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Preparation method of sugammadex sodium injection

A technology of sugammadex sodium injection, which is applied in the field of preparation of sugammadex sodium injection, to achieve the effects of increasing safety, reducing catalysis, and inhibiting the production of impurities

Pending Publication Date: 2021-06-11
HEFEI BOSIKC PHARMTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] At present, only one published patent CN110638751A describes the preparation method of sugammadex sodium injection. The method removes oxygen by replacing oxygen with inert gas, controls the oxygen content in the preparation process, and slows down the growth of sugammadex sodium oxidized impurities. , the above measures cannot completely solve the above problems

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  • Preparation method of sugammadex sodium injection
  • Preparation method of sugammadex sodium injection
  • Preparation method of sugammadex sodium injection

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Experimental program
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Effect test

Embodiment 1

[0043] Embodiment 1: the preparation of sugammadex sodium injection

[0044] Sugammadex Sodium Injection is commercially available in specifications of 200mg: 2ml and 500mg: 5ml. The injections of the two specifications are only different in filling volume and packaging material size. All the examples in the present invention are based on the specification of 200mg: 2ml The preparation process of the prescription is described as an example.

[0045] 1. Prescription

[0046]

[0047] 2. Process steps

[0048] (1) Add 80% of the prescribed amount of water for injection into the liquid mixing tank, fill with 99.999% of clean nitrogen, stir, and monitor the dissolved oxygen of the water for injection on-line;

[0049] (2) When the dissolved oxygen in water for injection reaches below 0.5mg / L, stop stirring and nitrogen filling, add the prescribed amount of sugammadex sodium raw material into the liquid mixing tank, start stirring, and nitrogen filling, and wait until the raw ...

Embodiment 2

[0055] Embodiment 2: Preparation of Sugammadex Sodium Injection

[0056] 1, carry out experimental operation according to embodiment 1 prescription

[0057] 2. Process steps

[0058] (1) Add 80% of the prescribed amount of water for injection into the liquid mixing tank, fill with 99.999% of clean nitrogen, stir, and monitor the dissolved oxygen of the water for injection on-line;

[0059] (2) When the dissolved oxygen in water for injection reaches below 0.5mg / L, stop stirring and nitrogen filling, add the prescribed amount of sugammadex sodium raw material into the liquid mixing tank, start stirring, and nitrogen filling, and wait until the raw material drug is completely dissolved , add inositol hexaphosphate 100g, fill with nitrogen and stir;

[0060] (3) Coarsely filter the liquid medicine, then pass through the GE8040F30 reverse osmosis membrane under nitrogen pressure, add water for injection to 95% of the total amount, and use hydrochloric acid or sodium hydroxide so...

Embodiment 3

[0066] Embodiment 3: Preparation of Sugammadex Sodium Injection

[0067] 1, carry out experimental operation according to embodiment 1 prescription

[0068] 2. Process steps

[0069] (1) Add 80% of the prescribed amount of water for injection into the liquid mixing tank, fill with 99.999% of clean nitrogen, stir, and monitor the dissolved oxygen of the water for injection on-line;

[0070] (2) When the dissolved oxygen in water for injection reaches below 0.5mg / L, stop stirring and nitrogen filling, add the prescribed amount of sugammadex sodium raw material into the liquid mixing tank, start stirring, and nitrogen filling, and wait until the raw material drug is completely dissolved , add 500 g of inositol hexaphosphate, fill with nitrogen and stir;

[0071] (3) Coarsely filter the liquid medicine, then pass through the GE8040F30 reverse osmosis membrane under nitrogen pressure, add water for injection to 95% of the total amount, and use hydrochloric acid or sodium hydroxid...

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Abstract

The invention discloses a preparation method of a sugammadex sodium injection, which comprises the following steps: preparing the sugammadex sodium injection under the protection of inert gas, adding a protective agent in the preparation process, coarsely filtering a liquid medicine, and removing the residual protective agent through a reverse osmosis membrane, wherein the protective agent is selected from phosphoinositide and derivatives thereof. The sugammadex sodium injection has good economical efficiency and is more suitable for industrial production, and the prepared sugammadex sodium injection is better in quality, safer and more stable.

Description

technical field [0001] The invention relates to a pharmaceutical preparation technology, in particular to a preparation method of sugammadex sodium injection. Background technique [0002] About 20 million patients receive general anesthesia every year in China. During the whole process of preoperative anesthesia, intraoperative sleep, and postoperative recovery, patients usually need three types of drugs, such as sedatives, analgesics, and muscle relaxants, to work together to reverse the patient's functional state in due course. [0003] Muscle relaxants represented by rocuronium bromide are commonly used as adjuvant drugs for anesthesia in surgical operations. They are used for tracheal intubation during routine induction of anesthesia and for maintaining skeletal muscle relaxation during surgery. However, after the operation, it is necessary to quickly reverse the patient's muscle relaxation state to restore spontaneous breathing and muscle function, so as to avoid comp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/724A61K47/24A61P21/02
CPCA61K9/08A61K9/0019A61K31/724A61K47/24A61P21/02
Inventor 郭辉盛荣
Owner HEFEI BOSIKC PHARMTECH CO LTD
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