Xiao'er Huatan Zhike Granule and its preparation method

Abstract

The invention belongs to the field of medicines, and particularly relates to a child phlegm resolving and cough relieving granule and a preparation method thereof. The child phlegm resolving and coughrelieving granule comprises, by weight, 10ml of bal loonflower root liquid extracts, 15ml of white mulberry bark liquid extracts, 60ml of tincture ipecac, 0.3-75g of ephedrine hydrochloride clathratecompounds, 0.208g of citric acid, 2.08g of sodium citrate and an appropriate amount of powdered sugar. High-substitution and low-substitution hydroxypropyl-beta cyclodextrin serves as a subject, ephedrine hydrochloride serves as an object, and the ephedrine hydrochloride clathrate compounds are prepared by an existing clathrate technique. The high-substitution and low-substitution hydroxypropyl-beta cyclodextrin serves as the subject to wrap the ephedrine hydrochloride to form a stable clathrate, the highest clathrate rate can reach 94.35%, and the method solves the technical problem that mark content of the ephedrine hydrochloride is reduced in the storage process. The stability of the prepared child phlegm resolving and cough relieving granule is greatly improved as compared with the prior art, and the drug use quality of the child phlegm resolving and cough relieving granule is remarkably improved.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to Xiaoer Huatanzhike granules and a preparation method thereof. Background technique [0002] Xiaoer Huatan Zhike Granule is a drug included in the national drug standards. The main ingredients are ephedrine hydrochloride, Morus alba liquid extract, Platycodon grandiflorum liquid extract, ipecac tincture, citric acid and sodium citrate, etc. It has antitussive and expectorant properties. Efficacy, clinically used for cough and expectoration caused by bronchitis in children. The 2005 version of the State Food and Drug Administration standard stipulates that the content of ephedrine hydrochloride in each bag of Xiaoerhua Zhike Granules (5g / bag) should be 1.688mg~2.062mg, although ephedrine hydrochloride itself is stable to light, heat and humidity, but The current production practice has proved that due to the complex ingredients in the prescription of Xiaoer Huatan Zhike Granule...

AI Technical Summary

Problems solved by technology

The 2005 version of the State Food and Drug Administration standard stipulates that the content of ephedrine hydrochloride in each bag of Xiaoerhua Zhike Granules (5g / bag) should be 1.688mg~2.062mg, although ephedrine hydrochloride itself is stable to light, heat and humidity, but The current production practice proves that due to the complex ingredients in the prescription of Xiaoer Huatan Zhike Granules, ephedrine hydrochloride will slowly degrade, and the Xiaoer Huatan Zhike Granules produced at a content of 105% will drop to about 90% after being stored for 18 months under specified conditions

It can be said that before the filing date, it was a mature technology to form an inclusion compound by inclusion of ephedrine hydrochloride with β-cyclodextrin, but there were still the following common defects: ①The existing inclusion process is prone to produce Fine precipitation, serious loss of ephedrine hydrochloride; ②The inclusion rate is low, generally 82.5-92.5%; ③Light resistance, heat, and humidity resistance still need to be improved

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