The Pharmaceutical Research of Biyan Tongqiao Spray

30. June 2012 · Comments Off · Categories: TCM

Title	The Pharmaceutical Research of Biyan Tongqiao Spray
Abstract	Biyan Tongqiao Spray compound is an empirical prescription of Teaching Hospital of Chengdu University of T.C.M to treat rhinitis. It is composed of five herbs such as ephedra, scutellaria, angelica root, wild mint and flower bud of lily magnolia. It has the efficacy of relief of obstruction of nasal cavity, and in clinic it is used to treat Nasal barrier, thick yellow nasal mucus, acute and chronic rhinitis, rhinosinusitis. This project had studied on preparation technology, quality standard and preliminary stability.Based on clinical use and thinking about this compound’ characteristic, we design spray to be the does type. At the aspect of technical study, we had accomplished the preparation technology of this sort of does type, including the study of extraction process of wild mint and flower bud of lily magnolia aromatic water, the study of rate of dry paste, ephedrine, ephedrine and baicalin water extraction process. Taking the extraction rate of volatile oil as the index, we used steam distillation to extract aromatic water; Taking the rate of dry paste, the yield of ephedrine and baicalin as evaluation indicator, we used orthogonal test to select the best water extraction process. Through these technical studies, we determined the extraction process of this does type:using wild mint, flower bud of lily magnolia, ephedra, scutellaria and angelica root, first, taking wild mint, flower bud of lily magnolia, angelica root and adding 10 times quantity water, collecting 3000ml aromatic water by distill them 6 hours, using the aromatic water to re-distill 5 hours to collect 300ml aromatic water for preparation. Using another contains to collect herbs water for preparation. Second, taking the dregs of a decoction, ephedra and scutellaria with adding 15 times quantity water, we decocted them 3 times by 0.5 hour each, and mixed these decocted water to filter and subsequently make vacuum concentration. Then add 95% ethanol to make the ethanol content achieve 65%, after Ethanol precipitation impurity and give 24 hours standing. Then filtered and recycled ethanol from filtrate, added water to make constant volume. Subsequently used NaOH solution to get pH 6.5, centrifugated, then added 0.5‰phenylformic acid, 3% glycerin and 300ml aromatic water, made constant volume, mixed well, put standing, filtered, split charging, sterilized, then get the spray. After 3 times experiments, the outcome demonstrated that this process route is basically Stable, feasible and operatable.At the study on quality standard, Using TLC to make qualitative identification of ephedra, scutellaria baicalensis and angelica root, the Spot separation was well and the blank test showed no interference. This mean that The method has characters of good selectivity. We used HPLC to do quantitative determination of ephedrine hydrochloride in ephedra, and did systemic methodology research, The results are in line with requirements. According to the results of batches of samples were determined, we worked out the ephedrine hydrochloride’s content limitation that is unless than 0.6mg of 1mg ephedra.3 months’ stability test indicated that this sample’s characteristic, identification, pH, relative density, content assaying and microbial limit test were up to specification. These results suggest that the sample were basicly stable during 3 months.Our studies suggests that Biyan Tongqiao Spray’s preparation technology is reasonable and feasible, the quality standard is controllable, finished goods’s quality is basicly stable
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