Bromfenac sodium eye drops and preparation process thereof

Abstract

The invention discloses bromfenac sodium eye drops and a preparation process thereof, which relate to eye drops. The eye drops comprise 0.001-0.15 weight percent of bacteriostatic agent methylparaben,0.01-0.6% weight percent of an antioxidant anhydrous sodium sulfite, 0.05-0.1% weight percent of a complexing agent disodium edetate, and 0.01-0.3% weight percent of a thickening agent polyvinylpyrrolidone, 0.05-0.5% weight percent of bromfenac sodium; and 0.1-0.15 percent of a pH regulator sodium hydroxide and water for injection. According to the invention, a bottle body is inverted and overturned in a liquid medicine stirring process by adopting an overturning type stirring device, so that liquid medicine in the bottle body is subjected to sufficient and complete convection and mixing, rawmedicine materials are thoroughly dissolved and uniformly mixed, medicine sedimentation is avoided, the content of each component in the bromfenac sodium eye drop raw medicine materials is uniform, and full-water-soluble and impurity-free filling is realized. By adding the raw materials in batches, the interaction among the medicines can be realized, the medicine effect is better, and the qualityof the bromfenac sodium eye drops and the curative effect of the medicines are ensured.

Description

technical field [0001] The invention relates to an eye drop, in particular to a bromfenac sodium eye drop and a preparation process thereof. Background technique [0002] Bromfenac Sodium Hydrate Eye Drops is indicated for the symptomatic treatment of inflammatory diseases of the outer eye and anterior eye, and is widely used clinically for conjunctivitis. Conjunctivitis is a relatively difficult ophthalmic disease, which is very popular and harmful. If it is not prevented properly, it will cause disease transmission and infection, threatening the health of others. In mild cases, conjunctival hyperemia, a small amount of purulent or watery secretions in the conjunctival sac, and itching is not suitable for foreign body sensation; in severe cases, conjunctival hyperemia, or subconjunctival hemorrhage, eyelid edema, a large amount of purulent or watery secretions, and even corneal epithelium can be seen. Symptoms such as peeling, burning pain, and decreased vision. Seriously...

AI Technical Summary

Problems solved by technology

[0006] 1. In the production of liquid medicine, during the stirring process of medicine, the mixing device generally has the characteristics of easy precipitation or dead angle in stirring, and the 360° turning and stirring of the mixing tank cannot be realized, which will easily lead to uneven distribution of medicine in the medicine liquid and affect Medicinal efficacy, it is inconvenient to export the medicinal liquid after stirring, the stirring state of the stirring blade is single, and it is impossible to carry out criss-cross stirring. Production is of great significance;

[0007] 2. In the existing mixing process of the liquid medicine, most of the dissolving and stirring are carried out in the same mixing tank, stirring while dissolving, the degree of dissolution of the liquid medicine is not thorough enough, and it will also cause the medicine powder to adhere to the inner wall of the mixing tank, causing The mixing and stirring of medicines brings great inconvenience;

[0008] 3. Most of the existing stirring devices cannot be sealed and stirred during stirring, which may easily cause the overflow of the liquid medicine and cause waste of the liquid medicine;

[0009] 4. It is very inconvenient to export the liquid medicine after being stirred by the existing stirring device, and it is necessary to pick up the stirring device manually, and pouring the liquid will easily cause splashing and leakage of the liquid medicine, resulting in loss of the liquid medicine, and the stirring device must be picked up manually When pouring the liquid medicine, if you keep one action for a long time;

[0010] 5. The existing stirring device is not well sealed, and it is impossible to realize the 360° turning of the entire stirring device. When stirring, the suspension will eventually sink to the bottom, resulting in uneven mixing of the drug in the liquid medicine, inconsistent concentration of the liquid medicine, and failure to meet the specified standards. , During use, it is easy to cause damage to the human body;

[0011] 6. Most of the existing stirring devices cannot be heated, and the automatic integration of stirring and heating cannot be realized. Stirring after heating will cause heat loss in the process, and large temperature changes will occur, which is not conducive to stirring and increases the cost of stirring. process;

[0012] 7. Most of the existing stirring devices that can be heated cannot maintain a constant temperature state, and cannot keep the liquid medicine at the best mixing and dissolving temperature, which is not convenient for stirring. If the temperature is too high, the pH of the liquid medicine changes too much, and May lead to the failure of certain components in the liquid medicine;

[0013] 8. Most of the stirring rods of the existing stirring devices are separate stirring pieces. In order to accelerate the stirring, the rotating speed of the stirring rods can only be increased, and the omnidirectional stirring cannot be realized. The raw material deposition is still common in the stirring of the liquid medicine. Uneven stirring does not solve the problem of drug suspensions sinking to the bottom;

[0014] 9. The existing stirring device has a single function. During the stirring process, the medicine adheres to the inner wall of the stirring device, and the powdered medicine sticks to the inner wall and agglomerates, which is not easy to dissolve, resulting in a decrease in the concentration of the liquid medicine and affecting the efficacy of the liquid medicine;

[0015] 10. The existing stirring device cannot be fixed during stirring. When the stirring device is tilted, it will cause splashing of the liquid medicine, which will cause the loss of active ingredients in the liquid medicine and reduce the efficacy of the medicine, which is not conducive to stirring. It is easy to cause liquid pollution;

[0016] 11. The existing stirring device needs to add water during the stirring process. When adjusting the thickness of the liquid medicine, it is very inconvenient to add water, and the amount of water added is not easy to control. It is easy to add too much water and cause the dosage of the liquid medicine to be inaccurate, which is inconvenient Preparation of liquid medicine;

[0017] 12. With the existing stirring device, after the stirring of the medicinal liquid is completed, during the extraction process of the medicinal liquid, most of the stirring devices are picked up artificially and poured into the container. It is very inconvenient to extract the medicinal liquid in batches, and the stirring device In the process of pouring into the container, there is also a problem with the docking, which can easily cause leakage of the liquid medicine and cause losses;

[0018] 13. The existing containers for receiving liquid medicine cannot be fixedly placed, and most of them are taken manually, and the container is prone to tilt, resulting in inaccurate dosage of liquid medicine

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