ABSTRACT
Objective To investigate the clinical effect of Ningmitai Capsule combined with Dirithromycin Enteric Tablets in the treatment of positive semen nonliquefaction in the culture of Ureaplasma urealyticum (Uu). Methods A total of 120 cases of semen liquefaction patients with positive semen Uu culture were randomly divided into treatment group with 80 cases and control group with 40 cases, which were continuous administrated for two weeks for a period of treatment and observated for two courses of treatment. In the treatment group, four Ningmitai Capsules were taken orally per time, three times per day, and 0.5 g Dirithromycin Enteric Tablets were taken orally per time, once per day, after meals, while the control group only took the Dirithromycin Enteric Tablets orally. Uu negative conversion rate and semen liquefaction time (min) were observed, and adverse reactions were also observed. Results The Uu negative conversion rate in the treatment group and control group after 2 weeks, 4 weeks was 72.5%, 95.0% and 55%, 92.5%, respectively, the negative conversion rate of treatment group was obviously higher than that of control group after 2 weeks treatment (P 0.05). The semen liquefaction time before treatment in the treatment group and control group respectively was (76.19 ± 14.13) min and (77.08 ± 13.34) min, which was (58.64 ± 13.15) min and (67.12 ± 12.52) min two weeks after treatment, (48.64 ± 12.38) min and (56.12 ± 12.86) min 4 weeks after treatment were, semen liquefaction time of the two groups before and after treatment was significant different (P < 0.05), and the treatment group was better than control group (P < 0.01). Conclusion Ningmitai Capsule combined with Dirithromycin Enteric Tablets can partly shorten the Uu negative conversion time, obviously shorten the semen liquefaction time, and has obvious clinical efficacy for Uu positive semen nonliquefaction disease.
ABSTRACT
Objective To evaluate the similarity of dissolution behavior in vitro of self-made and reference listed drug(RLD) of esomeprazole magnesium enteric tablets. Methods The dissolution test method and HPLC method were established according to Chinese pharmacopoeia. The HPLC method was validated according to ICH guidance. The dissolution behavior of the 3 batches of the self-made drug and RLD were compared in dissolution medium of pH 1.2 HCl solutuion,pH 4.5 phosphate buffer,pH 6.8 phosphate buffer,pH 1.2 HCl solutuion(2 h)and pH 6.0 phosphate buffer,pH 1.2 HCl solutuion(2 h)and pH 6.8 phosphate buffer,and puri?fied water with different rotation rates. Results The HPLC validation results for linearity,repeatability,recovery,etc. all met the re?quirement. The similarity factors F2 between the self-made drug and RLD were greater than 50 in different dissolution mediums. Con?clusion The dissolution behaviors of the self-made drug and RLD are similar.
ABSTRACT
Objective To evaluate the similarity of dissolution behavior in vitro of self-made and reference listed drug (RLD) of esomeprazole magnesium enteric tablets. Methods The dissolution test method and HPLC method were established according to Chinese pharmacopoeia. The HPLC method was validated according to ICH guidance. The dissolution behavior of the 3 batches of the self-made drug and RLD were compared in dissolution medium of pH 1.2 HCl solutuion, pH 4.5 phosphate buffer, pH 6.8 phosphate buffer, pH 1.2 HCl solutuion (2 h) and pH 6.0 phosphate buffer, pH 1.2 HCl solutuion (2 h) and pH 6.8 phosphate buffer, and purified water with different rotation rates. Results The HPLC validation results for linearity, repeatability, recovery, etc. all met the requirement. The similarity factors F2 between the self-made drug and RLD were greater than 50 in different dissolution mediums. Conclusion The dissolution behaviors of the self-made drug and RLD are similar.
ABSTRACT
AIM To study the pharmacokinetic characters following oral administration of colon specific tinidazole tablets in healthy dogs METHOD The plasma and intestine content concentration of tinidazole was determined by RP HPLC method following a single oral dose of 500 mg of two formulations given to each dogs in an open randomized two way crossover design RESULT The main pharmacokinetic parameters of test and reference tablets were as follow: T max : (6 3?1 2) h and (2 4?1 1) h; C max : (46 23?8 93) mg?L -1 and (58 08?14 65) mg?L -1 ; AUC 0-t : (423 21?93 08) mg?h?L -1 and (458 22?112 07) mg?h?L -1 The relative bioavailability of tinidazole colon specific enteric tablets was 92 9%?6 6%. 6 5 h after intake of colon specific tablets, there were a great deal of tinidazole in dogs colon but almost no tinidazole in small intestine CONCLUSION The result demonstrated that the colon tropic effect of the tablets is significant in dogs