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Quality control method for gastric condition-regulating pill as traditional Chinese preparation

A quality control method and a technology of traditional Chinese medicine preparations, which are applied in the directions of medical formulas, measuring devices, drug combinations, etc., can solve the problems of identification items, identification means, content determination methods, etc., and achieve the effect of improving quality control

Active Publication Date: 2011-05-25
津药达仁堂集团股份有限公司乐仁堂制药厂
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AI Technical Summary

Problems solved by technology

[0010] At present, there are many documents about Tiaowei Dan, but there is no comparison with the above-mentioned Ministry of Health standard WS 3 -B-0395-90 Tiaowei Dan has similar or identical prescriptions, the same proportioning ratio, and similar product standards. However, there are still shortcomings in the standards of the prior art, such as identification items, identification means, and content determination methods. For To improve the product quality of traditional Chinese medicine, it is necessary to improve the product quality standard

Method used

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  • Quality control method for gastric condition-regulating pill as traditional Chinese preparation
  • Quality control method for gastric condition-regulating pill as traditional Chinese preparation
  • Quality control method for gastric condition-regulating pill as traditional Chinese preparation

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preparation example Construction

[0064] Preparation of Reference Substance Solution Take appropriate amount of magnolol reference substance and honokiol reference substance, weigh them accurately, add methanol to make a solution containing 130 μg of magnolol and 45 μg of honokiol per 1 ml.

[0065] Preparation of the test solution Take an appropriate amount of this product, grind it into a fine powder, take 0.5g of the powder, accurately weigh it, accurately add 25ml of methanol, weigh it, treat it ultrasonically for 30 minutes, let it cool, weigh it again, and make up for it with methanol Subtract the lost weight, shake well, filter, take the continued filtrate, that is.

[0066] Determination method Draw the above-mentioned reference substance solution and 5 μ l of the test solution respectively, inject it into the liquid chromatograph, measure it, and obtain it. Each 1g of this product contains magnolol and magnolol (C 18 h 18 o 2 ) and honokiol (C 18 h 18 o 2 ) shall not be less than 1.6mg.

[0067...

Embodiment 2

[0069] Example 2 Tiaoweidan Quality Standard Drafting Instructions:

[0070] Identification:

[0071] 1. Instruments and reagents

[0072] High performance liquid chromatography: Shimadzu LC-2010A HT

[0073] Ultrasonic instrument: KUDOS SK8200LH (Shanghai Kedao Ultrasonic Instrument Co., Ltd.);

[0074] Electronic balance: Sartorius CP225D / CP224S (Beijing Sartorius Instrument System Co., Ltd.);

[0075] Silica gel G thin-layer board, silica gel H thin-layer board, high-efficiency silica gel G thin-layer board (Qingdao Ocean Chemical Factory Branch);

[0076] Reference substance: dehydrocresylide (batch number: 1525-200102)

[0077] Synephrine (Lot No.: 110727-200105)

[0078] The above reference substances were all purchased from China National Institute for the Control of Pharmaceutical and Biological Products;

[0079] The reagents used are analytically pure, and the water is redistilled deionized water;

[0080] Tiao Wei Dan (batch number: 060301, 060302, 0...

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Abstract

The invention relates to a quality control method for a gastric condition-regulating pill as traditional Chinese preparation, which is prepared from Chinese herbal medicines as raw materials, belonging to the technical field of Chinese patent medicine; the method comprises the steps that: a microscope is arranged for quality standard to identify whether the formula of the gastric condition-regulating pill contains betel nut, immature bitter orange, magnolia bark and cinnamon; with synephrine, dehydrocostus lactone and liquorice as reference substances, thin-layer chromatography is adopted to identify whether the formula of gastric condition-regulating pill contains the ingredients of synephrine, dehydrocostus lactone and liquorice; and with magnolol and honokiol as reference substances, high efficiency liquid chromatography is adopted to detect the quantitative index and the inspection method of the content of the magnolia bark in the formula of gastric condition-regulating pill, thereby relatively perfecting the quality standard, strictly controlling the quality of medicines, ensuring the improvement of product quality and improving the quality control for medicines owing to the revised quality standard.

Description

technical field [0001] The invention belongs to the technical field of Chinese patent medicines, and relates to a quality control method of Tiaowei Dan, a traditional Chinese medicine preparation made from Chinese medicinal materials. Background technique [0002] Tiaowei Dan is a classic Chinese patent medicine, the Ministry of Health standard WS 3 -B-0395-90 records the prescription and quality standard: [0003] Prescription: Woody Fragrance 75g Amomum 75g Licorice 75g [0004] Betel nut 75g Citrus aurantium (stir-fried) 75g Magnolia officinalis (made with ginger) 75g [0005] Cyperus (made from vinegar) 75g Cardamom 75g Wulingzhi (made from vinegar) 50g [0006] Ginger 25g Cloves 25g Cinnamon 25g [0007] Preparation method: crush the above twelve flavors into fine powder, sieve, mix evenly, make pills with water, and dry. For every 500g dry pills, coat with 16g of cinnabar powder and 3g of peach gum in water, polish, and dry to obtain . [0008] ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/9064A61P1/04A61P1/14G01N30/90G01N30/02A61K35/24
Inventor 陈坚王磊赵艳李林
Owner 津药达仁堂集团股份有限公司乐仁堂制药厂
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