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Quality control method for phlegm eliminating and asthma relieving cough syrup

A quality control method and technology for cough syrup, applied in the quality control field of expectorant, asthma and cough syrup, can solve the problems of no identification item, no reflected drug content determination item, poor qualitative analysis, etc., so as to improve quality control and ensure internal Quality and efficacy, the effect of perfect quality standards

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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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there are many product literatures with similar components and similar efficacy to the Great Wall Zhikechuan syrup standard, but there are no product literatures with the same ingredients and the same efficacy, but the above standards have the following problems: There is no identification in the original quality standard of Great Wall Zhikechuan Syrup item, there is poor qualitative analysis; in addition, there is no content determination item of the index component that reflects the internal quality of the drug, which is still lacking in quality control standards. In order 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 phlegm eliminating and asthma relieving cough syrup

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preparation example Construction

[0039] Preparation of Reference Substance Solution Take an appropriate amount of baicalin reference substance, weigh it accurately, add methanol to make a solution containing 0.06mg per 1ml, and obtain it.

[0040] Preparation of the test solution Precisely draw 1ml of this product and put it in a 10ml volumetric flask, dilute to the mark with 70% ethanol, shake fully, centrifuge, filter, and use it as the test solution.

[0041] Determination method Precisely draw 5 μl each of the reference substance solution and the test solution, inject it into the liquid chromatograph, measure it, and obtain it. This product contains not less than 0.6mg of baicalin per ml.

[0042] Functions and indications: anti-inflammatory cough, expectorant and asthma. For mild and medium chronic bronchitis, cough and asthma. Usage and dosage: take orally, 10ml each time, twice a day. Specifications: 100ml per bottle; Storage: Sealed and kept in a cool place.

Embodiment 2

[0043] Example 2 Drafting of Great Wall Zhikechuan Syrup Quality Standard Description: There is no identification and content determination in the original quality standard of Great Wall Zhikechuan Syrup. The TLC identification of Scutellaria baicalensis and Scutellaria baicalensis and the method of content determination of Scutellaria baicalensis were researched and tested, and the results were increased. TLC identification of red and scutellaria baicalensis; in addition, the content of baicalin in Great Wall Zhikechuan Syrup was determined by HPLC method, and the content of baicalin was determined.

[0044] 2. TLC identification

[0045] 1. Identification of Manshanhong

[0046] 1.1 Materials and reagents

[0047] Ethanol, ether, toluene, ethyl acetate, formic acid: analytically pure

[0048] Manshanhong reference medicinal material: China National Institute for the Control of Pharmaceutical and Biological Products, batch number: 1035-200003 high-efficiency silica gel G th...

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Abstract

The invention belongs to the technical field of Chinese patent medicaments, and relates to a quality control method for phlegm eliminating and asthma relieving cough syrup prepared from raw materials which are Chinese medicinal plants. In quality standards, Dahurian rhododendron leaf serves as a reference medicinal plant and baicalin serves as a reference substance, and whether the phlegm eliminating and asthma relieving cough syrup or Changcheng Zhikechuan Tangjiang contains Dahurian rhododendron leaf and baicalin components or not is detected by a thin layer chromatography. In the method, quack medicaments and inferior medicaments can be more accurately inspected and safety in use is improved; high performance liquid chromatography for detecting the baicalin content of the phlegm eliminating and asthma relieving cough syrup, the quantitative index of baicalin content of not less than 0.6 microgram of every milliliter of phlegm eliminating and asthma relieving cough syrup, and the inspection method improve the quality standard controllability of the phlegm eliminating and asthma relieving cough syrup, further ensure the inherent quality and curative effect of the product and relatively more perfect the quality standards; and modified quality standards enhance quality control over medicaments.

Description

technical field [0001] The invention belongs to the technical field of Chinese patent medicines, and relates to a quality control method for antiphlegm, asthma and cough syrup made from Chinese medicinal materials. Background technique [0002] Great Wall Zhike and Chuan Syrup (named in the present invention: the quality control method of expectorant, asthma and cough syrup) was included in the 20th volume of "Standards of the Ministry of Health of the People's Republic of China (Prescriptions of Traditional Chinese Medicine)" in 1998. When the Great Wall Zhike Chuan Syrup was included in the ministerial standards, the prescription quantity was not disclosed, and the quality standards of the components were recorded: [0003] Manshanhong, Houttuynia cordata, Coltsfoot, Forsythia, Scutellaria baicalensis, Ophiopogon japonicus [0004] poppy husk, crocodile, licorice; [0005] Preparation method: the above nine flavors, Manshanhong are infiltrated with ethanol, the percolati...

Claims

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Application Information

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IPC IPC(8): A61K36/8968A61K9/10A61P11/06A61P11/10A61P11/14G01N30/02G01N30/90
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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