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Quality control method for vatility source preparation

A quality control method and preparation technology, which can be used in testing pharmaceutical preparations, measuring devices, pharmaceutical formulations, etc., and can solve problems such as the inability to guarantee the clinical efficacy of Vitality Source preparations, the lack of identification and inspection methods, and the impact on product quality.

Inactive Publication Date: 2006-11-08
CHENGDU ZHONGHUI PHARM CO LTD
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0003] However, in these comparative documents, except that the Active Source Oral Liquid in Comparative Document 1 and the Active Source Tablet in Comparative Document 2 provided an identification method for ginsenoside Re, a component of total saponins in ginseng stems and leaves, none of them provided Other components of total saponins in ginseng stems and leaves in the preparation, as well as identification and inspection methods or limit inspection methods for raw materials such as Astragalus, Ophiopogon japonicus, Schisandra, and Fupian, did not provide a method for determining the content of active ingredients in the preparation, so it was not possible to well control all of them. The quality of the prepared preparation affects the improvement of product quality, and cannot well guarantee the clinical efficacy of the vitality source preparation
Another disadvantage of comparative document 1 and comparative document 2 is that when ginsenoside Re is identified, the number of extractions with n-butanol is too much, which increases the consumption of solvent; During the identification, the active ingredients of the sample are not completely dissolved by adding water, thus affecting the effect of the identification check

Method used

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  • Quality control method for vatility source preparation
  • Quality control method for vatility source preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0041] Embodiment 1: the quality control of vitality source tablet

[0042] Identification of Radix Ophiopogon japonicus: take the Vitality Source Tablet of Reference 2, remove the sugar coating, take 1.2g of fine powder, add 40ml of water, add 2ml of sulfuric acid, heat and reflux in a water bath for 1 hour, take it out, let it cool, centrifuge, take the supernatant and pipette Put it into a separatory funnel, extract with ether 3 times, 15ml each time, combine the ether solution, evaporate to dryness, add 1ml of chloroform to the residue to dissolve, and use it as the test solution. In addition, take 1 g of Ophiopogon japonicus reference medicinal material, add 40 ml of water, and start from "adding 3 ml of hydrochloric acid" as above to make a reference medicinal material solution. According to the thin-layer chromatography ("Chinese Pharmacopoeia" 2005 edition, an appendix VI B) test, take 10 μl of each of the above two solutions, respectively spot on the same silica gel G...

Embodiment 2

[0045] Embodiment 2: the quality control of vitality source oral liquid

[0046] Determination of the content of ginsenosides:

[0047] Chromatographic conditions and system suitability test: use octylsilane bonded silica gel as filler; acetonitrile-0.08% phosphoric acid (21:79) as mobile phase; detection wavelength 203nm; theoretical plate number according to ginsenoside Rg1, ginsenoside Re peak The calculation should be no less than 2000.

[0048] Preparation of the control solution: Accurately weigh the appropriate amount of reference substances of ginsenoside Rg1 and ginsenoside Re, add methanol to make solutions containing 0.2 mg and 0.4 mg per 1 ml, and obtain.

[0049] Preparation of the test solution: get 50ml of the Vigor Source Oral Liquid of Comparative Document 1, evaporate to dryness, transfer quantitatively to a 100ml conical flask with a stopper with 25ml of chloroform, heat and reflux for 30 minutes, filter, and put the stoppered cone The residue in the bottl...

Embodiment 3

[0052] Embodiment 3: the quality control of vitality source sheet

[0053] (1) Identification of ginsenosides: take the vitality source tablet of reference 2, remove the sugar coating, grind into fine powder, take 3g of fine powder, add 100ml of water, ultrasonically dissolve, filter, take 20ml of filtrate and put it in a separating funnel, and use water-saturated Extract with n-butanol 3 times, 15ml each time, combine the extracts, evaporate to dryness, add methanol 10ml to dissolve the residue, and use it as the test solution. Separately take appropriate amount of ginsenoside Rg1 reference substance and ginsenoside Re reference substance, respectively add methanol to make a solution containing 2mg per 1ml, as the reference substance solution. According to the test of thin-layer chromatography (Appendix VI B of "Chinese Pharmacopoeia" 2005 edition), draw 5 μl of each of the above two solutions, respectively spot on the same silica gel G thin-layer plate, and mix with chlorofo...

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Abstract

The present invention discloses quality control method for vitality source preparation. The quality control method includes the identification of ophiopogon, ginsenoside, schisandra and astragalus in the vitality source preparation; the limit inspection of aconitine; and the measurement of ginsenoside content. The identification, the inspection and the measurement may be adopted alone or in combination in the quality control. The present invention makes it possible to raise the quality of vitality source preparation so as to ensure the stable and reliable curative effect of vitality source preparation and reduce adverse reaction.

Description

technical field [0001] The invention relates to a method for quality control of medicines, in particular to methods for ingredient identification, limit inspection and content determination of energy source preparations. Background technique [0002] Liver Oral Liquid and Liver Tablets are a kind of Chinese patent medicine widely used clinically. They are made from 5 ingredients including 25 parts of total saponins from stems and leaves of ginseng, 50 parts of Astragalus membranaceus, 240 parts of Radix Ophiopogon japonicus, 120 parts of Schisandra chinensis, and 5 parts of Fupian. It has the functions of nourishing qi and nourishing yin, strengthening the heart and kidney, and is suitable for forgetful insomnia, memory loss, coronary heart disease, chronic hepatitis, diabetes and menopausal syndrome with the above syndromes. Its drug standards are recorded in the Drug Standards of the Ministry of Health of the People's Republic of China (Chinese Medicine Prescriptions), Vol...

Claims

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Application Information

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IPC IPC(8): A61K36/8968A61P1/16A61P3/10A61P9/10A61P15/12A61P25/20G01N30/90G01N33/15
Inventor 张沛冯华祥芮旭东周道铨
Owner CHENGDU ZHONGHUI PHARM CO LTD
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