JP5543737B2 - Povidone iodine preparation and production method thereof - Google Patents
Povidone iodine preparation and production method thereof Download PDFInfo
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- JP5543737B2 JP5543737B2 JP2009174077A JP2009174077A JP5543737B2 JP 5543737 B2 JP5543737 B2 JP 5543737B2 JP 2009174077 A JP2009174077 A JP 2009174077A JP 2009174077 A JP2009174077 A JP 2009174077A JP 5543737 B2 JP5543737 B2 JP 5543737B2
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- CPKVUHPKYQGHMW-UHFFFAOYSA-N 1-ethenylpyrrolidin-2-one;molecular iodine Chemical compound II.C=CN1CCCC1=O CPKVUHPKYQGHMW-UHFFFAOYSA-N 0.000 title claims description 129
- 229920000153 Povidone-iodine Polymers 0.000 title claims description 129
- 229960001621 povidone-iodine Drugs 0.000 title claims description 129
- 238000002360 preparation method Methods 0.000 title claims description 35
- 238000004519 manufacturing process Methods 0.000 title claims description 19
- NLKNQRATVPKPDG-UHFFFAOYSA-M potassium iodide Inorganic materials [K+].[I-] NLKNQRATVPKPDG-UHFFFAOYSA-M 0.000 claims description 53
- 238000004659 sterilization and disinfection Methods 0.000 claims description 34
- XMBWDFGMSWQBCA-UHFFFAOYSA-N hydrogen iodide Chemical compound I XMBWDFGMSWQBCA-UHFFFAOYSA-N 0.000 claims description 29
- 230000001954 sterilising effect Effects 0.000 claims description 27
- 238000003860 storage Methods 0.000 claims description 22
- FVAUCKIRQBBSSJ-UHFFFAOYSA-M sodium iodide Chemical compound [Na+].[I-] FVAUCKIRQBBSSJ-UHFFFAOYSA-M 0.000 claims description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 16
- 230000005855 radiation Effects 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 12
- 238000009472 formulation Methods 0.000 claims description 11
- -1 iodide ions Chemical class 0.000 claims description 7
- 235000009518 sodium iodide Nutrition 0.000 claims description 6
- 239000004909 Moisturizer Substances 0.000 claims description 4
- 239000003795 chemical substances by application Substances 0.000 claims description 4
- 230000001333 moisturizer Effects 0.000 claims description 4
- 230000003020 moisturizing effect Effects 0.000 claims description 3
- XMBWDFGMSWQBCA-UHFFFAOYSA-M iodide Chemical compound [I-] XMBWDFGMSWQBCA-UHFFFAOYSA-M 0.000 claims description 2
- 229940006461 iodide ion Drugs 0.000 claims description 2
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims 1
- ZHZNPWNAZPVNJH-UHFFFAOYSA-M [Na+].I.[I-] Chemical compound [Na+].I.[I-] ZHZNPWNAZPVNJH-UHFFFAOYSA-M 0.000 claims 1
- 230000001678 irradiating effect Effects 0.000 claims 1
- 239000000243 solution Substances 0.000 description 32
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 description 31
- 239000011630 iodine Substances 0.000 description 31
- 229910052740 iodine Inorganic materials 0.000 description 31
- 238000010894 electron beam technology Methods 0.000 description 25
- 229920000742 Cotton Polymers 0.000 description 10
- 239000004094 surface-active agent Substances 0.000 description 7
- 230000007423 decrease Effects 0.000 description 5
- 239000003002 pH adjusting agent Substances 0.000 description 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 4
- 239000003906 humectant Substances 0.000 description 4
- 239000008213 purified water Substances 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000004806 packaging method and process Methods 0.000 description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 3
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 229920002884 Laureth 4 Polymers 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- 230000033228 biological regulation Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 235000011187 glycerol Nutrition 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 description 1
- 229940058015 1,3-butylene glycol Drugs 0.000 description 1
- XZXYQEHISUMZAT-UHFFFAOYSA-N 2-[(2-hydroxy-5-methylphenyl)methyl]-4-methylphenol Chemical compound CC1=CC=C(O)C(CC=2C(=CC=C(C)C=2)O)=C1 XZXYQEHISUMZAT-UHFFFAOYSA-N 0.000 description 1
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 1
- 235000011054 acetic acid Nutrition 0.000 description 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 229940107816 ammonium iodide Drugs 0.000 description 1
- 235000010323 ascorbic acid Nutrition 0.000 description 1
- 239000011668 ascorbic acid Substances 0.000 description 1
- 229960005070 ascorbic acid Drugs 0.000 description 1
- 230000002238 attenuated effect Effects 0.000 description 1
- 235000019437 butane-1,3-diol Nutrition 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- 239000004359 castor oil Substances 0.000 description 1
- 235000019438 castor oil Nutrition 0.000 description 1
- 235000015165 citric acid Nutrition 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 239000000645 desinfectant Substances 0.000 description 1
- SZXQTJUDPRGNJN-UHFFFAOYSA-N dipropylene glycol Chemical group OCCCOCCCO SZXQTJUDPRGNJN-UHFFFAOYSA-N 0.000 description 1
- 239000001530 fumaric acid Substances 0.000 description 1
- 235000011087 fumaric acid Nutrition 0.000 description 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 1
- 229940093915 gynecological organic acid Drugs 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- PNDPGZBMCMUPRI-UHFFFAOYSA-N iodine Chemical compound II PNDPGZBMCMUPRI-UHFFFAOYSA-N 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 239000001630 malic acid Substances 0.000 description 1
- 235000011090 malic acid Nutrition 0.000 description 1
- 150000007524 organic acids Chemical group 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 229920002503 polyoxyethylene-polyoxypropylene Polymers 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
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Description
本発明は、消毒薬等に用いるポビドンヨード製剤及びその製造方法に関するものである。 The present invention relates to a povidone iodine preparation used for disinfectants and the like and a method for producing the same.
一般にポビドンヨード製剤は、ポビドンヨードを７．５ｗ/ｖ％又は１０ｗ/ｖ％を含有する液として使用されており、皮膚の局所用殺菌や、うがい等の口腔用殺菌に利用されている。 In general, a povidone iodine preparation is used as a liquid containing 7.5 w / v% or 10 w / v% of povidone iodine, and is used for topical sterilization of the skin and oral sterilization such as gargle.
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.
なお、本発明に関連する先行技術文献情報としては、例えば、下記の特許文献１等が既に存在している。
In addition, as prior art document information relevant to this invention, the following
しかしながら、ポビドンヨード溶液を照射滅菌する際には、照射のエネルギーにより下式の反応が進み、
（ＰＶＰ）Ｉ→Ｉ−＋Ｉ２＋Ｉ− ３
ポビドンヨードの有効ヨウ素に減衰を生じ、消毒の効力が落ちてしまうという問題があった。
However, when the povidone iodine solution is sterilized by irradiation, the following reaction proceeds by the energy of irradiation,
(PVP) I → I - + I 2 + I - 3
There was a problem that the effective iodine of povidone iodine was attenuated and the effectiveness of disinfection was reduced.
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際には、適切な有効ヨウ素の範囲である０．９％〜１．１％間に設定することが困難であるという問題があった。 Further, when the povidone iodine solution is sealed in a container and sterilized by irradiation, there is a problem that it is difficult to set between 0.9% and 1.1% which is an appropriate effective iodine range.
本発明は、斯かる実情に鑑み、照射滅菌によるポビドンヨードの有効ヨウ素の減衰を抑制すると共に、容器に封入されたポビドンヨード溶液を適切な有効ヨウ素の範囲に容易に設定し得るポビドンヨード製剤及びその製造方法を提供しようとするものである。 In view of such circumstances, the present invention suppresses the attenuation of effective iodine of povidone iodine due to irradiation sterilization, and allows a povidone iodine solution enclosed in a container to be easily set within an appropriate effective iodine range, and a method for producing the same Is to provide.
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５ｍｇ以上７ｍｇ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,
The iodide produces iodide ions in the povidone iodine solution by mixing, and is produced so that the iodide content is 5 mg or more and 7 mg or less with respect to 100 mg of povidone iodine.
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するように製造されることが好ましい。 Further, in the povidone-iodine formulations of the present invention, and radiation sterilization of povidone-iodine solution at 40kGy following radiation doses above 30 kGy, iodide, is preferably manufactured to be so that the potassium iodide and / or sodium iodide.
更に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が収納手段に封入されて照射滅菌されることが好ましい。 Furthermore, in the povidone iodine preparation of the present invention, it is preferable that the povidone iodine solution is sealed in a storage means and sterilized by irradiation.
又、本発明のポビドンヨード製剤においては、ポビドンヨードと水とヨウ化物と共に保湿剤を混合し、皮膚の殺菌にのみ用いることが好ましい。 In addition, in the povidone iodine preparation of the present invention, it is preferable that a moisturizer is mixed with povidone iodine, water and iodide and used only for sterilization of the skin.
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５ｍｇ以上７ｍｇ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,
The iodide generates iodide ions in the povidone-iodine solution by mixing, and the iodide content is 5 mg or more and 7 mg or less with respect to 100 mg of povidone iodine.
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することが好ましい。 Further, in the manufacturing method of povidone-iodine formulations of the present invention, and radiation sterilization of povidone-iodine solution at 40kGy following radiation doses above 30 kGy, iodide, to Rukoto preferably potassium iodide and / or sodium iodide.
更に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収納手段に封入して照射滅菌することが好ましい。 Furthermore, in the method for producing a povidone-iodine preparation of the present invention, it is preferable that the povidone-iodine solution is sealed in a storage means and sterilized by irradiation.
又、本発明のポビドンヨード製剤の製造方法においては、ポビドンヨードと水とヨウ化物と共に保湿剤を混合することが好ましい。 Moreover, in the manufacturing method of the povidone iodine formulation of this invention, it is preferable to mix a moisturizer with povidone iodine, water, and iodide.
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.
以下、本発明の実施の形態例を図１〜図３を参照して説明する。 Embodiments of the present invention will be described below with reference to FIGS.
実施の形態例である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共に界面活性剤、保湿剤を混合し、更にｐＨ調整剤を添加し、ポビドンヨードの含有量が７ｗ/ｖ％以上１５ｗ/ｖ％以下、好ましくは７．５ｗ/ｖ％又は１０ｗ/ｖ％になるように構成されており、その後１０ｋＧｙ以上５０ｋＧｙ以下、好ましくは３０ｋＧｙ以上４０ｋＧｙ以下の放射線量で照射滅菌されている。 The povidone iodine formulation which is an embodiment is a mixture of povidone iodine, water and iodide, a surfactant and a humectant, and further added with a pH adjuster, and the povidone iodine content is 7 w / v% or more and 15 w / v% or less. , Preferably 7.5 w / v% or 10 w / v%, and then sterilized by irradiation with a radiation dose of 10 kGy to 50 kGy, preferably 30 kGy to 40 kGy.
ポビドンヨードは、ポリビニルピロリドン（ＰＶＰ）とヨウ素の複合体のものを使用しており、水は精製水を使用している。 Povidone iodine uses a composite of polyvinylpyrrolidone (PVP) and iodine, and water uses purified water.
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.
界面活性剤は、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンポリオキシプロピレングリコール、ポリソルベート、ラウロマクロゴール等から選択されるものを使用していると共に、保湿剤は、ジプロピレングリコール、プロピレングリコール、１，３−ブチレングリコール、濃グリセリン等から選択されるものを使用している。ここで界面活性剤及び保湿剤は、本発明の効果を阻害しないならば、どのようなものを使用しても良い。 The surfactant is selected from polyoxyethylene hydrogenated castor oil, polyoxyethylene polyoxypropylene glycol, polysorbate, lauromacrogol, and the humectant is dipropylene glycol, propylene glycol, 1 , 3-butylene glycol, concentrated glycerin or the like is used. Here, any surfactant and humectant may be used as long as they do not impair the effects of the present invention.
ｐＨ調整剤は、クエン酸、酒石酸、乳酸、リンゴ酸、酢酸、コハク酸、フマル酸、アスコルビン酸等の有機酸や、塩酸、リン酸等の無機塩から選択されている。又ｐＨ調整剤は、界面活性剤及び保湿剤と同様に、本発明の効果を阻害しないならば、どのようなものを使用しても良い。 The pH adjuster is selected from organic acids such as citric acid, tartaric acid, lactic acid, malic acid, acetic acid, succinic acid, fumaric acid and ascorbic acid, and inorganic salts such as hydrochloric acid and phosphoric acid. Any pH adjusting agent may be used as long as it does not inhibit the effects of the present invention, like the surfactant and the humectant.
一方、ポビドンヨード製剤は、容器や包装体等の収納手段に封入されており、一例を示すと、ポビドンヨード製剤は図２に示す如く綿棒包装体１０に収納されている。
On the other hand, the povidone iodine preparation is enclosed in a storage means such as a container or a package. For example, the povidone iodine preparation is stored in a
綿棒包装体１０は、シール部（収納手段）１１と、カバー部１２とで構成されており、カバー部１２には、綿棒１の形状に沿うよう凹状の綿棒収納部１３を形成して綿棒１が配置されていると共に、綿棒１の綿部１ａの配置場所から所定幅の分離帯１４を介して凹状の収納部（収納手段）１５を形成してポビドンヨード製剤１６が溜められている。又、このような綿棒包装体１０の綿棒１を使用する場合には、綿棒収納部１３の押えマーク１９を押えて軸部１ｂと綿棒収納部１３の隙間１８を塞ぎ、液剤収納部１５を押圧することにより分離帯１４を連通して綿棒１の綿部１ａにポビドンヨード製剤１６を含浸させる。次に、シール部端１７を把持してシール部１１をカバー部１２より所定長さで引き剥がし、シール部１１とカバー部１２の間から綿棒１を取り出して使用するようになっている。ここでポビドンヨード製剤の収納手段は、ポビドンヨード製剤のみを入れる密閉可能な容器でも良いし、他の構造や形状の収納体でも良い。
The
以下、実施の形態例であるポビドンヨード製剤の製造方法を説明する。 Hereinafter, the manufacturing method of the povidone iodine formulation which is an embodiment is demonstrated.
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. .
又、ポビドンヨード製剤を図２の綿棒包装体１０に適用する場合には、図１に示すポビドンヨード、精製水、ヨウ化カリウム等を混合してポビドンヨード溶液を製造する工程と別工程で、カバー部１２を加熱成型した後、綿棒収納部１３に綿棒１を挿入して準備し、ポビドンヨード溶液をフィルタ等で濾過して収納部（収納手段）１５に充填し、シール部１１とカバー部１２を熱接着して綿棒１とポビドンヨード溶液を封緘（内封）する。そして包装した後にポビドンヨード溶液を綿棒包装体１０ごと電子線滅菌し、ポビドンヨード製剤を製造する。
When the povidone iodine preparation is applied to the
以下、電子線照射による有効ヨウ素の減少率の試験を試み、その結果を示す。 Hereafter, the test of the reduction rate of the effective iodine by electron beam irradiation is tried, and the result is shown.
［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.
結果は、図３に示す如く電子線の線量の増加に伴って有効ヨウ素の減少を生じる一方で、ヨウ化カリウムの含有量の増加に伴って有効ヨウ素の減少を抑制している。図３では濃度減少率が１６％〜１８％よりも上昇すると、有効ヨウ素の下限値０．９を超えている。 The results show that effective iodine decreases with increasing electron beam dose as shown in FIG. 3, while effective iodine decreases with increasing potassium iodide content. In FIG. 3, when the concentration reduction rate rises from 16% to 18%, the lower limit value 0.9 of effective iodine is exceeded.
このことからヨウ化カリウム０ｍｇの場合には濃度減少率が高く、電子線の線量３０ｋＧｙ近傍の時点で有効ヨウ素の下限値を超えて消毒の効力が落ちることを示している。又、ヨウ化カリウム３ｍｇの場合には濃度減少率が若干抑制でき、電子線の線量３５ｋＧｙ近傍まで有効ヨウ素の下限値を超えることがなく、消毒の効力を適度に維持することを示している。更にヨウ化カリウム５ｍｇ、７ｍｇの場合には濃度減少率が大幅に抑制でき、電子線滅菌の線量５０ｋＧｙ近傍まで有効ヨウ素の下限値を超えることがなく、又、電子線滅菌の線量４０ｋＧｙまでは有効ヨウ素の下限値を確実に超えることがなく、消毒の効力を十分に維持することが明らかとなった。 This indicates that the concentration reduction rate is high in the case of potassium iodide of 0 mg, and the disinfection efficacy falls below the lower limit of effective iodine at the time point near the electron beam dose of 30 kGy. Moreover, in the case of 3 mg of potassium iodide, the concentration reduction rate can be slightly suppressed, and the lower limit of effective iodine is not exceeded up to the vicinity of the electron beam dose of 35 kGy, indicating that the disinfection efficacy is maintained moderately. Furthermore, in the case of 5 mg and 7 mg of potassium iodide, the rate of decrease in concentration can be greatly suppressed, the lower limit of effective iodine is not exceeded up to around 50 kGy of electron beam sterilization, and it is effective up to 40 kGy of electron beam sterilization. It became clear that the lower limit of iodine was not exceeded and the disinfection efficacy was sufficiently maintained.
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.
更に実施の形態例において、ポビドンヨード溶液が綿棒包装体１０等の収納手段に封入されて照射滅菌されると、ポビドンヨード製剤の利用範囲が広がると共に、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適切に抑制することができる。
Further, in the embodiment, when the povidone iodine solution is sealed in a storage means such as a
更に実施の形態例において、ポビドンヨードと水とヨウ化物と共に保湿剤を混合し、皮膚の殺菌にのみ用いると、皮膚の殺菌に好適に利用できると共に、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。ここでポビドンヨード製剤は、皮膚の殺菌であって、手指の殺菌、ケガの消毒、注射針やカテーテル等の穿刺部の消毒等に用いるものならば特に制限されるものではない。 Further, in the embodiment, when moisturizer is mixed with povidone iodine, water and iodide and used only for skin sterilization, it can be suitably used for skin sterilization, and effective iodine attenuation of povidone iodine accompanying electron beam sterilization can be reduced. Can be suppressed. The povidone iodine preparation is not particularly limited as long as it is used for sterilization of the skin and used for sterilization of fingers, disinfection of injuries, disinfection of puncture portions such as injection needles and catheters.
尚、本発明のポビドンヨード製剤及びその製造方法は、上述の図示例にのみ限定されるものではなく、ポビドンヨード製剤は綿棒包装体以外に使用しても良いこと、照射滅菌は、電子線滅菌に限定されるものでなく、他の放射線を用いても良いこと、ポビドンヨード製剤の製造方法は更に受入試験等の処理を追加しても良いこと、その他、本発明の要旨を逸脱しない範囲内において種々変更を加え得ることは勿論である。 In addition, the povidone iodine preparation of the present invention and the production method thereof are not limited to the above illustrated examples. The povidone iodine preparation may be used other than the swab package, and the irradiation sterilization is limited to electron beam sterilization. However, other radiation may be used, and the method for producing povidone iodine preparation may be further subjected to processing such as an acceptance test, and various changes within the scope of the present invention are not deviated. Of course, can be added.
１１ シール部（収納手段）
１５ 液剤収納部（収納手段）
１６ ポビドンヨード製剤
11 Sealing part (storage means)
15 Liquid storage part (storage means)
16 Povidone iodine preparation
Claims (8)
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５ｍｇ以上７ｍｇ以下にするように製造されたことを特徴とするポビドンヨード製剤。 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,
The iodide is produced so that iodide ion is generated in the povidone iodine solution by mixing, and the iodide content is 5 mg or more and 7 mg or less with respect to 100 mg of povidone iodine. Formulation.
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５ｍｇ以上７ｍｇ以下にすることを特徴とするポビドンヨード製剤の製造方法。 Povidone iodine is prepared by mixing povidone iodine, water and iodide, producing a povidone iodine solution having a povidone iodine content of 7 w / v% or more and 15 w / v% or less, and irradiating and sterilizing the povidone iodine solution with a radiation dose of 10 kGy or more and 50 kGy or less. A method for producing a formulation comprising:
A method for producing a povidone-iodine preparation, characterized in that the iodide generates iodide ions in a povidone-iodine solution by mixing, and the iodide content is 5 mg or more and 7 mg or less with respect to 100 mg of povidone iodine.
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