Preparation And Quality Control Of CCT Soft Capsules

CCT is one of the metabolites of Vitamin D and the endogenous substances of the human body. CCT is the basic drug for the treatment of secondary hyperparathyroidism which can adjust the balance of phosphorus and calcium in the body by promoting the absorption of calcium in vivo in various ways. CCT does not dissolve in water and is unstable to the light, heat and oxygen which limits its preparation study. The CCT solution after the addition of antioxidant protection of medium chain fatty acid triglyceride(MCT)is filled in the soft gelatin capsule,designed to prevent the CCT from being destroyed by light and oxygen, to improve its bioavailability with the help of the capsule shell sealed package.The quantitative methods to determinate CCT soft capsules, such as CCT,Pre-CCT, dissolution and antioxidants including butyated hydroxyanisole and butyated hydroxytoluene are established by high performance liquid chromatography,which do well in linearity, precision, tolerance, system adaptability and receive a high recovery rate.The best rubber prescription of rubber of gelatin was: gelatin: mixed plasticizer:water =1:0.5:1 and the mixed plasticizer was glycerol : sorbitol= 2:1, which was choosed by comparison of viscosity, hardness and the swelling equilibrium quantity(Seq)of different rubber prescriptions;The prescription of content was loading MCT 160 mg, including calcitriol 0.000160%(w/w), each of BHA and BHT0.01%(w/w).Weighing the materials of the prescription about the soft capsule and producing it according to the parameters strictly. The sorbitol in this rubber prescription can prevent the capsule shell from being exposed on air and improve the problems of disintegration delay in long term storage.A series of quality control standards was established according to the characteristic of soft capsule formulation such as content uniformity, assay of calcitriol, dissolution, determination of related substances and microbial limit.We explored the stability of CCT soft capsules and what plays a significant role in its stability with influencing factor test, accelerated test and long-term test. The results can provide the theoretical support to the method of packing, the choice of storage condition and the design of the development period and the retest date about the CCT soft capsule.