Study On Preparation Technology And Quality Control Of Lanxiang Zhichuang Suppositories

Lanxiang Zhichuang Suppositories is improvement of the dosage form Lanxiang Zhichuang Ointments which is used in clinicin in a hospital,and it is consistsed of Herba Menthae Spicatae,Sophorae Flos,Orostachyis Fimbriatae Herba,Forge Calamina and Borneolum Syntheticum.The prescription from one hospital is an empirical anagraph and it has been used clinically for many years.Lanxiang Zhichuang Suppositories has the function of removing heat and dampness,promoting blood circulation to arrest,astringing to stop bleeding,removing the necrotic tissue and promote.It is used to treat for treating hemorrhoids blong to stagnation of dampheat in clinic,the symptoms are showed as follows,red tongue an greasy fur,slippery pulse,with abundant dry throat with bitter taste,poor appetite,anal area is swelling bleeding during defecation,dry stool,constipation and yellow urine.This subject is under the guidance of traditional Chinese theory and base on requirements of the 6.1 classification of traditional Chinese medicine,natural medicine new drug registration and combined with modern research technology to study the preparation process and quality Control of Lanxiang Zhichuang Suppositories which is to ensure the preparation process is scientific and rational,the quality is stable and controllable.1.Study on preparation process.The extraction process: Using the transfer rate of hesperidin,rosmarinic scid,rutin and extractive yieldas the evaluation index,applying the orthogonal design experiment,then combined with the pharmacodynamic test results,ultimately we determined the extraction process of Lanxiang Zhichuang Suppositories as follows: To take the Herba Menthae Spicatae,Sophorae Flos and Orostachyis Fimbriatae Herba three herbs in the prescription using 12 times amount of 60% ethanol,extracting 3 times,1.5 hours every time,filtering,merging filtrate,contentration and drying.Contentration and drying process: Using the transfer rate of hesperidin and rosmarinic scid as index,studying on thick paste concentration degree and drying temperature.The optimal concentration and drying procedure were that alcohol extract after the merger was decompression concentrated to a relative density of 1.28(60℃)thick cream after vacuum drying(80℃,-0.09Mpa)into dry extract,standby.Prepation Process: Different kinds of matrix,melting temperaturehad and casting temperature had been investigated combining with the ten batch of pilot test,and ultimately determine the armaceutics technology of Lanxiang Zhichuang Suppositories is taking the proper amount of matrix and melting at 55℃in the water bath,then mixing completely with Forge Calamina(which was passed sieve of number 9)and Borneolum Syntheticum(which was passed sieve of number 6)according to the proportion of prescriptions,then putting in the dry paste powder(80 mesh)stirring 10 min under 40℃ water bath,casting,solidification,namely.2.Study on quality controlTLC method is used to qualitatively identify Lanxiang Zhichuang Suppositories of Sophorae Flos,Orostachyis Fimbriatae Herba,Borneolum Syntheticum.Results in chromatography for sample,the control herbs or contrast product corresponding to the position of the same color fluorescent spots,and has no negative interference.Forge Calamina was used physical and chemical identification methods are to identify,adding potassium ferricyanide produce white precipitant or mixing with a trace of blue precipitation after removal of impurity,meanwhile negative did not produce precipitate.Study oncontent of HPLC determination: The HPLC method is used to determine the contains of hesperidin and rosmarinic acid in Herba Menthae Spicatae of Lanxiang Zhichuang Suppositories,the chromatography conditions as fllows: with eighteen alkyl silane bonded silica as filler;using acetonitrile and 0.2% phosphoric acid(16:84)as mobile phase;the detection wavelength of hesperidin and rosmarinic scid are 283 nm and 330nm;the column temperature of 30℃;flow velocity 1.0mL·min-1.Through the ten batch of pilot study,to determine the content of hesperidin in the product is not less than 0.74 mg and rosmarinic scid in the product is not less than 0.44 mg in each suppository finally.