Pharmaceutical Research On Yang Jing Capsules

Yang Jing Capsules are traditional Chinese medicines containing herbs:Herba Epimedii Preparata, Radix Rehmanniae Praeparata,Radix Astragali, Placenta Hominis,which have the effect of tonifying kidney and removing blood stasis to promote circulation, and are beneficial for the treatment of the oligozoospermia, weak azoospermia and functional loss of libido, erectile dysfunction and so on. Under the guidance of TCM theory and according to the State Food and Drug Administration, the article carries out the pharmaceutical research using modern science and technology.1.Study of the preparationIn the study of preparation technology, according to the effectiveness of prescription indications, clinical drug characteristics and the nature of the active ingredients of drugs, we design preparation process:(1)We grind the Placenta Hominis to fine powder with pulverizing method; (2)We use the single factor confrontation method to inspect the volatile oil of Radix Angelicae Sinensis with vapour distillation,the results show that the best conditions are immersing the powder of Radix Angelicae Sinensis with 12 times of water for 2 hours and distilling for 6 hours;(3)With Saturated aqueous solution, we use L9(34) perpendicular sheet to determine the best inclusion condition for the oil, and the results show the best conditions are inclusing the oil with 6 times ofβ-cyclodextrin, with 12 times of water for 2 hours;(4)We choose trational water abstraction methods to extract Herba Epimedii Preparata,et al.and do experiments according to L9(34) perpendicular sheet containing three factors-the amount of water, abstraction time and abstraction frequency. The best water abstraction schema is extracting them with water of 10 times for 3 times,1.5 hours once. (5) We choose drying method the to make granula,and do experiments according to L9(34) perpendicular sheet containing three factors.The best method to make granula is rollers speed 7 r·min-1,transmission speed 40 r·min-1,0.4mm as the distance of the two rollers.In order to test the rationality of the preparation, we have research on mid-experiment for three times,and the products are detected according to all the quality control.The the pratical production is feasible and the received products rate is above 90%.2.Study of the quality standard.We determine the index and methods of quality control.We use TLC toidentify Herba Epimedii Preparata, Radix Rehmanniae Praeparata,Radix Astragali.et.al.The results show that the spots are clear on the TLC picture and the negative control was non-interference,so we could use it as the qualition identification.HPLC is used to assay Icariine.The results show that the contents in every capsule of Icariine shouldn't be less than 0.51mg and the regression equation of Icariine was Y=21.869X+52.887,r=1,linear range was 0.1262～8.072μg.It says the quality of this preparation is stable.We check the moisture and disintegration time,et al of Yang Jing Capsules at last,too.3.Study of the stabilityIn order to examine the stability of the medicine and determine the time of validity of the medicine,we keep the wrapping material at indoor temperature and detect three batches of products according to all the indexes from the quality control.