Rhodiola Dripping Pills Preparation And Quality Of Research

Hongjingtian which was ever listed in《Pharmacopoeia of the People's Republic of China》(Edition 1977,VolumnⅠ)has curative effects on removing heat and toxic,depriving the evil wetness and it was originally used in the treatment of lung heat,pulse heat,seasonal febrile disease and four limbs swelling.Modem pharmacology indicates that Hong Jingtian activates blood flow and removes blood stasis,anti-myocardium ischemia.At present,the compound tablets of Hongjingtian and the capsules of Hongjingtian are applied to treat coronary heart disease and angina pectoris with definite therapeutic effectiveness and neglectable side effects.This research included:(1)the establishment of analytical methods of typical principles(2)the optimization on purification process of the active constituents(3)the pharmacodynamic study of Hongjingtian(4)the study on prepartion of Hong Jingtian dripping pills(5)the study on stability of Hong Jingtian dripping pills.Salidroside and p-Tyrosol,as typical principles were qualitalively analyzed with TLC methods and the corresponding R_f values were 0.358 and 0.584.HPLC methods were developed to determine their concentration in the medicinal materials and preparations.All of these methods were accurate and sensitive.The extraction and purification process of the active constituents were studied by the criterion of transference rate of Salidroside,p-Tyrosol and the extraction rate of the solid.The extracting solvents,the size that the medicinal materials were comminuted and the soaking time were studied to investigate the influence of single factor.Orthogonal tests were used to optimize the decoction time,decoction times and solvent volume.Alcohol precipitation method,chitosan flocculating method were used to optimize purification process,the result indicates that the chitosan flocculating method is better than the other because it can make the solution precipitate fast and has higher transference rate of typical principles:the transference rate of Salidroside and p-Tyrosol is 66.4%and the extraction rate of solid is 14.0%.The optimun method of extraction and purification process has a good repeatability.The pharmacodynamical experimentation of extract of Hong Jingtian which is gotton by using the optimun extraction and purification process indicates that Hong Jingtian dripping pills has definite treatment on anti-hypoxia,anti-fatigue,anti-hot,anti-cold with definite therapeutic effectiveness and neglectable side effects.Hong Jingtian dripping pills were prepared in this process:disperse extracts into the excipients by melting and drip the molten suspension into the condensation fluid,then drops were contracted,cooled and solidified into dripping pills.By the criterion of hardness,degree of circularity and dissolution time,the amounts range of extracts and excipients were obtained through single factor experiment.The formulation was optimized on the basis of three factors and three levels orthogonal design by appearance quality and dissolution time.The dripping condition was optimized using the same design by assessing mean variance of weight.Hong Jingtian dripping pills were prepared according to the best components and dripping condition.Dissolution rate was established by studing the effect of dissolution medium and rotation speed on the accumulative dissolution percentage of the total flavone of Hong Jingtian dripping pills.The repeatability of three batches of samples and stability of accelerating and room temperature test showed that Hong Jingtian dripping pills was stable, quality-controlled and met the purpose and requirement of dosage form design.