The Study Of Cangxin Nasal Drops’ Preparation Technology And Quality Control

Objective:Cang Xin Nasal Drops,a traditional Chinese medicine preparation from the First Affiliated Hospital of Medical University of Anhui Province which for external use,mainly used in the treatment of rhinitis, sinusitis and related complications,have been made and refined from the three Chinese medicine extract of xanthium, magnolia flower, angelica dahurica. The study, based on the former extration technics and the modern Chinese medicine research methods, focuses on the technics and quality control of Cang Xin Nasal Drops with the help of traditional chinese medicine theory, and aims to achieve resonable technics, quality control and clear theraputic effects.Methods:In the studies on its preparation technics, the method of volatile oil extraction was used to deal with Cocklebur, Magnolia and Angelica by means of grouping extraction.Then we applied orthogonal experiment to select factors of water extraction and alcohol precipitation, with Chlorogenic acid, extract yield and atractyloside taken as the index,respectively. In the studies on its preparation process, we studied the amount of the extraction liquid and the concentration ways to determine reasonable prescriptions of the nasal drops. At the same time, ternary phase diagrams have been used to screen Twain-80 levels of the solubilizer and optimize the preparation technology.In the study on its quality standard, the TLC method was employed to identify the herbal medicine in Cang Xin Nasal Drops, and the HPLC method was employed to determine the content of Chlorogenic acid and Magnelin. Research on whether the nasal drops were in line with 2010 pharmacopoeia standard and preliminary stability has been conducted in the study.Result:According to the study on the extration technics, the optimal conditions would be 8times(8.5 times for the first time) the amount of the water, 2 times with one hour eachtime. The optimal conditions for alcohol precipitation technology would be relative density 1.05, concentration of 70% and 24 hours. In the studies on its preparation process, the determined prescription would be 1ml Cang Xin Nasal Drops containing 1g medicine, The optimized stroma was 0.2%Kapommer-940; PH regulator was 1%Nao H Regulating p H value to 6.5; osmotic pressure regulator was 0.9%Na Cl; preservative was 0.01% merthiolate; and solubilizing agent was Twain-80. While,in the study of ternary phase diagrams, it was finally determined when the Twain-80 of the solubilizing agent was 8ml(0.53%), mild sticky, clear and stable high polymer solution nasal drops could be made. Three batches of samples(140521, 140523, and 1405215) have been achieved in the enlarged mid-test.In the study on the quality standard, the TLC method was employed to identify Cocklebur, Magnolia and Angelica in Cang Xin Nasal Drops; the content of Chlorogenic acid and Magnelin, the entry of heavy metals and arsenic salt limits, clarity, content uniformity and preliminary stability all meet the 2010 Pharmacopoeia standards.Conclusion:1. In the experiment, factors for water extraction and alcohol precipitation have been optimized by the orthogonal test. The extraction process of Cang Xin nasal drops is scientific and reasonable.2. The single factor screening has been conducted for the preparations in the experiment. The preparation technology of Cang Xin nasal drops is economic and feasible.3. Quality control over the herbs has been carried out through the experiments.The quality standard is simple and controllable, and preliminary stability research has been completed, which has laid a solid foundation for further research and clinical studies.