Weichangning tablets and quality control method thereof

A quality control method and technology for Weiweining tablets, which are applied in the field of traditional Chinese medicine preparations, can solve problems such as being unfavorable to product production control and quality supervision, and the safety of patients' medication is not guaranteed, and achieve the benefits of supervision, medication safety assurance, and product assurance. quality effect

Inactive Publication Date: 2009-09-23
吉林万通药业集团梅河药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The original quality standard did not identify or determine the content of any blind drug, which is not conducive t

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Weichangning Tablets (drug standard number is WS 3 -B-0335-90) quality control methods include:

[0018] 1. Content determination:

[0019] (1) Measured according to high performance liquid chromatography (Appendix VI D of Chinese Pharmacopoeia 2005 edition). Instrument: Shimadzu SPD-10Avp high performance liquid chromatography; Zorbax SB C18 5μm 4.6×150mm, SN: USCL012593. Reagent acetonitrile (chromatographically pure, batch number: 022920, Fisher). Potassium dihydrogen phosphate (analytical grade, batch number: 20020512, Beijing Chemical Plant). Chromatographic conditions and system suitability test, using octadecylsilane bonded silica gel as filler, acetonitrile-0.05mol / L potassium dihydrogen phosphate solution = 24:76 as mobile phase, detection wavelength is 265nm, and the number of theoretical plates is Berberine hydrochloride peak meter should not be less than 4000.

[0020] (2) Preparation of the reference substance solution, take an appropriate amount of th...

Embodiment 2

[0030] Weichangning Tablets (drug standard number is WS 3 -B-0335-90) quality control methods including assay:

[0031] (1) Measured according to high performance liquid chromatography (Appendix VI D of Chinese Pharmacopoeia 2005 edition). Instrument: Shimadzu SPD-10Avp high performance liquid chromatography; Zorbax SB C18 5μm 4.6×150mm, SN: USCL012593. Reagent acetonitrile (chromatographically pure, batch number: 022920, Fisher). Potassium dihydrogen phosphate (analytical grade, batch number: 20020512, Beijing Chemical Plant). Chromatographic conditions and system suitability test, using octadecylsilane bonded silica gel as filler, acetonitrile-0.05mol / L potassium dihydrogen phosphate solution = 24:76 as mobile phase, detection wavelength is 265nm, and the number of theoretical plates is Berberine hydrochloride peak meter should not be less than 4000.

[0032] (2) Preparation of the reference substance solution, take an appropriate amount of the reference substance of ber...

Embodiment 3

[0036] Weichangning Tablets (drug standard number is WS 3 -B-0335-90) quality control methods include identification of:

[0037] (1) Take this product and observe under a microscope: there are many fragments of epidermal tissue, the cells are square, and the pores are indeterminate; the fibers are mostly bundled, and some have calcium oxalate crystals on the surface, and occasionally scattered calcium oxalate clusters.

[0038] (2) Meridian wood identification, according to the chromatogram of the record under the item of embodiment 1 [assay], the retention time of the main peak of the test product should be consistent with the retention time of the main peak of the reference substance.

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PUM

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Abstract

The invention relates to a traditional Chinese medicine preparation, namely, Weichangning tablets, in particular to a quality control method thereof. The quality control method comprises the following steps of: the content measurement of caulis mahoniae: each tablet contains the caulis mahoniae of not being less than 0.50mg calculated by berberine hydrochloride; identification: the Weichangning tablet is taken and arranged under a microscope for observation: epidermal tissue fragments are more, cells are square and pores are inconstant; fibers form bundles, calcium oxalate crystals are attached on the surfaces of a plurality of the fibers, and the scattered calcium oxalate cluster crystals are occasionally seen; identification of the caulis mahoniae: in the chromatogram recorded according to the content measurement item, the retention time of a main peak of a test article is consistent with the retention time of the main peak of a contrast article. The quality standards adopted by the invention can effectively supervise the production, prevent the occurrence of phenomena of wrong feed, mis-feed or more feed or less feed, being more benfiicial to the supervision of product quality, ensuring the stability of the product quality and guaranteeing the safety of drug administration of patients.

Description

technical field [0001] The invention relates to a method for controlling the quality of Weichangning tablets, a traditional Chinese medicine preparation. Background technique [0002] In the prior art, Weichangning Pian (Weichangning Pian) is recorded on page 165 of the second volume of the Ministry of Health's Drug Standards for Traditional Chinese Medicine Prescriptions, and the standard number is WS 3 -B-0335-90. Prescription: Buza leaves 1300g, Polygonum 780g, Guava leaves 780g, Fotan mother 780g, Gongluomu 520g. Preparation method: take 100g of the above five flavors, crush them into fine powder, add the other four flavors such as cloth dregs and leaves, and the remaining fire charcoal to decoct twice, each time for 2 hours, combine the decoction, filter, and concentrate the filtrate to a relatively high temperature. The clear paste with a density of 1.09 (heat measurement), let it cool, add twice the amount of ethanol, stir well, let it stand for 24 hours, filter, th...

Claims

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Application Information

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IPC IPC(8): A61K36/704A61K9/20A61P1/00A61P1/14G01N30/36
Inventor 孟昭敏
Owner 吉林万通药业集团梅河药业股份有限公司
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