Ropivacaine hydrochloride injection and preparation method thereof

A technology for ropivacaine hydrochloride and injections, which is applied in the fields of pharmaceutical formulations, drug delivery, and active ingredients of heterocyclic compounds, and can solve problems such as high sodium chloride content and affecting the quality of injections

Inactive Publication Date: 2016-10-05
上海禾丰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The current preparation process of ropivacaine hydrochloride injection cannot meet the requirements of the above-mentioned "Notice", and the sodium chloride content in the current injection formula is too high, which affects the quality of the injection

Method used

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  • Ropivacaine hydrochloride injection and preparation method thereof
  • Ropivacaine hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A kind of ropivacaine hydrochloride injection, every 100kg contains,

[0031]

Embodiment 2

[0033] The preparation method of above-mentioned ropivacaine hydrochloride injection comprises the following steps:

[0034] (1) Add 90% of the total volume of water for injection below 30°C in the preparation container, and pass CO 2 , to make it saturated;

[0035] (2) Sodium chloride is dissolved in an appropriate amount of water for injection below 30°C, and the appropriate amount accounts for about 5% of the total preparation amount;

[0036] (3) Dissolve edetate disodium with boiled water for injection;

[0037] (4) Dissolve the sodium chloride solution obtained in step (2), the edetate disodium solution obtained in step (3) and epinephrine in the water for injection obtained in the above step (1), and stir to dissolve;

[0038] (5) Measure the pH value of the solution obtained in step (4), adjust the pH value of the solution to 3.6-4.0 with 1mol / L hydrochloric acid, add water for injection until the total amount is stirred;

[0039] (6) filter the solution obtained i...

Embodiment 3

[0042] The preparation method of above-mentioned ropivacaine hydrochloride injection comprises the following steps:

[0043] (1) Add 90% of the total volume of water for injection below 30°C in the preparation container, and pass CO 2 , to make it saturated;

[0044] (2) Sodium chloride is dissolved in an appropriate amount of water for injection below 30°C, and the appropriate amount accounts for about 5% of the total preparation amount;

[0045] (3) Dissolve edetate disodium with boiled water for injection;

[0046] (4) Dissolve the sodium chloride solution obtained in step (2), the edetate disodium solution obtained in step (3) and epinephrine in the water for injection obtained in the above step (1), and stir to dissolve;

[0047] (5) Measure the pH value of the solution obtained in step (4), adjust the pH value of the solution to 3.6-4.0 with 1mol / L hydrochloric acid, add water for injection until the total amount is stirred;

[0048] (6) filter the solution obtained i...

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Abstract

The invention provides a ropivacaine hydrochloride injection and a preparation method thereof. A formula of the ropivacaine hydrochloride injection contains 75 g of ropivacaine hydrochloride, 60 g of sodium chloride and the balance water for injection in 10000 ml injection. The quality of the ropivacaine hydrochloride injection meets the stipulations of 'Notification' issued by State Food and Drug Administration in 2008.

Description

technical field [0001] The invention relates to a production method of ropivacaine hydrochloride injection. Background technique [0002] In 2008, the Evaluation Center of the State Food and Drug Administration issued the State Food and Drug Administration [2008] No. 7 document - "Notice on Issuing the Basic Technical Requirements for Chemical Drug Injections and Multi-component Biochemical Drug Injections" (hereinafter referred to as "Notice"), which stipulates that small-volume injections should adopt a terminal sterilization process, and it is recommended that the overkill method be preferred (F 0 ≥12), if the product cannot tolerate overkill conditions, the survival probability method (8≤F 0 <12), but it should be ensured that the SAL (sterility assurance level) of the product after sterilization is not greater than 10 -6 . Use other F 0 Processes with terminal sterilization conditions whose value is less than 8 are not approved in principle. If there is sufficie...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/445
Inventor 蒋宇丹
Owner 上海禾丰制药有限公司
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