| Objective:Dan Deng Tong Nao slices with active blood、treatment of apoplexy efficacy root in Dan Deng Tong Nao capsule,Dan Deng Tong Nao capsules is a variety of Heilongjiang Jiren pharmaceutical co..Because the original prescription for capsule preparation containing more lipid soluble components,has many unstable factors for the capsule shell,resulting in the process of storage and transportation loss and reduction of drug storage is long,so the formulation and production process of the original prescription on the basis of the original optimized selection of film coated tablets for dosage form,the the transport,taking and carrying are convenient;more is to improve the safety,effectiveness and long-term stability of drugs,the prescription dosage form is more welcomed by patients.Methods:by orthogonal experimental design,the root,chuanxiong extract,salvia extract,Erigeron breviscapus extract single factor or multi factor study on the index components of Puerarin Content and the extract yield as indexes,screened the optimum extraction process;according to the experimental comparison of the existing equipment,drying at room temperature the effect of vacuum drying and drying method,determine the tablets;according to the soft material properties,compression effect,disintegration time and other factors selected material type and ratio and molding,the best coating process;by TLC on the main herbs in the prescription of TLC,HPLC was used for this product the content of Puerarin was determined,and the development of the light quality standard Dan slices;preliminary stability experiments were carried out on new forms of film coated tablets,the agent The storage conditions and the validity period of the type.Results:the best extraction technology of this product was obtained by orthogonal test:according to the prescription amount of processing good medicine,radix puerariae,Rhizoma Chuanxiong by adding 8,6,6 times the amount of boiling water extraction of 1 h,0.5h,0.5h,concentration,alcohol precipitation into paste drying;Salvia miltiorrhiza were added 70%ethanol 8,8,6 times the amount of reflux extraction three times,each time 1h,concentrating and drying;The extraction of 48 h,24h and 24h by impregnation of Erigeron breviscapus with 75%ethanol,8,6,and 6 times of impregnation,filtering and acid precipitation,sediment PH after vacuum drying;with three kinds of dry powder,crushing and sieving.The molding process is as follows:extract dry paste powder:filler=1:1.5 ratio,add starch and dextrin(1:1)as filling agent,add 2%hydroxypropyl cellulose and proper amount of magnesium stearate,85%ethanol as wetting agent,adhesive wet granulation,drying,pressing,coating.By test the calculated weight of one tablet 0.53 g,the index component of Puerarin per tablet is greater than or equal to 13mg/slices,preliminary stability test result shows that the tablet is not stable in high temperature and high humidity conditions,should be sealed storage shade,tentatively valid for 36 months.Conclusion:under the guidance of the theory of traditional Chinese medicine,the production process is optimized through the study of the extraction process and the molding process,and the quality standard scheme is set up.The results show that the extraction and molding process is reasonable and feasible,and the method of qualitative identification and content determination is simple,controllable,reproducible,and more consistent with the requirements of quality control.The prospect of the treatment of apoplexy drugs is very promising.This topic has laid a foundation for the development of apoplexy drugs. |
