Quality Control Of Gelatin For Capsules And Vacant Gelatin Capsules

Gelatin is made from moderately hydrolyzed collagen of animal skin, bone, tendon and ligament, and the vacant gelatin capsule is prepared with gelatin and auxiliary materials such as titanium dioxide, sodium dodecyl sulfate, edible pigment. Some harmful elements in gelatin and vacant gelatin capsule would be taken into human body by daily eating drug. The limited requirements of harmful elements in gelatin and vacant gelatin capsules was laid down in the Chinese pharmacopoeia (2010 edition) and its first supplement, in which chromium was inspected by atomic absorption spectrometry, arsenic and heavy metals were detected using chemical identification method. But these measurements can’t fully evaluate and control residual metal elements in the product.In this thesis, the gelatin for capsules and vacant gelatin capsules were selected as the research subjects, and the quality control methods for the harmful elements in these products were investigated. The main research contents and achievments are as follows:The quality of the gelatin for capsule and vacant gelatin capsules from different manufactures were evaluated according to the definition of the current Chinese pharmacopoeia. The results indicated that the current standards are comprehensive and suitable for the quality control of products, but still need to improve the standard of heavy metals.A novel method was developed for determing 10 kinds of element (vanadium, chromium, manganese, nickel, copper, cadmium, arsenic, strontium, barium, lead) in the gelatin for capsule and vacant gelatin capsules by microwave digestion and inductively coupled plasma mass spectrometry (ICP-MS). The method was validated by linearity, precision, recovery, etc. The results demonstrated that the proposed ICP-MS method was reliable and accurate, and it was suitable for the element residues control in gelatin for capsule and vacant gelatin capsules.The residues of 10 kinds of elements in the commercial gelatin for capsule and vacant gelatin capsules were investigated using inductively coupled plasma mass spectrometry.The results indicated that the industrial gelatin and vacant gelatin capsules were heavily polluted by heavy metals.The standard uncertainty of the proposed ICP-MS method was evaluated. The results suggested that the main inferencing factors was the instrument stability.