Study On The Fufangxiakucao Jiaonang

Based on the modern pharmaceutics technics, extracting the valid components from Chinese traditional medicine(CTM), then setting up a world-class quality standard on the entire process, is an important task of CTM modernization. Prunella vulgaris L.-Scutellaria baicalensis Georgi- Picrasma quassiooider(D.Don)Benn.-Uncaria rhynchophylla (Miq.)Jacks.- Nelunbo nucifera Gaertn.and Cassia obtusifolia L.( P-S-P-U-N-C), which have some anti-hypertensive effections, we picked the active ingredients among these materials as research objects, to perform different extracting methods and successfully get the Prunella vulgaris L. combination capsule. Finally, we evaluated the quality standard, stabilities, and pharmacological features of Fufangxiakucao Jiaonang.At first, we introduced the etiology mechanism of hypertension, and reviewed the situation of hypertension remedy in CTM. Then we explained the origination of this combination capsule, pharmic virtues of its every component, and their pharmacological mechanism.By the guideline of CTM theory, thinking of different property of every involved medicine material, we practised different extracting methods. By the orthogonal-lab law, we setted up the extracting condition, including concentration and dosage of the solutions, frequency and time of the operations etc.By figuring out influences of every method on extracting efficiency, we finally confirmed the best extracting way. Samely, comparing gain rates of various purifying and drying means, we designed the optimal final course to finish the product. At last, we got the complete route of making Xiakucao combination capsule, It was described as the following. In the first stage: For Prunella vulgaris L., adding Prunella vulgaris L.to ethanol, reacting in circumfluence equipment and partly distilling out the ethanal, we got the Prunella vulgaris L. paste. For Uncaria rhynchophylla (Miq.)Jacks., Picrasma quassiooider(D.Don)Benn., Nelunbo nucifera Gaertn., adding them into 80% ethanol, boiling and partly volatilizing out the ethanal, adjusting its PH, filtering, adjusting PH value to be neutral, adding ethanol and depositing it for a while, gathering these ethanol solutions, partly distilling out the ethanal, the remains was the mixed paste. For Scutellaria baicalensis Georgi, boiling in water, adding HC1 into the filtered solution, adjusting its PH, filtering, collecting the deposition, adjusing PH value to be neutral, resolved in, adjusting its back to PH 1-2 with the acid, collecting the deposition,cleaning its by using ethanol, drying under the vacuum, we gained the essential components of Scutellaria baicalensis Georgi. For Cassia obtusifolia L.,boiling in water, condensing the solution, adding ethanol and depositing,repeating the practice, partly distilling out the ethanal, we got the Cassia obtusifolia L. paste. In the second stage: We stirred the mixture of P-S-P-U- N- C pastes, adding the 10% dissolvable starch, and homogenizing; then we transferred them to the spray-dryer, converted the dried fine power to the particles by drying apparatus. In the third stage: Filling the particles in the No.O capsules, by packaging, we obtained the final products. Totally, this operation process is relatively compact, and easy to control.In our research, besides preparing the Prunella vulgaris L. capsules in the confirmed technics, we obeyed the normative requirements of CTM Study, and listed the following quality control aspects: the apperance of intermediates, TLC check, the content of heavy metals & arsenic salt, and the concentration of valid ingredients etc. Evaluating these items in methodology, we eventually established the quality standard of Fufangxiakucao Jiaonang. In the quality standard, we using the method of HPLC to research the content of Ursolic acid , the representative ingredient of Prunella vulgaris L.which is the vital component in this capsule. On the other hand, we qualified Scutellaria baicalensis Georgi, Picrasma quassiooider(D.Don)Benn., Uncaria rhynchophylla (Miq.)Jacks, Nelunbo nucifera Gaertn.,and Cassia obtusifolia L. by TLC analysis. With this standard, we repeatedly monitored samples ,which came from continuous three-batch productions in middle-scale manufacturing, and meanwhile, tested the pharmic stability of this Prunella vulgaris L.capsule. The results showed that this technics way made sure the steady quality of Fufangxiakucao Jiaonang , had a high repeatability , and the preparation kept in a good stable state. All of these completely accorded with the demand of CTM qulity standard. Finally, we studied the pharmacological action of Fufangxiakucao Jiaonang, and the results showed that the combination capsule have some anti-hypertensive effections.