JPH0156049B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention is particularly effective in treating wounds in diabetic patients. This invention relates to an insulin/gentamicin combination in the form of an ointment. Wound treatment in diabetic patients is more difficult than in non-diabetic patients, and it is necessary to perform adequate treatment at an early stage. Intractable ulcers and gangrene are important complications for diabetic patients, and their frequency has increased in recent years.In addition to malnutrition due to poor circulation due to vascular disorders, bacterial infections are difficult to treat, and the infection can worsen the diabetic condition. , sometimes leading to wound excision and death. Gentamicin ointment is the only formulation currently on the market for the treatment of wounds in such diabetic patients. Although this ointment is of course effective in treating wounds of diabetic patients, it has the disadvantage that it takes a long time to complete the treatment. On the other hand, it has recently been found that applying insulin as a poultice directly to the affected area has a significant healing effect, but in this case too, treatment takes a long time and cannot overcome the drawbacks of gentamicin ointment. . As a result of intensive research aimed at developing a topical formulation that is more effective in treating wounds, the present inventor discovered that by mixing appropriate amounts of gentamicin and insulin, the healing effects of both can be significantly enhanced. The invention was completed. That is, the present invention provides a wound treatment agent containing insulin and gentamicin as essential components. Although there is no particular restriction on the ratio of insulin and gentamicin contained in the therapeutic agent according to the present invention, it is usually preferable that the ratio is 0.1 to 1.5 mg (potency) of gentamicin to 5 to 20 units (IU) of insulin. Considering the intended use, the present therapeutic agent is preferably in the form of an ointment; in this case, the contents of insulin and gentamicin are 5 to 20 units/g and 0.5 to 1.5 mg, respectively, based on the total amount of the ointment.
(potency)/1g is sufficient, preferably 10 units/1g and 1mg(potency)/1g. This therapeutic agent can be manufactured according to conventional methods, and there are no special precautions to be taken when prescribing it. As mentioned above, this therapeutic agent is particularly effective in treating wounds in diabetic patients, but is also effective in treating wounds in areas with circulatory insufficiency, such as those seen in the elderly. The ointment according to the present invention (hereinafter referred to as IG ointment)
The therapeutic effects on erosion, burns, ulcers, and ulcers were compared with that of gentamicin ointment (hereinafter referred to as G ointment). Table 1 lists the formulations of the ointments used. The subjects were patients with stable diabetes treatment status as shown in Table 2.
The patients were between 29 and 76 years old, and there were 6 patients in the G ointment group.
Seven cases were used in the IG ointment group. Ointment was sufficiently applied to the wound, and it was covered with gauze, and the gauze was replaced at appropriate times. The treatment results are shown in Table 2. Table 1 Prescription of preparations used (1) Insulin/Gentamicin (IG) ointment (in 1g) Insulin/Regular preparation: 10 units Gentamicin sulfate: 1mg Strength White petrolatum: Appropriate amount Liquid paraffin: 88mg Sorbitan sesquioleate: 30mg (2) Gentamicin ointment (in 1g) Gentamicin sulfate: 1mg strength White petrolatum: appropriate amount Liquid paraffin: 88mg

[Table] As is clear from Table 2, the average number of treatment days in the G ointment group was 33.3 days, while in the IG ointment group it was 21.4 days.
Excellent therapeutic effects were seen in the IG ointment group in a short period of time. Cases Nos. 6 and 13 were from the same person, and the blisters that appeared due to diabetic bullosa were ruptured and there were many erosions, but IG ointment was far more effective and did not leave any pigmentation on the wound after healing. , this patient strongly preferred to use IG ointment rather than G ointment. Example 1 Preparation of IG Ointment A Preparation of Insulin Preparation Solution 1 Weigh out 1000 IU of insulin bulk powder into a suitable container and dissolve it by adding 2.5 ml of 0.1N hydrochloric acid. 2 Add an appropriate amount of 0.1N sodium hydroxide to the solution in 1 to adjust the pH to 7.2±0.2. 3 Add purified water to the solution in 2 to make a total volume of 10 ml. B. Preparation of Gentamicin Sulfate Preparation Solution 1 Weigh out 100 mg of gentamicin sulfate, place it in an agate mortar, add 5 g of liquid paraffin, and thoroughly grind. C IG Ointment Preparation 1 Weigh out 78.3 g of white petrolatum, 3.0 g of surfactant, and 8.7 g of liquid paraffin in a suitable container, and add 80±
Melt by heating at 2°C. 2 Cool 1 to 45±2°C while stirring. 3 Add the gentamicin sulfate pre-prepared solution (B) little by little to 2 and disperse uniformly while stirring. Note that the temperature is maintained at 45±2°C. 4 Add insulin preparation solution A little by little to 3.
Distribute evenly while stirring. Furthermore, the temperature is
Maintain the temperature at 45±2℃. 5. Cool to room temperature while stirring, and after cooling, divide into appropriate containers. According to the above method, ointments having the compositions shown in Tables 3 and 4 below were manufactured.

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Claims (1)

[Claims] 1. A wound treatment agent containing insulin and gentamicin as essential components.