Studies On Technology And Quality Specification Of Kang Lixin Tablet

Kang lixin tablet is a new generation drug of anti-malignant tumor which extracts anti-cancer active ingredients on the basis of the modern scientific research of the ancient Tibetan "XinGenjiGala". Kang lixin tablet could rapidly kill malignant cells, enhance the immune system of patients, the early cancer patients could be cured, and it also could improve the advance cancer patients'life and prolong their lives.The original party of this product is capsule, its clinical response is better. But to overcome the shortcomings of capsules, and to provide more options of formulation for clinicians, we developed a film-coated tablets agent. The film-coated tablets have many advantages, such as beautiful, easy to swallow, it can cover the herbal smell, separate from moisture, oxygen of the air and so on.Firstly, by the orthogonal experiments, this research determines the optimum extraction; Secondly, by the praeparatum form technics studies, and considering the actual situation, determines technical process; At last, determines the quality specification.1. Extraction technicsBy testing the multiple of adding ethanol, the optimum extraction of Aspongopus is 60% ethanol (10 times volume).As the L9 (34) orthogonal test, the water extraction conditions is that with 10 times the amount of water extract 2 times:the first time is 1.5 hours, the second time is 1 hour.As the experimental conditions test, the optimum process is adding 95% ethanol, to make the liquid containing 60% ethanol.2. Praeparatum form technicsBy sifting from formulation and technology, and to consider the actual production situation, we determine the 60% syrup as binder, and determine magnesium stearate as lubricant.3. Quality Specification studiesThe research showed that:TLC and HPLC have chromatographic characteristics,good specificity, repeated stability and linear relationship. The complements do not disturb the determination. The result is accurate. As a result, this method is feasible, it can be used to control the inside quality of the drug.