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Quality control of compound preparation for treating diabetes

A quality control method and technology for compound preparations, which are used in the testing of pharmaceutical preparations, medical preparations containing active ingredients, metabolic diseases, etc., which can solve the problem of simple and rough quality control methods, complex chemical components, and inability to comprehensively and accurately reflect and control compound prescriptions. Formulation quality and other issues

Active Publication Date: 2007-04-04
BEIJING JIAHE LEKANG TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the curative effect of the drug can only be guaranteed under the premise of quality control, and the existing quality control method of this drug combination is extremely simple and rough, and cannot fully and accurately reflect and control the quality of the compound preparation at all.
The chemical composition of traditional Chinese medicine is complex. Often there are dozens to hundreds of chemical components in each medicinal material, and there are no less than a few known biologically active ingredients. The chemical composition of traditional Chinese medicine compound preparations containing several medicinal materials ingredients are more complex
If only one or two active ingredients are used to illustrate its intrinsic quality, it is somewhat one-sided, not to mention that there is no relevant content determination method in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0441] TLC Identification of Radix Astragali in Example 1 Tablets

[0442]Take the sample to be tested, grind it finely, take an appropriate amount of powder, add ethanol to extract, filter, evaporate the filtrate to dryness, add 0.3% sodium hydroxide solution to dissolve the residue, filter, adjust the pH value of the filtrate to 5-6 with hydrochloric acid, and use ethyl acetate to Extract the ester, filter, evaporate the filtrate to dryness, add ethyl acetate to the residue to dissolve, and use it as the test solution; take another Astragalus control medicinal material, and prepare the contrast medicinal material solution in the same way; adopt thin-layer chromatography test, absorb the above-mentioned test solution and An appropriate amount of the control solution was spotted on the same silica gel G thin-layer plate, developed with chloroform-methanol = 10:1 as the developer, taken out, dried in the air, smoked in ammonia vapor, and then inspected under a 365nm ultraviolet ...

Embodiment 2

[0443] TLC Identification of Radix Astragali in Example 2 Pellets

[0444] Take the sample to be tested, grind it finely, take an appropriate amount of powder, add methanol to extract, filter, evaporate the filtrate to dryness, add 0.05% sodium potassium hydroxide solution to dissolve the residue, filter, adjust the pH value of the filtrate to 3-4 with hydrochloric acid, and use three Extract with methyl chloride, filter, evaporate the filtrate to dryness, add ethyl acetate to dissolve the residue, and use it as the test solution; take another Astragalus reference medicinal material, and prepare the reference medicinal material solution in the same way; use thin-layer chromatography to test, draw the above-mentioned test solution respectively Take an appropriate amount of the control solution, spot on the same silica gel H thin-layer plate, develop with dichloromethane-methanol=3:1 as the developer, take it out, dry it in the air, and inspect it under a UV lamp at 254nm. In the...

Embodiment 3

[0445] Thin-layer chromatography identification of Radix Astragali in embodiment 3 granules

[0446] Take an appropriate amount of the sample to be tested, add 50% ethanol to extract, filter, evaporate the filtrate to dryness, dissolve the residue with 5% ammonia solution, filter, adjust the pH value of the filtrate to 4-5 with hydrochloric acid, extract with chloroform, filter, The filtrate was evaporated to dryness, and the residue was dissolved in ethyl acetate, which was used as the test solution; another reference medicinal material of Astragalus membranaceus was prepared in the same way as a reference medicinal solution; the thin-layer chromatography test was used to absorb the appropriate amount of the above-mentioned test solution and control solution, and point on On the same silica gel G thin-layer plate, use chloroform-ethanol=10:0.2 as the developing agent, develop, take out, dry, put in ammonia vapor and smoke and then inspect under the ultraviolet lamp at 365nm. I...

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Abstract

A quality control method for the Chinese medicine used for treating diabetes and prepared from glibenclamide and 7 Chinese-medicinal materials including pueraria root, rehmannia root, astragalus root, yam, etc features the differentiation test method and / or content measuring method for its multiple components.

Description

technical field [0001] The invention relates to a quality control method of a compound preparation of medicine for treating diabetes, which belongs to the technical field of traditional Chinese medicine. Background technique [0002] The compound preparation of the present invention is a compound preparation made from the traditional Chinese medicine puerarin, rehmannia glutinosa, corn silk, trichosanthin, astragalus, schisandra, yam and chemical drug glibenclamide. It has the effects of nourishing kidney and yin, nourishing qi and promoting body fluid, and is used for polydipsia, polyuria, polyphagia, emaciation, fatigue and weakness, poor sleep and low back pain, urine sugar and elevated blood sugar. The category includes diabetes in modern medicine. According to reports, the total prevalence of diabetes in my country reached 2.4% in 2000, and the total number of diabetic patients in the country has reached nearly 31 million. In addition to the increasing number of diabe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/804A61P3/10G01N30/90G01N30/02G01N33/15A61K31/17
Inventor 于文风
Owner BEIJING JIAHE LEKANG TECH
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