Preparation method of compound pseudoephedrine hydrochloride capsule
An aminomamin capsule and capsule technology, which can be used in capsule delivery, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as impacts that have not yet been reported
Active Publication Date: 2012-05-16
SINOVA LABS +1
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Problems solved by technology
[0006] At present, there have been quite a lot of researches on the harm of chloroacetic acid to the human body, but the impact of residual chloroacetic acid in sodium starch glycolate on drugs has not yet been reported.
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Embodiment 1
[0029] Example 1 Huzhou Outlook 20100129
Embodiment 2
[0030] Example 2 Huzhou Outlook 20100360
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Abstract
The invention relates to a preparation method of a compound pseudoephedrine hydrochloride capsule. The preparation method provided by the invention is characterized by comprising the following steps of detecting chloroacetic acid content of sodium carboxymethyl starch, when the weight of chloroacetic acid is 0 to 0.05% of that of sodium carboxymethyl starch, mixing active ingredients and auxiliary materials well, carrying out granulation, drying, sieving and loading to obtain the compound pseudoephedrine hydrochloride capsule. Through the preparation method provided by the invention, it is avoided that chlorphenamine maleate and chloroacetic acid of the compound pseudoephedrine hydrochloride capsule undergo a chemical reaction in storage to produce an impurity shown in the formula I and thus chlorphenamine maleate content is reduced. The preparation method provided by the invention reduces factors causing preparation destabilization and improves preparation safety.
Description
technical field [0001] The invention relates to a preparation method of Ammamimin capsules, in particular to a method for controlling the content of chloroacetic acid in sodium carboxymethyl starch and a detection method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Ammamimin Capsules (Rilida) is a compound over-the-counter medicine for colds produced by Shenzhen Zhonglian Pharmaceutical Co., Ltd. Its main active ingredients are acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorpheniramine maleate. Among them, acetaminophen can inhibit the synthesis of prostaglandins, and has antipyretic and analgesic effects; pseudoephedrine hydrochloride can selectively constrict blood vessels in the upper respiratory tract, eliminate nasal congestion, and relieve symptoms such as nasal congestion, runny nose, and sneezing; dextromethorphan hydrobromide It can inhibit the cough center and produce ...
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IPC IPC(8): A61K31/485A61K31/167A61K31/137A61K31/4402A61K9/48A61P31/16A61P29/00A61P11/02A61P11/14A61P37/08G01N30/02
Inventor 李嘉和张群艳杨镜刘军梁永军
Owner SINOVA LABS
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