Preparation And Quality Investigation Of Senecio Eye Drops Based On PLGA-PEG-PLGA

In this paper,a traditional Chinese medicine Senecio in situ gel eye drop with reverse thermal sensitivity was developed.The prescription and production process were formulated,and the quality standard of traditional Senecio eye drops was upgraded.A draft quality standard for formulation was established.An HPLC method for simultaneous determination of chlorogenic acid and hyperoside in Senecio medicinal materials was established and the method was investigated.The precision,repeatability,linear relationship and sample recovery experiments of the method are in line with the methodological requirements.The established chromatographic method is simple,precise,accurate,and sensitive.The method can be used for the determination of index components in Senecio medicinal materials,and also provides a reference for the formulation of quality standards for Senecio related preparations.Using chlorogenic acid and hyperoside as indicators,high-performance liquid chromatography was used to analyze the active constituents in Senecio produced in Guizhou,Zhejiang,Guangxi,Guangdong and Hubei,which are the main producing places of Senecio medicinal materials,in order to compare research.The results showed that the active ingredients of Senecio medicinal herbs(chlorogenic acid and gold)from different producing areas are large differences in the content.The order of content was Zhejiang-made Senecio>Guangzhou-made Senecio>Guizhou-made Senecio>Guangxi-made Senecio>Hubei-made Senecio.The water extraction and alcohol precipitation method was used to optimize the extraction process of the active ingredients in the Chinese medicine Senecio.With the extraction time,extraction times and material ratio as the influencing factors,the water extraction process was studied by orthogonal method.The results showed that the optimal water extraction process was 1-time extraction,5h of extraction time,material ratio 1:15,The best extraction rate of active ingredients was 0.256%.Taking ethanol concentration,drug density,and standing time as factors,the reaction surface design in Design-Expert was used to study the alcohol precipitation process.The optimal alcohol precipitation process was ethanol concentration of 90%,drug densityof 1.08,and standing time of 6h,the best total retention of active ingredients was0.272%.The PLGA-PEG-PLGA triblock polymer was synthesized by ring-opening polymerization,and the synthesized PLGA-PEG-PLGA was characterized,including phase transition temperature,FT-IR,GPC and 1H-NMR.The Senecio in-situ gel eye drops were prepared by using the Senecio extract as a raw material to determine the formulation composition of the preparation.The eye drops were subjected to gelation temperature measurement,identification of active ingredients,and determination of active ingredient content.In addition,quality standards for the pH,osmotic pressure and clarity of eye drops are in compliance with the relevant regulations of the Chinese Pharmacopoeia.Eye drops have no eye irritation to rabbits and meet eye medication requirements.The Senecio in situ gel eye drop developed in this paper is a free-flowing liquid at room temperature,and can be administered by eye drop.After administration,it will be gelled at the eye administration site to form a semi-solid gel.The preparation can overcome the problem that the bioavailability is low and the dosage is difficult to control due to the loss of tears after the administration of the traditional Senecio eye drops,and the paste phenomenon caused by the traditional Chinese medicine eye ointment can be avoided,and It has certain reference value for the study of other traditional Chinese medicine eye drops.The research on the quality standard of Senecio in the process of preparation research also has certain reference value for the improvement of the quality standard of Chinese herbal medicine Senecio related preparations.