Quality control method for infantile cough syrup as Chinese medicine preparation

A quality control method and a technology for relieving cough in children, which are applied in directions such as pharmaceutical formulations, measuring devices, and drug combinations, can solve problems such as imperfect identification items and identification methods, and achieve the effects of perfecting quality standards and 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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Problems solved by technology

[0010] But do not see as yet identical with the Ministry of Health standard WS3-B-2832-98 infant cough syrup prescription of above-mentioned disclosure, proportioning is identical, the improved document of the product standard o

Method used

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  • Quality control method for infantile cough syrup as Chinese medicine preparation
  • Quality control method for infantile cough syrup as Chinese medicine preparation
  • Quality control method for infantile cough syrup as Chinese medicine preparation

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preparation example Construction

[0052] Preparation of reference substance solution: Take an appropriate amount of glycyrrhizic acid monoammonium salt reference substance, accurately weigh it, add methanol to make a solution containing 0.1mg per 1ml, and obtain (0.09795mg converted into glycyrrhizic acid).

[0053] Preparation of the test solution: Accurately measure 10ml of this product, put it in a 25ml measuring bottle, add an appropriate amount of methanol, shake well, dilute to the mark with methanol, shake well, centrifuge, take the supernatant, and get ready.

[0054] Determination method: Precisely draw 10 μl each of the reference substance solution and the test solution, inject it into the liquid chromatograph, measure it, and obtain it. Each 1ml of this product contains licorice and glycyrrhizic acid (C 42 h 62 o 16 ) shall not be less than 0.12mg.

[0055] Functions and Indications: Moisturizing the lungs and clearing away heat, relieving cough and reducing phlegm. It is used for fever due to i...

Embodiment 2

[0058] Example 2 Instructions for Drafting Quality Standards for Pediatric Cough Syrup:

[0059] Pediatric Cough Syrup is an exclusive variety produced by Lerentang Pharmaceutical Factory of Tianjin Zhongxin Pharmaceutical Group Co., Ltd., and its current quality standards are recorded in Volume 15 of the Ministry of Health's Drug Standards for Traditional Chinese Medicine Prescriptions. In order to improve the quality standard of children's cough syrup compared with the ministerial standard, the TLC identification method of Scrophulariae Radix, Ophiopogon japonicus and Zhimu in the prescription was added, and the content determination method of licorice was formulated with ammonium glycyrrhizinate as the quantitative index. The drafting work will now be explained as follows:

[0060] 1 Prescription and Preparation: Revised. Revision content: According to 1000 preparation units, the prescription dosage is revised in proportion. According to the relevant provisions of the 200...

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Abstract

The invention belongs to the technical field of Chinese patent drug, relating to a quality control method for infantile cough syrup as Chinese medicine preparation, which is prepared from Chinese herbal medicines as raw materials, comprising the following steps: with the reference substances of figwort, lilyturf root and Sarsasapogenin, distinguishing whether the prescription of the infantile cough syrup contains the compounds of figwort, lilyturf root and Sarsasapogenin with thin layer chromatography; and with the reference substance of mono-ammonium glycyrrhizinate, detecting the content of glycyrrhizic acid in the prescription of the infantile cough syrup with high performance liquid chromatography; therefore, the quality standard is relatively perfect, and the quality control of the medicine is improved due to the amended 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 a traditional Chinese medicine preparation children's cough syrup made from Chinese medicinal materials. Background technique [0002] Pediatric Cough Syrup is a classic Chinese patent medicine, listed in Volume 15 of the Ministry of Health’s Drug Standards for Traditional Chinese Medicine Prescriptions, Ministry of Health’s Standard WS 3 -B-2832-98 records the prescription and quality standards: [0003] Prescription: Scrophulariaceae 200g, Ophiopogon japonicus 200g, Dannanxing 200g [0004] Almond water 180ml Betel nut (charred) 150g Bellflower 150g [0005] Bamboo Ru 150g Mulberry Bark 150g Trichosanthin 150g [0006] Chuan Fritillaria 150g Melon Wilter 150g Licorice 150g [0007] Perilla seed (stir-fried) 100g Anemarrhena 100g Perilla leaf oil 0.32ml [0008] Preparation method: boil the above fifteen fla...

Claims

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Application Information

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IPC IPC(8): A61K36/899A61P11/14G01N30/90G01N30/36G01N30/02
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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