AIM: To study the stability on controlled release pellets of Ginkgolides. METHODS: According to the requirement of stability test of appendix XIXC of China Pharmacopoeia (2000 edition, Part Ⅱ), test for influencing factor, accelerated test and samples kept at room temperature were studied, applying similar factor analysis to appreciate the release stability. RESULTS: All the indexes accorded with the standard. CONCLUSION: Controlled release pellets have a good stability.

AIM: To optimize the excipient formulation of lactose,HPMC_(SH4000) and Carbopol 71 G in breviscapin sustained release tablets by mixture uniform design. METHODS: Different formulations,single factor f_2 and multifactors of cumulative release as index,were evaluated respectively. RESULTS: The optical formulations obtained by the two methods were identical,and the tablets with optical formulation had ideal sustained release. CONCLUSION: Mixture uniform design is simple,direct and uniform.It can be used in optimization of formulation with invariable amount.

Objective: To establsh the quality standard for Fufang Jiangya liniment (Folium Apocyni Veneti, Semen Cassiae, Semen Vaccariae, etc.). Methods: Semen Cassiae, Folium Apocyni Veneti and Semen Vaccariae were identified by TLC. Fructus Coriandri was identified by GC. Chrysophanol and quercetin were determined by RP HPLC. Results: The petroleum ether (boiling range: 30～60?C) n hexane ethyl acetate formic acid (1∶3∶1.5∶0.01) was used as the developer for the identification of Semen Cassiae on silica gel G coating plate. The toluene ethyl acetate formic acid (5∶4∶1) was used as the developer for the identification of Folium Apocyni Veneti and Semen Vaccariae, respectively, also on silica gel G coating plate. By GC, licareol as standard substance, Fructus Voriandri could be identified. By RP HPLC, kromasil C 18 as fixed phase, when methyl alcohol water perchloric acid (80∶20∶0.1) was used as the mobile phase. ( ? =257nm), the average recovery of chrysophanol was 0.0298mg?mL -1 , methyl alcohol 0.5% phosphoric acid solution (1∶1) was used as the mobile phase ( ? =370nm), the average recovery of quercetin was 1.1522mg?mL -1 . Conclusion: The methods established are simple, feasible and reproducible and can be used as the quality standards for Fufang Jingya Liniment.

Objective To study the effect of Jiajian Guishen Pill on apoptosis of rat's granulosa cells of ovary.Methods Rats' granulosa cells of ovary were cultured in vitro,stimulated with serum containing Jiajian Guishen Pill.The apoptosis rate was checked by flow cytometer and BCL-2 protein expression by immuno-fluorescence 6 hours later with the serum containing Zishen Yutai Pill and human menopausal gonadotropin(HMG)served as the control drugs.Results The apoptosis rate of the low-dosage group of serum containing Jiajian Guishen Pill was significantly lower than those of the other groups(P

0.999). The relative standard deviation (RSD) of chromatogram area was less than 1.0% for all of them after six successive injections. The detection limit was 0.05 ?g/mL for norephedrine (NE), 0.04 ?g/mL for norpseudoephedrine (NPE), 0.1 ?g/mL for E and PE, and 0.2 ?g/mL for mephedrine (ME) and mepseudoephedrine (MPE), respectively (S/N≥3). The recovery rate was more than 97.1% for six ephedrine alkaloids. Under this method system, all of the above-mentioned six samples were tested and found to contain some of the impurity at different levels. Conclusion This developed method, which is very simple, perfect precision, high sensitivity, and selectivity, can be used for the qualitative and quantitative determination of impurities of ephedrine alkaloid-type samples.

Objective To study the preparation and stability of paclitaxel self-microemulsifying drug delivery system ( PTX-SMEDDS) . Methods The formulation of the PTX-SMEDDS was optimized by monitoring the appearance, particle size, concentration, relative substance, and bacterial endotoxin. Influence of different pH and different dosage of activated carbon on PTX-SMEDDS was investigated. Subsequently it was subjected to stability studies. Results The PTX-SMEDDS was a translucent diluted-yellow solution with a mean diameter of 19. 6 nm. High speed centrifugal test indicated PTX-SMEDDS was stable. The result of the influential factor tests showed PTX-SMEDDS was unstable to high temperature and light. In the accelerated tests for 6 months, the quality of PTX-SMEDDS was stable. The samples should be sealed and stored at low temperature and shady place. Conclusion Easily prepared and stable formulation of PTX-SMEDDS is achieved, and further investigation is warranted to develop self-microemulsifying drug delivery system for injection.

AIM: To optimize the formulation in the preparation of the Breviscapine Liposomes. METHODS: Using film evaporation-extrusion method to prepare Breviscapine Liposomes according to the uniform design,a optimum formulation was established by determining the entrapment efficiency and the ratio of loading drug. RESULTS: The entrapment efficiency and the ratio of loading drug of Breviscapine Liposomes prepared with cholesterol and lecithin were determined to be 69.60% and 29.06%,respectively.The average diameter is 105.6 nm. CONCLUSION: The application of the uniform design is useful to achieve a large entrapment efficiency and ratio of loading drug.

Objective To summarize the relationship between metabolic syndrome (MS),its components and T1 stage with high grade urothelial carcinoma (HGUC) of the Bladder.Methods The clinical data of 200 patients with T1 high grade bladder cancer who were admitted to our hospital from January 2010 to June 2014 were retrospectively analyzed,including 155 males and 45 females.Ages were 24 to 86 years old,average 66 years old.Based on the history or blood glucose levels,patients were divided into diabetic group (n =41) (20.5％) and non diabetes group 159 cases (79.5％);According to the body mass index (BMI) were divided into obese group (≥25 kg / m2) of 98 cases (49.0％) and non obese group (＜ 25 kg / m2) of 102 cases (51.0％).According to the blood pressure level,71 cases (35.5％) were divided into hypertension group and 129 cases of non hypertension group (64.5％).MS and its components and the relationship between the recurrence and progress of bladder cancer were analyzed.The Kaplan Meier method was used to assess MS and its components division of tumor progression free survival (progress-free survival,PFS) and recurrence free survival (recurrence-free survival,RFS) influence.Cox regression model of multi factor analysis were used to evaluate the PFS and RFs of MS and its components with bladder cancer.Results Of the 200 cases,16 cases (8.0％) were MS.Tumor recurrence occurred in 121 cases (60.5％),and 84 patients (42.0％) were in progress.Diabetes and non diabetes groups the average RFs were 21.7 and 29.3 months respectively,and the difference was statistically significant (x2 =10.115,P =0.001);The median PFS were 32.8 and 39.8 months respectively,the difference has statistical significance (x2 =14.760,P ＜0.001).Obese group and non obese group average RFs were 34.7 and 42.0 months respectively,and the difference were statistically significant (x2 =16.077,P ＜ 0.001);The median PFS were 22.8 and 32.6 months respectively,the difference was statistically significant (x2 =16.174,P＜0.001).The average RFS of MS group and non MS group were 21.5 and 28.4 months respectively,the difference was statistically significant (x2 =5.429,P =0.02);the average PFS was 35.1 and 38.7 months respectively,and the difference was statistically significant (x2 =3.854,P ＜ 0.05).Cox multivariate survival analysis showed that diabetes and obesity can increase the risk of recurrence and progression of T1 advanced stage bladder cancer (HR =1.792,P =0.013,HR =2.498,P ＜ 0.001;HR =0.559,P ＜ 0.001;HR =0.492,P ＜ 0.001).Conclusions Diabetes mellitus and obesity are high risk factors for the recurrence and progression of T1 advanced stage bladder cancer,but MS is not related to the prognosis of T1 patients with advanced bladder cancer.

OBJECTIVETo establish a method to evaluate the in vitro release of Chinese medicinal compound sustained release preparations using multi-index chromatographic fingerprint.

METHODWith the Chinese medicinal compound Jiangya sustained tablets as model preparation, the in vitro cumulative release of the main component flavones and fingerprint were determined by HPLC fingerprint. Aacacetin, rutin, luteolin, fingerprint were determined simultaneously and used to calculate the in vitro cumulative release of the tablets.

RESULTAacacetin, rutin, luteolin, and the fingerprint had different cumulative release.

CONCLUSIONMulti-index chromatographic fingerprint can reflect different content of multi components of preparations and can be used in the evaluation on in vitro release of the sustained release preparations of Chinese medicinal compound. The method is simple, rapid, and of multi information.

AIM: To establish methods for identifying the antetype of Compound Qingkailing(Calculus bovis,Concha margaritifera,Radix isatidis,Cornu bubali) in rat serum by HPLC-MS~n and HPLC-TOF-MS. METHODS: Addition of methanol to serum after Qingkailing given intravenously to rats was used to precipitate protein.The HPLC-TOF-MS provided the exact molecular weight and the HPLC-ESI-MS~n provided the m/z of multilevel fragment.The medicine antetypes were identified by combining the two methods. RESULTS: Four main medicine antetypes in rat serum,such as geniposide,baicalein,wogonoside and cholic acid,were identified. CONCLUSION: It is a rapid and exact method that can be used to identify other complicated traditional Chinese medicine in vivo.