阅读说明：本技术 一种即型凝胶型中药抑菌剂 (in-situ gel type traditional Chinese medicine bacteriostatic agent ) 是由 刘志东 潘运平 袁子淳 开海琴 于 2019-10-18 设计创作，主要内容包括：本发明涉及一种即型凝胶型中药抑菌剂,其包含下列组分(按重量份计),0.05-10份五花,18-27份温度敏感材料,0.05-3份增稠剂,0.1-2份防腐剂和10-60份纯化水。本发明还涉及所述温度敏感型五花皮肤在体凝胶制剂的制备方法,以及其在制备预防和/或治疗皮肤炎症的药物中的用途。(The invention relates to an immediate gel type traditional Chinese medicine bacteriostatic agent, which comprises the following components (by weight part), 0.05-10 parts of five flowers, 18-27 parts of temperature sensitive materials, 0.05-3 parts of thickening agents, 0.1-2 parts of preservatives and 10-60 parts of purified water.)

1. The immediate gel type traditional Chinese medicine bacteriostatic agent comprises the following components:

the components in parts by weight

0.05-10 of five flowers;

i.e. forming gel material 18-27;

0.05 to 3 portions of thickening agent;

0.1-2% of preservative;

10-60 parts of water.

2. The ready-to-gel traditional Chinese medicine bacteriostatic agent of claim 1, wherein the temperature sensitive material is selected from at least of polyoxyethylene polyoxypropylene ether block copolymer, poly (N-isopropylacrylamide) (PNIPAAm) and acrylic acid polymer.

3. The immediate gel type Chinese medicinal bacteriostatic agent according to claim 1, wherein the thickening agent is selected from at least of hydroxypropyl methylcellulose (HPMC), methylcellulose, ethylcellulose, povidone and polyvinyl alcohol, and the preservative is selected from at least of benzyl alcohol, potassium sorbate, sodium benzoate, phenoxyethanol, benzalkonium chloride, methyl paraben, ethyl paraben and propyl paraben.

4. The immediate gel type traditional Chinese medicine bacteriostatic agent of claim 1, wherein the temperature sensitive material is poloxamer 127 and poloxamer 188, the thickening agent is HPMC E4M, and the preservative is ethylparaben.

5. The immediate gel type traditional Chinese medicine bacteriostatic agent of in any one of claims 1-4, which comprises (by weight parts) 0.05-10 parts of WUHUA, 16-20 parts of poloxamer 127, 2-8 parts of poloxamer 188, 0.1-10 parts of HPMC E4M, HPMC F4M or HPMC K4M, 0.001-3 parts of ethylparaben and 15-60 parts of purified water.

6. The in-situ forming gel type traditional Chinese medicine bacteriostatic agent of claim 5, which comprises the following components (by weight portion): 0.05-1.5 parts of five flowers, 16-19 parts of poloxamer 127, 5-7 parts of poloxamer 188, 0.3-3 parts of HPMC E4M, HPMC F4M or HPMC K4M, 0.001-0.1 part of ethylparaben and 10-60 parts of purified water.

7. The in-situ forming gel type traditional Chinese medicine bacteriostatic agent of claim 6, which comprises the following components (by weight portion): 1 part of five-flower, 16 parts of poloxamer 127, 5 parts of poloxamer 188, 0.05 part of HPMC E4M, 1.0 part of PEG6000, 0.01 part of ethylparaben and 17.94 parts of purified water.

8. The method for preparing an instant gel type Chinese medicinal bacteriostatic agent of any in claims 1-7, which comprises the following steps:

(1) preparing a matrix: according to the weight parts, adding a temperature sensitive material and a thickening agent into a proper amount of purified water under the condition of continuously stirring, and uniformly stirring to obtain a matrix;

(2) preparing a medicine solution: taking the five flowers and the preservative according to the parts by weight, and uniformly mixing to obtain a medicinal solution;

(3) mixing: and (3) adding the medicinal solution prepared in the step (2) into the matrix prepared in the step (1) under continuous stirring, adding purified water to the total amount of the prescription, and uniformly stirring to obtain the gel preparation.

9. Use of the instant gel type traditional Chinese medicine bacteriostatic agent of any in claims 1-7 for preparing a medicament for preventing and/or treating skin inflammation.

Technical Field

The invention relates to instant gel type traditional Chinese medicine bacteriostats, and a preparation method and application thereof.

Disclosure of Invention

The invention provides instant gel type traditional Chinese medicine bacteriostatic agent, which is reddish brown, is liquid in vitro, is coated on the surface of skin to form gel, and the viscosity of the gel is reduced along with the increase of external stress.

The invention relates to aspects of immediate gel type traditional Chinese medicine bacteriostats, which comprise the following components:

the components in parts by weight

0.05-10 of five flowers;

i.e. forming gel material 18-27;

0.05 to 3 portions of thickening agent;

0.1-2% of preservative;

10-60 parts of water.

The temperature sensitive material is used for adjusting the transformation of the gel matrix between a liquid state and a semi-solid gel state under the physiological condition and the non-physiological condition of a human body, can increase the bioavailability of the medicine and improve the compliance of a patient, wherein the temperature sensitive material comprises at least of polyoxyethylene polyoxypropylene ether block copolymer, poly (N-isopropyl acrylamide) (PNIPAAm) and acrylic acid polymer, and in embodiments of the invention, the temperature sensitive material is polyoxyethylene polyoxypropylene ether block copolymer, such as poloxamer 188, poloxamer 127 and the like.

The ingredients and amounts of the thickening agent are conventional in the art and include, but are not limited to or more of hydroxypropyl methylcellulose (HPMC), methylcellulose, ethylcellulose, povidone, and polyvinyl alcohol, wherein HPMC can be E4M, E10M, F4M, or K4M, and in embodiments of the present invention, HPMC E4M.

The ingredients and amounts of the preservative are conventional in the art and include, but are not limited to, or more of benzyl alcohol, potassium sorbate, sodium benzoate, phenoxyethanol, benzalkonium chloride, methyl, ethyl, and propyl parabens, and in embodiments of the present invention, the preservative is ethyl paraben.

Preferably, the instant gel type traditional Chinese medicine bacteriostatic agent comprises the following components in parts by weight: 0.05-10 parts of five flowers, 16-20 parts of poloxamer 127, 2-8 parts of poloxamer 188, 0.1-10 parts of HPMC E4M, HPMC F4M or HPMCK4M, 0.001-3 parts of ethylparaben and 15-60 parts of purified water.

More preferably, the instant gel type traditional Chinese medicine bacteriostatic agent comprises the following components (in parts by weight): 0.05-1.5 parts of five flowers, 16-19 parts of poloxamer 127, 5-7 parts of poloxamer 188, 0.3-3 parts of HPMC E4M, HPMC F4M or HPMC K4M, 0.001-0.1 part of ethylparaben and 10-60 parts of purified water.

In embodiments of the invention, it consists of (by weight parts) 1 part of Woodflower, 16 parts of Poloxamer 127, 5 parts of Poloxamer 188, 0.05 part of HPMC E4M, 1.0 part of PEG6000, 0.01 part of ethylparaben and 17.94 parts of purified water.

In another embodiments of the invention, it consists of (by weight parts) 1 part of pentaflower, 19 parts of poloxamer 127, 7.21 parts of poloxamer 188, 0.05 part of HPMC E4M, 1.09 parts of PEG6000, 0.01 part of ethylparaben, and 12.64 parts of purified water.

In another embodiments of the invention, it consists of (by weight parts) 1 part of Woodflower, 16 parts of Poloxamer 127, 2 parts of Poloxamer 188, 0.05 part of HPMC E4M, 1.09 parts of PEG6000, 0.01 part of ethylparaben and 20.85 parts of purified water.

The invention relates to a preparation method of an instant gel type traditional Chinese medicine bacteriostatic agent, which comprises the following steps:

(1) preparing a matrix: according to the weight parts, adding a temperature sensitive material and a thickening agent into a proper amount of purified water under the condition of continuously stirring, and uniformly stirring to obtain a matrix;

(2) preparing a medicine solution: taking the five flowers and the preservative according to the parts by weight, and uniformly mixing to obtain a medicinal solution;

(3) mixing: and (3) adding the medicinal solution prepared in the step (2) into the matrix prepared in the step (1) under continuous stirring, adding purified water to the total amount of the prescription, and uniformly stirring to obtain the gel preparation.

Advantageous effects of the invention

The invention provides an instant gel type traditional Chinese medicine bacteriostatic agent which is reasonable in composition, is liquid in vitro (the temperature value is about 20-29 ℃) and becomes gel when being dripped on skin (the temperature value is about 31-32 ℃), and the gel viscosity is reduced along with the increase of external stress. The skin preparation of the present invention has the following advantages:

1) the instant gel type traditional Chinese medicine bacteriostatic agent can well keep the activity and permeability of the five flowers while solving the problem of normal conversion of dosage forms under different temperature conditions, can well keep an acidic environment, and enables a disinfectant to play the maximum efficacy at the optimum pH value.

2) The application of the in-vivo gel preparation can increase the residence time of the five flowers on the skin, and effectively solves the problems that the single iodine disinfectant liquid of the five flowers is too fast to volatilize and can not be retained on the skin for a long time.

3) The application of the in-vivo gel preparation can increase the attachment time of the WUHUA on the skin, play a role of slow release, can keep a larger drug concentration in hours, reduce the times of medication and improve the compliance of patients.

Drawings

FIG. 1 temperature variation range of viscosity of skin-in-vivo gel of the present invention

Figure 2 results of rheological experiments on the skin of the invention at a temperature of 27.9 ℃ (non-physiological conditions) and at a temperature of 31 ℃ (physiological conditions).

Detailed Description

Embodiments of the present invention will be described in detail below with reference to examples, but those skilled in the art will appreciate that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products commercially available.