Quality Analysis And Evaluation Of Drugs Containing Aconitine-type Alkaloids

Objective:Decoction pieces, compound recipe granules, and preparations containing aconitine alkaloids which were commonly used in clinical are determined the limited dose of toxic components and contents by the chromatographic and spectroscopic techniques. And then, preparations were evaluated and analyzed through pharmacological experiments in further.Methods:the limited dose of aconitum alkaloids and six kinds of index components in decoction pieces, compound recipe granules, and preparations are determined using thin-layer chromatography (TLC) and high performance liquid chromatography (HPLC). Quality stability of lumbar pain capsule is investigated according to UV spectrum. Skin safety of compound vine Ukraine ointment is inspected.Results:Aconitine content in the three kinds of preparations is not meeting the requirements. monoester aconitine in the parts of Radix Aconiti preparata、Radix Aconiti Kusnezoffii Preparata is not meeting national standards. Six alkaloids content in compound recipe granules with different batches are quite different. UV spectrum of waist rest pain capsules displays homoousia. There was no toxicity and irritation to rats intact skin which was acted with compound vine black ointment preparations, but a slight irritation which can be released itself within24h.Conclusion:In this experiment, the quality standards for traditional Chinese medicine preparation and dispensing granule with Aconitum were improved by determination of the content of alkaloids in the preparation and compound recipe granules. UV spectrum group map of the waist rest pain capsules was established. It is safety for applying compound vine black ointment.