Efficient gynecological antibacterial liquid and preparation method thereof

Abstract

The invention discloses efficient gynecological antibacterial liquid and a preparation method thereof, and belongs to the technical field of medical instruments. The efficient gynecological antibacterial liquid is prepared from active ingredients, auxiliaries and deionized water, the active component is prepared from the following raw materials: zein, a chitosan derivative, metal ions, fullerene and epsilon-polylysine; the efficient gynecological antibacterial liquid does not contain a vitamin B component, and the preparation raw materials do not contain the vitamin B component. The efficient gynecological antibacterial liquid does not contain vitamin B, artificial essence and plant-derived aromatic substances, has no unpleasant smell when in use, and has good antibacterial performance.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular to a highly effective gynecological antibacterial liquid and a preparation method thereof. Background Art

[0002] Gynecological antibacterial liquid is a personal care product designed for women. It plays an important role in maintaining the health of the female reproductive system. Gynecological antibacterial liquid is essential for maintaining female reproductive health. It helps prevent and control bacterial and fungal infections and maintains the natural balance of vaginal microecology, which is essential to resist the overgrowth of harmful microorganisms. In addition, this type of product improves women's comfort and quality of life by reducing odor and itching. Gynecological antibacterial liquids usually have mild ingredients and are designed to reduce irritation to the sensitive vaginal mucosa and ensure safe use. They are easy to use and help women pay more attention to personal hygiene and promote regular gynecological examinations.

[0003] CN114767708A discloses a stable gynecological antibacterial composition and gynecological care solution, the main components of which are ε-polylysine; vitamin B; and zein / chitosan derivatives. Experiments have shown that the antibacterial composition has excellent fungal and bacterial inhibition activity under acidic, neutral and alkaline conditions, and the antibacterial composition can significantly reduce the expression level of inflammatory factors in vaginal epithelial cells. Vitamin B has no obvious antibacterial activity, but it is essential to maintain the high antibacterial activity of the composition. Comparative tests have confirmed that the composition without vitamin B shows lower fungal and bacterial antibacterial activity. The gynecological care solution with vitamin B added has a faint unpleasant taste.

[0004] Fullerene C60, also known as buckyballs because of its structure similar to a traditional English soccer ball, has a wide range of applications due to its unique physical and chemical properties. Summary of the invention

[0005] In view of the above problems, the researchers of the present invention found in the study of gynecological antibacterial liquid that after adding fullerene, with the assistance of metal ions, vitamin B is no longer a necessary component. Not adding vitamin B has no significant effect on the sterilization rate of bacteria and fungi in gynecological antibacterial liquid.

[0006] The first aspect of the present invention is to disclose a highly effective gynecological antibacterial liquid, comprising active ingredients, adjuvants, and deionized water;

[0007] The raw materials for preparing the active ingredient include zein, chitosan derivatives, metal ions, fullerene and ε-polylysine;

[0008] The high-efficiency gynecological antibacterial liquid does not contain vitamin B components, and the preparation raw materials do not contain vitamin B components either.

[0009] In some embodiments of the present invention, the auxiliary agent includes at least one of a surfactant, a humectant and a preservative.

[0010] In some embodiments of the present invention, the chitosan derivative is at least one of acetylated chitosan, carboxymethyl chitosan, hydroxypropyl chitosan, sulfated chitosan, quaternized chitosan, and alkylated chitosan.

[0011] In some embodiments of the present invention, the metal ion is a divalent metal ion, preferably a magnesium ion or a calcium ion.

[0012] In some preferred embodiments of the present invention, the metal ion is a magnesium ion.

[0013] In some embodiments of the present invention, the fullerene is a water-soluble fullerene.

[0014] In some embodiments of the present invention, the zein, chitosan derivative, metal ions and fullerene form supported composite micelles.

[0015] In some embodiments of the present invention, the mass percentage concentration (w / v) of the ε-polylysine in the high-efficiency gynecological antibacterial liquid is 0.1-5%, preferably 0.5-2.5%;

[0016] And / or, the mass percentage concentration (w / v) of the supported composite colloid particles in the high-efficiency gynecological antibacterial liquid is 10-30%, preferably 20-25%.

[0017] In some preferred embodiments of the present invention, the mass percentage concentration (w / v) of the ε-polylysine in the high-efficiency gynecological antibacterial liquid is lower than 3%.

[0018] In some embodiments of the present invention, in the loaded composite micelles, the weight ratio of zein, chitosan derivatives, metal ions and fullerenes is (10-50): (0.1-5): (0.1-1): (0.005-0.03), preferably (20-30): (0.5-1.5): (0.1-1): (0.01-0.02).

[0019] In some embodiments of the present invention, the mass percentage concentration (w / v) of the surfactant in the high-efficiency gynecological antibacterial liquid is 1-5%;

[0020] And / or, the mass percentage concentration (w / v) of the moisturizing agent in the high-efficiency gynecological antibacterial liquid is 1-3%;

[0021] And / or, the mass percentage concentration (w / v) of the preservative in the high-efficiency gynecological antibacterial liquid is 0.1-0.5%.

[0022] The second aspect of the present invention is to disclose a method for preparing the high-efficiency gynecological antibacterial liquid according to the first aspect, comprising the following steps:

[0023] S01, using zein, chitosan derivatives, metal ions and fullerene as raw materials to prepare loaded composite colloid particles;

[0024] S02, the loaded composite colloid particles obtained in step S01 are mixed with ε-polylysine, an auxiliary agent and water to obtain a high-efficiency gynecological antibacterial liquid.

[0025] In some embodiments of the present invention, S01 includes the following steps:

[0026] S11, slowly adding the zein ethanol solution dropwise to the hydroxypropyltrimethylammonium chloride chitosan aqueous solution, stirring; removing the ethanol by rotary evaporation, centrifuging, and freeze-drying the supernatant;

[0027] S12, add ionized water, add metal ions and fullerene, stir, and freeze-dry again.

[0028] In some embodiments of the present invention, S02 further includes a step of adjusting pH.

[0029] In some embodiments of the present invention, in S02, the pH is 3.5-5.

[0030] Beneficial effects:

[0031] The high-efficiency gynecological antibacterial liquid of the present invention does not add vitamin B, artificial flavors and aromatic substances from plant sources, has no unpleasant odor when used, and has good antibacterial performance. DETAILED DESCRIPTION

[0032] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0033] Unless otherwise specified, the examples and comparative examples are parallel tests with the same parameters such as components, component contents, preparation steps, preparation parameters, and sizes. The fullerene is a water-soluble fullerene, i.e., a hydroxylated derivative. The vitamin B is a B complex vitamin. The surfactant is cocamidopropyl betaine, the moisturizer is sodium hyaluronate, and the preservative is methylchloroisothiazolinone.

[0034] Example 1

[0035] A method for preparing a highly effective gynecological antibacterial liquid comprises the following steps:

[0036] 1 Preparation of composite particles:

[0037] 1.1 Prepare a 1% (w / v) zein solution with zein and 70% (v / v) ethanol aqueous solution, slowly add it to a 1% (w / v) methyl chitosan aqueous solution, stir and mix; remove ethanol by rotary evaporation, centrifuge, and freeze-dry the supernatant; wherein, zein 23g, methyl chitosan 1g;

[0038] 1.2 Add ionized water, 0.5 g magnesium chloride and 15 mg fullerene, based on 10 ml deionized water per 1 g, stir, and freeze-dry again;

[0039] 2 Preparation of gynecological antibacterial solution

[0040] Mix with 1 g of ε-polylysine, add deionized water, 3 g of surfactant, 2 g of humectant, 0.2 g of preservative, make up to 100 mL, stir, and adjust the pH to 4.2 ± 0.2.

[0041] Comparative Example 1

[0042] A method for preparing a highly effective gynecological antibacterial liquid comprises the following steps:

[0043] 1 Preparation of composite particles:

[0044] 1.1 Prepare a 1% (w / v) zein solution with zein and 70% (v / v) ethanol aqueous solution, slowly add it to a 1% (w / v) methyl chitosan aqueous solution, stir and mix; remove ethanol by rotary evaporation, centrifuge, and freeze-dry the supernatant; wherein, zein 23g, methyl chitosan 1g;

[0045] 1.2 Add ionized water, 0.5 g magnesium chloride, 15 mg fullerene and 0.5 g vitamin B, based on 10 ml deionized water per 1 g, stir and freeze-dry again;

[0046] 2 Preparation of gynecological antibacterial solution

[0047] Mix with 1 g of ε-polylysine, add deionized water, 3 g of surfactant, 2 g of humectant, 0.2 g of preservative, make up to 100 mL, stir, and adjust the pH to 4.2 ± 0.2.

[0048] Comparative Example 2

[0049] A method for preparing a highly effective gynecological antibacterial liquid comprises the following steps:

[0050] 1 Preparation of composite particles:

[0051] A 1% (w / v) zein solution is prepared by using zein and 70% (v / v) ethanol aqueous solution, and the solution is slowly added to a 1% (w / v) methyl chitosan aqueous solution, and stirred to mix; the ethanol is removed by rotary evaporation, centrifuged, and the supernatant is freeze-dried; wherein the zein solution contains 23g and the methyl chitosan solution contains 1g;

[0052] 2 Preparation of gynecological antibacterial solution

[0053] Mix with 1 g of ε-polylysine, add deionized water, 3 g of surfactant, 2 g of humectant, 0.2 g of preservative, make up to 100 mL, stir, and adjust the pH to 4.2 ± 0.2.

[0054] Example 2

[0055] A method for preparing a highly effective gynecological antibacterial liquid comprises the following steps:

[0056] 1 Preparation of composite particles:

[0057] 1.1 Prepare a 1% (w / v) zein solution with zein and 70% (v / v) ethanol aqueous solution, slowly add it to a 1% (w / v) methyl chitosan aqueous solution, stir and mix; remove ethanol by rotary evaporation, centrifuge, and freeze-dry the supernatant; wherein, zein 23g, methyl chitosan 1g;

[0058] 1.2 Add ionized water, 0.5 g magnesium chloride and 15 mg fullerene, based on 10 ml deionized water per 1 g, stir, and freeze-dry again;

[0059] 2 Preparation of gynecological antibacterial solution

[0060] Mix with 0.5 g ε-polylysine, add deionized water, 3 g surfactant, 2 g humectant, 0.2 g preservative, make up to 100 mL, stir, and adjust the pH to 4.2 ± 0.2.

[0061] Example 3

[0062] A method for preparing a highly effective gynecological antibacterial liquid comprises the following steps:

[0063] 1 Preparation of composite particles:

[0064] 1.1 Prepare a 1% (w / v) zein solution with zein and 70% (v / v) ethanol aqueous solution, slowly add it to a 1% (w / v) methyl chitosan aqueous solution, stir and mix; remove ethanol by rotary evaporation, centrifuge, and freeze-dry the supernatant; wherein, zein 23g, methyl chitosan 1g;

[0065] 1.2 Add ionized water, 0.5 g magnesium chloride and 15 mg fullerene, based on 10 ml deionized water per 1 g, stir, and freeze-dry again;

[0066] 2 Preparation of gynecological antibacterial solution

[0067] Mix with 1.5 g ε-polylysine, add deionized water, 3 g surfactant, 2 g humectant, 0.2 g preservative, make up to 100 mL, stir, and adjust the pH to 4.2 ± 0.2.

[0068] Example 4

[0069] A method for preparing a highly effective gynecological antibacterial liquid comprises the following steps:

[0070] 1 Preparation of composite particles:

[0071] 1.1 Prepare a 1% (w / v) zein solution with zein and 70% (v / v) ethanol aqueous solution, slowly add it to a 1% (w / v) methyl chitosan aqueous solution, stir and mix; remove ethanol by rotary evaporation, centrifuge, and freeze-dry the supernatant; wherein, zein 23g, methyl chitosan 1g;

[0072] 1.2 Add ionized water, 0.5 g magnesium chloride and 15 mg fullerene, based on 10 ml deionized water per 1 g, stir, and freeze-dry again;

[0073] 2 Preparation of gynecological antibacterial solution

[0074] Mix with 2 g of ε-polylysine, add deionized water, 3 g of surfactant, 2 g of humectant, 0.2 g of preservative, make up to 100 mL, stir, and adjust the pH to 4.2 ± 0.2.

[0075] Example 5

[0076] The difference from Example 1 is that magnesium chloride is replaced by an equimolar amount of calcium chloride.

[0077] Performance test bactericidal performance

[0078] The gynecological antibacterial liquids of Examples 1-5 and Comparative Examples 1 and 2 were subjected to sterilization test according to the detection method in Appendix C of "GB15979-2002 Hygienic Standard for Disposable Hygienic Products".

[0079] The results show that the sterilization rates of Staphylococcus aureus and Candida albicans of the gynecological antibacterial liquid of Example 1 are 96% and 93% respectively; while those of Comparative Example 1 are 95% and 94% respectively, and the difference is not significant. The sterilization rates of Staphylococcus aureus and Candida albicans of Comparative Example 2 are 85% and 81% respectively, which are significantly lower than those of Example 1 and Comparative Example 1. The results show that the sterilization performance of Example 1 without the addition of vitamin B is equivalent to that of Comparative Example 1, while the sterilization performance of Comparative Example 2 without the addition of vitamin B is significantly lower than that of Comparative Example 1, which indicates that vitamin B is no longer necessary for improving the sterilization performance of ε-polylysine and methyl chitosan-loaded zein in the presence of metal ions and fullerenes.

[0080] The results showed that compared with Example 1, the sterilization rates of Example 2 and Example 4 were slightly improved, and Example 3 was significantly improved, reaching 97% and 95%. The study also found that after adding more than 3g of ε-polylysine, the gynecological antibacterial liquid was prone to stratification after long-term sunlight exposure.

[0081] The results showed that compared with Example 1, the sterilization rate of Example 5 was slightly lower (P<0.05), indicating the influence of different metal ions.

[0082] The preferred specific implementation modes and embodiments of the present invention are described in detail above, but the present invention is not limited to the above implementation modes and embodiments, and various changes can be made within the knowledge scope of those skilled in the art without departing from the concept of the present invention.

Claims

1. A highly effective gynecological antibacterial liquid, characterized in that: Including active ingredients and additives, deionized water; The raw materials for preparing the active ingredient include zein, chitosan derivatives, metal ions, fullerene and ε-polylysine; The high-efficiency gynecological antibacterial liquid does not contain vitamin B components, and the preparation raw materials do not contain vitamin B components either.

2. The high-efficiency gynecological antibacterial liquid according to claim 1, characterized in that: The auxiliary agent includes at least one of a surfactant, a moisturizer and a preservative.

3. The high-efficiency gynecological antibacterial liquid according to claim 1 or 2, characterized in that: The chitosan derivative is at least one of acetylated chitosan, carboxymethyl chitosan, hydroxypropyl chitosan, sulfated chitosan, quaternized chitosan, and alkylated chitosan; And / or, the metal ion is a divalent metal ion, preferably a magnesium ion or a calcium ion; And / or, the fullerene is a water-soluble fullerene.

4. The high-efficiency gynecological antibacterial liquid according to any one of claims 1 to 3, characterized in that: The zein, chitosan derivatives, metal ions and fullerene form loaded composite colloid particles.

5. The high-efficiency gynecological antibacterial liquid according to any one of claims 1 to 4, characterized in that: The mass percentage concentration (w / v) of the ε-polylysine in the high-efficiency gynecological antibacterial liquid is 0.1-5%, preferably 0.5-2.5%; And / or, the mass percentage concentration (w / v) of the supported composite colloid particles in the high-efficiency gynecological antibacterial liquid is 10-30%, preferably 20-25%.

6. The high-efficiency gynecological antibacterial liquid according to any one of claims 1 to 5, characterized in that: In the loaded composite micelles, the weight ratio of zein, chitosan derivatives, metal ions and fullerenes is (10-50): (0.1-5): (0.1-1): (0.005-0.03), preferably (20-30): (0.5-1.5): (0.1-1): (0.01-0.02).

7. The high-efficiency gynecological antibacterial liquid according to any one of claims 1 to 6, characterized in that: The mass percentage concentration (w / v) of the surfactant in the high-efficiency gynecological antibacterial liquid is 1-5%; And / or, the mass percentage concentration (w / v) of the moisturizing agent in the high-efficiency gynecological antibacterial liquid is 1-3%; And / or, the mass percentage concentration (w / v) of the preservative in the high-efficiency gynecological antibacterial liquid is 0.1-0.5%.

8. A method for preparing a highly effective gynecological antibacterial liquid according to any one of claims 1 to 7, characterized in that: The following steps are involved: S01, using zein, chitosan derivatives, metal ions and fullerene as raw materials to prepare loaded composite colloid particles; S02, the loaded composite colloid particles obtained in step S01 are mixed with ε-polylysine, an auxiliary agent and water to obtain a high-efficiency gynecological antibacterial liquid.

9. The high-efficiency gynecological antibacterial liquid according to claim 8, characterized in that: S01 includes the following steps: S11, slowly adding the zein ethanol solution dropwise to the hydroxypropyltrimethylammonium chloride chitosan aqueous solution, stirring; removing the ethanol by rotary evaporation, centrifuging, and freeze-drying the supernatant; S12, add ionized water, add metal ions and fullerene, stir, and freeze-dry again.

10. The high-efficiency gynecological antibacterial liquid according to claim 8 or 9, characterized in that: S02 also includes a step of adjusting pH.