| Conjunctivitis,with a high incidence,become one of the major causes of blindness.As the accelerating pace of modern life,people’s increase dependence on the phone,computer and this type of electronic products,with the lack of good eye habits make the conjunctivitis become one of the common eye diseases.Modern Chinese medicine conjunctivitis is a Chinese black eye shade areas,lead to conjunctivitis main pathogenic microorganisms become fungi,bacteria,viruses,etc.This paper studied Radix ophthalmic pH sensitive in-situ gel,Radix original dosage form is eye drops,mainly used in clinical detoxification,storm off the heat-TG in wind syndrome(acute bacterial conjunctivitis)White eye redness,cell eyelid redness,burning photophobia.In this study,Radix ophthalmic pH sensitive gel in situ extraction process,the molding process,quality standards,stability and fingerprinting experiment.using orthogonal experiment method to the content of adenosine as index of Radix made water extraction and alcohol precipitation to liquidity,gelling and dissolution of the product as an index gel matrix screening,develop product molded process;qualitative identification of Radix and adenosine,(R,S)-report content measured by HPLC spring;and to develop "Chinese medicine,natural medicine stability of technical guidelines," according to the State food and Drug Administration relevant provisions of the three batches of samples for 6 months at room temperature and accelerated stability study.At the same time,to develop characters(appearance,color,mobility),pH value,as the determination of the indexes of Radix pH sensitive eye gel were factors accelerating light,heat,cold,freezing,centrifugation and other tests;and 10 batches of Radix ophthalmic pH sensitive in situ gel were fingerprint.As a result,Radix optimum extraction was 10 times the amount of water refluxing 2 times,each time 2h,concentration of alcohol precipitation is 60%.Experimental preferably Carbopol 940 become gel matrix,HPMC become a thickener.Quality Standard of the TLC qualitative identification results show that:in the test was the same color spots corresponding to the reference position,the negative control without interference;adenosine,(R,S)-epigoitrin content of not less than the original formulation,quantity of contents,pH values are in line with the "Chinese Pharmacopoeia"2015 edition an appendix under IQ gels provision.Experimental study on the stability of the stress testing,long-term stability and accelerated stability experiments show that the formulation quality control,good stability.Fingerprint fingerprints of 10 batches of medicines were eligible. |