Breakthrough In The Study Of Rujiean In Pharmaceutics

Chinese medicine prescription is a kind of Biotech drugs which made of appropriate medicinal odour and dosage, according to the "assistant and guide" of principles of formulating prescription under the theory of traditional Chinese medicine by the ancient Chinese medicine doctors. Prescription is the quintessence of Chinese medicine.Rujiean is a kind of Chinese medicine compose preparation, which consists of ten herbs such as Danshen Root.It is indicated for the treatment of Mammary Glands. The validity of this drug is proved in the clinical research for a long time.The old prescription is limited by shortcomings, such as tedious boiling and unconvenient carrying. Under the guidance of traditional Chinese medicine theory, combined with the characteristics of the disease, clinical study necessary and modern pharmaceutical formulations of the request, the use of modern science and technology.Chinese medicine prescription's modernization is the key to the modernization of Chinese medicine.In this dissertation, the extraction and purification, preparation process, quality control, pharmacokinetics, sustained release tablets and release in vitro are studied.1 Study on Extraction and PurificationOn the basis of the action indications, the character of the ingredients included in the herbs, the optimum extract conditions about water extraction and alcohol precipitation were selected by using orthogonal design which use quite a few assessing norms to evaluate them comprehensively. The extract yield and extractive transfer rate of Hesperdine were used as observing targets, the optimum condition for reflux method also was selected with the orthogonal test. The optimum extracting conditions were adding ten times water and boiling extraction twice with 1.5 hours every time. The relative density of liquid concentrated to 1.20, with 70% alcohol, keeping for 24h at 4℃. The extraction and purification process is reasonable and practical.2 Study on Preparation and Quality Control of The CapsulesBase on the clinic demand, the dosage form was chosen as capsules. Added some starch to the clear extract to make granulation, then made capsule. Sodiun Danshensu, Ferulic acid were qualitatively identificated by TLC. The result showed that all separated spots were in a clear map, and negative control without interference. Meanwhile, by means of HPLC to determine the content of Hesperdine and accomplished the systematic methodology. The results showed that quantitative methods are accurate, simple, reliable and can be used for the contents of the corresponding components determination. According to the results, the Hesperdine of the capsule is 3.27mg.3 Study on PharmacokineticsPharmacokinetics is the application principle of dynamics and a mathematical method research medicine in vivo process speed rule science. The phamacokinetic study of compounds of Traditional Chinese Medicine should be performed on the basis of systematic pharmacological research, and under the guidance of Traditional Chinese Medicine theory. Using the pharmacokinetics principle and method to study the effect of Traditional Chinese Medicine process in vivo, is of great significance for reasonable forms and processes selection, design of the correct evaluation of the quality of preparation, and clinical medicine.In this chapter, Danshensu had been taken as the reference to establish a method to determine rabbit's serum concentration of Danshensu by HPLC. The result shows Rujiean took effect too quickly. Therefore it was necessary to prepare a kind of sustained release preparation.4 Study on Preparation of Sustained Release Tablets and the release in vitroFor plain tablets, the frequent administrations led to fluctuation in blood concentration and high incidence of adverse effects.Therefore it was necessary to prepare a kind of sustained release preparation.Targeting for the cumulative release percentage of Danshensu, a method to determine release in vitro was established. The effect of dissolution conditions, prescription factor, craft factor to drug release has been investigated. Based on the results of single-factor tests, orthogonal design test was carried out to optimize the prescription with 40% HPMC (50mPa-s),10% EC (7×10-3 Pa·S),5% MCC and 5% lactose. The weighs about 500mg. The results show that the tablets seem well, and the preparation process is reasonable and practical, And release about 80% after taking it for 8 hours.