JPH0681816B2 - Indicator composition for wet heat sterilization - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION In medical institutions such as hospitals, all instruments and articles used for surgical treatment such as surgery are sterilized and used. Heat sterilization or ethylene oxide sterilization is performed as a sterilization method in hospitals, and there are wet heat sterilization and dry heat sterilization for heat sterilization, but most of them are wet heat sterilization by steam. As a standard for sterilization treatment in the Japanese Pharmacopoeia, wet heat sterilization (steam) 121 ° -20 minutes dry heat sterilization 180 ° -1 hour or more is indicated, and wet heat sterilization kills bacteria efficiently at a relatively low temperature. You can Sterilization is carried out in a sterilizer, but chemical indicators and biomarkers are used to check whether or not sufficient moist heat or heat necessary for sterilization has been applied to every corner of the sterilizer placed in the sterilizer. A logical indicator is used. The chemical indicator based on Japanese Examined Patent Publication No. 52-2324 is important as an indicator that shows the degree of sterilization correctly in a wet heat state, but it has a weak point that it discolors relatively easily even when it is dry heat, and it can be damaged by a sterilizer failure. When the wet heat state cannot be obtained and the dry heat state is obtained, there is a risk of making a mistake in the judgment, and improvement of this point has been strongly demanded. As a result of further research, we found that the softening point of the resin used was low, and by using a maleic acid resin and / or a styrene-maleic acid resin with a softening point of 130 ° C or higher. The problem was solved and the present invention was completed.

As shown in the examples, a chemical indicator obtained by applying a color-changing ink using a maleic acid resin having a softening point of 140 ° to paper has a wet heat of 121 ° -20 minutes and a dry heat of 180 ° -1.
It changes to the color that has been sterilized according to time, and sterilizes with heat and humidity.
It can be used as an indicator for both dry heat sterilization. If styrene-maleic acid resin with a softening point of 180 ° is used, it will change color in 121 ° -20 minutes under wet heat, but 180 ° C under dry heat.
A product which does not show sufficient discoloration even at -1 hour is obtained.
However, if an appropriate amount of a resin having a low softening point of 130 ° C. or less is added to this composition, it is possible to freely control only the discoloring condition at the time of dry heat, while hardly affecting the discoloration at the time of wet heat. In JP-A-58-52374, a similar composition is exemplified as a rubber vulcanization marking ink composition.
The inventors have obtained new knowledge about the relationship between the softening point of resin and discoloration, and have reached the present invention.

A methine dye or a cyanine dye which is discolored by heat in the present invention is used as a coloring component, and a maleic acid resin having a softening point of 180 ° C. or higher and / or a styrene-maleic acid resin and an organic solvent miscible with these components. It is a composition consisting of

Further, other dyes or pigments can be appropriately added for fine adjustment of color development. As the resin component, other oil-soluble resin cellulose resin can be added in addition to the above-mentioned two kinds of resins in order to adjust the discoloration temperature and the viscosity.

Illustrating the components used in the present invention in more detail, various known methine dyes and polymethine dyes having a methine group can be used as the methine dye, and various known methine dyes can be used. I can. Specifically, for example, the following can be exemplified.
That is, color index basics (CIBasi
c Red) 12,13,14,15,27,35,36,37,45,48,49,52,53,66 and 68, Color Index Basic Yellow (C.
I.Basic Yellow) 11,12,13,14,21,22,23,24,28,29,33,3
5,40,43,44,45,48,49,51,52 and 53, Color index basic violet (CIBasic Violet) 7,1
5,16,20,21,39 and 40, Color Index Basic Blue 62 and 63, Color Index Basic Orange 27,4
2, 44, 46 and the like can be exemplified. Among these methine-based or cyanine-based dyes, particularly desirable ones are color index / basic kraft 12, 13, 14, 1
5 and 37, Color Index Basic Yellow 11
And 13, color index / basic violet 15 and the like.

As the resin, a maleic acid resin having a softening point of 180 ° C. or higher and / or styrene-maleic acid can be used. The higher the acid value, the greater the effect of fixing the dye, and the greater the effect of preventing the dye from seeping out with water after printing. In wet heat sterilization, steam constantly cools and water constantly exists, so that the dye does not flow out into water is an important factor as an indicator. Examples of the resin satisfying the above conditions include maleic acid resin, Tesquid MRM-53 manufactured by Tokushima Oil Co., Ltd., and styrene-maleic acid resin such as Suprapearl AP manufactured by BASF.

Cellulosic resins can be added for the purpose of adjusting the viscosity of other inks. In addition to the above maleic acid resin and / or styrene-maleic acid resin, the softening point is 13
Addition of an appropriate amount of oil-soluble resin at 0 ° C or less has no significant effect on the discoloration speed due to wet heat, and it becomes possible to accelerate the discoloration speed due to dry heat. Others are shown in Comparative Table 1 of Example 1 and Comparative Example 4.

As the solvent, the above-mentioned three components are used as compatible single solvents or as mixed solvents. Alcohols such as ethanol, butanol, cyclohexanol, ethylene glycol alkyl ethers such as ethylene glycol monoethyl ether, ethylene glycol monoacetate. Etc., ethylene glycol alkyl esters, methyl ethyl ketone, methyl isobutyl ketone, isophorone, cyclohexanone, etc. ketones, benzene, toluene, xylene, etc. aromatic hydrocarbons, N-hexane, etc., aliphatic hydrocarbons, cyclohexane, etc. Aromatic hydrocarbons, esters such as ethyl acetate and propyl propionate, and other solvents used for inks can all be used. As the dyes and pigments for finely adjusting the color development, any oil-soluble dyes used in oil-based inks and pigments having good dispersion stability in the inks can be used.

The amounts of these components used are 0.01 to 10 parts, preferably 0.5 to 5 parts, of methine dye or cyanine dye per 100 parts by weight of ink composition (hereinafter abbreviated as "part").
Parts, the maleic acid resin and / or the styrene-maleic acid resin component is 3 to 60%, preferably 10 to 45%, the solvent component is 30 to 90 parts, preferably 40 to 70 parts, and other dyes to be added supplementarily. Supplementally added. Other resin components can be added as needed.

To prepare the ink of this invention, a solvent is added to a dye and a resin, and a dye or a resin which is added if necessary, and the temperature is 50 ° C to 80 ° C.
It can be prepared by stirring for 1 to 3 hours.

Conclusion Table 1 will be explained.

Each of Example 1 and Comparative Examples 1 to 4 is adjusted so as to change its color so that the sterilized state can be detected when it is wet and hot. However, discoloration during dry heat is greatly affected by the softening point of the resin,
The higher the softening point of the resin, the less likely it is to discolor. Further, it can be seen from the comparison between Example 1 and Comparative Example 3 that the speed of discoloration during dry heating can be freely changed by changing the ratio of the resin having a high softening point and the resin having a low softening point. Next, the present invention will be further clarified by describing examples.

Example 1 CI BASIC SECRETED 37 2.4 parts (Hodogaya Chemical Co., Ltd., Eisencatilone Brilliant Scarlett RH) Suprapearl AP30 15.0 parts (BASF, styrene-maleic acid resin) ethylene glycol monoethyl ether 82.6 parts The above 3 components at 70 ° The solution was stirred for 2 hours to dissolve and obtain a red ink.

The respective color-change inks were obtained in the same manner as in Example 1 below.

Comparative Example 1 CI Basked Crete 37 2.4 parts Marquid 33 30.0 parts (Arakawa Chemical Co., Ltd., maleic acid resin) Ethylene glycol monoethyl ether 67.6 parts Comparative Example 2 CI Basked Creeds 14 1.0 parts (Hodogaya Chemical Co., Ltd., Aizen Katyrone Brilliant Toledo) 4GH) Suprapearl AP160 15.0 parts (BASF, styrene-maleic acid resin) Etocello 10 10.0 parts (Dow, Chemical Co., ethyl cellulose resin) Ethylene glycol monopropyl ether 73.75 parts Oil blue # 8 0.05 parts (Chuo Synthetic Chemical, Blue dye) Ceresello GRN 0.2 part (Bayer Co., yellow pigment) Comparative Example 3 CI Basic Violet 7 1.5 parts (Hodogaya Chemical Co., Ltd. Aizen Catillon Red 6BH) Supra Pearl Green 8730 2.5 parts (BASF, processed) Pigment) Suprapearl AP30 10.0 parts (BASF, styrene-maleic acid resin) Manoru 100S 3.0 parts by (manufactured by Arakawa Chemical phenolic resin) ethanol 83.0 parts of the above embodiment and the same manufacturing method, the resin component was prepared in Comparative Example 1 containing only a low softening point resin.

Comparative Example 4 CI Basked Plate 37 2.4 parts Tamanol 100S 30.0 parts Ethylene glycol monoethyl ether 67.6 parts

 ─────────────────────────────────────────────────── ─── Continuation of the front page (56) References JP-A-58-52374 (JP, A) JP-B-52-2324 (JP, B2)

Claims (1)

[Claims] 1. A sterilization indicator composition comprising a methine dye and / or a cyanine dye, a maleic acid resin and / or a styrene-maleic acid resin and an organic solvent, wherein the maleic acid resin and / or the styrene-maleic acid resin is used. An indicator composition for wet heat sterilization, which has a softening point of 180 ° C. or higher.