Studies On The Preparing Technology And Quality Standard Of Chuan'e Rhinitis Spray

Chuan'e Rhinitis Spray is a compound formulation which consists of Andrographis paniculata (Burm. f. ) Nees, Centipeda minima (L.) A. Br. et Aschers., Magnolia biondii Pamp. (Magnolia denudata Desr. Magnolia sprengeri Pamp.), peppermint oik eucalvutus oil, Diphenhydramine hydrochloride and Ephedrine hydrochloride. According to clinical use for many years, it has good effect on allergic rhinitis.On the base of reliable effect in clinic and the Guidance of Provision for New Drug Approval, Chuan'e Rhinitis Spray has been studied on preparing technology , quality standard and preliminary stability by modern scientific methods. According to their different solubility, the active components in the prescription were extracted in different ways. The optimal extracting conditions were screened by orthogonal design. The solubilization technique of volatile oil and Andrographis paniculata (Burm. f. ) Nees were studied with emphasis. The results showed that the procedure is reasonable, stable and practical. The quality standards of Chuan'e Rhinitis Spray include the Thin Layer Chromatography (TLC) identification of Andrographis paniculata (Burm. f. ) Nees, Centipeda minima (L.) A. Br. et Aschers. peppermint oil and eucalvutus oil. We established the constant determination methods of the Andrographis paniculata (Burm. f.) Nees, Diphenhydramine hydrochloride, Ephedrine hydrochloride(by High Pressure Liquid Chromatography) and peppermint oil(by Gas Chromatography). The results indicated that the methods were sufficiently simple, sensitive and reproducible. Preliminary stability tests showed that the Chuan'e Rhinitis Spray is stable in three months.