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Phenylephrine ketorolac solution and preparation method

A technology of phenylephrine and phenylephrine hydrochloride, which is used in pharmaceutical formulations, drug delivery, sensory diseases, etc., to relieve postoperative pain, increase safety, and prevent intraoperative pupil dilation.

Inactive Publication Date: 2015-08-26
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] The above data shows that the application of phosphate buffer system and citrate buffer system will have some potential risks in terms of compatibility and containers

Method used

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  • Phenylephrine ketorolac solution and preparation method
  • Phenylephrine ketorolac solution and preparation method
  • Phenylephrine ketorolac solution and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1: One of the preparations of phenylephrine ketorolac solution

[0034] (4ml: phenylephrine 40.64mg and ketorolac 11.52mg)

[0035]

[0036] Remarks: Phenylephrine hydrochloride is fed at 100%, and ketorolac tromethamine is fed at 104%.

[0037] Preparation process: Weigh 49.6 g of phenylephrine hydrochloride and 17.64 g of ketorolac tromethamine according to the prescription amount, add them to water for injection at 50°C, and stir to dissolve completely. Use 0.05% (w / v) activated carbon for needles and stir at 50°C for 20min. Use a 0.45 μm filter membrane to filter the filtrate through a 0.22 μm filter membrane, then adjust the pH to about 6.3 with 1% (w / v) sodium hydroxide solution or 1M hydrochloric acid solution, and finally add water for injection to make up to 4000ml , intermediate detection. Nitrogen protection, filling and sealing in 5ml ampoules, 4ml / branch. 121°C, 15min high-pressure steam sterilization, leak detection, light inspection of a...

Embodiment 2

[0038] Example 2: According to the prescription in WO2014066485A1, a phenylephrine ketorolac solution was prepared.

[0039] (4ml: phenylephrine 40.64mg and ketorolac 11.52mg)

[0040]

[0041]

[0042] Remarks: Phenylephrine hydrochloride is fed at 100%, and ketorolac tromethamine is fed at 104%.

[0043] Preparation process: Weigh 49.6g of phenylephrine hydrochloride, 17.64g of ketorolac tromethamine, 0.96g of citric acid (monohydrate), and 23.53g of sodium citrate (dihydrate) according to the prescription amount, add Into the water for injection at 50°C, stirring and dissolving completely. Use 0.05% (w / v) activated carbon for needles and stir at 50°C for 20min. Use a 0.45 μm filter membrane to filter the filtrate through a 0.22 μm filter membrane, then adjust the pH to about 6.3 with 1% (w / v) sodium hydroxide solution or 1M hydrochloric acid solution, and finally add water for injection to make up to 4000ml , intermediate detection. Nitrogen protection, filling an...

Embodiment 3

[0044] Embodiment 3: in the preparation process of embodiment 1 and embodiment 2, we have investigated pH value. And with reference to the drug stability guidelines, the samples prepared in Example 1 and Example 2 were respectively investigated for influencing factors, placed under the conditions of a temperature of 60 ° C and a light of 4500 ± 500 lx, and samples were taken out on the 5th and 10th days respectively Perform a pH test. The results are shown in Table 1.

[0045] Table 1 Changes in pH during the preparation process and influencing factors of self-developed and patented prescriptions

[0046]

[0047] The test results show that the pH values ​​of the self-developed and patented prescriptions are relatively stable after the pH is adjusted during the preparation process and placed under the conditions of high temperature of 60°C and light of 4500±500lx for 5 days and 10 days. This proves that the self-developed prescription can have a relatively stable pH value...

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Abstract

The invention relates to phenylephrine ketorolac solution and a preparation method, and provides intraocular operation washing concentrated solution without a preservative, an antioxidant and a buffer system. The phenylephrine ketorolac solution is capable of preventing the intraoperative miosis and relieving the postoperation pain, and avoiding the side effects caused by the preservative, the antioxidant and the buffer system.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a sterile liquid preparation containing phenylephrine and ketorolac as active ingredients and a preparation method thereof. technical background [0002] Cataract is a common disease in everyday life and the world's leading cause of blinding eye disease, most commonly occurring in people over the age of 50. As China rapidly enters an aging society, there are more and more cataract patients. Cataract or other various lens replacement procedures are performed on the order of 4 million per year in the United States and approximately 20 million per year globally. In China, according to statistics, there are 1.2 million new cataract patients every year. The General Office of the National Health and Family Planning Commission reported that my country reported a total of 1.208 million cases of cataract surgery in 2013, 1.11 million cases in 2012, and a total of 5.588 million...

Claims

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Application Information

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IPC IPC(8): A61K31/407A61K9/08A61P27/04A61P29/00A61K31/137
Inventor 詹慧杨波于艳春向文殿程雅丽郭婷婷
Owner WUHAN WUYAO SCI & TECH
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