Study On Preparation Technology And Quality Standard Of Tong Xinluo Drop Pills

Tongxinluo capsule is one of the preparations included in the 2015 edition of Chinese pharmacopoeia,which can be clinically used in the treatment of coronary heart disease angina pectoris or stroke.It can invigorate qi,promote blood circulation and activate meridians to stop pain.This study intends to reform the dosage form of tongxinluo capsule and transform it into tongxinluo drop pills,so as to improve the disadvantages of the original capsule type capsule shell easy to break and the content easy to agglomerate,and further improve the stability of the product.At the same time,compared with the original capsule,tongxinluo drop pills are better for human absorption,better bioavailability,simpler production process and lower production cost.In this study,single factor investigation and orthogonal experimental design were used to optimize the extraction process and preparation forming process of tongxinluo drop pills.The optimal extraction process of tongxinluo drop pills is as follows:(1)Leech,scorpion,periostracum cicada,ground beeltle,centipede were extracted by bionic enzymatic method.Artificial gastric juice was first added to adjust the PH to 2.0,followed add 3% pepsin to enzymatic hydrolysis for 2 h,then artificial intestinal juice was added to adjust the PH to 7.5,followed add 3% trypsin to enzymatic hydrolysis for 2 h.The obtained enzymatic hydrolysate was concentrated by vacuum and dried,and then prepared into fine powder,which was then obtained as the bionic enzyme enzymatic hydrolysis extract powder.(2)Sandalwood,lignum dalbergiae odoriferae and frankincense add 8.92 times the amount of water,soak for 12 h,and continuously extract the volatile oil for 6h.The obtained volatile oil was coated with 8 times the amount of saturated solution of β-CD water,and was magnetically stirred at 40℃(200r/min rotation speed)for 2h to produce the volatile oil β-CD inclusion compound.(3)Ginseng,jujube kernel(Fried),radix paeoniae rubra were mixd with the pharmaceutical residue which has been extracted of volatile oil,then add 8 times of water,fry for 1h,fry for 3times.The water decoction was concentrated by vacuum and dried,and then prepared into fine powder,which was then obtained as the water decoction powder.The best preparation forming process of tongxinluo drop pills is as follows: the borneol was crushed into fine powder(120 mesh),which was then mixed with the bionic enzyme enzymatic hydrolysis extract powder,the volatile oil β-CD inclusion compound and the water decoction powder.The above powder and substrate(PEG4000:PEG6000 =2:1)were mixed in a ratio of 1:2,then melted at 80℃.Liquid paraffin was used as the condensing agent,the drop rate was 30 drops/min,the drop spacing was 5cm,and the condensation temperature was 5-10℃,and then obtained the product of tongxinluo drop pills.In this study,the quality standard of three batches of tongxinluo drop pills(batch no.190510,190514,190518)was studied,and the characters,general inspection items,TLC identification and content determination were investigated separately.The quality standard draft of tongxinluo drop pills was established,which confirmed the character was brown drop pills,with slightly fishy smell,slightly bitter taste and salty taste and the TLC identification methods of ginseng,leech,frankincense and borneol.The content determination results showed that each 1g of the product should contain at least 1.82 mg of paeoniflorin,at least 0.195 mg of ginsenoside Rg1,at least 0.680 mg of ginsenoside Re,and at least 0.618 mg of ginsenoside Rb1.In this study,three batches of tongxinluo drop pills were tested for accelerated stability and long-term stability,results can be seen,under the conditions of acceleration and long-term test,the data of three batches of samples,such as character,moisture,weight difference,dissolution time,TLC identification,content determination,etc.remain stable.It can be seen that the quality of tongxinluo drop pills were stable and good within 9 months.To sum up,the preparation process of tongxinluo drop pills established in this study is stable and feasible,and the quality of tongxinluo drop pills were stable and controllable.