Study On The Compatibility Of Polypropylene Ampoule Packaging For Paclitaxel Injection

As an antitumor drug,Paclitaxel injection is widely used in clinical treatment.It can make microtubules stable and have good effects on various solid tumors.The injection is composed of paclitaxel,polyoxyethylene castor oil(CremopHor EL),ethanol,and sodium citrate.The main packaging forms of Paclitarel Injection are low borosilicate glass ampoule packaging and penicillin bottle packing now.These two kinds of packaging are fragile,not conducive to transportation and has many other quality problems.So the passage mainly study on a new package material polypropylen ampoule and Paclitaxel Injection.According to the regulations,it is necessary to study on compatibility between drugs and packaging materials when the packaging is changed.The purpose of this study is evaluate the compatibility of Paclitaxel Injection packaged with polypropylen ampoule with extraction test,migration test and adsorption test.Trying to explore whether polypropylene anpoule can be used to package Paclitaxel Injection in mass production.Based on the analysis of the polypropylene ampoules,the antioxidants is the greatest impact on Paclitarel Injection.Therefore,in the extraction experiment,we first carried out the study of the antioxidant assay,and determined the feasibility of HPLC for the determination of antioxidant.Then we use heating reflux method to extract antioxidant with suitable solvents,the sorts and quantities of antioxidants is be identificated.,and the best extraction time was determined.Through the study,we found the method is accurate,effectiv and feasible.The optimum extraction time was 3 hours.Antioxidant 1010,antioxidant 168 and antioxidant 1076 were detected in acetonitrile extract,but the contents of several antioxidants are all in regulations.No antioxidant was detected in 0.9%Sodium Chloride Injection extract,pH3.5 sodium acetate extract and 15%ethanol extract.Antioxidants are unlikely to dissolve in these three solutions.In the migration test,we inspect content of antioxidants under the accelerated test conditions and long-term experimental conditions by HPLC.But after experiment,any antioxidants isn't be detected in Paclitaxel Injection.The antioxidants in the polypropylene ampoule did not migrate to Paclitarel InjectionIn the adsorption experiment,we design the test conditions strip to refer to the stability test conditions of Paclitarel Injection.We use Paclitaxel Injection glass bottles as parallel control group.We investigated the variety of propertis,inspection,content of Paclitaxel Injection under ampoule,acceerated test and long-term test conditions.The content of paclitaxel and sodium citrate was determined by HPLC.The content of ethanol was determined by GC.We compared whether the ingredients of the API and the ingredients of the excipient were reduced with glass bottles.The water loss rate of Paclitarel Injection was investigated by weight method under special requirement conditon.After adsorption test,we found all the survey items of the polypropylene ampoule Paclitaxel Injection which placed in stability conditions conformance to requirements.The content of paclitaxel,excipient,ethanol and sodium citrate did not change significantly,and the water loss rate was no more than 5%.Polypropylene ampoules had no obvious adsorption on paclitaxel.The research results show that the extraction and detection methods of antioxidants are effective,scientific and feasible,there is no interaction between polypropylene ampoules and Paclitarel Injection,and their compatibility is good.The polypropylene ampoules can be used as the internal packing of Paclitarel Injection in mass production production and improve the efficiency of the enterprises.