Bromfenac sodium eye drops and preparation technology thereof

Abstract

The invention provides bromfenac sodium eye drops and preparation technology thereof, and relates to eye drops and preparation technology thereof. The eye drops comprise the following components in percentages by weight: 0.001-0.15% of a bacteriostat potassium sorbate, 0.10-3.25% of an anti-oxidant sodium bisulfite, 0.04-2.52% of a lubricant magnesium lauryl sulfate, 0.15-0.55% of bromfenac sodium, a pH conditioning agent and injection water. A series of mixing and stirring steps are used in order to prepare the bromfenac sodium eye drops. A stirring mechanism on a base plate as well as stirring fans on a vertical plate and stirring fiber bars arranged on the stirring fans are used for realizing partial stirring in one cubic centimeter, partial stirring can be used for substantially reducing suspended solids, stirring time is shortened, uniform dissolving is realized, content of each component in bromfenac sodium eye drop bulk pharmaceutical chemicals is uniform, stirring efficiency of bulk pharmaceutical chemicals is substantially improved, and current speed during stirring is substantially improved.

Description

technical field [0001] The invention relates to a stirring device, in particular to a bromfenac sodium eye drop and a preparation process thereof. Background technique [0002] In pharmaceutical production, mixing and stirring is a widely used pharmaceutical process. Its main purpose is to: ① prepare a uniform mixture; ② provide good conditions for certain unit operations or chemical reaction processes. When preparing a homogeneous mixture, the mixing effect is measured by the degree of mixing of the mixture. [0003] The so-called mixing means that under the action of external force, various material components are blended with each other, so that the particles of various components in the volume are evenly distributed. It is an important link to ensure the quality of materials and improve the effect of materials. The purpose of mixing and stirring is to make the content of each component in the prescription uniform, so as to ensure the accurate, safe and effective dosa...

AI Technical Summary

Problems solved by technology

[0005] For the preparation process of bromfenac sodium eye drops currently on the market, the main pharmaceutical preparation process is mixing and stirring. The quality of the mixing and stirring results directly affects the appearance and internal quality of the preparation, and affects the efficacy of the drug. However, the publication number is A kind of ophthalmic gel preparation of bromfenac sodium hydrate disclosed by CN101322683B and a kind of ophthalmic pharmaceutical composition containing bromfenac sodium disclosed by CN10313899B are all disclosed in the preparation method of the specification. Simply use the existing stirring technology in the pharmaceutical process to mix the various liquid medicines. However, for liquid medicines such as eye drops, mixing and stirring is the key technology for preparing liquid medicines. During the traditional medicine dissolution and stirring process, suspension often occurs. Turbidity and suspension are caused by the inability of the current stirring device to stir locally. The suspension eventually sinks to the bottom, which not only makes the concentration of the final dissolved medicinal solution fail to meet the specified standard, but also leads to waste. At present, there is no one that can A high-efficiency mixing and stirring device that realizes partial stirring; in addition, in the traditional process of dissolving the original drug material and feeding the original drug before stirring, most of the original drug is put into the mixing container at once, even if it is added in batches, the original drug is also directly due to gravity. Sinking to the bottom can easily lead to the accumulation of raw materials, and once the raw materials are piled up, it is difficult to fully stir them, which not only leads to waste but also makes the stirring efficiency low. Residual impurities in the drug will affect the efficacy of the drug, and the eye drops are applied to the sensitive organ of the human body - the eye, which is afraid of irritation, uneven mixing and stirring will also lead to eye side effects

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