White Fine Cough Cream Preparation Process And Quality Standards

Objective: Wheezing and cough are common respiratory symptoms in children with tracheitis, bronchitis, repetatus respiratory infection,or bronchial asthma, etc. It's generally accepted by traditional and modern medicine that repetatus respiratory infection and bronchial asthma are refractory respiratory diseases and have high morbility. With the increase of the morbidity, developing safe and effective medicine has become one of medical workers' tasks.Recurrent attacks is the clinical future of these two diseases and prophylaxis is important to them. Traditional Chinese medicine has unique advantages in treating children's repetatus respiratory infection and bronchial asthma. Now most available prophylactic agents are oral preparation or injection. Recent studies have suggested that topical creams not only play topical effect by penetrating into skin, but also systemic effect by penetrating into blood through skin capillary, which avoids first pass effect and decreases side effects. This study aims to develop a safe,efficient,convenient and stable cream preparation based on cipher prescription which had been used in clinic for many years.Method:①manufacture procedure: Optimization of ethanol-extracting procedure for Semen Sinapis albae combined with Rhizoma Corydalis and Radix Kansui., the polysaccharides from Radix Saposhnikoviae, essential oil from Radix et Rhizoma Asari and cream-forming procedure by orthogonal test.②quality standard: the concentration of Sinapine thiocyanate in cream was qualitatively analyzed by HPLC, and the medical component in cream was qualitatively identified by TLC.③stability: the stability of the cream was investigated by sample-keeping observation method.④safety: the toxicology study of the cream was made, such as acute toxicity test, skin stimulation test and hypersensitive reaction test.