ABSTRACT
A very simple, precise, economical, accurate, robust, and reproducible reverse phase-high-performance liquid chromatography method along with stability indicating attributes has been developed for estimating of prucalopride succinate (PRU) in both bulk and tablet formulation (PRUVICT 2). The estimation of the solutes was performed on a Grace C18 column of dimension 150 mm × 4.6 mm, 5 μm. PRU was eluted with acetonitrile: 0.02 M potassium dihydrogen phosphate in the ratio of 20:80 v/v in a 10 min isocratic mode at a flow rate of 1 ml/min at 30°C column temperature and monitored at a wavelength of 277 nm. The retention time of PRU was found to be 5.416 minutes. The Q2b validation of the analytical method revealed good linearity over the concentration range 2–12 μg/mL for IVA with r2 of 0.999. The mean recovery % over the three tested ranges of 50%, 100%, and 150% were found to be 100.173%, 99.077%, and 98.575%, respectively. In intra-day variability study, the % RSDs was detected to be 0.754, 1.032, and 0.482 whereas the inter-day variability study demonstrated % RSDs of 0.797, 0.559, and 0.524, respectively. The acid, alkali, boiled water, hydrogen peroxide, dry heat, and UV radiations based stress studies presented the formation of a variety of characteristic degradation products. The developed analytical method may be employed for the routine analysis of PRU in bulk and tablet formulations.
ABSTRACT
Objective To compare the short-term curative effects of prucalopride and mosapride respectively combined with low dose polyethylene glycol in treating elderly refractory functional constipation.Methods Ninety patients with elderly refractory functional constipation in the outpatient department of our hospital from May 2014 to February 2016 were retrospectively analyzed and divided into two groups randomly,45 cases in each group.the prucalopride group:Prucalopride Succinate Tablets,2mg,4 times daily;the mosapride group:Mosapride Citrate Capsules,5mg,3 times daily.Polyethylene Glycol Electrolytes Powder(PEG) was also used in the two groups,13.125g,twice daily.The course of treatment was 4 weeks.The first defecating time and defecation difficulty relief time,average weekly spontaneous complete bowel movements (SCBM),defecating difficulty,stool character,adverse reactions and change of life quality were observed in the two groups.Results The treatment effective rate of slow transit constipation(STC) and defecatory disorder had the statistical difference between the two groups (P0.05).Compared with the mosapride group,the first defecating time and defecation difficulty relief time in the prucalopride group were shorter with statistical difference (P0.05).The total effective rate had statistical difference between the two groups(P<0.05).The incidence rate of adverse reactions had no statistical difference between the two groups(17.78% vs.15.56%,P<0.05).The total average score of PAC-QOL after treatment in the two groups were both decreased,moreover the decrease in the prucalopride group was more obvious;the difference between the two groups had statistical significance(P<0.05).Conclusion Prucalopride +PEG take effect faster in the treatment of elderly refractory functional constipation and has the advantages in the aspects of overall curative effect and life quality improvement,which is specially suitable for STC and defecatory disorder type.
ABSTRACT
Objective To observe the therapeutic effect of Baizhu Shengjiang Decoction combined with Prucalopride Succinate Tablets for chronic functional constipation. Methods Sixty patients with chronic functional constipation were randomly divided into treatment group and control group, 30 cases in each group. The treatment group was treated with Baizhu Shengjiang Decoction combined with Prucalopride Succinate Tablets orally, and the control group was treated with oral administration of Prucalopride Succinate Tablets alone. The therapeutic effects on traditional Chinese medicine (TCM) symptoms and constipation, and the follow-up therapeutic effect of the two groups were evaluated after treatment. During the three months after the completion of treatment course, the recurrence of constipation was monitored. Results (1) The cure rate of the treatment group was 90.0％ and that of the control group was 60.0％, indicating that the therapeutic effect on TCM symptoms in the treatment group was stronger than that of the control group(P < 0.05).(2) In respect of the relief of constipation, the markedly effective rate was 93.3％ in the treatment group and was 50.0％ in the control group, and the overall effective rate was 100.0％ in the treatment group and was 73.3％ in the control group, the difference being significant between the two groups(P<0.05 or P<0.01).(3) During the treatment, the percentage of patients with weekly completely spontaneous defecation frequency ≥3 was 86.7％ in the treatment group, and was 53.3％ in the control group, the difference being significant (P < 0.05). (4) The results of 3-month follow-up after the completion of treatment course showed that one case from the treatment group had the recurrence of constipation, and the recurred cases from the control group were 6, the difference being significant (P < 0.05). Conclusion Oral use of Baizhu Shengjiang Decoction combined with Prucalopride Succinate Tablets exerts certain therapeutic effect for chronic functional constipation, which is effective both on relieving constipation symptoms and on reducing recurrence rate.