Pharmaceutical Research Of Sanjie Capsule

Objective:The prescription of Sanjie capsule is derived from clinical eff ective prescription. The prescription has the effect of soft firm fights、f acilitating the pain、invigorate the circulation of blood and phlegm swel ling. The prescription attending hyperplasia of mammary gland, breast dise ase, abnormal lacteal painful disease, breast fibroadenoma. With the guidan ce of the theories of Traditional Chinese Medicine and Pharmacy, according to the requirements of new drugs of traditional Chinese medicine researc h, pre clinical pharmaceutical research of the preparation technology res earch, study on the quality standard and stability study of Sanjie capsule had been developed. Through the optimization of the extraction and purifi cation technology, the prescription was made capsules to improves the effe ctive composition content, lows the doses and make sure that it would be s afe and effective and easy to carry.Methods:According to the function and treatment as well as the properties of the component of the drugs, the dosage was chosen as capsule. Based on the physical chemical properties of the herbs, the reasonable technologica 1 line was established. Analyzed bupleurum saponin a and bupleurum saponin d levels, paeoniflorin content, the content of hesperidin, the sum of the s um of hydroxy safflower yellow pigment and rhizoma kaempferiae content, ta nshinone Dan phenolic acids a and B content in the sum, rosemary acid, and the extract rate as examining index, combining with the multi index compre hensive evaluation method. Using the method of orthogonal test design pref erred Radix Bupleuri, cat’s claw, mountain arrowhead, white peony root, tange rine peel, safflower, Prunella vulgaris and Salvia miltiorrhiza eight herbs. Select the best extraction process;used orthogonal test to prefer the bes t extraction and volatile oil beta cyclodextrin inclusion technology in R hizoma Cyperi, radix curcumae, Radix Angelicae sinensis, Rhizome of Chuanxio ng. Using the sum of the ferulic acid content in terms of glycosides, the c ontent of baicalin, the soil nail content, extract, n-butanol extract and e thanol extract as examining index, Determine the water extraction process of the medicine residue of Rhizoma Cyperi, radix curcumae, Radix Angelica s inensis and Rhizoma Chuanxiong with Radix Scrophulariae, raw oysters,kelp, seaweed, baikal skullcap root, Rhizoma Bolbostemmae. Then combining with flo w extract powder, bulk density investigation results to determine the opti mal molding process.Study on quality standard, the TLC was used to identify Rhizoma Cyperi, radix curcumae, Rhizoma Chuanxiong, Radix Scrophulariae, Radix Paeoniae Alba, Radix Scutellariae, cat’s claw. The measurement method of Ferulic acid, tube imoside, saikosaponin a, saikosaponin d and rosmarinic acid were determined by HPLC. Meanwhile, the determination method and content limit of them wer e building.In the study of stability, according to the requirements of new drugs of traditional Chinese medicine research, observe the preparation prelimi nary stability and accelerated stability. Results:The better extraction and purification process is:Radix Bupleuri, cat’s claw, mountain arrowhead, white peony root, tangerine peel, safflower, P runella vulgaris and Salvia miltiorrhiza using 75% ethanol refluxing and extracting for two times, the first 10 times volume of solvent, the second 8 times volume of solvent,each one-hour. Rhizoma Cyperi, radix curcumae, Rad ix Angelicae sinensis, Rhizome of Chuanxiong this four medicinal herbs cru shed into coarse powder, adding 8 times amount of water, the volatile oil w as extracted from 8 hours by steam distillation method. The extracted vola tile oil entrapped β-cyclodextrin by grinding method. Volatile oil and β-cyclodextrin quality ratio is 1:8 and adding four times the amount of wa ter grinding for three hours. After extraction of volatile oil,the dregs w ith Radix Scrophulariae, raw oysters, kelp, seaweed,baikal skullcap root, Rhi zoma Bolbostemmae decocted two times, the first 12 times amount of water, the second 10 times amount of water,each two-hour.In the quality standar, identificated the TLC method of Rhizoma Cyperi, radix curcumae, Radix Scrophulariae,angelica, chuanxiong, Radix Paeoniae Alb a, Radix Scutellariae, Radix Ranunculi ternate, specificity and good reprodu cibility. Through high performance liquid chromatography, using ferulic aci d,soil fritillaria glycosides, bupleurum saponin a and bupleurum saponins d, rosemary acid and carries as index, established the method for the deter mination of Angelica sinensis, Rhizoma Bolbostemmae, bupleurum, Prunella vul garis. Established the HPLC of ferulic acid, soil fritillaria glycosides, bu pleurum saponin a and bupleurum saponins d, rosemary acid and carries on t he methodology. The Linear regression equation of ferulic acid y=132789x-2 14502, r=0.9999;the Linear regression equation of soil fritillaria glycosi des y=2226295.344x+132999.4596, r=0.9998;bupleurum saponin a and bupleurum saponin d regression equations, respectively y=9212423.77x+112395.1996r= 0.9994, y=9592159.868x+92163.99237r=0.9998;the Linear regression equation of rosemary acid y=58333020.66x-284012.424r=0.9996;The RSD of precision i nspecting, repeatability, stability test and recovery test were all in the range of 3%.Stability study showing that the preparation of Sanjie capsule have a stable quality. Conclusion:This paper used modern extraction method and determined extrac tion and purification process, the results of quality standards showed tha t the research method is reasonable and reliable, and provided the foundat ion for the study of pharmacodynamics.