OBJECTIVE To evaluate the quality of calcium carbonate and vitamin D3 preparations based on national drug sampling tests, and analyze existing quality problems and improve quality standards, thereby providing references and suggestions for quality control of this variety.
METHODS Through statutory specification and exploratory research, the causes of unqualified samples, dissolution and dissolution curve, content and content uniformity, related substances and hardness of chewable tablets were studied and evaluated.
RESULTS The qualification rate of 205 batches of samples according to statutory specification was 83.9%, and the unqualified samples which were produced by the same manufacturer were all abnormal in assay of vitamin D3. In addition, the control for some key quality project such as related substances and uniformity of dosage units were lacking, and the common names and quality standards implemented of formulations with the same components and specifications were inconsistent. The exploratory study results indicated that the prescription(the type of the raw material of vitamin D3) and processes(antioxidant) were the main reasons for the unqualified samples. The methods for uniformity of dosage units, dissolution and related substances had been established to reanalysis the samples and the results showed the qualification rate were decreased compared to the statutory specification.
CONCLUSION The overall quality status is generally average, and the current quality standards are basically feasible while remaining to be revised and improved. Individual manufacturers need to re-optimize the prescription and processes to improve the stability of the formulations. Individual manufacturers should revise the generic names of drugs and implement the current national standards. The manufacturers of chewable tablet need to conduct further research on dissolution and optimize prescription and processes if necessary.
DownLoad: