Ropivacaine hydrochloride sodium chloride injection and preparation process thereof

A technology for the preparation of ropivacaine hydrochloride, sodium chloride, and injection, which is applied in liquid treatment, liquid bottling, bottle filling and other directions, can solve problems such as poor stability, and achieves quality assurance, mature preparation technology, and clear efficacy. Effect

Pending Publication Date: 2022-07-29
江苏长江药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to design a kind of ropivacaine hydrochloride sodium chloride that can effectively solve the above-mentioned technical problems for existing ropivacaine hydrochloride sodium chloride injection, which has poor stability and problems in the filling process. Injection and preparation process and device

Method used

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  • Ropivacaine hydrochloride sodium chloride injection and preparation process thereof
  • Ropivacaine hydrochloride sodium chloride injection and preparation process thereof
  • Ropivacaine hydrochloride sodium chloride injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1 discloses a ropivacaine hydrochloride and sodium chloride injection. The injection includes the following components: 0.40g of ropivacaine hydrochloride, 1.72g of sodium chloride, and water for injection are mixed in every 200ml of the injection. to 200ml. In addition, the injection also includes appropriate amounts of dilute hydrochloric acid and sodium hydroxide, and the pH value of the injection is controlled at 4.0-6.0 by the added dilute hydrochloric acid and sodium hydroxide.

[0052] Wherein, the preparation technology of this Ropivacaine Hydrochloride Sodium Chloride Injection comprises the following steps:

[0053] S1: Weigh an appropriate amount of ropivacaine hydrochloride and sodium chloride according to the above ratio for use.

[0054] S2: Add 80% water for injection to the liquid preparation tank, and control the temperature to be 65 ° C. After starting the stirring, first put in ropivacaine hydrochloride, stir until dissolved, then put in s...

Embodiment 2

[0058] Embodiment 2 discloses a ropivacaine hydrochloride and sodium chloride injection, which includes the following components: 0.40 g of ropivacaine hydrochloride, 1.72 g of sodium chloride, and 0.40 g of ropivacaine hydrochloride, 1.72 g of sodium chloride, and water for injection in every 200 ml of the injection. to 200ml. In addition, the injection also includes appropriate amounts of dilute hydrochloric acid and sodium hydroxide, and the pH value of the injection is controlled at 4.0-6.0 by the added dilute hydrochloric acid and sodium hydroxide.

[0059] Wherein, the preparation technology of this Ropivacaine Hydrochloride Sodium Chloride Injection comprises the following steps:

[0060] S1: Weigh an appropriate amount of ropivacaine hydrochloride and sodium chloride according to the above ratio for use.

[0061] S2: Add 80% water for injection to the liquid preparation tank, and control the temperature to be 60°C. After turning on the stirring, first put in ropivacai...

Embodiment 3

[0065] Embodiment 3 discloses a ropivacaine hydrochloride and sodium chloride injection. The injection includes the following components: 0.40g of ropivacaine hydrochloride, 1.72g of sodium chloride, and 0.40g of ropivacaine hydrochloride, 1.72g of sodium chloride, and water for injection in every 200ml of the injection. to 200ml. In addition, the injection also includes appropriate amounts of dilute hydrochloric acid and sodium hydroxide, and the pH value of the injection is controlled at 4.0-6.0 by the added dilute hydrochloric acid and sodium hydroxide.

[0066] Wherein, the preparation technology of this Ropivacaine Hydrochloride Sodium Chloride Injection comprises the following steps:

[0067] S1: Weigh an appropriate amount of ropivacaine hydrochloride and sodium chloride according to the above ratio for use.

[0068] S2: Add 80% water for injection to the dosing tank, and control the temperature to be 70°C. After turning on the stirring, first add ropivacaine hydrochlo...

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Abstract

The invention belongs to the technical field of injection production, and particularly relates to a ropivacaine hydrochloride sodium chloride injection and a preparation process. The ropivacaine hydrochloride injection comprises 0.40 g of ropivacaine hydrochloride and 1.72 g of sodium chloride in every 200 ml of the ropivacaine hydrochloride injection, and injection water is added to 200 ml of the ropivacaine hydrochloride injection. In addition, the preparation device comprises a machine body assembly, an injection storage box, a sterile filling mechanism, a cover pressing mechanism and a control box, the sterile filling mechanism comprises a conveying pump, the conveying pump is connected with a liquid conveying main pipe, and the lower end of the liquid conveying main pipe is connected with a plurality of liquid conveying branch pipes at intervals; the ropivacaine hydrochloride sodium chloride injection provided by the invention is clear in drug effect and high in safety, determination results of various indexes in a stability test all meet regulations, and the preparation device ensures the product quality of the prepared injection, so that the drug effect of the injection is clear, and the safety is high.

Description

technical field [0001] The invention belongs to the technical field of injection production, in particular to a ropivacaine hydrochloride sodium chloride injection and a preparation process. Background technique [0002] Ropivacaine is the first synthetic pure isomer of new long-acting amide local anesthetics. Its pharmacological properties are low cardiotoxicity, more obvious separation of sensory block and motor block, and vasoconstriction. Ropivacaine has dual effects of anesthesia and analgesia. High concentrations can produce surgical anesthesia, while lower concentrations can effectively block sensory nerve transmission and produce analgesic effects. It has less effect on motor nerves. Therefore, ropivacaine It is a safe and effective local anesthetic in clinical application and has high application value. The current existing ropivacaine hydrochloride injection has the problem of poor stability due to insufficient preparation technology. [0003] In addition, the ex...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/445A61K47/02A61J3/00B67C7/00B67B3/10B67C3/22B67C3/26A61P23/02A61P29/00
CPCA61K31/445A61K9/08A61K9/0019A61K47/02A61P23/02A61P29/00A61J3/00B67C7/0073B67C3/26B67C3/222B67B3/10B67C2007/0066B67C2007/006
Inventor 刘正华陶谦唐明瑶陶春梅
Owner 江苏长江药业有限公司
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