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Wasting-thirst pill quality control method

A quality control method, the technology of Xiaoke Pills, which is applied in the field of medicine, can solve problems such as great influence, poor specificity, and inability to accurately reflect glibenclamide, so as to achieve the effect of quality control and drug safety

Active Publication Date: 2006-07-19
GUANGZHOU BAIYUNSHAN ZHONGYI PHARMA COMPANY
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Problems solved by technology

The quality control of the final product is carried out according to the standard MS-B-3476-98 issued by the Ministry of Health of China. In the standard, only the microscopic identification of astragalus, Schisandra chinensis and Chinese yam is carried out, and the specificity is poor. The spots are observed by TLC The size of the area is used to check the limit of glibenclamide. The limit of this thin-layer method is determined by many factors during the operation process. The subjective factors of observing the size of the spots are greatly affected, which cannot accurately reflect the content of glibenclamide in the product. , so it is necessary to further study the quality control method of this variety

Method used

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Examples

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Embodiment

[0023] Embodiment: Take the Xiaoke Pill whose batch number is E00532 produced by Guangzhou Zhongyi Pharmaceutical Co., Ltd.

[0024] 1. Identification of Astragalus in Xiaoke Pills:

[0025] Crush 5.5g of Que Ke Wan, add 30ml of methanol, sonicate for 15 minutes, filter, evaporate the filtrate to dryness, add 30ml of 95% n-butanol, sonicate for 15 minutes, filter, and wash the filtrate with 1% sodium hydroxide solution for 3 times , 20ml each time, discard the lye, wash 2 times with n-butanol-saturated water, 30ml each time, discard the washing solution, evaporate to dryness n-butanol, add methanol 1ml to dissolve the residue, and obtain the test solution; Add methanol to dissolve the astragaloside IV reference substance, and make a solution containing 1mg in 1ml as the reference substance solution; according to the thin-layer chromatography test in the appendix of the Chinese Pharmacopoeia 2000 edition, draw 3 μl of each of the above two solutions, and apply samples respectiv...

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Abstract

The invention provides a quantity control method for a kind of antidiabetic, which belongs to medication field. Concretely, It relates to the quantity control method of the combination of the Traditional Chinese medicine with the Westen medicine. It adds the following method to the original quantity control standard. (1): adopting thin layer chromatography, contrasting to to identify if the antidiabetics contain astragalus. (2) adopting thin layer chromatography to comparing the Wuweizisu A to schisandra chinenis positive to indetify if the antidiabetics contain kadsura longepedunculata (3) Adopting high performance chromatography to assay the percentage content of the weigh of the glyburide is 0.07%-0.11%. The invention improves the quantity control technique of the antidiaetics, increase the identification method of if the abtidiabetics with high sepcificity contain astragalus and schisandra and can make a quantitative assay for the glyburide content, so as to control the quantity of the products to secure the safety to human pharmacy.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a quality control method of Chinese and Western medicine compositions. Background technique [0002] A drug for the treatment of diabetes, Xiaoke Pills has been on the market for many years and has a positive clinical effect. It is also a drug that has been included in the standards issued by the Ministry of Health of China. Xiaoke Pill is a compound composition of traditional Chinese medicine Pueraria root, Rehmannia glutinosa, Radix Astragali, Trichosanthum officinalis, corn silk extract, Schisandra chinensis, yam powder and synthetic drug (commonly known as western medicine) glibenclamide, according to the conventional process of preparing pills from traditional Chinese medicine preparation. The quality control of the final product is carried out according to the standard MS-B-3476-98 issued by the Ministry of Health of China. In the standard, only the microscopic identifi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/90G01N30/02G01N21/29G01N21/64G01N30/00G01N30/14G01N30/88
Inventor 李惠霞侯雪英苏碧茹罗亦芬何艺兰
Owner GUANGZHOU BAIYUNSHAN ZHONGYI PHARMA COMPANY
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