Study On Preparation And Quality Standard

Objective：Study on the preparation technology and quality standard of Zhibituo softcapsule， provide a preliminary experimental basis for drug application.Method：（1）Research on the preparation technique：According to the advantages anddisadvantages of literature reports and the oil and the choice of PEG soybean oil asbase；The sedimentation coefficient as the evaluation index, the amount of wax werestudied to select the most appropriate dosage by single factor experiments；Thedisintegration time as index, single factor experiments was used to the capsule shellformulation optimization.（2）Study on quality standard：Determination of the content of lovastatin on Zhibituosoft capsule by HPLC, According to "the people’s Republic of China Pharmacopoeia"2010edition of characters、the load difference、disintegration time、Microbial limitdetermination and so on，Study and test method.（3）Study on the stability：The three batch of Zhibituo soft capsule was acceleratedstability and long-term stability according to "the people’s Republic of ChinaPharmacopoeia"2010Edition.Result：（1）According to the test results to determine the Zhibituo soft capsuleformulation and capsule shell formulation, selection of soybean oil was315g/1000particle, beeswax was12g/1000particle; gelatin capsule shell prescription: Glycerin:water=1:0.4:1, shading liquid prescription for titanium dioxide6.5g/1000g gelatin,cacao pigment was2.6g/1000g gelatin.（2）The quality control system of scientific, reasonable, controllable establishedaccording to the experimental results. Finally determined according to pharmacopoeiamethod to check the characters, the load difference, disintegration time, microbiallimit, soft capsule by qualitative identification of the fat will TCL method, lovastatinwith soft capsule was determined on the lipid will use HPLC.（3）The three batch of Zhibituo soft capsule stability tests are in line with therequirements.Conclusion：This study adopted Zhibituo soft capsule preparation process isreasonable；Study on quality standard of strong specificity，Can effectively control theZhibituo capsule quality，To provide the basis for the declaration...