 An appropriate amount, add methanol to make a solution containing 0.3mg per 1ml, as a reference solution;

[0511] (3) Chromatographic conditions: The chromatographic column uses octadecylsilane bonded silica gel as the filler; mobile phase A is 0.05mol / L potassium dihydrogen phosphate solution, mobile phase B is acetonitrile-water 80:20, gradient elution, solvent The ratio is from 0 minutes to 5 minutes, the ratio of mobile phase B is 25%, from 5 minutes to 40 ...

Embodiment 2

[0518] Example 2: Using liquid chromatography to measure the fingerprint spectrum with the main component characteristics of Schisandra:

[0519] (1) Preparation of the test solution: accurately weigh an appropriate amount of the freeze-dried powder to be tested, add water to make a solution containing 50mg per 1ml, filter it with a 0.45μm microporous membrane, and take the additional filtrate as the test solution ;

[0520] (2) Preparation of reference solution: accurately weigh an appropriate amount of Schizandrin A reference substance, add water to make a solution containing 0.1 mg per 1 ml, as the reference solution;

[0521] (3) Chromatographic conditions: The chromatographic column uses octadecylsilane bonded silica gel as the filler; the mobile phase is methanol-water, gradient elution, the solvent ratio is from 0 minutes to 6 minutes, the methanol ratio is 68%, from 6 From 8 minutes to 8 minutes, the proportion of methanol rose from 68% to 76%, from 8 minutes to 10 minutes...

Embodiment 3

[0528] Example 3: Using liquid chromatography to determine the fingerprints of red ginseng or ginseng and Ophiopogon japonicus as main component characteristics:

[0529] (1) Preparation of the test solution: accurately weigh an appropriate amount of the freeze-dried powder to be tested, add methanol to make a solution containing 50mg per 1ml, filter it with a 0.45μm microporous membrane, and take the subsequent filtrate as the test product Solution

[0530] (2) Preparation of reference solution: accurately weigh ginsenoside Rb 1 Appropriate amount, add ethanol to make a solution containing 0.3mg per 1ml, as a reference solution;

[0531] (3) Chromatographic conditions: The chromatographic column uses octadecylsilane bonded silica gel as the filler; mobile phase A is 0.05mol / L sodium dihydrogen phosphate solution, mobile phase B is acetonitrile-water 85:15, gradient elution, solvent The proportion is from 0 minutes to 4 minutes, the proportion of mobile phase B is 22%, from 4 minu...

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Abstract

The quality control method for Shengmai injection includes fingerprint test, identification, content measurement and other items. The present invention obtains ideal fingerprint of red ginseng or ginseng, ophiopogon root and schisandra in certain conditions. The quality control method is effective on the Chinese medicine injection prepared with red ginseng or ginseng, ophiopogon root and schisandra and possesses high precision and high stability.

Description

Technical field [0001] The invention is a quality control method for Shengmai injection, which belongs to the technical field of quality control, especially a quality control method for traditional Chinese medicine injection preparations. Background technique [0002] Shengmai injection is made of ginseng, Ophiopogon japonicus and Schisandra as raw materials. It has the effects of replenishing qi, nourishing yin, and restoring pulse and solidifying. It is used for palpitations, qi deficiency, cold limbs and myocardial infarction due to deficiency of both qi and yin. , Cardiogenic shock, septic shock, currently clinically used to treat coronary heart disease angina, spleen and stomach weakness, acute viral myocarditis, malignant tumors, severe pneumonia in children, viral pneumonia, viral hepatitis, optic atrophy, diabetes, Cervical spondylosis, psoriasis, sudden deafness and other diseases; it is modified from traditional Shengmai powder, which overcomes the shortcomings of slow ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8968A61K9/08A61P9/10A61P11/00A61P1/16A61P31/12A61P35/00A61P3/10A61P17/06A61P27/16A61P19/08G01N30/02G01N30/90G01N33/15
Inventor 于文勇
Owner 北京六盛合医药科技有限公司