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Stable Shugeng glucose sodium injection and preparation method thereof

A technology of sugammadex sodium and injection, which is applied in the field of medicine, can solve the problems such as the increase of impurities in sugammadex sodium injection and the color change of the liquid medicine, so as to achieve excellent product quality and stability, reduce the change of color, The effect of reducing the growth of impurities

Pending Publication Date: 2020-01-03
HUNAN WARRANT PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Sugammadex sodium will be oxidatively degraded in an aerobic environment; at the same time, because the chemical structure of sugammadex sodium is a cavity structure, it is very easy to chelate metal ions (such as iron, arsenic, nickel, manganese, etc.), in an aerobic environment, the existence of trace metal ions will catalyze the oxidative degradation of sugammadex sodium injection, resulting in a significant increase in the impurities of sugammadex sodium injection and a significant change in the color of the drug solution

Method used

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  • Stable Shugeng glucose sodium injection and preparation method thereof
  • Stable Shugeng glucose sodium injection and preparation method thereof
  • Stable Shugeng glucose sodium injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0065] prescription

[0066] Sugammadex sodium injection (2ml: 200mg) production process prescription

[0067]

[0068] Preparation Process

[0069] 1. Preparation

[0070] 1) Turn on the vacuum of the batching tank to make the vacuum in the tank reach -0.085Mpa~-0.09Mpa, and fill it with 99.999% clean nitrogen gas to normal pressure;

[0071] 2) Add 80L of prescribed amount of water for injection into the liquid mixing tank, turn on the liquid mixing tank to stir, open the chilled water jacket of the liquid mixing tank, and lower the temperature of the water for injection to about 25°C;

[0072] 3) Bubble 99.999% clean nitrogen into the liquid mixing tank, monitor the dissolved oxygen in the water for injection online, so that the dissolved oxygen in the water for injection does not exceed 0.1ppm;

[0073] 4) When the dissolved oxygen in water for injection reaches below 0.1ppm, stop stirring in the liquid mixing tank, open the feeding port, add the prescribed amount of...

Embodiment 2

[0090] prescription

[0091] Sugammadex sodium injection (5ml: 500mg) production process prescription

[0092]

[0093] Preparation Process

[0094] 1. Preparation

[0095] 1) Turn on the vacuum of the batching tank to make the vacuum in the tank reach -0.085Mpa~-0.09Mpa, and fill it with 99.999% clean nitrogen gas to normal pressure;

[0096] 2) Add 80L of prescribed amount of water for injection into the liquid mixing tank, turn on the liquid mixing tank to stir, open the chilled water jacket of the liquid mixing tank, and lower the temperature of the water for injection to about 25°C;

[0097] 3) Bubble 99.999% clean nitrogen into the liquid mixing tank, monitor the dissolved oxygen in the water for injection online, so that the dissolved oxygen in the water for injection does not exceed 0.1ppm;

[0098] 4) When the dissolved oxygen in water for injection reaches below 0.1ppm, stop stirring in the liquid mixing tank, open the feeding port, add the prescribed amount of...

Embodiment 3

[0115] prescription

[0116] Sugammadex sodium injection (2ml: 200mg) production process prescription

[0117]

[0118] Preparation Process

[0119] 1. Preparation

[0120] 1) Turn on the vacuum of the batching tank to make the vacuum in the tank reach -0.085Mpa~-0.09Mpa, and fill it with 99.999% clean nitrogen gas to normal pressure;

[0121] 2) Add 80L of prescribed amount of water for injection into the liquid mixing tank, turn on the liquid mixing tank to stir, open the chilled water jacket of the liquid mixing tank, and lower the temperature of the water for injection to about 25°C;

[0122] 3) Bubble 99.999% clean nitrogen into the liquid mixing tank, monitor the dissolved oxygen in the water for injection online, so that the dissolved oxygen in the water for injection does not exceed 0.1ppm;

[0123] 4) When the dissolved oxygen in water for injection reaches below 0.1ppm, stop stirring in the liquid mixing tank, open the feeding port, add the prescribed amount of...

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to stable Shugeng glucose sodium injection and a preparation method thereof. The preparation method comprises the following steps that (1) medicine liquid is prepared, specifically, inert gas is blown into a liquid preparation tank, dissolved oxygen of the water for injection is monitored, raw materials of Shugengglucose sodium with prescription quantity are added into the liquid preparation tank and stirred, and the inert gas is continuously blown into the liquid preparation tank; (2) filling and sealing areconducted, specifically, after an intermediate is inspected to be qualified, sterilizing and filtering are conducted, after visible foreign matters are inspected to be qualified, filling is conducted,in the filling process, sterile inert gas is firstly used for purging an ampule bottle, and the ampule bottle is filled with the sterile inert gas; the ampule bottle is filled with the medicine liquid; and the ampule bottle filled with the medicine liquid is filled with the sterile inert gas, and the sealing of the ampule bottle is completed; (3) sterilization and leak detection are conducted; and (4) inspection and warehousing are conducted.

Description

Technical field [0001] The invention belongs to the field of medical technology, and specifically relates to a stable sugammadex sodium injection and a preparation method thereof. Background technique [0002] Neuromuscular blocking drugs (NMBA) are one of the three elements to ensure the smooth implementation of general anesthesia surgery. However, as long as neuromuscular blocking drugs are used, residual neuromuscular blockade may occur after surgery, causing the patient to suffer from severe hypoxia. Upper respiratory tract obstruction may even occur, which is an important factor causing complications and death in patients during the perianesthesia period. Since routine neuromuscular conduction monitoring is not carried out clinically, the occurrence of residual neuromuscular blockade after surgery is often difficult to identify. In order to prevent residual neuromuscular blockade after surgery, anesthesiologists generally adopt the following two methods: 1) Extend the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/724A61K47/02A61K47/12A61P21/02
CPCA61K9/0019A61K9/08A61K31/724A61K47/02A61K47/12A61P21/02
Inventor 张锐郑丽娟吴卫良
Owner HUNAN WARRANT PHARMA
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