Research On Preparation Technology And Quality Standard Of Two Dosage Forms Of Promoting Blood Circulation To Arrest Pain

The capsule of Promoting Blood Circulation to Arrest Pain is the products of Zhuhai Ansheng phoenix Pharmaceutical Co.Ltd.The original craft for the capsule is filling with medicinal powder.This preparation of process is relatively simple and has some problems,such as poor stability,large difference in load capacity,poor quality control and so on.According to the usage investigation for the capsule,we can find it has obvious curative effect,and it is suitable for the current medical situation in our country.So the subject is research to improve dosage form of capsules for Promoting Blood Birculation to Arrest Pain.Improvement for the extraction of medicinal excipient respectively will after preparation is dripping pills and concentrated capsule,the two dosages are all have strengths of modern forms for traditional Chinese medicine.Then,study and make sure the best preparation process.Established the quality control standard is relatively simple and accurate and controllable.And study on the preliminary stability for products of dropping pills and capsules.The main contents:To optimize the preparation process of this experiment using single factor experiment method of Promoting Blood Circulation to Arrest Pain dropping pill.The matrix type,proportion of main drugs and substrates,melting temperature of medicine,condensate type,condensation column length,upper temperature and condensing droplets from other factors are investigated.Choose the main and auxiliary ratio,melting temperature,condensation temperature of upper as factors proceed the orthogonal design experiment.Determined the optimal preparation technology with statistical comparison of Promoting Blood Circulation to Arrest Pain dropping pill.Show the optimum preparation process is that the main and auxiliary ratio is 1:2.1,temperature of molten medicine 70? the upper temperature condensate 50?.Then use thin-layer chromatography(TLC)method for the identification of the pseudo-ginseng,Angelica sinensis,borneol.By high performance liquid chromatography(HPLC)for the quantitative determination of ferulic acid and panax notoginseng saponins.The qualitative and quantitative analysis method was established for the composition of the Promoting Blood Circulation to Arrest Pain dropping pill.And set up the quality standard for it.Made of three batches of samples were consistent with the standard.Inspect the stability of 3 months of pills,showed stable quality in 3 months.Study on Promoting Blood Circulation to Arrest Pain capsule preparation process that first by single factor experiment to optimize the preparation process.The influence factors were investigated filler selection,wetting agent of ethanol concentration,drying temperature etc.Then make the orthogonal experimental design method.With the amount of accessories,accessories category,the concentration of ethanol as factors.Make a statistical comparison,so as to optimize the best preparation technology with Promoting Blood Circulation to Arrest Pain capsule.Show the optimum preparation process is the auxiliary materials for starch and 5%silica gel material dosage is 20%,the concentration of ethanol is 95%.And use TLC method for the qualitative identification of pseudo-ginseng,Angelica sinensis,borneolin prescription.Through the HPLC method for the quantitative determination of ferulic acid and panax notoginseng saponins.The qualitative and quantitative analysis method was established for the composition of the Promoting Blood Circulation to Arrest Pain capsule.Then set up the quality standard of concentration capsule.Made of three batches of samples were consistent with the standard.Inspect the stability of 3 months of pills,showed stable quality in 3 months.Compared with national drug standard for Promoting Blood Circulation to Arrest Pain capsule,the content of ferulic acid in Angelica sinensis was increased by HPLC method.The method has strong specificity,good linear relationship,highly stability and so on.