| The prescription is consist of Hedyotis diffusa, Scutellaria Barbata and many other herbs, it achieves good therapeutic effect as the adjuvant treatment of heat toxin and blood stasis of liver cancer in clinic. The decoction not only is inconvenience to carry, but also has an difference of taste, poor compliance issues for liver cancer patients. Due to liver cancer patients need long-term medication, this subject adopts the modern research methods to make it convenient and easy to carry. In this study, the modern research methods were used to make modern preparation-capsule, which is convenient to take, easy to carry. And the preparation process and quality standards and other pharmaceutical related content were studied.In the preliminary experiments, on the basis of relevant standards and literature review, the standard of s Hedyotis diffusa was established, adding oleanolic acid and ursolic acid content determination and fingerprint identification. The experiments raised the standards, which laying foundation for the quality control method and preparation of Compound Hedyotic diffusa capsule.According to the function of the prescription, combined with the physical and chemical properties of the drug and the actual production, using orthogonal test to determine the zedoary turmeric volatile oil extraction and bonding process for package: Rhizoma Curcuma adding 10 times amount of water, soaking 2h, extracting for 6h, collecting volatile oil, retention of water extract and residue. Each milliliter of volatile oil added to five times the amount of P-CD,100ml water, colloid grinding package 30min, grinding fluid device refrigerator temperature of 4 ? standing for 24 h, centrifugation, filtration, and the washing, complexes to 40 ? dry spare. Using the single factor tests and response surface method multi-index comprehensive evaluation method to select the alcohol extraction of Curcuma dregs and Hedyotic diffusa other herbs. The alcohol extracting process of Curcuma dregs, Hedyotis diffusa and other herbs were adding 11 times amount of 70%?ethanol, refluxing for 2 times,92 minutes each time. The concentration and drying process were:alcohol extract standing overnight, filtration, the filtrate vacuum recovery of pure alcohol without flavor; merging distilled water solution of Rhizoma Curcuma, vacuum concentrated to the relative density of 1.15?1.25 with control of condensation temperature of 50?, the vacuum degree of 0.07-0.08MPa; then 50 ? vacuum drying to obtain the dry extract. The lathrate compound and dry paste of alcohol extract were mixed grinding, over six sieve, then obtaining compound Hedyotic diffusa extract powder. In the granulation process, the grain yield was regarded as the evaluation index to determine the optimum process for dry granulation. In granulation process, setting the roller pressure 6MPa, speed of 121·min-1,40r·min-1 of material transfer speed to dry granulation, and then to encapsulate. In quality standard, the separation of Hedyotis diffusa and other herbs was good, negative samples were without interference. The content and methodology study of oleanolic acid, ursolic acid and scutellarin were determined by HPLC method. The oleanolic acid and ursolic acid content of compound Hedyotic diffusa capsules shall not be less than 1.7mg, the scutellarin content should not be less than 2.6mg each grain.In stability test, the preparation was investigated by 6 months accelerated test and 12 months long-term test. The results of the examination indexes were conform to the rules, showing that the preparation quality was stable within a year and worthing promoting. |
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