JPH09169655A - Powder for external use for dermatic ulcer - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide the subject powder composed of a sugar, a water-swelling cellulose compound, a binder and an iodophor, having excellent fluidity and water-absorptivity, easily absorbing and removing the exudate from wound surface and giving low stimulation to the wound. SOLUTION: This powder is composed of (A) 60-80wt.% of a sugar (preferably sucrose), (B) 20-40wt.% of a water-swelling cellulose compound (preferably a hydroxypropylcellulose having low substitution degree), (C) 0.5-3.0wt.% of a binder (preferably a hydroxypropylcellulose) and (D) 0.5-10wt.% of a iodophor (preferably povidone iodine). The powder can be produced preferably by mixing the component A with the component B, adding a solution produced by dissolving the component C in a lower alkanol (e.g. methanol) to the mixture, kneading, drying and granulating the product and mixing with the component D.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to an external powder for skin ulcer, and more particularly to an external powder for skin ulcer containing sugar and iodine as active ingredients.

[0002]

2. Description of the Related Art Iodophor has a strong bactericidal activity, and since it has low irritation and tissue damage, it is used for disinfecting fingers and surgical sites, and honey, molasses,
Sugar such as sucrose has long been used to treat burns and wounds.

With the expectation of the bactericidal action of iodine and the granulation formation promoting action of sugar, an ointment mainly containing iodine and sugar is prepared and used in university hospitals. As an improved product of such a preparation, an ointment comprising sugar, povidone iodine, water and a buffer for adjusting pH is known (Japanese Patent Publication No. 1-23210). In this formulation, the content of povidone iodine is not constant, the mixing of povidone iodine and sugar is difficult, the formulation is separated into two layers, the active ingredient is decomposed and the medicinal effect is lowered, and the drawbacks of conventional ointments. Has been overcome and is widely marketed. However, it has been pointed out that this ointment is hard and has poor spreadability and is difficult to apply to the wound surface, and has a drawback that absorption of exudate from the wound surface is not sufficient.

To facilitate application to the wound surface, a free-flowing wound powder containing iodine, which is obtained by spraying a fine sugar with a solution in which iodine is dissolved (JP-A-61-215).
324) has been proposed. In addition, since the iodine preparation in the form of a solution is difficult to handle, an iodine composition in the form of a granule or a powder comprising water-soluble iodine and urea or sugar alcohol (particularly mannitol) (Japanese Patent Laid-Open No. 63-77805) has been proposed. Proposed. These iodine-hole preparations have the advantages that they are excellent in homogeneity and fluidity, can be freely sprayed on the wound surface, and are easy to handle. However, since all the formulations are water-soluble, the absorption of exudate when applied to the wound surface is not always sufficient.

[0005]

DISCLOSURE OF THE INVENTION The present invention retains the advantages of conventional powders that are excellent in fluidity, can be freely sprayed on the wound surface, and are easy to handle, and further have a pH value.
It is intended to provide an external powder for skin ulcer that has a form that reduces irritation without adjustment, absorbs exudate on the wound surface, and is easy to remove.

[0006]

The present invention provides sugars 60-80.
% By weight, 20 to 40% by weight of water-swellable cellulose compound,
Binder 0.5-3.0% by weight and iodine hole 0.5-
It consists of an external powder for skin ulcer consisting of 10% by weight.

Further, according to the present invention, a sugar and a water-swellable cellulose compound are mixed, a solution in which a binder is dissolved in a lower alkanol is added to the mixture, and the mixture is kneaded. The kneaded product is dried and then sized. A method for producing the external powder for skin ulcer, which comprises adding iodine hole to the mixture and mixing.

As the sugar in the present invention, a sugar having a granulation promoting action and a bacteriostatic action is used, and examples thereof include sucrose, glucose, dextrose, fructose, lactose and the like. Sucrose, particularly sucrose and purified sucrose of the Japanese Pharmacopoeia, are preferred. The compounding amount is an amount capable of exerting a granulation formation promoting action and a bacteriostatic action, and is 60 to 80% by weight of the total composition.

The water-swellable cellulose compound used in the present invention is a cellulose compound which is insoluble in water and absorbs water to swell when added with water, for example, a low-substituted hydroxy compound. Examples include propyl cellulose, carboxymethyl ethyl cellulose, carmellose, carmellose calcium, croscarmellose sodium, crystalline cellulose, and cellulose acetate. Since these cellulose compounds are excellent in water absorption, they can absorb exudate when the powder of the present invention is applied to the wound surface. A particularly preferred cellulose compound is low substituted hydroxypropyl cellulose. This is a low-substituted hydroxypropyl ether of cellulose, which has a hydroxypropoxy group of 5.
Including 0 to 16.0%. A water-swellable cellulose compound such as low-substituted hydroxypropyl cellulose is usually used as a binder and a disintegrant in a solid preparation in an amount of 2.0 to 5.0% by weight of the total composition, but in the present invention, it is used as a powder. 20 to 40% by weight of the total composition is used in order to improve the properties, the water absorbing ability from the wound surface and the peelability due to swelling.

As the binder, those commonly used in external powders such as hydroxypropyl cellulose which is easily soluble in lower alkanols are used. The amount used is 0.5-3.0% by weight of the total composition.

The iodophor used in the present invention is a physiologically acceptable complex of iodine and an organic polymer such as polydextrose or polyvinylpyrrolidone (povidone). Particularly, povidone iodine, which is a complex of iodine and povidone, is preferably used. The amount used is 0.5 to 10% by weight of the total composition, preferably 1.0 to 5.0% by weight.

The powder for external use of the present invention is prepared by mixing sugar and a water-swelling cellulose compound, kneading the mixture with a solution of a binder dissolved in an appropriate amount of a lower alkanol, and kneading the mixture. It is preferably produced by adding iodine holes to the sized product and mixing them. The above-mentioned steps of mixing, kneading and granulation can be carried out according to a conventional method for producing a powder for external use. As the lower alkanol, methanol, ethanol, isopropanol and the like are used, and ethanol is most preferable. It is desirable to use those listed in the Japanese Pharmacopoeia or the Japanese Pharmacopoeia Standards for Pharmaceutical Ingredients.

[0013]

EXAMPLES Next, the present invention will be described more specifically by showing Examples and Test Examples. Example 1 Povidone-iodine 3.0% by weight Purified sucrose 70.0% by weight Low-substituted hydroxypropylcellulose 26.0% by weight Hydroxypropylcellulose 1.0% by weight Mixing with a stirrer while rotating and flowing, Japanese Pharmacopoeia Knead and granulate by adding a solution prepared by dissolving an appropriate amount of ethanol. This is dried and sized with 40 mesh.
Add to the sized powder and mix to make a powder for external use. The external use powder obtained in Example 1 exhibits fluidity, and when it absorbs water, it becomes a lump with elasticity, is easily peeled off without irritating the skin surface, and can be easily washed off with water. The appearance of the above powder when stored in a sealed aluminum bag at 40 ° C. for 4 months was observed. The content of sugar is measured by high performance liquid chromatography, and the content of available iodine is measured by titration method.
The residual rate was calculated. Table 1 shows the results. As is clear from the results in Table 1, the powder of the present invention is stable over time.

[0014]

[Table 1] 2 months 4 months Example 1 Powder Remaining rate of sugar (%) 99.1 99.4 Remaining rate of available iodine (%) 94.5 92.3 No change in external appearance No change

Comparative Example 1 Povidone iodine 3.0% by weight Purified sucrose 70.0% by weight D-mannitol 26.0% by weight Hydroxypropylcellulose 1.0% by weight Instead of the low-substituted hydroxypropylcellulose of Example 1, a known compound was used. A powder for external use was prepared by the production method of Example 1 using mannitol, which is a sugar alcohol of the formulation example (JP-A-63-77805). The following water absorption test was conducted on the powders of Examples 1 to 4, the powder of Comparative Example 1 and the water-swellable cellulose used in the present invention. [Water absorption test method] Water Absorption Apparatus [Akihiko Ito et al .: "Hospital Pharmacy" Vol. 20, No. 1, p. 43 (1994)]
It was measured with time that the liquid amount of the beaker on the electronic balance decreased due to the liquid absorption of 2 g of the sample and the weight indicated by the electronic balance changed, and the value was read and the amount at saturation was taken as the water absorption amount. Table 2 shows the results. It is clear from Table 2 that the powders of Examples 1 to 4 have superior absorption ability as compared with the powder of Comparative Example 1. In particular, the powder of Example 1 has a water absorption capacity 7 times that of the powder of Comparative Example 1 (about 10 times that of the powder of Example 4).
Further, it is clear that the water-swellable cellulose used in the present invention has an excellent water absorbing ability.

[0016]

Table 2 Product name Water absorption (g) Example 1 powder 2.68 Example 2 powder 1.68 Example 3 powder 1.29 Example 4 powder 3.59 Comparative example 1 powder 0.36 D-mannitol 0.81 Low-substituted hydroxypropyl cellulose 11.97 Carmellose 4.60 Carmellose calcium 9.82 Croscarmellose sodium 13.06 Crystalline cellulose 5.27 Cellulose acetate 5.65 (Temperature 25.5 ° C, Humidity 49%)

Example 2 Povidone-iodine 3.0% by weight Purified sucrose 65.0% by weight Carmellose 35.0% by weight Hydroxypropylcellulose 2.0% by weight An external use powder having the above composition was prepared in the same manner as in Example 1.

Example 3 Povidone-iodine 3.0% by weight Purified sucrose 60.0% by weight Crystalline cellulose 30.0% by weight Hydroxypropylcellulose 2.0% by weight An external powder having the above composition was prepared in the same manner as in Example 1. .

Example 4 Povidone-iodine 3.0% by weight Purified sucrose 70.0% by weight Croscarmellose sodium 26.0% by weight Hydroxypropylcellulose 1.0% by weight As in Example 1, an external use powder having the above composition was used. Manufactured.

[0020]

INDUSTRIAL APPLICABILITY According to the present invention, an external powder for skin ulcer containing povidone iodine having excellent fluidity and water absorbability can be obtained. Since the preparation of the present invention is a flowable powder, it is easy to handle and can be applied so as to be intimately adhered to the wound surface. Further, since it is excellent in water absorption, it can absorb the exudate from the wound surface, which can lead to dryness of the wound surface, suppression of bacterial infection, and promotion of granulation. Furthermore, according to the present invention, an external powder for skin ulcer that can be easily removed from the wound surface after use is obtained. The powder of the present invention absorbs the exudate to form an elastic mass and is easily separated from the wound surface, so that the powder can be easily removed, and can be easily washed off with water. The external use powder of the present invention is stable over time without adjusting the pH, and has little skin irritation. Due to these advantages, the povidone-iodine external powder for skin ulcers of the present invention can be suitably used for the treatment of skin ulcers such as pimples and burns.

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Claims (6)

[Claims] 1. Sugar 60 to 80% by weight, water-swellable cellulose compound 20 to 40% by weight, binder 0.5 to 3.0% by weight.
And an external powder for skin ulcer, which comprises 0.5 to 10% by weight of iodine. 2. The external powder for skin ulcer according to claim 1, wherein the sugar is sucrose. 3. The external powder for skin ulcer according to claim 1, wherein the water-swellable cellulose compound is low-substituted hydroxypropyl cellulose. 4. The external powder for skin ulcer according to claim 1, wherein the binder is hydroxypropyl cellulose. 5. The external powder for skin ulcers according to claim 1, wherein the iodine hole is povidone iodine. 6. A sugar and a water-swellable cellulose compound are mixed, a solution of a binder dissolved in a lower alkanol is added to the mixture, and the mixture is kneaded. After drying the kneaded product, iodine is added to the sized product. The method for producing an external powder for skin ulcer according to claim 1, which comprises adding and mixing.