| Jiajianyijing granules were developed based on the first affiliated hospital of Guang Zhou University of Traditional Chinese Medicine of gynaecological clinical prescription which had been widely used for treating premature ovarian failure and has good effects for many years.It is composed of Cuscuta chinensisLam,Rehmannia glutinosa Liboschh,Paeonia lactiflora Pall and other nine Chinese medicine.The clinical observation show it can reinforce kidney and strengthen spleen,smoothing liver and promoting blood circulation.In clinical application the prescription was primitively by water-boiling because of the large dosage.With inconveniences in taking,carring,keeping and other problems,it has poor compliance.In order to overcome these disadvantages,the researches developed the prescription into granules.The researches were prepared with modern Chinese medicine technologies to study on preparation technology,quality standard and stability,pharmacodynamics.These systematic studies which provide experiment basis.ObjectiveAccording to the registration and guiding principles of sixth type of new TCM to exploit a new TCM used to treat and prevent premature ovarian failure.Methods1.Studies on the prepartion technology systematically(1)Study on the extration process:With contents of hyperin,paeoniflorin and solid as a comprehensive score,single factor experiment and orthogonal table were arranged to investigate the watering times,extracting times and extracting time on the influence of the water extraction process to optimization the best craft.(2)Study on purification process:Taking the thymus coefficient,spleen coefficient,serum E2 level in serum and overy coefficient as index to compare the effects of samples which deposited with alcohol and which not deposited with alcohol.(3)Study on the concentration and drying technology:Taking hyperin and paeoniflorin retention as indexs to compare atmospheric concentration and vacumm concentration.2.Studies on molding ration(4)To study the moisture absorption,critical relative humidity,angle of repose of extract powder.Taking granules molding ration,hydroscopicity and melting rate to select the most potimal filler.The dry granulating conditions,physical propertie of granules and packaging materials also be determined;Meanwhile the pilot production was performed to verify the rationality of process.3.Studies on quality standardThe qualitative identifications of Cuscuta chinensis Lam,Rehmannia glutinosa Liboschh,Paeonia lactiflora Pall and so on were carried out by TLC as well as the content of hyperin in monarch drug Cuscuta chinensis Lam and paeoniflorinin adjuvant drug Paeonia lactiflora Pall were determined by HPLC according to Chinese Pharmacopoeia(2010 edition,volume I);Meanwhile the grain size,moisture,melting and the difference of filling quantity were referring to Chinese Pharmacopoeia(2010 edition,volume appendix I C granules);Preliminary stability of three batches of prepararation were detected by accelerated test and long-term test.4.Studies on pharmacodynamicsThe effects of Jiajianyijing granules on the experimental premature ovarian failure anlimal models by taking E2,FSH,LH level in serum and overy coefficien.Results.(1)The optimum water extration were as follows:adding water equivalent to 8 times,extracting three times and 1 hour for each time.The average extraction rate of hyperin and paeoniflorin were 56.96%and 61.79%.The average dry extract yielding rate was 27.60%.(2)Pharmacodynamics results showed that compared with normal control group and model control group with thymus,spleen coefficient,serum E2 level,ovarian coefficient decreased significantly(P<0.01).Compared with model control group,the deposited with alcoholsamples and without alcohol samples were increased significantlyin mice thymus coefficient and spleen coefficient,serum E2 level,coefficient of the ovary(P<0.05).The without alcohol samples have significantly higher levels in thymus coefficient(P<0.05),suggesting,may polysaccharide components has certain influence to the effect,therefore,this product does not need to alcohol precipitation.(3)Taking vacuum concentration.The retention of hyperin andpaeoniflorin were 94.88%and 93.31%.Taking vacuun drying by 60～70℃ under-0.085Mpa.The thickness of the plate was no more than 0.8cm and the retention of hyperin and paeoniflorin were 90.98%～91.02%and 93.09%～94.17%.(4)The hygroscopicity of extract powder is strong,critical relative humidity is 58%,angle of repose was 45.2°.Molding process results show that the filler was malt dextrin and adding product particle 1%stevia sugar as the best tase;The dry granulating control with water content from 3%～5%and CRH was 58%;Using pure aluminum packaging material and three batches of pilot samples examined all meet requirementswith received product rate above 90%.Thetransport rate of hyperin and paeoniflorin were 36.46%～38.04%and 46.64%～47.99%.(5)Established the quality standard of Jiajianyijing granules.Regulating the TCL identification method of Cuscuta chinensis Lam,Rehmannia glutinosa Liboschh,Paeonia lactiflora Pall,Salvia miltiorrhiza Bge and Bupleurum chinense DC.The detection methods and the minimum content of hyperin and paeoniflorin also be required.According to Chinese Pharmacopoeia(2010 edition,appendi Ⅰ Cgranules)the properties of products,particle size,mostiure content,melt,the difference of filling quantity also be formulated.The long-term test and accelerated test(6 months)prove that the Jiajianyijing granules were stable.The products were accorded with the requirement of quality standard.(6)The Jiajianyi jing granules can increase the level of serum E2 and overy coefficient while reduce the level of serum FSH and LH;As result it can impove premature ovarian failure siginificantly;ConclusionThe optimum process of Jiajianyijing granules were reasonable,practicable,effectivitly and feasible,the quality of the product could control stablely and effectively which provide experimental basis for clinical application and industrial production. |
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