Optimization of Calcium Carbonate and Vitamin D3 Chewable Tablets Formulation Optimization of Calcium Carbonate D3 Chewable Tablet Formulation Based on Reducing Side Effects of Constipation
[Objective]To investigate the optimal method of calcium carbonate D3 chewable tablet formulation based on reducing side effects of constipation.[Methods]The effects of different excipients on small intestine movement of mice were investigated by literature,and 5 commercially available products composed of different ex-cipients were selected.According to the excipients composition of commercially available products,2 kinds of fin-ished products were made in the laboratory,and the optimal excipients composition was selected by mouse small intestine movement test.ICR mice were randomly divided into 8 groups according to body weight,namely blank control group,401 self-made group,601 self-made group,marketed product 1,2,3,4 group and Jinbei commer-cial product group,with 20 mice(half male and half female)in each group.Single administration test(once ad-ministration)and repeated administration test(30 days administration)were conducted respectively.The dose of mice in each administration group was 130 mg/kg(measured by calcium),and the corresponding volume of pure water was given to the blank control group.The general clinical manifestations and fecal characteristics of mice were observed every day during the experiment.The fecal properties of mice in each experimental group were ob-served and photographed every week in the repeated administration test groups,and the fecal weight was measured within 6 hours.Intestinal propulsion test was performed after the last administration in both single administration test and repeated administration test to calculate the intestinal ink propulsion rate of mice.[Results]Single admin-istration of Calcium carbonate and vitamin D3 chewable tablets composed of different excipients had no significant effect on small intestinal propulsion rate in mice.After repeated administration for 30 days,compared with the blank control group,fecal dryness was observed in mice in 601 self-made group,marketed product 1,2,3,4 group,and the ink advancing rate was significantly reduced(P＜0.05).The fecal weight of mice treated with 3 weeks and 4 weeks in 601 self-made group,marketed product 3,4 group,and the fecal weight of mice treated with 4 weeks in marketed product 1,2 group were significantly reduced(P＜0.05);There were no significant effects on fecal traits,intestinal propulsion rate and fecal weight in 401 self-made group and Jinbei brand market group.[Conclusion]Calcium carbonate and vitamin D3 chewable tablets containing defecation promoting compo-nents can reduce constipation side effects caused by repeated administration,and excipients with different defeca-tion promoting mechanisms can play a synergistic role.Through comparison in this study,Jinbei brand Calcium carbonate and vitamin D3 chewable tablets(patent No.CN112972408A),which is owned by Zhejiang Huantling Technology Co.,LTD.,has the best prescription process.It can effectively reduce the side effect of constipation caused by repeated administration.
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