Studies On Design And Quality Evaluation Of TCM Complex Dosage Mainly Containing Volatile Ingredients

Volatile ingredients are one kind of familiar and important ingredients in Traditional Chinese Medicine(TCM),which are provided with remarkable action and clinical curative effects.Developmennt and design of TCM Complex Dosage mostly include the development of medicinal materials technology quality standard of quality and stability.Using a TCM Complex mainly containing volatile ingredients as model,this project is to study the relations among ingredient dosage form preparation technology and curative effects,further exploring the method of reasonability for design and quality evaluation of TCM Complex Dosage mainly containing volatile ingredients.Model is proved to be a recipe with remarkable effects,composed with three medicinal materials containing volatile ingredients and one medicinal material not containing volatile ingredients.Depending on evaluation index founded by the experiment, the paper systematically studied the process conditions purification methods formulation design Pharmacodynamics standard of quality and stability of preparation seek the way and method of improving the quality of TCM Complex Dosage mainly containing volatile ingredients theoretically and practically and to promote the development of it.Establishment of evaluation indexes and methods is the key to evaluate reasonable method of preparation and important aspect of quality evaluation of TCM Complex Dosage. In the light of nature of ingredient, the paper set up HPLC and UV method of Peonol HPLC method of Matrine to select processcondition of preparation technology and to determine effective components.It is prior condition to guarantee effectivenss of TCM Preparation that valid compositions in CMM are leached fully. In the light of nature of ingredient, considering reference and pre-experiment, this project employed experiment of mono-factor and orthogonal design to choose better technique of single and blend extraction of CMM. In this research, also studied technique of CO2 Supercritical Fluids Extraction(CC>2-SFE) which is used to extract volatile ingredients widely at present, and compared with general extraction technique in the whole extraction rate> extraction rate of quantificational ingredient reservation of other ingredient The result indicated that the whole extraction rate n extraction rate of quantificational ingredient of CO2-SFE are lower than general extraction technique, reservation of other ingredient of CO2-SFE is lacker than general extraction technique. So general extraction technique is more proper for the four CMM.Purification is the key to changing coarse ^ large and black states of TCM Dosage. On the base of controling active ingredient and the whole extraction rate, employed experiment of mono-factor to establish the proper technique of Precipitant The method can effectively get rid of tannin, etc. but not infect active ingredient, ensure the quality of preparation.After obtaining semi-manufactured goods steadily, according to the dosage of it and excipient, abandon soft capsule and choose hard capsule as dosage form of finished product finally. The chemical and physical research for semi-manufactured goods indicated that the main active ingredient Peonol is unstable for heat Considering reference and pre-experiment, this project adopted preparing inclusion compound to stabilize the volatile ingredients, by technique optimizing, achieved preparing inclusion compound, and prove the structure of "inclusion compound with UV and TLC method, further confirm the feasibility of inclusion compound by one month accelerated testing. Then studied micromeritics characters and moisture absorption of the powder in capsule, prepared the finished product,choose complex aluminium-plastic materials as wrapper.This project also use Pharmacodynamical experiment to evaluate the effects of preparation and the reasonability of technology. Effects of the capsule on the coordination sedation effect were studied in normal mice by using sleep-promoting test in combination with pentobarbital sodium of threshold dose and subthreshold dose respectively. The result proved that capsule can obviously bring the coordination sedation effect, also can obviously promote sleep in combination with pentobarbital sodium, further illustrated the reasonability of technology.Perfect and overall quality control can guarantee the quality of TCM. This project established the standard of quality of this capsule referring to Chinese Pharmacopoeia and the principle of study of TCM, and reviewed stability to evaluate quality of the preparation. The results illustrated that capsules were stable at room temperature condition for three month. This paper systematically and generally studied the design and quality evaluation of TCM Complex Dosage mainly containing volatile ingredients, riches the content of this TCM complex dosage theoretically and practically.