JP2661783B2 - Pharmaceutical composition for hand rubbing - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION (Industrial application field) The present invention relates to a quick-drying rub containing iodine having a broad spectrum, which enables a medical worker such as a medical institution to easily and securely disinfect a finger anywhere. Type hand sanitizer.

(Problems to be solved by the prior art and the invention) Usually, hand disinfection using a disinfectant disinfectant includes a basin method using a wash basin and a towel, a scrub method using water and a towel for rubbing by hand and then removing the disinfectant. Both brushing and brushing instead of rubbing with a hand used towels or hot air for drying. Although these are relatively simple, there is a risk of contamination of the disinfectant itself, the effect of simply soaking hands in a diluted disinfectant, and the risk of cross-infection and hospital-acquired infection depending on the disease due to the shared use of towels. Frequent liquid exchange and the use of paper towels are desired, but there are also economic problems.

Since ancient times, wiping with alcohol cotton has been common. However, the method of dipping in alcohol cannot actually be sterilized in a short time.

Therefore, a low concentration of a germicidal disinfectant is added to ethanol for disinfection, and about 3 ml of the solution is taken in the palm of the hand, and heat is generated by friction by strong rubbing. A quick-drying disinfection method has been devised that penetrates and kills bacteria almost completely, while at the same time evaporating the drug solution and drying the fingers.

This disinfecting method always uses up a new disinfecting solution one time, thereby contaminating the sterilizing solution itself, which is one of the problems of the conventional basin method, and reducing the possibility of cross-infection by not using towels. It has attracted attention as a simple, convenient, and easy-to-use method for disinfecting hands anytime, anywhere.

However, the drugs that can be used in this method are colorless and have no sticky feeling on the fingers.

They are germicidal disinfectants such as benzalkonium chloride, benzethonium chloride, chlorhexidine gluconate, and alkyldiaminoethylglycine hydrochloride, and are sold as commercial products or practically used as hospital preparations. However, these germicidal disinfectants are ineffective against some bacteria, fungi, tuberculosis bacteria, viruses, and the like, and the skin irritancy of the germicidal disinfectant itself causes problems such as rough hands due to long-term continuous use.

An iodine preparation represented by povidone-iodine has a sticky feeling and a residual color when rubbed into a finger, and was considered unsuitable for a quick-drying rub-in type hand sanitizer. Further, when povidone-iodine is dissolved in relatively low-concentration alcohols, it is difficult to maintain the stability for practical use as a drug for two years, and there is also a problem of formulation.

(Means for Solving the Problems) The present inventors have conducted intensive studies on how to use an iodine preparation having a strong bactericidal activity as a quick-drying hand-rubbing agent. As a result, a pharmaceutical composition containing a) an iodine preparation containing 0.01 to 0.2% as effective iodine, b) 50 to 80% by weight of a disinfecting alcohol, and c) 0.01 to 1% by weight of a hand anti-corrosion agent is suitable for the purpose. I found something to do. The iodine preparation and the anti-rough agent are insoluble in water or alcohols and may be merely dispersed, but are preferably water-soluble,
And it is desirable that it be soluble in alcohol.

Examples of the iodine preparation include iodine (I ₂ ), potassium iodide (KI), potassium iodate (KIO), potassium periodate (KIO ₃ ), povidone iodine (PVP-I), poloxamer iodine, etc., alone or as a mixture. Used as

As the disinfecting alcohol, 70% ethanol, 50% isopropanol and the like or denatured alcohols thereof are used alone or as a mixture.

Glycerin, urea, cholesterol, allantoin, coconut oil fatty acid polyoxyethylene glyceryl, diisobutyl adipate, and hyaluronic acid are used alone or as a mixture as anti-hand roughness agents.

As an iodine formulation, povidone-iodine is particularly suitable for the present invention. It is known that the bactericidal activity of povidone-iodine is deeply related to I ₂ (free iodine), but the concentration of I ₂ when this product is dissolved in ethanol for disinfection is 1% as povidone-iodine.
(Effective iodine 0.1%) concentration is the highest, so it is considered that a concentration in the vicinity of this is preferable from the viewpoint of bactericidal activity.

However, when judging comprehensively the rough hands, the feeling of stickiness, the feeling of residual color, the stability of the preparation and the bactericidal activity, it was found that povidone-iodine 0.1 ~
A range of 2% (0.01 to 0.2% as effective iodine) is preferable.

The pharmaceutical composition according to the present invention is effective as a quick-drying hand-rubbing disinfectant in the following uses.

1. In the case of normal hand disinfection of medical staff Take about 3 ml of this agent once on the palm and rub until dry. However, if organic substances such as serum and pus are attached, wash thoroughly and then disinfect with this drug.

2.In the case of operator's hand disinfection before and after operation, wash hands and forearms thoroughly with soap, wash off soap thoroughly with water, take about 3 ml of this agent on palm, rub until dry, Further, the disinfection with this agent is repeated twice.

Example 3 ml of this agent (povidone iodine 0.5% by weight, ethanol 70% by weight, cholesterol 0.025% by weight) was taken in the palm of 11 subjects for the purpose of checking the in vitro bactericidal effect.
After rubbing into fingers until dry, the number of viable bacteria remaining on the palm was measured. Rubbing and disinfection were performed once and three times in a row. As a result, the average sterilization rate after one use is
It was 92.3%, but it was 98.5% for three consecutive treatments. In each case, strong bactericidal action of this drug was observed. From these results, it is considered that one use is sufficient for disinfecting a hand in a normal ward or the like, but it is considered that three times continuous use is required particularly when an operating room, a sterile room, or the like is required to be particularly clean.

The drug was applied 5 times a day for 7 days to healthy skin obtained by removing the back skin of six female rabbits with an electric hair clipper for the purpose of checking skin irritation. As a control, a commercially available 0.2% benzalkonium chloride was used. The ethanol solution preparation was applied in the same manner, and its irritation was compared and examined. As a result, the irritation of this drug was extremely weaker than that of the control drug.
Erythema-expressing rabbits appeared on and after the day, and edema was observed in one or two cases on and after the ninth day, all of which were soft. With the control drug, erythema appeared in all cases from day 1 and 8 from day 2
From the 5th day, edema appeared in all cases from day 5, and rabbits forming crusts appeared on day 9; crusts were formed in all cases from day 14 onward. From the above results, it was considered that the stimulation was extremely weak for continuous long-term use.

(Effect of the Invention) The present invention provides a simple and practical pharmaceutical composition for iodine compound-based hand disinfection.

Continued on the front page (72) Inventor Junko Yatsushiro 2-4-16 Kyobashi, Chuo-ku, Tokyo Meiji Seika Co., Ltd. (72) Inventor Kaoru Hosoi 760 Shiokaokacho, Kohoku-ku, Yokohama, Kanagawa Prefecture Meiji Seika Co., Ltd. In-house (72) Inventor Kuniko Shoji 760 Meijioka-cho, Kohoku-ku, Yokohama-shi, Kanagawa Prefecture Inside the Pharmaceutical Research Laboratory (72) Inventor Takemi Nakayu 760 Meijioka-cho, Kohoku-ku, Yokohama-shi, Kanagawa Prefecture Meiji Pharmaceutical Research Company (72) Inventor Takao Kunisada 760, Shioka-cho, Kohoku-ku, Yokohama-shi, Kanagawa Prefecture Meiji Seika Seiyaku Co., Ltd.Investigator, Seiko Tamura (56) References JP-A-1-156904 (JP, A) JP-A-63-264528 (JP, A) Japan Hospital Pharmacists Association, “Guidelines for the Use of Disinfectants in Hospitals” (April 2, 1987) Published by Yakuji Nippo. 199, Extraordinary issue of Fragrance Journal No. 9 “The Science of Moisturizers” (1988) 34− 39

Claims (2)

(57) [Claims] 1. The method according to claim 1, wherein a) the effective iodine of the iodine compound is 0.01
-0.2% by weight, b) 50-80% by weight as alcohols,
c) A pharmaceutical composition containing 0.01 to 1% by weight as an anti-rough agent, which is compatible with a), b) and c) and is chemically and formulationally stable for hand-rubbing. 2. The method according to claim 2, wherein the effective iodine of the iodine compound is 0.01%.
0.2% by weight, b) 50-70% by weight as alcohols,
2. A pharmaceutical composition for hand-rubbing according to claim 1, which is c) a formulation containing 0.025 to 1% by weight as an anti-rough agent, which is compatible with a), b) and c) and is chemically and formulationally stable. Stuff.