JPS6219869B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention relates to chlorhexidine antiseptic compositions containing sodium chloride. Chlorhexidine (mainly chlorhexidine digluconate) has a bactericidal effect, and sterilizing cotton and wipe cotton (or clean cotton) made by soaking cotton with this dilute aqueous solution are commercially available. These disinfectant cottons and cleaning cottons are widely used for first aid for minor injuries, for disinfecting nipples during breastfeeding, and for other convenient cleaning and disinfection purposes. Although chlorhexidine is an excellent bactericidal agent, it has a serious drawback in that it is adsorbed by cellulose compositions such as cotton, so that the above-mentioned sterilized cotton and wiping cotton cannot exhibit sufficient bactericidal effects. Therefore, it has been a challenge to develop a method for preventing the adsorption of chlorhexidine to cotton. Various techniques have been developed to solve this problem. For example, a method for preventing adsorption by adding divalent or higher metal salts (Special Publication No. 52-3195), a method for preventing adsorption by adding higher alcohol sulfate salts (Special Publication No. 3195),
52-37044) and a method for preventing adsorption by adding a nonionic surfactant (Japanese Patent Publication No. 53-20568). However, none of these adsorption prevention methods are completely satisfactory. For example, in the method of adding divalent or higher metal salts, calcium chloride, which has a good adsorption prevention effect, has a strong local irritating effect, and magnesium chloride has a very strong bitter taste, so it cannot be used for cleaning nipples. has. The higher alcohol sulfate ester addition method has a problem in that the bactericidal activity of chlorhexidine is reduced. Another disadvantage is that higher alcohol sulfates themselves have undesirable effects on the skin (penetration, irritation). The disadvantage of the nonionic surfactant addition method is that it requires high concentrations and that this additive reduces the bactericidal power of chlorhexidine. Furthermore, even though these adsorption prevention technologies have been reported, commercially available sterilized cotton and cleaning cotton still have a considerable amount of chlorhexidine adsorbed to the cotton, and the present invention reveals that their bactericidal effect can hardly be expected. We found out the results of their research. In view of the above facts, the present inventors conducted repeated research to develop an adsorption inhibitor that actually prevents adsorption, does not reduce the bactericidal effect, and is harmless to the human body.As a result, we found a surprising result. It has been found that all of these problems can be solved by adding sodium chloride, which is the physiologically safest substance. The present invention therefore provides a disinfectant composition containing chlorhexidine, characterized in that it contains an amount of sodium chloride sufficient to prevent the adsorption of the chlorhexidine to cellulose compositions (e.g. cotton). TECHNICAL FIELD The present invention relates to disinfectant compositions. The present invention further provides a method for producing a germicidal composition comprising impregnating a cellulose composition with a solution containing chlorhexidine, the method comprising impregnating a cellulose composition with a solution containing chlorhexidine in an amount sufficient to prevent adsorption of the chlorhexidine to the cellulose composition. The present invention relates to a method for producing a chlorhexidine antiseptic composition, characterized in that sodium chloride is added to the solution. In the present invention, the chlorhexidine sterilizing composition refers not only to a sterilizing and disinfecting aqueous solution containing chlorhexidine as an active ingredient (hereinafter referred to as a liquid sterilizing composition), but also to a cellulose composition obtained by impregnating the same into a cellulose composition. say. To prepare the disinfectant composition according to the present invention, chlorhexidine, sodium chloride, and optionally other ingredients are dissolved in purified water in a conventional manner, and the resulting liquid composition is optionally soaked in a cellulose composition. All you have to do is have it included. The content of chlorhexidine in the liquid composition according to the present invention is usually 0.01 to 0.10% by weight, and the content of sodium chloride is usually 0.05 to 0.5% by weight, although it depends on the concentration of chlorhexidine. If a larger amount of sodium chloride is used, a precipitate may be formed due to the interaction between chlorhexidine and sodium chloride, which will actually reduce the effective amount of chlorhexidine. As expected, this phenomenon becomes more pronounced as the concentration of chlorhexidine increases. Other ingredients that may be included in the sterilizing composition of the present invention include medicinal ingredients normally contained in sterilizing disinfectants, such as local anesthetics, capillary constrictors, and granulation agents, such as allantoin, dibucaine hydrochloride, and napazoline hydrochloride. Examples include. The contents of these other components have no particular significance for the composition according to the present invention. Typical examples of the cellulose composition, which is one of the constituent components of the composition according to the present invention, include cotton, nonwoven fabric, and gauze. Practically speaking, the liquid sterilizing composition of the present invention is soaked in cotton that has been processed and formed into a certain shape (mainly square shape), and the liquid composition is soaked in a cotton swab as shown in Fig. 3. The present invention also includes those in which the liquid composition is impregnated into gauze, dried, and attached to a bandage to make an emergency bandage. These finished cellulosic compositions are conveniently stored in sealed polyethylene bags for each single use. However, the sterilizing composition according to the present invention is not limited in any way by these usage types. Test 1 The concentration of chlorhexidine remaining in the liquid obtained by compressing commercially available sterilized swabs and wipes was measured by a colorimetric method. The results are shown in Table 1.

[Table] As is clear from Table 1, the concentration of chlorhexidine remaining in the liquid is significantly lower than the indicated value. Test 2 A bactericidal activity test was conducted on commercially available products B and C used in Test 1, the product of the present invention obtained in Example 1 described below, and a control product (0.02% by weight chlorhexidine digluconate solution). Bacillus subtilis, Staphylococcus aureus, and Escherichia coli were used as test bacterial strains, and the test was carried out by a strip culture method. The results are shown in Table 2. In the table, the length of the inhibition zone is the length of the inhibition zone after 0.005 ml of the liquid obtained by compressing the commercially available product and the product of the present invention, and the control product, respectively, were placed in the perforation and incubated at 30°C for 48 hours. means.

[Table] Table 2 shows that the bactericidal activity of the commercially available product is significantly lower than that of the product of the present invention and the control product. moreover,
Since the bactericidal effects of the inventive product and the control product are almost the same, sodium chloride prevents the adsorption of chlorhexidine digluconate to cotton;
It can also be seen that sodium chloride has no effect on reducing the bactericidal activity of chlorhexidine digluconate. Test 3 The adsorption phenomenon of chlorhexidine digluconate on cotton was investigated over time. Pharmacopoeia 1g cotton
Fill a glass container with 10ml of 0.02%, 0.05%, and 0.1% chlorhexidine digluconate solutions, seal tightly and store at 30°C, and after a certain period of time, compress cotton into the solution obtained. The concentration of remaining chlorhexidine digluconate was measured by a colorimetric method. The results are shown in Figure 1. As is clear from the figure, the concentration of chlorhexidine digluconate decreases very quickly, and this tendency is more pronounced as the initial concentration is lower. Many commercially available products have a labeled concentration of 0.02%, but it can be seen that at this concentration, most of the chlorhexidine digluconate is adsorbed to cotton in just one day. In addition, when chlorhexidine digluconate was stored under the same conditions without being soaked into the cotton, the concentration did not decrease at all. Test 4 Sodium chloride was added at various concentrations to 0.02, 0.05 and 0.1% by weight chlorhexidine digluconate solutions, and the effect of preventing the adsorption of chlorhexidine digluconate on cotton was investigated. The test method was the same as Test 3, and the concentration was measured on the 7th day after storage. The results are shown in Table 3 and Figure 2.

【table】

[Table] *Precipitate formation As is clear from Table 3 and FIG. 2, it can be seen that the adsorption of chlorhexidine digluconate to cotton is significantly suppressed by the addition of sodium chloride. For example, when the concentration of chlorhexidine digluconate is 0.02% by weight, adding 0.5% by weight of sodium chloride increases the residual rate by about 8 times compared to the case without addition. In addition, the concentration of chlorhexidine digluconate is
In the case of 0.05% by weight or more, if 0.5% by weight of sodium chloride is added, the residual rate will actually decrease. This is due to the precipitation of chlorhexidine digluconate. Therefore, when preparing the disinfectant composition of the present invention with a relatively high concentration, the concentration of sodium chloride should be adjusted.
It is desirable that the content be 0.3% by weight or less. Examples of the sterilizing composition according to the present invention are given below. Example 1 Purified water is added to 0.02 g of chlorhexidine digluconate and 0.5 g of sodium chloride to make 100 ml. 1 g of pharmacopoeial cotton is soaked with 10 ml of this solution, sealed in a polyethylene bag, and used as a wiping cotton. Example 2 Purified water is added to 0.05 g of chlorhexidine digluconate and 0.2 g of sodium chloride to make 100 ml. 1 g of pharmacopoeial cotton is soaked with 10 ml of this solution and sealed in a polyethylene bag to make sterilized cotton. Example 3 Purified water is added to 0.05 g of chlorhexidine digluconate, 0.2 g of sodium chloride, 0.2 g of allantoin, 0.1 g of dibucaine hydrochloride and 0.1 g of napazoline hydrochloride to make 100 ml. A cotton swab made from 0.1 g of pharmacopoeial cotton is soaked with 1 ml of this solution and sealed in a polyethylene bag to make a swab for sterilization. Example 4 Purified water is added to 0.02 g of chlorhexidine digluconate and 0.5 g of sodium chloride to make 100 ml. 1 g of nonwoven fabric is impregnated with 10 ml of this solution, sealed in a polyethylene bag, and used as a towel. Example 5 Purified water was added to 0.05 g of chlorhexidine digluconate, 0.2 g of sodium chloride, and 0.2 g of allantoin to make 100 ml. Gauze is soaked in this solution and then dried, and the dried gauze is attached to a bandage to form an emergency bandage. Example 6 Purified water was added to 0.05 g of chlorhexidine digluconate, 0.2 g of sodium chloride, 0.2 g of allantoin, 0.1 g of dibucaine hydrochloride, and 0.1 g of napazoline hydrochloride to make 100 ml. This solution is a sterilizing disinfectant solution that is used by impregnating the cellulose composition before use.

[Brief explanation of the drawing]

Figure 1 is a graph showing the residual rate of chlorhexidine digluconate over time in a chlorhexidine solution soaked into cotton, and Figure 2 is the relationship between the concentration of sodium chloride and the amount of chlorhexidine digluconate adsorbed on cotton. FIG. 3 is a perspective view of a cotton swab which is one embodiment of the sterilizing composition of the present invention. 1... Chlorhexidine digluconate concentration 0.1% by weight, 2... 0.05% by weight, 3... Same
0.02% by weight, 4...cotton impregnated with liquid sterilizing composition, 5...stick.

Claims (1)

[Scope of Claims] 1. A germicidal composition comprising a cellulose composition impregnated with a dilute aqueous solution of chlorhexidine, the composition comprising sodium chloride in an amount sufficient to prevent adsorption of the chlorhexidine to the cellulose composition. A chlorhexidine antiseptic composition further comprising chlorhexidine. 2. The composition according to item 1, wherein the concentration of chlorhexidine is 0.01 to 0.1% by weight based on the liquid component in the composition. 3. The composition according to claim 1 or 2, wherein the concentration of sodium chloride is 0.05 to 0.5% by weight based on the liquid component in the composition. 4 Items 1 to 3 further containing one or more medicinal ingredients selected from the group consisting of allatoin, dibucaine hydrochloride, and naphazoline hydrochloride.
The composition according to any of paragraphs. 5. A method for producing a germicidal composition comprising impregnating a cellulose composition with a solution containing chlorhexidine, the method comprising: impregnating a cellulose composition with an amount of sodium chloride sufficient to prevent adsorption of the chlorhexidine to the cellulose composition; A method for producing a chlorhexidine antiseptic composition, which comprises adding the chlorhexidine antiseptic composition to the solution.