Study on the preparation process and quality control of Compound Cistanche Chewable Tablets
Objective To study the preparation process and quality control method of Compound Cistanche Chewable Tablets.Methods Based on the theory of traditional Chinese medicine,Cistanche deserticola,Polygonatum sibiricum and Codonopsis pilo-sula were combined.The extract of the medicinal materials was mixed with several excipients in equal amounts,and then magnesium stearate was added and mixed through 80 mesh sieve for 3 times.Each mixing time was more than 5 minutes,and the tablets were made into Cistanche deserticola compound chewable tablets.The process was preliminarily screened with appearance,hardness and taste as in-dexes,and the prescription was optimized by orthogonal test.The quality of the chewable tablets prepared with the optimal prescription was evaluated,and the content of active ingredients was determined by HPLC.The effects of low,medium and high doses of Compound Cis-tanche Chewable Tablets on body weight,exhaustive swimming time and fatigue metabolites of mice were studied to verify the efficacy of the Compound Cistanche Chewable Tablets in alleviating physical fatigue.Results The results of three batches of process verification showed that the chewable tablets prepared with the optimal prescription had delicate taste and suitable sweet and sour taste.The tablet weight was 0.5 g per tablet,the hardness was greater than 8 kg·mm-2,and the friability was less than 1％.Each tablet contains echinaco-side higher than 0.025 g,and echinacoside higher than 0.003 g.0.25,0.50,and 1.50 g·kg-1·d-1 doses of Cistanche Compound Chewable Tablets can significantly prolong the exhaustive swimming time of mice,reduce the content of urea nitrogen and lactic acid,increase the content of liver glycogen and muscle glycogen,and the difference was significant(P＜0.01).Conclusion The prescription process of Com-pound Cistanche Chewable Tablets was optimized.After evaluation,the appearance,taste,hardness and friability all meet the expected requirements.The prepared Compound Cistanche Chewable Tablets can relieve physical fatigue.
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