Study On Asarone Sodium Chloride Injection

As one of main active ingredient in Acorus tatarincuii Schott , Asarone has a strong pHarmacological activity of expectorant ,cough relieving,antispasmodic and anticonvulsant, and it particularly has a significant effect on pneumonia, bronchial asthma and chronic obstructive pulmonary disease and other common lung diseases .But owning to its poor water solubility, which severely limits the efficacy .At present, the formulation which has been on the market are tablets, capsules. According to the literature and a large number of clinical trials, , it is difficult for the oral solid dosage forms with low bioavailability to play effect. The injection which has been studied for a long time has not ratified onto the market,because the content was decreased sharply after sterilization and the security of degradation products of can not be confirmed.for that reason , asarone injection has been listed in the ranks of high-risk drugs.High performance liquid chromatography(HPLC) method with UVdetection was developed for determination of content,solubility and oil/water partition coefficient of asarone.The analysis method is precise simple and reliable ,and suitable for quality control of asarone injectionIn this paper,asarone injection was overall studied on formulation design and optimization of preparation. As to improve stability and insoluble of asarone , suitable solubilizer, antioxidant,and metal chelator are selected out, and the amount of activated carbon, filtration conditions, sterilization conditions in preparation process are also investigated. Finally, the formulation and preparation of injection was optimized and decided with the methtod of single factor investigation.Beside, the quality control criteria and stabiliy are deeply investigated in this paper .In this paper,the quality standard of asarone injection was studied.Its chemical identification,the method of determination of general and related substance and assyaing were established based on structure property ,and its quality standard of asarone injection was also established .This paper provide a scientific basis for the production of asarone sodium chloride injection and offer a simple accurate and suitable for the quality control for asarone injection...