Study On Prepration And Quanlity Standards Of Shuxiong Orally Disintegrating Tablet

This topic comes from the 2005 edition of Chinese Pharmacopoeia, Shuxiong Tablet, the original formulation is Rhizoma Chuanxiong, Flos Carthami, and Notoginseng Radix et Rhizoma.The main clinical for the treatment of coronary heart disease, angina, cardiac arrhythmia. The preparation of this study was to re-group prescription, using PNS, the extraction of Flos Carthami and Rhizoma Chuanxiong, changing the dosage form development as orally disintegrating tablets(ODT). On the basis of preliminary studies, the author reaserch the formation process and quality standards, for its further study of pharmacology and toxicology research.1,Study of the preparation Process(1)The proportion of materials.Through the repeated experiment with signal factor,the diluents, disintegrating agents, taste masking agents, lubricants and were investigated.From the test results, the author obtained the optimized prescription of orally disintegrating tablets(1000 piece):the powder of mixed extraction70g,microcrystalline cellulose60g,mannitol 20g,C-CMSNa12g,PVPP8g,citric acid0.4%, stevioside 0.5%, magnesium stearate 0.5%, colloidal silicon dioxide 1.0%.(2)Investigation of the pressure of the tablet press.The optic pressure of shuxiong orally disintegrating tablet is 5.5～6.0kg.(3) The humidity control during the preparation process. Combination of the result of experiment and production experience, the operating environment should be controlled below 50% relative humidity.(4)the preparation process.Weigh the amount of PNS, the extraction of Flos Carthami and Rhizoma Chuanxiong as prescriptions, adding diluents, disintegrating agents, taste masking agents, lubricants,, adjusting the pressure presses between 5.5～6.0Kg, control the hardness of about 3.0～3.5 Kg/mm2.2,Study of Quality StandardsThe Rhizoma Chuanxiong, Flos Carthami, and Notoginseng Radix et Rhizoma were identified TLC. The examinations of heavy metal and arsenic salt of ODT by the methods of pharmacopeia.The content of HSYA, Chuanxiongzine and ferulic acid, notoginsenoside R1, ginsenoside Rg1, ginsenoside Rb1 were determined by HPLC. The methods above are precise, reliable, repeatable, and can be applied for the quality control of the Shuxiong Orally Disintegrating Tablet. To ensure the safety of medication, this study for the determination of organic residues with macroporous resin in Notoginsenoside by GC-MS.we established an effective detective method of organic residues, as Hexahydrotoluene, Benzene, Toluene,Xylene,Phenylethylene, Divinyl benzene. From the results of detection,the PNS,the Chuanxiong extraction, the safflower extraction, shuxiong orally disintegrating tablets were detected by GC-MS, the conten of Toluene were less than 0.02%,meeting the requirements of Center for Drug Evaluation. The other 5 kinds of organic residues were not detected, indicating that the normal use of the macroporous resin is safe.