The Study Preparation Process And Quality Standard Of Pulsatile Tablets Of Extraction From Semen Raphani Alkaloids

Semen Raphani is mature dry seeds, sexual flavour XinGan flat to the lungs of spleen and stomach, with food in addition to bulge, drop the effect of eliminating phlegm to gas. Modern research shows that with water-soluble alkaloids as the main components of the water extract of Semen Raphani has significant antihypertensive effect.At present resist average hypertension medicine movie requires gradually to be accustomed to many times, blood medicine thickness fluctuation is big, but night does not exchange guarantee when requiring that effective blood poisons thickness; And sustained-release preparations and ordinary preparations, is long time to maintain steady blood drug concentration, and can’t meet the treatment of hypertension rhythm attack needs, easy creation is able to bear by nature, the lessening curative effect; For high blood pressure in the night, often at attack, at this time the injection application, which interfere with sleep and easy for patients with high concentration produces for side effects. This paper according to the dosage form of different levels of abuse, in the hour or hour pharmacology, pharmacokinetics and time therapeutic guidance, semen raphani was made to be the water-soluble Semen Raphani Alkaloids press-coated tablet pulsing, can be in disease onset provide effective blood drug concentration.Ensure the specific process parameters of extraction and purification of Semen Raphani, with the method of many factors combining with orthogonal design in the research of extraction and purification.In traditional Chinese medicine theory guidance, adopting the modern preparation technology, and based on the national drug registration management regulations of the water extract of Semen Raphani pulsed press-coated tablet production process, quality standards and the primary stability were studied.In the molding process study to pulse type of press-coated tablet important index of the delay and the accumulation of drug release rate as evaluation index, a visit to the compressor method, tablet hardness, filling agent, disintegrating agent and coating film the sort of material, the dosage and proportion, the completion of the water extract of Semen Raphani pulsed press-coated tablet prescription screening and technology research; quality standard study, established in the determination of Semen Raphani and in vitro dissolution method for testing, and the test samples from the stability of the preliminary research.So the study shows that preparation technology of press-coated tablet of water-soluble Semen Raphani Alkaloids is not only simple, scientific, reasonable, feasible, but also is stable, controllable. In addition, The nature of the preparation is basically stable.