Résumé
Objective:To develop a method of quantitative analysis of multi-components by single marker ( QAMS) for the deter-mination of five index components in Fuke Qianjin tablets. Methods:Using erulic acid as the reference,an HPLC method with a Hy-persil GOLD C18 column (250 mm × 4. 6 mm,5 μm) was applied,the mobile phase was acetonitrile-0. 1% phosphoric acid with gradi-ent elution,the flow rate was 1. 0 ml·min-1 ,the detection wavelength was 254 nm,the column temperature was 30℃ and the injection volume was 10 μl. The relative correction factors among the five index components were detected by QAMS. The contents of the index components were determined respectively by an external standard method and QAMS, and the results were compared between them. The practicability and stability of QAMS were verified. Results:The established QAMS was used to determine the five index compo-nents in Fuke Qianjin tablets,and totally 6 batches of Fuke Qianjin tablets were determined. There were no significant differences be-tween the calculated values and the determined ones (P>0. 05). Conclusion:The QAMS method is simple,effective and accurate in determining the contents of five index components in Fukeqianjin tablets,which can be used for the quality control of Fuke Qianjin tab-lets and provide reference for the further studies.
Résumé
Objective:To develop a method of quantitative analysis of multi-components by single marker ( QAMS) for the deter-mination of five index components in Fuke Qianjin tablets. Methods:Using erulic acid as the reference,an HPLC method with a Hy-persil GOLD C18 column (250 mm × 4. 6 mm,5 μm) was applied,the mobile phase was acetonitrile-0. 1% phosphoric acid with gradi-ent elution,the flow rate was 1. 0 ml·min-1 ,the detection wavelength was 254 nm,the column temperature was 30℃ and the injection volume was 10 μl. The relative correction factors among the five index components were detected by QAMS. The contents of the index components were determined respectively by an external standard method and QAMS, and the results were compared between them. The practicability and stability of QAMS were verified. Results:The established QAMS was used to determine the five index compo-nents in Fuke Qianjin tablets,and totally 6 batches of Fuke Qianjin tablets were determined. There were no significant differences be-tween the calculated values and the determined ones (P>0. 05). Conclusion:The QAMS method is simple,effective and accurate in determining the contents of five index components in Fukeqianjin tablets,which can be used for the quality control of Fuke Qianjin tab-lets and provide reference for the further studies.
Résumé
To investigate the effect of Fuke Qianjin tablets on the pharmacokinetics of Azithromycin(AZM) in rats with chronic pelvic inflammation, and evaluate the rationality of the drug combination. The animal models of chronic pelvic inflammatory disease were established by intrauterine injection of mixed bacterial suspension plus mechanic injury in female Sprague-Dawley(SD) rats. The model rats were randomly divided into control group and drug combination group. The rats in control group were given with Azithromycin 10 mg•kg⁻¹•d⁻¹ by intragastric administration, while the rats in drug combination group were given with Fuke Qianjin tablets 1.66 g•kg⁻¹•d⁻¹ by intragastric administration 2 hours after the equivalent dose of azithromycin, once a day, consecutively for 7 days. Plasma samples were collected at different time points and the concentration of AZM in plasma was determined by high performance liquid chromatography coupled with mass spectrometry(HPLC-MS). ADAPT 5.1 software was used to calculate the pharmacokinetic parameters of each group by Inverse Gaussian Function model. SPSS software was used for the statistical analysis of data in each group. The results showed that Fuke Qianjin tablets had no significant effects on the main pharmacokinetic parameters of AZM, including CLt, CLd, MIT and F. The study showed that Fuke Qianjin tablets can be combined with azithromycin for treatment of chronic pelvic inflammation disease.
Résumé
Objective To explore the effect of Fuke Qianjin Tablets on quality of life and clinical efficacy in patients with endometriosis uterina post-operation.Methods 76 cases with endometriosis were collected and divided into the control group and the treatment group, 38 cases in each group.The two groups were based on the location of endometriosis lesions to the implementation of surgical resection, the control group was given the Gestrinone Capsules 2.5 mg orally post-operation, twice weekly, the treatment group was given Fuke Qianjin Tablets 6 tablets, 3 times per day at the first day after first menstruation, 21 days for a course, a total of two treatment cycles.Clinical curative effect, postoperative quality of life and adverse reactions were compared after treatment.Results Compared with the control group, treatment group, the clinical total efficiency of the treatment group was higher (P<0.05),the sexual desire, sexual arousal, orgasm, sexual psychology, abnormal sexual behavior, and BISF weighted scores were increased in 2 groups ( P <0.05 ) , compared with the control group, sexual desire, sexual arousal, orgasm, sexual psychology, abnormal sexual behavior, and BISF weighted scores of the treatment group were higher (P<0.05).there was no statistically significant difference in adverse reactions between two groups.Conclusion Fuke Qianjin Tablets have significant therapeutic effect in the treatment of endometriosis uterina, can also improve the quality of life after surgery.
Résumé
To systemically evaluate the clinical efficacy of Fuke Qianjin tablets combined with antibiotics in the treatment of endometritis. The databases such as PubMed, CNKI, VIP and WanFang Data were searched to collect the randomized controlled trials(RCTs) about Fuke Qianjin tablets combined with antibiotics for endometritis since 2010. According to the Cochrane Reviewer's Handbook, two reviewers independently screened the literature, extracted the data and assessed the methodological quality of the included studies. Then the Meta-analysis was performed by using RevMan 5.3 software. 16 RCTs were included, involving 2 299 patients. Meta-analysis showed that after endometritis was treated by Fuke Qianjin tablets combined with antibiotics, the thickness of endometrium was higher than that in antibiotics group[MD=1.20, 95％CI (1.10, 1.29), P<0.000 01]; the occurrence rate of normal menstrual cycle[OR=1.46,95％CI (1.21, 1.77), P=0.000 1] and total effective rate [OR=1.19, 95％CI (1.15, 1.24), P<0.000 01] were increased ; the irregular vaginal bleeding [OR=0.21, 95％CI (0.14, 0.30), P<0.000 01] and inflammatory reactions[OR=0.19, 95％CI (0.10, 0.37)] were reduced. In short, Fuke Qianjin tablets combined with antibiotics have better effects than antibiotics alone for endometritis, so it is worthy to be recommended for clinical application.
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Objective To establish a HPLC method for determining of the content of palmatine hydrochloride in Fuke Qianjin Tablets. Methods HPLC was performed on Shimadzu-C18 column. The mobile phase consisted of 0.05 mol·L-1 sodium acid phosphate (pH=3, adjusted by phosphoric acid)-acetonitrile (72 : 28). The detection wavelength was at 265 nm. Results The linear correlation was in the range of 0. 051 μg～0. 255 μg(r=0. 999 9). The average recovery was 100. 04 %, and RSD=1.03 % (n=5). Conclusion The method is accurate and specific.
Résumé
Objective To establish a HPLC method for determining of the content of palmatine hydrochloride in Fuke Qianjin Tablets. Methods HPLC was performed on Shimadzu-C18 column. The mobile phase consisted of 0.05 mol? L-1 sodium acid phosphate (pH=3, adjusted by phosphoric acid)-acetonitrile (72 ∶ 28). The detection wavelength was at 265 nm. Results The linear correlation was in the range of 0.051 ? g～ 0.255 ? g(r=0.999 9). The average recovery was 100.04 % , and RSD=1.03 % (n=5). Conclusion The method is accurate and specific.