CN109432201B - Gynecological antibacterial gel and preparation method thereof - Google Patents

Abstract

The invention provides gynecological antibacterial gel which is prepared from poloxamer, an electrolytic silver ion antibacterial agent and glycerol, wherein the silver ion concentration of the electrolytic silver ion antibacterial agent is controlled, and the electrolytic silver ion antibacterial agent, the poloxamer and the glycerol are matched within a proper content range to form pasty gel which has a slow release effect, can adjust the phase change temperature to be adaptive to the temperature of a human body and stays in the vagina for a long time, and can well exert antibacterial performance. And after the electrolytic silver ion antibacterial agent, the chamomile extract and the rose extract are compounded, the antibacterial and bactericidal effects are better, the adhesive property of the paste gel to the inner wall of the vagina can be kept, and the long-time drug effect can be maintained.

Description

Gynecological antibacterial gel and preparation method thereof

Technical Field

The invention relates to the field of medicinal preparations, in particular to gynecological antibacterial gel and a preparation method thereof.

Background

The gynecological antibacterial gel is a gynecological medicine and is used for treating various gynecological vaginitis and cervicitis, and comprises the following components: bacterial vaginitis, trichomonas vaginitis, mixed vaginitis, gonococcal infection, chronic cervicitis and cervical erosion, and has the effects of diminishing inflammation, sterilizing and relieving itching. The gynecological antibacterial gel on the market has various varieties and formulas, is generally Chinese herbal medicine extract antibacterial gel, comprises ginseng, radix sophorae flavescentis, stephania japonica, golden cypress, aloe and the like, the western medicine antibacterial gel comprises guanidine, cationic antibacterial agents, chlorhexidine acetate, chlorhexidine gluconate, benzalkonium chloride and the like, and the matrix of the common gel is carbomer. However, when the traditional antibacterial gel is injected into the vagina, the traditional antibacterial gel is easy to become thin immediately when encountering salt and electrolyte in a human body, and effective medicaments are easy to naturally flow out when staying on the inner wall of the vagina to play an antibacterial effect, so that the gynecological gel has low efficacy and poor treatment effect.

Disclosure of Invention

In view of the above, there is a need to provide a gynecological antibacterial gel which has good antibacterial effect, can effectively stay in vagina for a long time, and is safe, non-toxic and non-irritating.

In order to realize the purpose of the invention, the specific technical scheme is as follows:

the gynecological antibacterial gel comprises the following raw materials in parts by weight:

the concentration of silver ions in the electrolytic silver ion antibacterial agent is 22-28 ppm.

The invention also aims to provide a preparation method of the gynecological antibacterial gel, which comprises the following specific technical scheme:

a preparation method of gynecological gel comprises the following steps:

(1) taking the raw materials;

(2) adding poloxamer into deionized water, and stirring at 16-20 ℃ until the poloxamer is completely dissolved to be in a transparent state;

(3) adding electrolytic silver ion antibacterial agent, flos Matricariae Chamomillae extract, flos Rosae Rugosae extract and glycerol, and stirring.

Based on the technical scheme, the invention has the following beneficial effects:

the gynecological antibacterial gel is prepared from poloxamer, an electrolytic silver ion antibacterial agent and glycerol, wherein the silver ion concentration of the electrolytic silver ion antibacterial agent is controlled, and the silver ion concentration is matched with the poloxamer and the glycerol within a proper content range, so that a pasty gel which has a slow release effect, can adjust the phase change temperature to be adaptive to the temperature of a human body and stays in the vagina for a long time is formed, and meanwhile, the antibacterial performance can be well exerted. And after the electrolytic silver ion antibacterial agent, the chamomile extract and the rose extract are compounded, the antibacterial and bactericidal effects are better, the adhesive property of the paste gel to the inner wall of the vagina can be kept, and the long-time drug effect can be maintained.

Detailed Description

In order that the invention may be more readily understood, reference will now be made to the following more particular description of the invention, examples of which are set forth below. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. These embodiments are provided so that this disclosure will be thorough and complete. Each of the raw materials used in the examples is a commercially available product unless otherwise specified.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

The invention provides a gynecological antibacterial gel which comprises the following raw materials in parts by weight: 8-13 parts of poloxamer; 90-110 parts of an electrolytic silver ion antibacterial agent; 40-60 parts of chamomile extract; 15-25 parts of rose extract; 15-25 parts of glycerol; wherein the concentration of silver ions in the electrolytic silver ion antibacterial agent is 22-28 ppm. The gynecological antibacterial gel is prepared from poloxamer, an electrolytic silver ion antibacterial agent and glycerol, wherein the silver ion concentration of the electrolytic silver ion antibacterial agent is controlled, the silver ion antibacterial agent is matched with the poloxamer and the glycerol within a proper content range, a pasty gel which has a slow release effect, can adjust the phase change temperature to adapt to the temperature of a human body and can stay in the vagina for a long time is formed, and meanwhile, the antibacterial performance can be well exerted. Wherein, silver ion concentration in the electrolysis-type silver ion antibacterial agent plays an important role, on the one hand, silver ion concentration is to the stability of poloxamer and glycerine formation gel, adhesion performance produces the influence, on the other hand, glycerine of suitable proportion, poloxamer and the silver ion of suitable concentration just can better exert bactericidal action, when silver ion concentration is too big or the undersize, the bactericidal effect in the vagina is all nonideal, only under suitable silver ion concentration, with appropriate amount of poloxamer, appropriate amount of glycerine cooperation, just can compromise and need to possess stability, the effect of adhesion and bacterinertness performance. Preferably, the concentration of the silver ions is 24-26 ppm, and more preferably 25 ppm.

Preferably, the ratio of the poloxamer, the electrolytic silver ion antibacterial agent and the glycerol is 1: (9-11): (1-2); under the proper proportion, the gel has good stability and vaginal inner wall adhesion performance, and can simultaneously slowly release silver ions and matched natural antibacterial components, namely chamomile extract and rose extract, at a reasonable rate to achieve stable and remarkable antibacterial effect, and more preferably, the proportion of poloxamer, electrolytic silver ion antibacterial agent and glycerol is 1: 10: 2.

among them, chamomile is generally used for relieving pain symptoms including headache, neuralgia, toothache and earache, and also is often used for relieving premenstrual syndrome and climacteric symptoms; the rose extract is also called as rose essential oil, has the effects of supplementing water, moisturizing, quickly diminishing inflammation, resisting allergy, relieving itching and delaying aging, and also has the effects of preventing wrinkles and color spots, delaying skin aging, soothing nerves, moisturizing, moistening skin, relieving tension, adjusting physiological cycle, balancing skin pH value and the like. In the gynecological antibacterial gel, the electrolytic silver ion antibacterial agent, the chamomile extract and the rose extract are compounded in a proper proportion, so that the gynecological antibacterial gel not only can play a strong role in bacteriostasis and sterilization, but also is beneficial to the physical and psychological health of women when applied to gynecology. Preferably, the electrolytic silver ion antibacterial agent, the chamomile extract and the rose extract are used in a ratio of (9-11): (4-6): 2.

further preferably, the ratio of poloxamer 188 to poloxamer 407 is (9-11): within this ratio range, the stability, adhesion and antibacterial properties of the gel are optimal. More preferably, the ratio of poloxamer 188 to poloxamer 407 is 9: 1. On one hand, poloxamer is used as an emulsifier and a stabilizer, oily materials in a formula are uniformly emulsified and stabilized in gel, and simultaneously, poloxamer is used as a slow-release material, has phase change at the body temperature of a human body, has strong adhesion performance to the vagina and has a slow-release effect on antibacterial compounds. On the other hand, the gynecological antibacterial gel can stay in the vagina for a long time, has good compatibility with vaginal mucosa, has no irritation, can increase skin permeability, and is beneficial to deep sterilization.

The invention also provides a preparation method of the gynecological gel, which comprises the following steps: (1) taking the raw materials; (2) adding poloxamer into deionized water, and stirring at 16-20 ℃ until the poloxamer is completely dissolved to be in a transparent state; (3) adding electrolytic silver ion antibacterial agent, flos Matricariae Chamomillae extract, flos Rosae Rugosae extract and glycerol, and stirring.

The raw material source information in this embodiment is as follows:

electrolytic silver ion antibacterial agent: supplied by Guangzhou Bokung chemical technology, Inc., model number 76000-AG-25, and production lot number 2016-2-1/160312.

Chamomile extract: purchased from Zhenghe (Guangzhou) Biotech limited, cat #: L1-CY1080, CAS number: 84649-86-5.

Rose extract: purchased from Zhenghe (Guangzhou) Biotech limited, cat #: L1-CY1043, CAS number: 90106-38-0.

Example 1

The gynecological antibacterial gel and the preparation method thereof comprise the following raw materials in parts by weight:

wherein the concentration of silver ions in the electrolytic silver ion antibacterial agent is 25 ppm;

the preparation method of the gynecological antibacterial gel by adopting the raw materials comprises the following steps:

adding poloxamer 188 and poloxamer 407 into deionized water, wherein the ratio of the total weight of poloxamer 188 and poloxamer 407 to the added deionized water is 1:80 in g/ml. Stirring, dissolving completely at 18 deg.C to transparent state, adding electrolytic silver ion antibacterial agent, flos Matricariae Chamomillae extract, flos Rosae Rugosae extract and glycerol, stirring to obtain transparent solution, and packaging.

Example 2

The gynecological antibacterial gel and the preparation method thereof comprise the following raw materials in parts by weight:

wherein the concentration of silver ions in the electrolytic silver ion antibacterial agent is 27 ppm;

the preparation method is the same as that of example 1.

Example 3

The gynecological antibacterial gel and the preparation method thereof comprise the following raw materials in parts by weight:

wherein the concentration of silver ions in the electrolytic silver ion antibacterial agent is 25 ppm;

the preparation method is the same as that of example 1.

Comparative example 1

Compared with the raw material components in the gynecological antibacterial gel and the preparation method thereof in the comparative example, the raw material components are only different from those in the example 1 in that the silver ion concentration in the comparative example is 35ppm, and the rest components and the preparation method are the same as those in the example 1.

Comparative example 2

Compared with the raw material components in the gynecological antibacterial gel and the preparation method thereof in the comparative example, the raw material components are only different from the components in the example 1 in that the silver ion concentration in the comparative example is 18ppm, and the rest components and the preparation method are the same as the components in the example 1.

Comparative example 3

In the gynecological antibacterial gel and the preparation method thereof in the comparative example, compared with the example 1, the raw material components are only different from poloxamer 188 and poloxamer 407 but carbomer in the comparative example, and the rest components and the preparation method are the same as the example 1.

Comparative example 4

Compared with the raw material components in example 1, the gynecological antibacterial gel and the preparation method thereof only differ in that in the comparative example, the dosage of the electrolytic silver ion antibacterial agent is 90 parts, the dosage of the chamomile extract is 70 parts, the dosage of the rose extract is 15 parts, and the rest components and the preparation method are the same as those in example 1.

Experimental example 1

According to GB15979-2002 hygienic standard appendix C (product sterilization performance, bacteriostasis performance and stability test method), the silver ion antibacterial agent, examples 1-3 and comparative examples 1-5 are respectively subjected to a sterilization effect test. The test items are bactericidal rate, and the test bacteria comprise escherichia coli 8099, staphylococcus aureus ATCC 6538, pseudomonas aeruginosa ATCC 15442, candida albicans ATCC 10231 and salmonella typhi CMCC 50094. The results are shown in Table 1.

TABLE 1 Sterilization test results

As can be seen from the above table, the gynecological antibacterial gel of the embodiments 1-3 of the invention has good antibacterial effects on Escherichia coli 8099, Staphylococcus aureus ATCC 6538, Pseudomonas aeruginosa ATCC 15442, Candida albicans ATCC 10231 and Salmonella typhi B CMCC 50094, and the sterilization rate is more than 98%. The antibacterial effects of the comparative examples 1 to 4 are poor because, on one hand, the viscosity of gel formed by poloxamer and glycerin is affected by too high silver ion concentration in the comparative example 1, and the gel cannot stay in the body for a long time, on the other hand, when the silver ion concentration in the silver ion antibacterial agents of the comparative examples 1 and 2 is too high or too low, a stable drug release system cannot be formed under reasonable matching with the poloxamer and glycerin, the antibacterial effect is greatly weakened, the proportion and the dosage of the silver ion antibacterial agent, the chamomile extract and the rose extract in the comparative example 4 are not in reasonable ranges, and the effective antibacterial effect when the three are reasonably compounded cannot be fully exerted after the gel is prepared.

Experimental example 2

The silver ion antimicrobial used in the present invention and the gynecological gel described in example 1 were tested according to the method described in the disinfection specifications (2002 edition).

Animal strains were used: new zealand rabbit, normal grade;

animal sources: the production license number is SCXK (Zhe) 2013-;

a breeding environment: the temperature of a common-grade animal house is 20.3-23.2 ℃, and the relative humidity is 56.3% -67.2%.

The results of the stimulation test are shown in table 1, wherein:

the average integral is the sum of the stimulation response integrals of 3 sites of 3 animals/total number of observations (number of animals × 3);

stimulation index is the average integral of silver ion antibacterial agent group-average integral of blank control group

TABLE 1 vaginal mucosal irritation test results

As can be seen from the above table, the irritation index of the silver ion antibacterial agent group is 0.22, and the irritation index of the gynecological gel group is 0, and thus, neither the silver ion antibacterial agent group nor the gynecological gel group has irritation to the vaginal mucosa.

Experimental example 3

At present, no authoritative and systematic in-vitro bioadhesion evaluation method and biological annual delivery in-vitro correlation theory are formed in the prior art, so that 21 healthy Wistar female mice (about 250g) without vaginal diseases are adopted in the experimental example of the invention according to the characteristics of vaginal administration, the mice are randomly divided into 7 groups, corresponding to examples 1-3 and comparative examples 1-4, 3 mice in each group are respectively injected with 0.25ml of each prepared gel in each group into the vagina, and the adhesion and retention conditions of each group of gels after being injected into the vagina of a rat are observed. The results show that after the gels of examples 1-3, comparative example 2 and comparative example 4 are injected into the vagina of a rat, no liquid or gel-like fluid is observed to flow out of the vagina of all rats, and the poloxamer 188, the poloxamer 407 and the glycerol in the examples show that under the proper proportion, the gel containing the proper silver ion concentration has a good adhesion effect, and under the action of the body temperature of the vagina of the rat, the phase change occurs, the adhesion performance to the vagina is remarkably enhanced, and the gel can be effectively retained in the vagina.

While comparative example 1, after being injected into the vagina of a rat, 2 rats in the gel have a small amount of liquid outflow and 1 rat has a large amount of liquid outflow, the reason for this may be that in comparative example 1, although poloxamer 188, poloxamer 407 and glycerol are also included to undergo phase transition at the body temperature of the rat, the viscosity and the adhesive property of the gel are increased to some extent, but the stability of the gel is affected to some extent due to the excessive concentration of silver ions, so that the gel in comparative example 1 has a small amount of liquid outflow after being injected into the vagina of the rat.

After injecting the gel of comparative example 3 into the vagina of a rat, almost complete outflow of the gel was observed because the gel had a very low viscosity without the use of poloxamer 188, poloxamer 407 and glycerol, and could not be transformed into a gel-like substance with good adhesive properties, and was still in a very thin state, and was difficult to stay in the vagina and was very easy to flow out of the vagina.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. The gynecological antibacterial gel is characterized by comprising the following raw materials in parts by weight:

the concentration of silver ions in the electrolytic silver ion antibacterial agent is 22-28 ppm;

the ratio of the poloxamer, the electrolytic silver ion antibacterial agent and the glycerol is 1: (9-11): (1-2);

the poloxamer is a compound of poloxamer 188 and poloxamer 407, and the weight and dosage ratio of the poloxamer 188 to the poloxamer 407 is (9-11): 1.

2. the gynecological antibacterial gel according to claim 1, wherein the concentration of the silver ions is 24-26 ppm by weight.

3. The gynecological antiseptic gel of claim 2, wherein the concentration of silver ions is 25 ppm.

4. The gynecological antibacterial gel according to claim 1, wherein the dosage ratio of the poloxamer 188 to the poloxamer 407 is 9: 1.

5. the gynecological antibacterial gel according to claim 1, wherein the electrolytic silver ion antibacterial agent, the chamomile extract and the rose extract are used in a ratio of (9-11): (4-6): 2.

6. the gynecological antibacterial gel according to claim 5, wherein the electrolytic silver ion antibacterial agent, the chamomile extract and the rose extract are used in a ratio of 10: 5: 2.

7. the gynecological antibacterial gel according to claim 6, characterized in that the raw materials comprise the following components in parts by weight:

the concentration of the silver ions was 25 ppm.

8. The gynecological antibacterial gel according to claim 1, characterized in that the raw materials comprise the following components in parts by weight:

the concentration of silver ions in the electrolytic silver ion antibacterial agent is 27 ppm.

9. The gynecological antibacterial gel according to claim 1, characterized in that the raw materials comprise the following components in parts by weight:

the concentration of silver ions in the electrolytic silver ion antibacterial agent is 25 ppm.

10. The preparation method of the gynecological gel is characterized by comprising the following steps:

(1) preparing a feedstock as claimed in any one of claims 1 to 9;

(2) adding poloxamer into deionized water, and stirring at 16-20 ℃ until the poloxamer is completely dissolved to be in a transparent state;

(3) adding electrolytic silver ion antibacterial agent, flos Matricariae Chamomillae extract, flos Rosae Rugosae extract and glycerol, and stirring.