Pharmaceutics Of Tuizhang Ophthalmic Gel

Pharmaceutics of Tuizhang ophthalmic gelTuizhang oculentum, comes from Chinese patented medicines of the standard of Chinese ministry of health, is used to cure the incipient cataract and corneal macula. Modern research has shown the following pharmacologic effects of this herbal recipe as reducing the level of lens turbid, enhancing the metabolism of retinal photoreceptors, improving the vision as a result. To avoided the disadvantages of Tuizhang oculentum, such as bad transparency, lower bioavailability, poor compliance of patients, Tuizhang gel was developed and overall studies were performed in these aspects, including formulation, technology, quality standard, the release characteristics in vitro, irritability, allergy, stability, etc. Seven main sections were included in this paper:1,study on the optimized extraction process of Tuizhang gelPrimary study on preparation process of standard extracts of the Tuizhang. Orthogonal test was employed in selection of optimal conditions for the extraction procedure, including the optimal amount of water used in decoction, optimal times and duration of decoction and optimal alcoholic concentration in sedimentation.2,study on the screening for kinds of ophthalmic gelTaking properties, irritation, rheology as screening indexs, Screening of hydrogel kinds was performed, including natural high molecular, semisynthesis high molecular synthesized materials, mixed substrates of Carbomer-980 and HPMC-K4M was ultimately determined。3,study on the processing technology of Tuizhang gelThrough sdudying the preparation process of Tuizhang gel, we discoved that adding sequence and quantity of pH regulators have affections on the property of Tuizhang gel while the method of colloidal solution preparation and the pH regulators kinds have none. It has heavy soap smell added pH regulators before forming while that has none behind. Ultimately the preparation technology for Tuizhang hydrogel are determined: CP-980,HPMC-K4M being wetting by glycerin, then being swelling after adding pure water, 10% NaHCO₃ as the pH regulators being adding before forming.4,study on the optimization of the formulation of Tuizhang gelTaking viscosity, rheology, accumulate release degree of emodin and chrysophanol in 6 hr as Screening indexs, formulation of Tuizhang hydrogel optimized by using CCD-RSM, the best base material prescription proportion was ultimately determinded: CP-980 2% , HPMC 0．2%～0．5%.5,study on the release characteristics in vitro of Tuizhang gelStuding by bag filter method, the characteristics of Tuizhang gel on the drug-releasing in vitro were evaluated by comparison with Tuizhang oculentum. Results showed that the emodin and chrysophrranol in Tuizhang gel released (98．3±1．1) %, (95．8±1．8) % within 24 hours, respectively, while those in in Tuizhang oculentum released (10．62±0．7) %, (10．46±0．4) %, respectively; The emodin and chrysophrranol in Tuizhang gel released more quickly and completely than in Tuizhang oculentum, Tuizhang gel has improved the bioavailability. So we conclude that Tuizhang gel is characterized by slow-release to some degree, and it shows a promising future on ophthalmic drug delivery.6,study on the irritability and allergy of Tuizhang gelThe irritating experiment with eyes showed that short-time multiple and long-time regular irritation have no markedly influences on tested rabbit eyes, both corneas are transparent without turbidness, no conjunctiva hyperemia, no edema and no discharge, So Tuizhang hydrogel is safety for clinic application.7,study on the quality standard of Tuizhang gelWe completed the studying on the quality standard of Tuizhang hydrogel. Though the test , Quality standards for Tuizhang hydrogel, including identification of Cassia obtusifolia L, Polygonum multiflorum Thunb, Notopterygium incisum Ting ex H.T.Chang, Clematis chinensis Osbeck by TLC, determination of emodin and chrysophanoand have been drawn up preliminary .As an important quality standard, the content of Emodin can not be less than 0．04 mg in 1 g extracts ,and Chrysophanol 0．07 mg either.8,study on the stability of Tuizhang gelInfluencing factors including light radiation, high temperature, and high humidity on the stability of Tuizhang hydrogel were investigated. It is demonstrated that if sample kept under light radiation for 10 days, the viscosity are reduced, sample kept under other influencing factors has no change.Therefore it should be stored at low temperature without light.The base of Tuizhang gel was elementarily investigated and evaluated in this paper, it provided a reference for development of ophthalmic gel of traditional Chinese medicine.