The Key Technology Research And Application Of Moisture Resistance In HGT Capsule

Tradit ional C hinese medicine capsule is one of the main forms of modern Chinese medicine preparations,the outstanding moisture absorption is a common problem in the development of tradit ional C hinese medicine.We chose the HGT capsule as a model drug,it has the funct ions of dispelling wind and dampness and relieving pain,and it is ma inly used in the treatment of anemofr igid-damp arthralgia.But it has high moisture absorption in the production and storage process.In this paper,starting wit h the forming process of the tradit ional C hinese medicine capsule,we synthet ically researched on excipients selection,granulating and coating technology.With the optimization of the extraction process,we get the Heiguteng compound powder.We chose 14 kinds of common excipents to study their moisture proof performance.Through the int uit ive moisture absorption curve,moisture proof performance of the lactose,mannitol,mic rocrystalline cellulose,?-cyclodextrin and calcium hydrogen phosphate were better.With filtered excip ients of good moisture proof,we prepared pellets by extrusion spheronizat ion.Using the software of Design Expert 8.06 on the materia l selection,we get the proportion of excipients on pellets.Using the single factor experiment such as adhesive and drug loading,and optimized its preparation technology.The results show that the prescription was composed of 40% Heiguteng compound powder,45% microcrysta lline cellulose and 15% lactose;spheronization frequency was 45 Hz,spheronizat ion time was 10 minutes,extrusion frequency was 35 Hz.It had smooth surface,good roundness,high yield and good release in vitro.Then we get the Heiguteng compound pellets.Heiguteng compound pellets were coated by Fluidized bed spray.And the moisture proof ability of Opadry 200 ? O padry XY ? Eudragit E PO ?Readi LYCO AT D were studied.The results show that the Readi LYCO AT D had good mo isture proof ability and no effect of the rele ase.The optimized proeess parameters were: atomized pressure was 0.24 MPa,temperature was 30-40?,peristalt ic frequency was 0.5 m L/ min,blower frequency was 45 Hz.The Heiguteng compound film coating pellets were Installed into capsule shells,then we can get the Heiguteng compound film coating pellets capsule.The methods of HPLC was respectively used for the determination of the content of Sinomenine.The method had good linear relationship.The quait y of Heiguteng compound film coating pellets capsule and the original drug were compared,including the moisture absorption rate,hygroscopic balance curve,the test of influencing factors and dissolution.The results show that the moisture absorption rate of new preparations was only 7.42 % in 48 h,compared with the HGT capsules,stabilit y of appearance and content were greatly improved in high humidity environment.The study on the stability of the Heiguteng compound film coating pellets capsule was done by investigat ing appearance,moisture content,determina t ion and release rate,inc luding influenced factor test,accelerated test and long term test.In influenced factor test,it had a phenomenon of adhesion under high humidity(90%)conditions,and showed a more stable state under high temperature and high light condit ions.In long term test,appearance,content and drug release were qualified.