| Shangkexiaoyan paste is the external preparation used for Detumescence , activating blood and relieving pain. It is developed by Jangsu Provincial Hospital Of TCM.The prescription includes eight herbs such as Rhubarb , Salvia, pubescent angelica, Aconitum Kusnezoffii and curcuma longa. Salvia is the monarch drug in the Shangkexiaoyan paste which activates blood and relieves pain. Aconitum Kusnezoffii , the assisting drug , eliminates wind and dampness and warms meridian. Pubescent angelica and Dipsacus join muscle and joint, and Rhubarb and honey locust clear heat and toxins, which are complement drugs. The whole prescription has great theraputical effect on chronic injuries and sequelae of injury. It has been in clinicial application for many years , and there is no report about serious side-effect.However, the Shangkexiaoyan paste has some drawbacks, including inconvenient use, low permeability and contamination of clothing, which cannot meet the requirements of modernization of Chinese medicine. The subject carried out a series of research on preparation and related basic study, with the purpose of better developing clinical effective prescription and taking advantage of modern formulation of TCM. The research includes six aspects.First, the study on the extraction process. On the basis of single factor experiments, the optimal extraction process had been obtained with orthogonal design.Second, the study on the concentration process. The retention rates of TanshinoneⅡA and Salvianolic Acid B were chosen as indexes to investigate water-bath concentration and vacuum concentration.Third, the study on the preparation process of cataplasm. It was divided into two parts. First , On the basis of single factor experiments on agglutinants, Moisturizing Agent and addition sequence, the optimal matrix proportion in the blank cataplasm had been obtained with orthogonal design. Second, skin permeation test in vitro was used to study the cumulative permeation quantity and permeation rate with different penetration enhancers. Thus, the category and quantity of penetration enhancers and the preparation process of cataplasm were determinedFourth, the study on the quality standard includes the TLC identification , the limited amount of toxicity of aconitine, the establishment of the determination method for Salvianolic Acid B and some related examinations of cataplasm.Fifth, the study on the skin irritation and allergy. The effects of Shangkexiaoyan cataplasm on the normal skin of mice and damaged skin were chosen as indexes and the result showed that the cataplasm had no obvious irritation on skin.Finally, the tests on the preliminary stability of cataplasm. The result reflected that the Shangkexiaoyan cataplasm was stable and effective after being placed at the temperature of 17-25℃and the humidity of 25-75%. |