The Application Of Superfine Pulverization Technology In Traditional Chinese Medicine Granule Of Prescription

Traditional Chinese medicine granule of prescription has the characteristics of modern Chinese medicine of being safe,effective,convenient,stable and controllable. However,there still exist some problems,such as the low transfering rate of active ingredients,not being extracted of active ingredients completely,losting of volatile ingredients easily,being unstable of ingredients content,and so on.Preparing traditional Chinese medicine granule of prescription by the superfine pulverization technology has the following advantages:（1）to improve the utilization of herbal medicine and protect Chinese medicine resource,（2）to speed np the dissolution rate of active ingredients and improve the preparation process of Chinese medicine preparation,（3）to increase the bioavailability of the drug and enhance its therapeutic efficiency,（4）to improve the quality of preparation and reduce the drug toxicity.Therefore,the objective of this topic are:by selecting Rhizoma Gastrodiae and Resina Draconis as the researching objects, superfine pulverization technology was used as the breakthrough point to study and resolve the technical difficulties during the preparation process of traditional Chinese medicine granule of prescription,to make systematic study on the common key superfine pulverization technology in the preparation of traditional Chinese medicine granule of prescription,to improve the overall technology and the intrinsic quality of traditional Chinese medicine granule of prescription.1.Quality evaluation for Rhizoma Gastrodiae and Resina Draconis medicinal material.The TLC of Rhizoma Gastrodiae and Resina Draconis were studied.The results show that in the sample chromatography,there exist the same colour spots in the corresponding position of the reference medicinal material or the reference substance chromatography.The content of Gastrodin which is the indicative ingredient of Rhizoma Gastrodiae and Dracaena-B which is the indicative ingredient of Resina Draconis were determined.The results are in line with the Pharmacopoeia and the relevant standard,so these medicinal material can be used as material selected.2.Study on the preparation process of Rhizoma Gastrodiae and Resina Draconis granule of prescription.Single factors which affect the superfine pulverization process of Rhizoma Gastrodiae and Resina Draconis were investigated.It shows that decreasing the water content of medicinal material,improving the degree of fineness of medicinal material,reduction of pulverization temperature are conducive to improve the degree of fineness of products.Compared among each other,the first two factors are more obvious,and the extension of pulverization time does not improve the degree of fineness of poducts significantly.When the pulverization time was extended to a certain extent,the grain size distribution would achieve a relatively stable state.The mcroscopic characteristics of Rhizoma Gastrodiae and Resina Draconis powder of different grain size were observed.The results show that superfine pulverization could make the drug powder much more minor and uniform,which is conducive to increase the efficiency of drug cell’s breaking and the damage to the overall organization of drug.The extractives,the dissolution rate and the dissolution quantity of active ingredients from Rhizoma Gastrodiae and Resina Draconis power of different degree of fineness were studied comparely.The results show that compared with the coarse pulverization,superfine pulverization could increase the extractives significantly and enhance the dissolution rate and dissolution quantity of the active ingredients,which is conducive to enhance its therapeutic efficiency.The granulating process of Rhizoma Gastrodiae and Resina Draconis superfine powder were studied.The results show that in the granulating process of Rhizoma Gastrodiae power,the flowability and solubilization of one-step granulating are better than that of adding excipients,so we can consider adding no excipient.Compared with conventional pulverization granule and all Rhizoma Gastrodiae capsule,the dissolution rate of granule of prescription which was prepared with Rhizoma Gastrodiae superfine powder was studied comparely.The results show that after wet type granulating,the dissolution rate of Rhizoma Gastrodia.e superfine powder（400 mesh） is superior to that of conventional pulverization granule（100～200 mesh）(T₅₀:P＜0.01)and that of Rhizoma Gastrodiae granule of prescription(T₅₀:P＜0.01).Resina Draconis was prepared solid dispersion firstly.The main factors which affect its dissolution rate and the dissolution quantity were studied.The results show that the dissolution rate and dissolution quantity of the solid dispersion in which the proportion of drug and PEG4000 is one to four prepared by solvent-melting method is the best.3.Study on the quality standard of Rhizoma Gastrodiae and Resina Draconis granule of prescription.The name,source,processing,preparation,trait,identification,content determina -tion,function and indication,directions and dosage,attention,specification,storage, expiry of Rhizoma Gastrodiae and Resina Draconis granule of prescription were studied systematicly by TLC,HPLC and so on.The quality standard of Rhizoma Gastrodiac and Resina Draconis granule of prescription were developed and the note of quality standard were drafted,which further improve the level of quality standard of traditional Chinese medicine granule of prescription.4.Pharmacodynamic study on Rhizoma Gastrodiae,and Resina Draconis superfine powder.By using hot plate method and writhing method,the analgesic activity of Rhizoma Gastrodiae and Resina Draconis coarse powder and superfine powder were studied comparely.The results show that compared with the reference groups,Rhizoma Gastrodiae and Resina Draconis high-dose groups could prolong the pain threshold of hot plate irrigation to the mice.obviously and reduce the number of the mice’s writhing significantly.Compared among the same dose groups,the superfine powder groups are slightly better than the coarse powder groups numberaly.However,there are no statistical differences.