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Quality control method of Yangrong Baicao Wan for treating irregular menses caused by hemophthisis

A quality control method and a technology for irregular menstruation, applied in the field of quality control of Yangrong Baicao Pills, can solve the problems of different proportions, identification items, imperfect identification methods and content determination methods, and achieve the effect of improving product quality

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

[0014] The above disclosure is similar or identical to the prescription disclosed by the Ministry of Health standard WS3-B-1406-93 Yangrong Baicao Pill, with different proportions and similar efficacy. However, there are still identification items, identification means, and content determination in the prior art. Incomplete methods and other shortcomings

Method used

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  • Quality control method of Yangrong Baicao Wan for treating irregular menses caused by hemophthisis
  • Quality control method of Yangrong Baicao Wan for treating irregular menses caused by hemophthisis
  • Quality control method of Yangrong Baicao Wan for treating irregular menses caused by hemophthisis

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preparation example Construction

[0059] Preparation of reference substance solution Weigh an appropriate amount of paeoniflorin reference substance, weigh it accurately, put it in a 100mL measuring bottle, add 50% methanol to dilute to the mark, shake well, and get it. (Each 1mL contains paeoniflorin 0.1mg)

[0060] Preparation of the test solution Weigh 1g of this product, weigh it accurately, put it in a 100mL conical flask with a stopper, add 50mL of 50% ethanol, weigh it, treat it with ultrasonic for 30 minutes, take it out and let it cool, weigh again and make up the ultrasonic solution. Reduce the amount lost, shake well, filter through a 0.45μm filter membrane, and take the subsequent filtrate to obtain the product.

[0061] Determination method Draw the above-mentioned two reference substance solutions and 5 μL of the test solution respectively, inject it into the liquid chromatograph, measure it, and obtain it. Each gram of this product contains Radix Paeoniae Alba and Paeoniflorin (C 23 h 28 o 1...

Embodiment 2

[0064] Example 2 Yangrong Baicao Pill Quality Standard Drafting Description: In order to achieve the purpose of the present invention in the research of qualitative identification of this product, the design carries out qualitative identification to tangerine peel and Cyperus cyperi in the prescription, using different sample processing methods and different polarities Separation was carried out with the expansion system, and after the improvement in sample processing, the plate was identified again. As a result, the separation of tangerine peel and Cyperus cyperi was better, and the same spots were on the same position as the reference substance, and the negatives had no interference, and the reproducibility was good. Therefore, the TLC identification method of tangerine peel and Cyperus cyperi in the prescription was established. In the design of the quantitative analysis of this product, the composition analysis experiment was carried out with the prescription Baishao first....

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Abstract

The invention belongs to the technical field of Chinese patent medicine, relates to a quality control method of Yangrong Baicao Wan which is prepared from traditional Chinese medicine and used for treating irregular menses caused by hemophthisis, wherein the quality standard comprises the authentication items of dried orange peel and nutgrass galingale rhizome, the content of paeoniflorin (C23H28O11) in the medicine is measured by means of high efficiency liquid chromatography, the medicine of each gram comprises radix paeoniae alba of not less than 3.0 mg by means of quantitative indexes and inspection method based on the paeoniflorin (C23H28O11), so that the quality standard is relatively complete, the quality of the medicine is controlled strictly, and the improvement for the quality of the product is ensured.

Description

technical field [0001] The invention belongs to the technical field of Chinese patent medicines, and relates to a quality control method of Yangrong Baicao Pills made from Chinese medicinal materials for treating women's anemia and irregular menstruation. Background technique [0002] Yangrong Baicao Pill is a classic Chinese patent medicine, the standard WS of the Ministry of Health 3 -B-1406-93 records the prescription and quality standards: [0003] Prescription: Radix Paeoniae Alba 160g Angelica 80g Sangjisi 80g [0004] Rehmannia glutinosa 80g Eucommia (charcoal) 80g Chuanxiong 60g [0005] Cyperus (made with vinegar) 60g Ophiopogon japonicus 40g Tangerine peel 40g [0006] Poria cocos 40g donkey-hide gelatin 20g licorice 20g [0007] Black beans 16g [0008] Preparation method: Grind the above thirteen flavors into fine powder, sieve, mix well, pill with water, and dry to obtain. [0009] At present, there are many patents and documents si...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8968A61K9/20A61P15/00G01N30/02G01N30/90A61K35/36
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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