JP2011026248A5

JP2011026248A5 -

Info

Publication number: JP2011026248A5
Application number: JP2009174077A
Authority: JP
Filing date: 2009-07-27
Publication date: 2014-01-16
Anticipated expiration: 2029-07-27

Description

ポビドンヨード製剤を製造する際には、１００ｍｇのポビドンヨード、１０ｇの水、所定量の界面活性剤等を夫々秤量して混合すると共に更にｐＨ調整剤を添加し、ポビドンヨードの含有量を７．５ｗ/ｖ％又は１０ｗ/ｖ％以下にしてポビドンヨード溶液を作成し、その後、ポビドンヨード溶液を照射滅菌してポビドンヨード製剤を製造している。 When producing a povidone iodine preparation, 100 mg of povidone iodine, 10 g of water, a predetermined amount of a surfactant and the like are weighed and mixed, and a pH adjuster is further added, so that the povidone iodine content is 7.5 w / A povidone-iodine solution is prepared at a concentration of v% or 10 w / v% or less, and then the povidone-iodine solution is sterilized by irradiation to produce a povidone-iodine preparation.

本発明のポビドンヨード製剤は、ポビドンヨードと水とヨウ化物とを混合し、ポビドンヨードの含有量が７ｗ/ｖ％以上１５ｗ/ｖ％以下であるポビドンヨード溶液を作成し、該ポビドンヨード溶液を１０ｋＧｙ以上５０ｋＧｙ以下の放射線量で照射滅菌して製造されるポビドンヨード製剤であって、
前記ヨウ化物は混合によりポビドンヨード溶液にヨウ化物イオンを生じるものであると共に、前記ヨウ化物の含有量をポビドンヨード１００ｍｇに対して３ｍｇ以上５０ｍｇ以下にするように製造されるものである。 The povidone-iodine preparation of the present invention is prepared by mixing povidone-iodine, water, and iodide to prepare a povidone-iodine solution having a povidone-iodide content of 7 w / v% or more and 15 w / v% or less. The povidone-iodine solution is 10 kGy or more and 50 kGy or less A povidone iodine preparation manufactured by sterilization with radiation dose,
Wherein with iodide is caused iodide ions to povidone-iodine solution by mixing, it is manufactured as below 3mg or 50mg respect povidone iodine 100 m g the content of the iodide.

又、本発明のポビドンヨード製剤においては、ポビドンヨード溶液を３０ｋＧｙ以上４０ｋＧｙ以下の放射線量で照射滅菌し、ヨウ化物を、ヨウ化カリウム又は／及びヨウ化ナトリウムにし、ヨウ化物の含有量をポビドンヨード１００ｍｇに対して５ｍｇ以上７ｍｇ以下にするように製造されることが好ましい。 In addition, in the povidone iodine preparation of the present invention, the povidone iodine solution is sterilized by irradiation with a radiation dose of 30 kGy or more and 40 kGy or less, the iodide is changed to potassium iodide and / or sodium iodide, and the iodide content is set to 100 mg of povidone iodine. On the other hand, it is preferably produced so as to be 5 mg or more and 7 mg or less.

又、本発明のポビドンヨード製剤の製造方法は、ポビドンヨードと水とヨウ化物とを混合し、ポビドンヨードの含有量が７ｗ/ｖ％以上１５ｗ/ｖ％以下であるポビドンヨード溶液を作成し、該ポビドンヨード溶液を１０ｋＧｙ以上５０ｋＧｙ以下の放射線量で照射滅菌するポビドンヨード製剤の製造方法であって、
前記ヨウ化物は混合によりポビドンヨード溶液にヨウ化物イオンを生じるものであると共に、前記ヨウ化物の含有量をポビドンヨード１００ｍｇに対して３ｍｇ以上５０ｍｇ以下にするものである。 Further, the method for producing the povidone iodine preparation of the present invention comprises mixing povidone iodine, water and iodide to prepare a povidone iodine solution having a povidone iodine content of 7 w / v% or more and 15 w / v% or less. A method for producing a povidone iodine preparation that is sterilized by irradiation with a radiation dose of 10 kGy or more and 50 kGy or less,
Wherein with iodide is caused iodide ions to povidone-iodine solution by mixing, it is intended to below 3mg or 50mg respect povidone iodine 100 m g the content of the iodide.

又、本発明のポビドンヨード製剤の製造方法においては、ポビドンヨード溶液を３０ｋＧｙ以上４０ｋＧｙ以下の放射線量で照射滅菌し、ヨウ化物を、ヨウ化カリウム又は／及びヨウ化ナトリウムにし、ヨウ化物の含有量をポビドンヨード１００ｍｇに対して５ｍｇ以上７ｍｇ以下にすることが好ましい。 Further, in the method for producing the povidone iodine formulation of the present invention, the povidone iodine solution is sterilized by irradiation with a radiation dose of 30 kGy or more and 40 kGy or less, the iodide is changed to potassium iodide and / or sodium iodide, and the iodide content is adjusted to povidone iodine. it is preferable to 7mg inclusive 5mg against 100 m g.

本発明のポビドンヨード製剤及びその製造方法によれば、ポビドンヨード溶液を１０ｋＧｙ以上５０ｋＧｙ以下の照射滅菌する場合であっても、ヨウ化物を、ポビドンヨード溶液にヨウ化物イオンを生じるものにすると共に、ヨウ化物の含有量をポビドンヨード１００ｍｇに対して３ｍｇ以上５０ｍｇ以下にするので、照射滅菌に伴うポビドンヨードの有効ヨウ素の減衰を抑制することができる。又、ポビドンヨード溶液を容器内に封入して照射滅菌する場合であっても、ポビドンヨードの有効ヨウ素の減衰を抑制するので、適切な有効ヨウ素の範囲である０．９％〜１．１％間に容易に設定することができるという優れた効果を奏し得る。 According to the povidone-iodine preparation and the method for producing the same according to the present invention, even when the povidone-iodine solution is sterilized by irradiation at 10 kGy or more and 50 kGy or less, iodide is generated in the povidone-iodine solution and iodide ions are generated. since the content is below 3mg or 50mg respect povidone iodine 100 m g, it is possible to suppress the attenuation of the effective iodine povidone-iodine with the radiation sterilization. Moreover, even when the povidone iodine solution is sealed in a container and sterilized by irradiation, attenuation of effective iodine in povidone iodine is suppressed, so that the appropriate effective iodine range is between 0.9% and 1.1%. An excellent effect that it can be easily set can be achieved.

ヨウ化物は、ヨウ化物イオンであって、ヨウ化カリウム、ヨウ化ナトリウム、ヨウ化アンモニウム等から選択されるものであり、好ましくはヨウ化カリウム又は／及びヨウ化ナトリウムを使用し、特に好ましくはヨウ化カリウムを使用している。ここでヨウ化物は、ポビドンヨード１００ｍｇに対して３ｍｇ以上５０ｍｇ以下、好ましくは５ｍｇ以上７ｍｇ以下になるようにしている。 The iodide is an iodide ion selected from potassium iodide, sodium iodide, ammonium iodide and the like. Preferably, potassium iodide and / or sodium iodide is used, and particularly preferably iodine. Potassium halide is used. Here iodide, 3 mg or more 50mg or less with respect to povidone iodine 100 m g, preferably set to be below 7mg than 5 mg.

図１に示す如く、ポビドンヨード製剤を製造する際には、最初に、ポビドンヨード１００ｍｇと、精製水１０ｇと、ヨウ化カリウム３ｍｇ以上５０ｍｇ以下、好ましくは５ｍｇ以上７ｍｇ以下と、所定量の界面活性剤（ラウロマクロゴール）と、所定量の保湿剤（濃グリセリン）とを夫々秤量し、次にポビドンヨード、精製水、ヨウ化カリウム、界面活性剤、保湿剤を３０分から６０分撹拌して混合し、更に所定量のｐＨ調整剤を添加してポビドンヨードの含有量を７ｗ/ｖ％以上１５ｗ/ｖ％以下、好ましくは７．５ｗ/ｖ％又は１
０ｗ/ｖ％にしてポビドンヨード溶液を作成する（図１では１０ｗ/ｖ％のポビドンヨード溶液を示す）。その後、ポビドンヨード溶液を密閉可能な収納手段に封入し、ポビドンヨード溶液を１０ｋＧｙ以上５０ｋＧｙ以下、好ましくは３０ｋＧｙ以上４０ｋＧｙ以下の電子線量（放射線量）で電子線滅菌（照射滅菌）してポビドンヨード製剤を製造する。 As shown in FIG. 1, when producing a povidone iodine preparation, first, 100 mg of povidone iodine, 10 g of purified water, 3 mg to 50 mg of potassium iodide, preferably 5 mg to 7 mg, and a predetermined amount of surfactant. (Lauromacrogol) and a predetermined amount of moisturizing agent (concentrated glycerin) are weighed respectively, then povidone iodine, purified water, potassium iodide, surfactant, moisturizing agent are stirred for 30 to 60 minutes and mixed, Further, a predetermined amount of a pH adjusting agent is added so that the povidone iodine content is 7 w / v% or more and 15 w / v% or less, preferably 7.5 w / v% or 1
A povidone iodine solution is prepared at 0 w / v% (FIG. 1 shows a 10 w / v% povidone iodine solution). Thereafter, the povidone iodine solution is sealed in a sealable storage means, and the povidone iodine solution is subjected to electron beam sterilization (irradiation sterilization) with an electron dose (radiation dose) of 10 kGy to 50 kGy, preferably 30 kGy to 40 kGy to produce a povidone iodine preparation. .

［実施例１］
試験は、ポビドンヨード１００ｍｇに対して夫々ヨウ化カリウム０ｍｇ（Blank）、３
ｍｇ、５ｍｇ、７ｍｇを混合してポビドンヨード溶液を準備し、夫々のポビドンヨード溶液に線量２０ｋＧｙ、３０ＫＧｙ、４０ｋＧｙの電子線を照射して電子線滅菌し、有効ヨウ素の減少率を夫々調べた。ここで有効ヨウ素は医薬品の規制から０．９％から１．１％までの間に設定する必要があり、電子線照射前には有効ヨウ素を１．０８％近傍にしている。 [Example 1]
The test was conducted using 0 mg (Blank) of potassium iodide and 100 mg of povidone iodine.
mg, 5 mg and 7 mg were mixed to prepare povidone-iodine solutions. Each povidone-iodine solution was irradiated with electron beams with doses of 20 kGy, 30 KGy and 40 kGy to sterilize with electron beams, and the reduction rate of effective iodine was examined. Here, effective iodine needs to be set between 0.9% and 1.1% from the regulation of pharmaceuticals, and the effective iodine is set to around 1.08% before electron beam irradiation.

而して、このように実施の形態例によれば、ヨウ化物を、ポビドンヨード溶液にヨウ化物イオンを生じるものにすると共に、ヨウ化物の含有量をポビドンヨード１００ｍｇに対して３ｍｇ以上５０ｍｇ以下にするので、電子線滅菌に伴うポビドンヨードの有効ヨウ素の減衰を抑制することができる。又、ポビドンヨード溶液を容器内に封入して電子線滅菌する場合であっても、ポビドンヨードの有効ヨウ素の減衰を抑制するので、適切な有効ヨウ素の範囲である０．９％〜１．１％間に容易に設定することができる。ここでヨウ化カリウムの含有量を３ｍｇ未満にした場合には濃度減少率が若干高く、電子線の線量３０ｋＧｙから４０ｋＧｙの間で有効ヨウ素の下限値を超えて、消毒の効力が低下するという問題がある。 And Thus, according to the example of such implementation, iodide, as well as those resulting iodide ions to povidone-iodine solution is below 3mg or 50mg respect povidone iodine 100 m g the content of iodide Therefore, attenuation of effective iodine of povidone iodine accompanying electron beam sterilization can be suppressed. Moreover, even when the povidone iodine solution is sealed in a container and sterilized by electron beam, since the attenuation of effective iodine of povidone iodine is suppressed, the appropriate effective iodine range is between 0.9% and 1.1%. Can be set easily. Here, when the content of potassium iodide is less than 3 mg, the concentration reduction rate is slightly high, and the lower limit of effective iodine is exceeded between the doses of electron beams of 30 kGy to 40 kGy, and the disinfection efficacy decreases. There is.

又、実施の形態例において、ポビドンヨード溶液を３０ｋＧｙ以上４０ｋＧｙ以下の電子線量で電子線滅菌し、ヨウ化物を、ヨウ化カリウム又は／及びヨウ化ナトリウムにし、ヨウ化物の含有量をポビドンヨード１００ｍｇに対して５ｍｇ以上７ｍｇ以下にするように製造されると、電子線滅菌に伴うポビドンヨードの有効ヨウ素の減衰を好適に抑制することができる。又、ポビドンヨード溶液を容器内に封入して電子線滅菌する場合であっても、ポビドンヨードの有効ヨウ素の減衰を抑制するので、適切な有効ヨウ素の範囲である０．９％〜１．１％間に一層容易に設定することができる。ここでヨウ化カリウムの含有量を５ｍｇ未満にした場合には濃度減少率が好適に抑制できず、有効ヨウ素が電子線の線量４０ｋＧｙから５０ｋＧｙの間で下限値を超えて消毒の効力が低下する可能性があり、ヨウ化カリウムの含有量を７ｍｇより多くする場合には医薬品の規制により制限を受けるため適切ではない。又、電子線滅菌の線量３０ｋＧｙ未満にした場合には、確実に殺菌できないという問題があり、電子線の線量４０ｋＧｙより大きくした場合には、電子線滅菌に伴うポビドンヨードの有効ヨウ素の減衰が大きくなるという問題がある。 In the embodiment, the povidone-iodine solution is sterilized with an electron beam at an electron dose of 30 kGy or more and 40 kGy or less, the iodide is changed to potassium iodide and / or sodium iodide, and the iodide content is 100 mg of povidone iodine. When it is manufactured so as to be 5 mg or more and 7 mg or less, the attenuation of effective iodine of povidone iodine accompanying electron beam sterilization can be suitably suppressed. Moreover, even when the povidone iodine solution is sealed in a container and sterilized by electron beam, since the attenuation of effective iodine of povidone iodine is suppressed, the appropriate effective iodine range is between 0.9% and 1.1%. Can be set more easily. Here, when the content of potassium iodide is less than 5 mg, the concentration reduction rate cannot be suitably suppressed, and effective iodine exceeds the lower limit between 40 kGy and 50 kGy of the electron beam, and the disinfection efficacy decreases. There is a possibility, and when the content of potassium iodide is more than 7 mg, it is not appropriate because it is restricted by the regulation of pharmaceuticals. In addition, when the dose of electron beam sterilization is less than 30 kGy, there is a problem that the sterilization cannot be surely performed. When the dose is higher than 40 kGy of electron beam, attenuation of effective iodine of povidone iodine accompanying electron beam sterilization increases. There is a problem.

Claims

Povidone iodine, water and iodide are mixed, a povidone iodine solution having a povidone iodine content of 7 w / v% to 15 w / v% is prepared, and the povidone iodine solution is irradiated and sterilized with a radiation dose of 10 kGy to 50 kGy. A povidone iodine formulation produced,
Povidone-iodine formulations wherein the iodide together with those which give iodide ion to povidone-iodine solution by mixing, prepared the content of the iodide to the 3mg or 50mg or less with respect to povidone iodine 100 m g .

Povidone iodine solution irradiated sterilized by 40kGy less radiation dose than 30kGy and iodide, and potassium and / or sodium iodide iodide, the content of iodide as below 7mg than 5mg respect povidone iodine 100 m g The povidone iodine preparation according to claim 1, wherein the preparation is manufactured.

The povidone-iodine preparation according to claim 1 or 2, wherein the povidone-iodine solution is sealed in a storage means and sterilized by irradiation.

A povidone iodine preparation according to claim 1 or 2, wherein a moisturizer is mixed with povidone iodine, water and iodide, and used only for sterilization of the skin.

Povidone iodine, water, and iodide are mixed to prepare a povidone iodine solution having a povidone iodine content of 7 w / v% or more and 15 w / v% or less, and the povidone iodine solution is 10 kG.
A method for producing a povidone iodine preparation which is sterilized by irradiation with a dose of y to 50 kGy,
Wherein with iodide is caused iodide ions to povidone-iodine solution by mixing manufacturing method of povidone-iodine preparation, characterized by a content of the iodide 3mg or 50mg or less with respect to povidone iodine 100 m g.

Povidone iodine solution irradiated sterilized by 40kGy less radiation dose than 30kGy and iodide, and potassium and / or sodium iodide iodide, to the 7mg inclusive 5mg respect povidone iodine 100 m g the content of iodide The method for producing a povidone iodine preparation according to claim 1, characterized in that:

The method for producing a povidone iodine preparation according to claim 5 or 6, wherein the povidone iodine solution is sealed in a storage means and sterilized by irradiation.

Method for producing a povidone-iodine preparation according to claim 5 or 6, characterized by mixing humectant with povidone-iodine and water and iodide.