Zhaoke (Guangzhou) Ophthalmic Drug Company Limited

Xiaoyi Li

Gang Li

Xiangrong Dai

Jing Liu

Juan Ling

Lei Yin

Kailei Cao

Dongsheng Ni

A treatment process of cyclosporine eye gel, comprising the steps of: adding carbomer to water, stirring thoroughly and homogenizing; after the prepared carbomer base swollen, stirring and homogenizing; cooling the carbomer base after moist heat sterilization, performing vacuum degassing, adjusting the pH of the base to 5.0-9.0 with filtered sodium hydroxide solution; mixing polyoxyl 35 castor oil, cyclosporin A raw material, 1,2-propanediol and water in a suitable ratio, preparing into a clear solution under a water bath at 35 to 45&#xb0; C., and filtering; mixing the filtrate uniformly with the carbomer base, performing vacuum degassing; performing aseptic filling after another filtration. For the process of the present invention, sterilization and filtration is performed before adding carbomer, which is convenient for industrial production.

Treatment process of cyclosporine eye gel

A dispersion process of adapalene gel preparation, including the following steps: pulverizing adapalene raw material to D50 not more than 10 &#x3bc;m and D90 not more than 30 &#x3bc;m by dry detection; adding methyl p-hydroxybenzoate, 1,2-propanediol, carbomer 980 and disodium edetate in water, heating and stirring consistently to obtain a matrix in a uniform jelly; adding poloxamer 188, propylene glycol and ethylene glycol phenyl ether in water, stirring and heating to prepare a mixed solution; adding adapalene in the mixed solution prepared, emulsifying at a high speed, then adding to the matrix for thorough stirring; and then adding a triethanolamine aqueous solution for homogenization and stirring. The preparation prepared has good emulsifying and dispersing effect of adapalene, can be expanded on a large scale, and the industrial promotion prospect is good.

Dispersion process of adapalene in a gel preparation

The invention provides a process of controlling the impurities of clindamycin hydrochloride, comprising a step of purifying said clindamycin hydrochloride by two-phase high performance liquid chromatography, wherein the chromatographic conditions are as follows: the detection wavelength is 200-220 nm; the column temperature is 20-40&#xb0; C.; the flow rate is 0.8-1 ml/min; Mobile phase A: 0.025 mol/L potassium dihydrogen phosphate solution; Mobile phase B: Acetonitrile; and gradient elution is performed. The method of controlling impurities of the invention can solve the problem of the interference by excipients and the problem of the separation of many impurities at the same time. It also provides an effective method for setting quality standard of impurities in such a formulation.

Process of controlling the impurities of clindamycin hydrochloride

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Xiaoyi Li