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Production process for manufacturing solid-phase povidone iodine

A production process, povidone iodine technology, applied in the production process field of solid phase povidone iodine, can solve the problems of povidone iodine quality hidden danger, inevitable iodine vapor loss, acceleration, etc.

Active Publication Date: 2011-08-10
BOAI NKY PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0045] First, crude iodine contains volatiles of other components, which will cause unpredictable quality hazards to povidone-iodine finished products
The second is that the complexation reactor requires a waste conduit to export the inert gas poured into the reactor as waste gas to the waste tank, and in the waste tank, sodium thiosulfate solution is used to absorb iodine vapor, so it is inevitable that some Loss of iodine vapor, and disposal burden of saturated sodium thiosulfate waste
[0046] This patent also cannot guarantee that high-quality povidone-iodine reaches available iodine content > 10.6%, and the solution stability is according to the available iodine loss rate (stability detection) < 6% under the accelerated test method

Method used

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  • Production process for manufacturing solid-phase povidone iodine
  • Production process for manufacturing solid-phase povidone iodine
  • Production process for manufacturing solid-phase povidone iodine

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0090] Embodiment one: the steps of embodiment one of the present invention are as follows:

[0091] 1. Weigh 200 kg of povidone K30 powder (produced by Boai Xinkai Kaiyuan Pharmaceutical Co., Ltd., brand: KoVidone K30) that meets the requirements of the United States Pharmacopoeia USP32 version and add it to the double-cone rotary reactor with jacket. According to the analysis, its water content is 3.26%.

[0092] 2. Weigh 7.48kg of pure water and add it to a closed jacketed evaporator, heat it to vaporize it and then pass it into the rotary reactor, so that the moisture content of povidone K30 after fully absorbing the moisture reaches 7%.

[0093] 3, take by weighing 36.7kg of refined iodine (I: PVP-I=15.5% addition), add in the iodine kettle, turn on the iodine kettle rotary switch, adjust the governor to 4 rpm, and stir for 2 hours.

[0094] 4. Open the steam inlet and outlet valve of the equipment jacket and start to heat up. The first stage: the temperature rises to 52...

Embodiment 2

[0099] Embodiment two: the steps of embodiment two of the present invention are as follows:

[0100] 1. Weigh 200 kg of povidone K30 powder (produced by Boai Xinkai Kaiyuan Pharmaceutical Co., Ltd., brand: KoVidone K30) that meets the requirements of the United States Pharmacopoeia USP32 version and add it to the double-cone rotary reactor with jacket. According to the analysis, its water content is 3.57%.

[0101] 2. Weigh 7.86kg of pure water and add it to a closed jacketed evaporator, heat it to vaporize it and then pass it into the rotary reactor, so that the moisture content of povidone K30 after fully absorbing the moisture reaches 7.5%.

[0102] 3, take by weighing 37.3kg of refined iodine (I: PVP-I=15% addition), add in the iodine kettle, turn on the iodine kettle rotary switch, adjust the governor to 4 rpm, and stir for 2.5 hours.

[0103] 4. Open the steam inlet and outlet valves of the equipment jacket and start to heat up. The first stage: the temperature rises to...

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Abstract

The invention discloses a production process for manufacturing solid-phase povidone iodine. The production process is characterized in that: the raw materials used in the preparation process comprise 80 to 84.5 percent by weight of povidone K30 and 20 to 15 percent by weight of iodine; before the povidone iodine is subjected to a complex reaction, actual water content of the povidone raw materialis detected first and then the water content of the povidone K30 is increased to between 4 and 8 percent by a method for accurately measuring and adding pure water into the povidone raw material and evaporating the pure water to make the pure water adsorbed by the povidone; and the temperature range of the complex reaction is between 50 and 95 DEG C and the time of the complex reaction is between25 and 36 hours. The technical scheme of the invention can guarantee that the effective iodine content of the excellent povidone iodine reaches over 10.6 percent and the stability of solution of the excellent povidone iodine is less than 6 percent according to the effective iodine loss rate (stability test) in an accelerated test method.

Description

technical field [0001] The invention relates to a production process for making solid-phase povidone-iodine, especially one that can achieve an available iodine content > 10.6%, and the solution stability is based on the available iodine loss rate (stability detection) < 6% under the accelerated test method povidone-iodine production process. Background technique [0002] Povidone iodine (also known as polyvinylpyrrolidone iodine, polyvinylpyrrolidone iodine, PVP-I) is composed of PVP and I 2 A complex formed by a complexation reaction. PVP-I has certain physical and chemical stability, and there is a certain chemical balance relationship between free iodine under certain conditions, so it can greatly reduce the I 2 Therefore, it can become a broad-spectrum, high-efficiency, and low-toxic agent in the solution state. The bactericidal efficacy and bactericidal spectrum of povidone-iodine are equivalent to that of iodine, and it has a strong killing effect on bacteria...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08F26/10C08F8/22A61K31/79A61P31/00
Inventor 王坚强阎重朝
Owner BOAI NKY PHARMA LTD