A Study Of Preparation Of Rabeprazole Sodium Enteric-coated Tablet And Improvement Of Quality Control

Purpose: Peptic ulcer is a common disease in the world, and proton pump inhibitor is one of the most advanced and effective drugs in the treatment of peptic ulcer. As the typical drug, preparation of Rabeprazole Sodium Enteric-coated Tablets are prone to arise exquisite material changes, acid resistance and dissolution rate do not accord with requirements and methods for determination have certain limitations. Based on the reasons above, the paper will study from the perspective of timeliness, accuracy and cost of inspection as well as quality standard for enteric-coated tablets etc. The paper studies on preparation of Rabeprazole Sodium Enteric-coated Tablet and improvement of quality control so as to improve the quality control of it.Methods:(1) Rabeprazole Sodium Enteric-coated Tablets are made from coated plain tablets which are mainly composed of rabeprazole sodium, filler, stabilizer, disintegrating agent, lubricant and adhesion agent. The study is to screen the best prescription through exprimental researches on compatibility between rabeprazole sodium and excipient.(2)The coating qualities of Rabeprazole Sodium Enteric-coated Tablets often do not meet the requirements of Pharmacopoeia. The key technology of coating mainly includes two aspects respectively as buttering and enteric layer. The study will upgrade through experimental investigation on solvent, components and dynamiting of isolation layer as well as dynamiting of enteric layer.(3) Rabeprazole Sodium Enteric-coated Tablets are common dosage forms and the quality control of enteric layer is a crucial element. In the paper, the method to determination is HPLC in which the filter is octadecylsilane chemically bonded silica and the mobile phase is acetonitrile and water and triethylamine whose proportion is 30:70:0.5( with ortho-phosphoric acid to regulate PH value to 7.0).The detection wavelength is at 292 nm. The paper will test and verify from several aspects including accuracy, linearity, specificity, stability, LOD and LOQ etc.Results:(1) Tablets take starch and amylum pregelatinisatum as filters, avicel and hydroxypropylmethyl- cellose as disintegrating agent, magnesia as stabilizer, dolomol aslubricant and 10%PVPK30 solution as adhesion agent. 18 orders filtrate prill and dry in 50 degrees for one and half hours. Then 16 orders filtrate whole grain and compress tablets mixed with dolomol. The study will upgrade through experimental investigation on solvent,components and dynamiting of isolation layer as well as dynamiting of enteric layer.Finally 80 percent of alcohol and moderate Opadry will be coated as buttering with dynamiting between 3% and 5%. At the same time, water and debita spissitudine ACRYL-EZE will be coated as enteric layer with dynamiting between 10% and 13%. Also growth of related substances of enteric layer should be less than 0.5%.Conclusions:(1) Preparation of Rabeprazole Sodium Enteric-coated Tablets meet the requirement of quality standards. Production and operation of coating technology is simple with strong feasibility.(2) New method which is accordance with relevant of Pharmacopoeia in 2006 can fundamentally solve the problems of inconformity of the first and final inspection of related substance, blocking of liquid chromatograph and serious loss of chromatographic column. We can learn that new method can solve the problems of previous method to determination and make quality detection of Rabeprazole Sodium Enteric-coated Tablets so as to formulate quality standards of it.