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Detection method of quality cold relief capsule

A detection method and capsule technology, applied in the field of medicine, can solve problems such as imperfection, slow onset of effect, uncertainty of drug efficacy, etc., and achieve improved quality monitoring and good treatment effects

Pending Publication Date: 2017-08-04
吉林修正药业新药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Ganyu capsules are refined from Radix Isatidis, honeysuckle, artificial bezoar, acetaminophen, amantadine hydrochloride, and starch. It is the exclusive product of our company. It can effectively cure influenza, but according to clinical feedback, some batches of samples are slow to take effect. In order to further ensure the quality of the product and be more conducive to the supervision and management of the product quality, it is necessary to improve the detection of the product, so as to make it more effective. Further guarantee the quality and curative effect of the product
[0004] The quality standard of Ganyu Capsules is the National Drug Standard of the State Food and Drug Administration: WS-10368 (ZD-0368)-2002. The content of amantadine hydrochloride was determined; the release of the preparation in the body was not tested in the standard, resulting in uncertainty in the efficacy of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0049] A detection method for Ganyu capsules. According to parts by weight, the capsules are prepared into 1000 capsules with 250g isatidis, 150g honeysuckle, 10g artificial bezoar, 250g paracetamol, 100g amantadine hydrochloride and 3.3g starch Agent; It is characterized in that, this detection method comprises the following steps:

[0050] 1. Properties: This product is a capsule, and the content is a yellow-brown powder; it tastes bitter;

[0051] 2. Identification:

[0052] (1) Take 4g of the content of this product, add 20ml of petroleum ether (60-90°C), ultrasonicate for 20 minutes, discard the petroleum ether, add 30ml of ethyl acetate to the residue, ultrasonicate for 30 minutes, filter, and evaporate the filtrate to dryness. Add 2ml of ethyl acetate to the residue to dissolve it, and use it as the test solution; take another chlorogenic acid reference substance, add methanol to make a solution containing 0.5mg per 1ml, and use it as the reference solution; test accor...

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PUM

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Abstract

The invention relates to a detection method of a cold relief capsule, which is mainly used for controlling the quality in the medicine production process. The detection method comprises identification of radix isatidis, identification of honeysuckle flower, identification of calculus bovis factitius, and measuring of contents of paracetamol and amantadine hydrochloride. The detection method has the beneficial effects that the radix isatidis, the honeysuckle flower and the calculus bovis factitius in a recipe are qualitatively identified; the specificity, recurrence and durability are better; the paracetamol and the amantadine hydrochloride are quantitatively analyzed; the separation degree is high, the analysis time is short, and the operation is simple; the production efficiency is effectively improved, and the energy source is saved.

Description

technical field [0001] The invention belongs to the technical field of medicine, relates to the quality analysis of pharmaceutical preparations, in particular to a quality control method for Ganyu capsules. Background technique [0002] Cold is a kind of modal respiratory system disease, with nasal congestion, runny nose, sneeze, cough, headache, aversion to cold, fever, general malaise, etc. as the main clinical manifestations of exogenous diseases. In recent years, scholars have done a lot of research on the treatment of colds, and have made great progress. TCM syndrome differentiation and treatment, solution to express evil, reconcile yin and yang, the effect is better than Western medicine antibiotic treatment, therefore, the rapid development of new drug research technology and Chinese and Western mixture Advances in technology have provided a solid foundation and efficient technical support for the research of antiviral drugs. [0003] Ganyu capsules are refined from ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/90
CPCG01N30/02G01N30/06G01N30/90
Inventor 曹翠阎君白冰徐建李桂峰常红刘学峰于施
Owner 吉林修正药业新药开发有限公司
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