This paper reported all kinds of assay of soybean isoflavone on the basis of collecting and analyzing relating literatures at home and abroad. The assay conditions were listed and compared in this paper. The authors believed that the assay should be selected according to the circumstances.

[Objective] To observe the therapeutic effect of electroacupuncture(EA) collagen-induced arthritis(CIA) in rats and explore the partial mechanism via regulating blood rheology.[Methods] Bovine type II collagen was intradermally injected into the back of anesthetized rats to induce arthritis,the animal model of rheumatoid arthritis.Electroacupuncture(continuous waves,2 Hz,5 mA) was applied unilaterally and alternatively to Zusanli(ST 36) and Sanyinjiao(SP 6) for 30min,given once a day for 30 days.The paw edema,pain threshold and joint pathological changes in CIA rats were observed.Some indexes in blood rheology such as viscosity and erythrocyte aggregation were also examined.[Results] EA at point Zuansanli(ST 36) and Sanyinjiao(SP 6) reduced paw swelling and increased pain threshold significantly.Pathological damages of joint in CIA rats were effectively prevented by EA treatment.Meanwhile,the low blood viscosity in EA group were lower obviously than that in control group,and the erythrocyte aggregation indexes were down-regulated by EA.[Conclusion] EA has a pronounced therapeutic effect on collagen-induced arthritis in rats.Regulating the blood rheology in CIA rats may be the mechanism of EA.

BACKGROUND:Insulin taken orally is easy to be degraded by hydrochloric acid in the gastric juice and various enzymes in the gastrointestinal tract.It is hard for oral insulin to pass through the epithelial cell membrane in the gastrointestinal tract.Insulin delivered by injection needs at least 36 hours every administration.Many pulmonary administrations of insulin have been recentl studied,such as dry powder inhalation,aerosol inhalation,electron spraying,insulin nanometer technique,and absorption enhancer,with promising clinical application prospects.OBJECTIVE:To investigate the glucose-lowering effects of insulin delivered by oral inhalation in normal rats.METHODS:Thirty healthy male rats,weighing (220±30) g were randomly divided into seven groups:low dose insulin (1.0 U/kg,n=4),middle dose insulin (5.0 U/kg,n=4),high dose insulin (10,0 U/kg,n=4),insulin (2.0 U/kg) +5% lecithin (n=5),insulin (2.0 U/kg)+1% oleic acid (n=5),insulin (2.0 U/kg) +1% diethylenetriaminepentaacetic acid (DTPA; n=5),and blank control (n=3).At 0,30,60,120,180,240 minutes after administration.1.5μL blood was taken from rat tails through the use of ONE TOUCH~(TM) BASICTM PLUS blood glucose detection system for determination of blood glucose level and calculation of insulin pharmacological bioavailability under various conditions.RESULTS AND CONCLUSION:Insulin (1U/kg) markedly decreased glucose levels immediately after inhalation.Blood glucose level decreased with increasing insulin dose.Insulin (10 U/kg) could produce a 14.5% decrease of blood glucose level.Insulin (1 U/kg) could yield a pharmacological bioavailability of 11.5% in the absence of absorption enhancer.The concomitant administration of oleic acid,DTPA and lecithin appeared to be more effective in enhancing the pulmonary absorption of insulin,and decreasing blood glucose level.

BACKGROUND: Reumatoid arthritis (RA) is a well-known autoimmune disease. Recently, polyglycosides of tripterygium wilfordii hook F (T Ⅱ), a traditional Chinese herb, has been widely used to treat rheumatoid arthritis.But the effects of TⅡ on the joints' synovium inflammation and whether TⅡcan prevent the reumatoid arthritis need to be investigated further.OBJECTIVE: To study the effects of T Ⅱ on the relative data of ankle joints of adjuvant arthritis (AA) rats.DESIGN: A randomized controlled experiment based on rats. SETTING: Departments of Histology and Embryology and Neurobiology, West China School of Preclinical and Forensic Medicine, Sichuan University. MATERIALS: A total of 20 healthy clean grade female SD rats, aged 2 to 3 months old, weighing 185-215 g, were provided by the Experimental Animal Center of West China Medical Center of Sichuan University. Fre und's complete adjuvant (FCA) was produced by Sigma Company. TⅡ was produced by Zhuzhou 3rd pharmacy of Hunan Province (certification number: 2005 No 055172, 10 mg/pill).METHODS: The experiment was completed in Department of Histology and Embryology and Neurobiology in Sichuan University from May 2004 to March 2005. ① All the 20 rats were randomly divided into 4 groups with 5 rats in each group by lots: normal group, without Freund's complete adjuvant (FCA) injection and TⅡ administration; model group, with FCA intradermal injection (0.2 mL) into the left hind paw and without TⅡ administration; TⅡ preventive group, first we use the same way as model group to replicate the AA model in rats, then on the 7th day AA rats were feed by TⅡ 30 mg/kg every day for 7 days; TⅡ therapeutic group, AA rats model were built with the same way as model group, on the 19th day AA rats were feed by TⅡ 30 mg/kg every day for 7 days. During this period, the swelling dimension of hind paw both primary and secondary are mea sured before immunization with FCA and after immunization, that was, on the 2nd, 10th, 15th, 19th, 22nd and 26th days. ② Arthritis index have been recorded according to inflammatory state of other three uninjected limbs.③ On the 28th day, all the rats were killed, the ankle joints are collected after perfusion-fixation. These joints were sectioned and colorated with H. E staining. Then we observe the histopathological changes in the synovium of ankle joints. MAIN OUTCOME MEASURES: Swelling dimension of joints and arthritis index, histopathology of anklebone joint's synovium. RESULTS: All of the 20 rats completed the experiment without missing. ① On the 2nd day after FCA injection, the primary hind paw of other three groups beside normal group appeared obvious swelling; from 2nd to 26th days, the volume of hind paw in other three groups was larger than that of normal group (t=2.315-3.041, P ＜ 0.05). The volume of primary hind paw in TⅡ preventive group at different time points (10th, 15th, 19th, 22nd and 26th days) was obviously less than that of model group (t=2.064-2.683, P ＜ 0.05). The volume of primary hind paw in TⅡ therapeutic group on the 22nd and 26th days was less than that of model group (t=2.112-2.578, P ＜ 0.05). Fifteen days after FCA injection, the volume of secondary hind paw in model group and T Ⅱ therapeutic group was larger than that of normal group (t=2.201-2.546, P ＜ 0.05). On the 15th, 19th, 22nd and 26th days, the volume of secondary hind paw in T Ⅱ preventive group was obviously less than that of model group (t=2.373-2.425, P ＜ 0.05). The volume of secondary hind paw in T Ⅱ therapeutic group on the 26th day was obviously less than model group (P ＜ 0.05). ② On the 14th day after FCA injection(after T Ⅱ preventive administration for 7 days), arthritis index of model group was (8.3±2.0) points, while arthritis index of TⅡ preventive group was (0.4±0.95) points (t=2.64, P ＜ 0.05), there was an obvious decline in T Ⅱ preventive group compared with model group. On the 26th day after FCA injection (after TⅡ therapeutic administration for 7 days), arthritis index of model group was (11.2±0.7), whileinflammatory disease in AA rats and prevent the secondary arthritis in the rats of AA as well.

Objective To assess the diagnostic significance of T cell receptor gamma gene rearrangemerits in mycosis fungoides (MF), so as to develop a sensitive diagnosis tool. Methods A total of 50 specimens were collected, including 33 skin lesion specimens and 2 lymph specimens from 30 patients with MF,15 skin lesion specimens from 15 patients with inflammatory dermatoses. PCR was performed with specific primers targeting TCR V gamma 8, 9, 10, 11 to detect T cell receptor gamma gene rearrangement. Results Monoclonai rearrangements of TCR gene was observed in 88% (29/33) of specimens from patients with MF and 33% (5/15) of samples from patients with inflammatory dermatoses. Conclusions The detection of TCR gene rearrangements, as an ancillary test, is useful in the diagnosis and differential diagnosis of MF.

Objective To observe the clinical efficacy of warm needling in treating chronic prostatitis due to kidney-yang deficiency.Method Seventy-eight patients with chronic prostatitis due to kidney-yang deficiency were randomized into a treatment group of 40 cases and a control group of 38 cases. The treatment group was intervened by warm needling, while the control group was by oral administration of Terazosin hydrochloride tablets. The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) and white blood cell (WBC) count in prostatic fluid were observed before and after treatment, and the clinical efficacies were compared.Result The total effective rate was 92.5% in the treatment group versus 76.3% in the control group, and the difference was statistically significant (P<0.05). The NIH-CPSI scores and WBC counts were significantly changed in both groups after treatment (P<0.05). After treatment, the NIH-CPSI score of the treatment group was significantly different from that of the control group (P<0.05). There was no significant difference in comparing the WBC count between the two groups after treatment (P>0.05).Conclusion Warm needling is an effective approach in treating chronic prostatitis due to kidney-yang deficiency.

OBJECTIVE:To study the bioequivalence of Levodopa micro-capsule floating tablets in Beagle dogs after multi-dose administration. METHODS:6 dogs were collected and divided into Levodopa micro-capsule floating tablets group and Com-pound levodopa preparation group (Benserazide tablet,reference preparation). They were given levodopa 200 mg intragastrically, every 8 h,for consecutive 4 day. In two-period crossover test,HPLC method was established to determine the concentration of le-vodopa in dog. The pharmacokinetic parameter,bioequivalence and plasma concentration fluctuation of steady state were calculated. RESULTS:The main pharmacokinetic parameters of Levodopa micro-capsule floating tablets and reference preparation were as that cmax were(4.23±0.75)and(8.47±1.18)μg/ml;AUC0-∞ were(12.18±1.16)and(13.81±2.12)μg·h/ml;tmax were(1.83±0.26) and(0.67±0.13)h,respectively. 90% confidence intervals for the geometric mean ratio of AUC0-∞ for test and reference prepara-tion were 80.61%-97.90%,and that for cmax were 42.75%-57.63%,respectively. There was statistical significance in tmax between test and reference preparation. Degree of fluctuation of test and reference preparation at steady state were(283.914±43.217)% and (506.489±78.965)%,and fluctuation coefficient were(177.463±7.873)% and(187.405±1.650)%,respectively. The degree of fluctuation of test preparation was significantly less than that of reference preparation. CONCLUSIONS:Levodopa micro-capsule floating tablets show good sustained-release property,and are bioequivalent with reference preparation in absorption after multiple dose administration. It also has lesser fluctuation of blood concentration.

To optimize the formula of levodopa microcapsules floating tablets. Methods:The contents of levodopa and benserazide in the microcapsules floating tablets were determined by HPLC simultaneously. The release rate as the index, an orthogonal design was used to optimize the formula and preparation technology of levodopa microcapsules floating tablets. The release property of the microcapsules floating tablets was evaluated. Results:The HPLC method for the in vitro determination of levodopa and benserazide in the floating tablets met the methodological requirements. The selected formula was as following:the amount ratio of stearic acid, the drugs, acrylic resin and HPMC was 2∶5∶2∶1. The average weight of the tablets was 550 mg. The results of validated tests showed that the microcapsules floating tablets had floating and sustained release property, which could be used by divided dose. Conclusion: The optimized formula of the microcapsules floating tablets is reasonable, and the production process is stable and feasible.

Aims To study single dose toxicity of poly-phenols effective parts from Punica granatum,to eval-uate their safety,and thus to provide a theoretical basis for drug development and clinical use.To observe their protective effect on ethanol-induced gastric ulcer in rats.Methods 50 healthy Kunming mice were ran-domly divided into five groups and given different doses of polyphenols’effective parts from Punica granatum via intragastric administration.Toxicity and death in each group of mice were observed and recorded after administration for 14 d.The median lethal dose was calculated by Bliss method.70 rats were randomly di-vided into normal group,model group(constant volume of normal saline),sanjiuweitai particles(1 850 mg· kg-1 )group,colloidal bismuth subcitrate (33 mg · kg-1 )group and polyphenols effective parts from Puni-ca granatum low-dose,medium-dose,high-dose(430, 852,1 704 mg·kg-1 )groups.On the 9th day of 10 days’gavage,all except the normal group were fed ethanol (1.5 mL/only)to induce gastric mucosal inju-ry in rats with acute gastric ulcer.Gastric ulcer index, the rate of ulcer inhibition were calculated for each group.The morphological changes of gastric mucosa were observed.The gastric mucosa levels of PGE2 , NO,SOD and MDA were determined.Results The LD50 and 95%confidence limit of the polyphenols’ef-fective parts from Punica granatum were 8 520.9 mg· kg-1 and 7 291.2 ~9 914.4 mg·kg-1,respectively. Pathology showed that the organs receiving dose of 16 000 mg · kg-1 had different degrees of damage . Compared with the model group,the extract from Puni-ca granatum significantly repaired the gastric mucosa, and significantly increased the gastric mucosa levels of NO and reduced MDA content,and improved SOD content and the levels of PGE2 .Conclousion The dose of 5 063 mg · kg-1 of polyphenols effective part from Punica granatum showed no death.The dose of 16 000 mg · kg-1 of polyphenols effective parts from Punica granatum could cause varying degrees of dam-age in heart,liver,lung,kidney or the death of mice. The LD50 and 95% confidence limit of the polyphenols effective parts from Punica granatum were 8 520.9 mg ·kg-1 and 7 291.2 ~9 914.4 mg·kg-1,respective-ly.The extract from Punica granatum plays a protective role against gastric mucosa damage induced by absolute ethanol,and the mechanism may be related to promo-ting ulcer epithelial cells synthesis,enhancing mucosal regeneration function,regulating NO content and en-hancing antioxidant capacity.

Objective:To establish the quality standard for peganum harmala alkaloids cream ( CAPH) . Methods: The general quality of CAPH was inspected according to the general notices described in Chinese Pharmacopoeia volumeⅠ2010 edition. The qual-itative identification was carried out by TLC with harmine and harmaline as the index ingredients. The content determination was carried out by HPLC methods with harmine, harmaline and vasicine as the index ingredients. Results:The inspection items were all met the requirements. The experimental samples and the reference substances in TLC showed the identical spots with the same color and shape at the same position. The calibration curve of harmaline, harmine and vasicine was linear within the concentration range of 3. 440-110. 000 μg·ml-1 , 3. 340-107. 000 μg·ml-1 and 1. 380-22. 000 μg·ml-1 , respectively. The recovery was 98. 1%, 99. 8% and 99. 3% with RSD of 1. 75%, 1. 78% and 1. 95%, respectively (n=6). Conclusion: The established quality control methods meet the requirements of methodology, and the results lay foundation for the quality standard for CAPH.