| Objective:This research project focuses on modern medicine in the treatment of postpartumabdominal pain, the lochia and other gynecological diseases, according to therapeuticdrug of the recovery period for the disease after therapy is less, through literature researchand clinical practice, with Angelica Jianzhong Tang Fang-based party from “Qian Jin YiFang” written by Dynasty Sun S M, according to Chinese medicine theory ofcompatibility of the blood, nourishing yin and hemostatic effects of donkey hide gelatin,and used of modern technology means the product was developmented into granules, inorder to overcome the traditional decoction is difficult to boiling, taking large, save tobring inconvenience and other shortcomings, and its quality standard was researched, toprovide a theoretical basis for the further development of the preparation.Methods:1. During the researching of pharmaceutical technology, through literature andpre-experimental study, the Chinese medicine containing a larger proportion of volatileefficacy such as angelica, through the single factor investigation to determine theextraction process of volatile organic compounds; for volatile pharmacologicalcompounds with β-cyclodextrin inclusion technique, the inclusion process of thecomposition of volatile efficacy was determine, with inclusion rate and the inclusioncompound yield to be evaluation index; The residue with jujube and licorice was extracted,used water as the extraction solvent, the content of ferulic acid for evaluation; extractionprocess of white peony root was be determined, used ethanol as the extraction solvent andthe content of paeoniflorin for evaluating the process; selected vacuum belt drying methods and dry granulation technology to complete the preparation of the product dryand granular.2. In the study of the quality standard of preparation, through the system research,TLC was established of the angelica, white peony root, cinnamon, donkey-hide gelatinand licorice Smell; HPLC was established of the ferulic acid in angelica and the peonyglucosinolate in white peony root, and completed its methodology investigation.3. In the initial study of the stability, the medicinal preparation was respectivelystudied by characters, moisture, particle size identification, content, and microbial limit in0month,2months,3months, through analog commercially available aluminum-plasticcomposite bag conditions at40℃±2℃, relative humidity environment of75%±5%.Results:1.Process studies have showed that, shamisen herbs, which include Angelica,Cinnamon and Pried Ginger, add12times the amount of water was extracted essential oil6hours,1ml volatile oil add8g β-cyclodextrin and four times the amount of30%ethanolusing colloid mill grinding20minutes, filtered and dry4hours at40℃，Income thingswere porphyrized and reserved; Income medicine liquid was filtrated and reserved; dregs,jujube and licorice add six times the amount of water extracted2times, one hour eachtime, filter the medicine liquid and mix in the liquid with the above; Centrifugation withthe speed of8000r/min, the supernatant was concentrated to a relative density of1.10(60℃) in the temperature of70℃, and the vacuum degree for-0.08~-0.1MPa, reserved theextracts; Ejiao was added into the amount of water, and then melt into the relative densityof1.20~1.30(60℃),reserved the solution; Root of herbaceous peony extract two times,each time1h with8times of60%ethanol, mixed the filtrate, then the ethanol wasrecovered, the filtrated would be concentrated to a relative density of1.10(60℃) in thetemperature of70℃and the vacuum degree for-0.08~-0.1MPa, reserved the extracts.The above three clear pastes were mixed, then would be concentrated to a relativedensity of1.20~1.30(60℃) in the temperature of70℃and the vacuum degree for-0.08~-0.1MPa. After that, the thick paste would be dried using vacuum belt dryingequipment in the condition of vacuum-0.1MPa, the heating temperature was (80℃,85℃,80℃), the crawler speed was20cm/min, feed rate was16L/h, under this conditions,80mesh drying clear cream powder was prepared, add Aspartame, citric acid, β-cyclodextrin inclusion mixture, and soluble starch, after blending, they are prepared to granules, in the roller pressure for60~65kgf/cm2, roll speed for10~12r/min, sendpowder speed14~16r/min conditions.2. In its quality standard study, through the system study, angelica, root ofherbaceous peony, cinnamon, donkey-hide gelatine and licorice were identified by TLC,and blank control no interference. Ferulic acid and herbaceous peony glucoside weredeterminated by HPLC, the regression equation of ferulic acid isY=2700470.4225X3201.4, related coefficient r=0.9996, results indicates that within0.071~0.426μg range the linear relationship is good; the regression equation ofherbaceous peony glucoside is Y=2762638.3399X-213199.1, related coefficient r=0.9996,results indicates that within0.253~1.265μg range the linear relationship is good.3. Preliminary stability test results show that each index of the standard qualityconform to the standards in three months, the results show that preliminary stability isgood.Conclusion：After three group of pilot test and verify, confirmed that the preparation process issafe, reliable and repeatability; the indexes of the quality standard can be examinedstrongly, inspection method is stability, repeatability is good; Preliminary stabilityexperiments show that the selection of aluminum-plastic composite bag packaging is theideal packaging material for this product. |
PDF Full Text Request