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Pharmaceutical preparation of povidone iodine and preparation method thereof

A technology of povidone-iodine and pharmaceutical preparations, which is applied in the directions of botanical equipment and methods, pharmaceutical combinations, pharmaceutical formulations, etc., can solve the problems of inability to maintain the drug concentration for a long time, poor stability of the solution, easy volatility and the like, and avoid hypertonicity. Dehydration, suitable osmotic pressure, highly volatile effect

Active Publication Date: 2009-09-09
NAVY MEDICINE RES INST OF PLA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Povidone-iodine solution is currently the most commonly used external dosage form, and has a wide range of applications in actual clinical use. However, in the external application of PVP-I solution, available iodine is easy to degrade, and there is often instability, and then the curative effect Decrease, so that the effective period of povidone-iodine solution is significantly shortened
Point out in Chinese patent such as patent No. 99114144. X " mixed type povidone iodine disinfectant and preparation method thereof ": " present povidone iodine disinfectant mostly is unilateral, promptly after directly adding water with solid povidone iodine Direct use, because the iodine in it is relatively active and volatile, so the quality of this disinfectant is unstable, the shelf life is short, and the curative effect is reduced.”
In the patent No. 03117635.6 "Highly Water-Soluble Povidone-iodine Film", it is pointed out: "The solution has poor stability, is easy to lose, and cannot maintain effective drug concentration for a long time"
Therefore, although povidone-iodine has the characteristics of broad spectrum, low toxicity, high efficiency and safety, its application range is limited due to the inconvenience of using the current povidone-iodine solution and its poor stability.
Especially when stockpiling war medicinal materials, the instability of solutions is severely limited

Method used

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  • Pharmaceutical preparation of povidone iodine and preparation method thereof
  • Pharmaceutical preparation of povidone iodine and preparation method thereof
  • Pharmaceutical preparation of povidone iodine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～2

[0034] The molecular weight of the polyethylene glycol of embodiment 1 is 4000, and the molecular weight of the polyethylene glycol of embodiment 2 is 6000

[0035] Weigh povidone iodine, grind povidone iodine and citric acid, stir and mix, then grind, stir and mix with sodium bicarbonate, finally add polyethylene glycol, mix, sieve, and tablet . Each component in the tablet is shown in Table 1 below, and the consumption is weight (parts).

[0036] Table 1

[0037]

[0038]

[0039] Weigh 271 parts by weight of phosphoric acid, 236 parts by weight of acetic acid, 247 parts by weight of boric acid, 280 parts by weight of sodium hydroxide, and 90-120 parts of methylparaben and mix them, then add 99000 parts by weight of deionized water, and adjust the pH with sodium hydroxide The value was 5.8 ± 0.2, obtaining a liquid phase buffer.

[0040] Put the tablets obtained in Examples 1-2 together with the liquid-phase buffer solution in a kit and pack them in isolation. When ...

Embodiment 3

[0043] Weigh 271 parts by weight of phosphoric acid, 236 parts by weight of acetic acid, 247 parts by weight of boric acid, 280 parts by weight of sodium hydroxide, and 100 parts of methylparaben and mix them, then add 99000 parts by weight of deionized water, and adjust the pH value with sodium hydroxide. 5.8 ± 0.2, to obtain the liquid phase buffer.

[0044] Put the tablets obtained in Examples 1-2 together with the liquid-phase buffer solution in a kit and pack them in isolation. When in use, take out the solid tablets and put them in the buffer solution. After they are completely dissolved, they can be used directly.

[0045] The weight ratio of the tablet to the liquid phase buffer is: solid tablet part: liquid phase buffer part = 1:40.

Embodiment 4

[0047] Stability test:

[0048] Carry out stability test respectively to prepared povidone-iodine tablet, test method:

[0049] Place the tablet in a sealed commercially available package, put it in a constant temperature oven at a temperature of 40±2°C, conduct an accelerated test, and take samples for measurement at 0, 1, 2, 3, and 6 months. The test items include: Appearance, identification, inspection (difference in disintegration time and tablet weight), content determination. This tablet is investigated 6 months by the constant temperature accelerated test method, and the results are as follows:

[0050] Table 2 Accelerated test report form

[0051] Sample name: Povidone-iodine tablets Lot number: 060619

[0052]

[0053]

[0054] Table 3 Accelerated test report form

[0055] Sample name: Povidone-iodine tablets Lot number: 060620

[0056]

[0057] Table 4 Accelerated test report form

[0058] Sample name: Povidone-iodine tablets Lot ...

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Abstract

The invention provides a povidone-iodine pharmaceutical preparation and a preparation method thereof, the preparation is a preparation in which a solid tablet part and a liquid phase buffer part are separated, and is composed of a solid tablet part and a liquid phase buffer part; said The components and parts by weight of the solid tablet are: 200-1200 parts of povidone-iodine, 100-900 parts of citric acid, 80-850 parts of sodium bicarbonate, 50-350 parts of polyethylene glycol; 220-310 parts of phosphoric acid 190-280 parts of acetic acid, 200-290 parts of boric acid, 240-320 parts of sodium hydroxide, 90-120 parts of methyl paraben, 95,000-110,000 parts of water, and the pH value is 5.6-6.0; the solid tablet part and The weight ratio of the liquid-phase buffer part is: solid tablet part: liquid-phase buffer part=1:30-50. The povidone-iodine pharmaceutical preparation provided by the invention has increased drug stability, quick use, convenient carrying, suitable osmotic pressure and good bactericidal effect.

Description

technical field [0001] The invention relates to a povidone-iodine pharmaceutical preparation. Background technique [0002] Povidone-iodine (PVP-I) is a complex formed by iodine element and polyvinylpyrrolidone (PVP) in the form of complexation by means of hydrogen bonds and other attractive forces. [0003] Povidone-iodine is a broad-spectrum, high-efficiency, low-toxicity, and safe disinfectant. It has a good killing effect on bacteria, fungi, viruses, protozoa, etc. PVP-I is one of the earliest developed iodophors. It has many excellent characteristics, strong user acceptance, and retains the good sterilization of iodine. Performance, widely used in hospital disinfection at home and abroad. [0004] At present, this drug variety has been included in the 2005 edition of the Chinese Pharmacopoeia, and it is an excellent skin disinfectant. PVP-I was included in the 2005 edition of "Chinese Pharmacopoeia" as a raw material, and also included solutions, ointments, supposito...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/80A61K47/34A61K9/20A01N59/12A61P31/00A61P17/00A01P1/00A61K47/32
Inventor 刘玉明巴剑波殷明徐雄利林永丽陈双红孙锦程武文斌郝蕙玲
Owner NAVY MEDICINE RES INST OF PLA
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