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.
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[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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