Gongyanqing solution and preparation method thereof

Abstract

The invention relates to the field of vaginal irrigation, in particular to a Gongyanqing solution and a preparation method thereof. The hysteritis removing solution is prepared from the following raw materials in parts by mass: 30 to 40 parts of policresulen, 40 to 50 parts of cosolvent, 0.8 to 1.2 parts of preservative and 5 to 30 parts of purified water. The preparation method comprises the following steps: mixing and heating a cosolvent and a preservative, then adding policresulen, stirring, adding purified water, and adjusting the pH value to be acidic to obtain a semi-finished product hysteritis clearing solution; and filtering, filling, sealing and packaging the semi-finished product hysteritis clearing solution to obtain the hysteritis clearing solution. The Gongyanqing solution prepared by the invention breaks through the dissolvability limitation of high-concentration policresulen through solvent system optimization and pH regulation and control, obviously improves the drug effect and clinical applicability on the premise of ensuring the safety, and has important clinical value and market potential.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of vaginal irrigation, in particular to a Gongyanqing solution and a preparation method thereof. BACKGROUND

[0002] Polymyxin sulfobenzimidazole has broad-spectrum antibacterial effect, including common gram-positive bacteria, gram-negative bacteria, mold and virus, etc. Polymyxin sulfobenzimidazole has been used for treating cervical erosion for decades in foreign countries. It can rapidly kill trichomonas, gram-positive bacteria, gram-negative bacteria, mold and virus, etc. It has good effect in sterilization and is beneficial to restore the acidic environment of the vagina. However, the solubility of polymyxin sulfobenzimidazole is low, and it is less used in animals. Therefore, a high-concentration polymyxin sulfobenzimidazole solution with good stability and bactericidal effect for chronic endometritis, cervicitis and vaginitis of cattle and pigs is needed. SUMMARY

[0003] In view of the above problems, the present application provides a Gongyanqing solution which has good effect on chronic endometritis, cervicitis and vaginitis of cattle and pigs.

[0004] In order to achieve the above-mentioned purpose, the present application provides a Gongyanqing solution, which is composed of the following mass parts of raw materials: 30-40 parts of polymyxin sulfobenzimidazole, 40-50 parts of a cosolvent, 0.8-1.2 parts of a preservative, and 5-30 parts of purified water.

[0005] Further, the cosolvent is propylene glycol or ethanol.

[0006] Further, the preservative is benzyl alcohol or potassium sorbate.

[0007] A preparation method of a Gongyanqing solution, comprising the following steps: S1, mixing and heating the cosolvent and the preservative, then adding polymyxin sulfobenzimidazole and stirring, adding purified water and adjusting the pH value to be acidic to obtain a semi-finished Gongyanqing solution; S2, filtering, filling, sealing and packaging the semi-finished Gongyanqing solution to obtain the Gongyanqing solution.

[0008] Further, the heating is heated to 55-65℃.

[0009] Further, the stirring is at a speed of 250-300 rpm for 15 min.

[0010] Further, the pH value is adjusted to 3.0-3.5.

[0011] Further, the filter membrane has a pore size of less than 0.45 μm.

[0012] In summary, the present application has the following beneficial effects: The Gongyanqing solution prepared in this application, through solvent system optimization and pH control, overcomes the solubility limitations of high-concentration polycresolsulfonate, significantly improving efficacy and clinical applicability while ensuring safety, and has important clinical value and market potential. Detailed Implementation

[0013] The technical solutions in the embodiments of this application will be clearly and completely described below with reference to the embodiments of this application. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0014] The raw materials used in the specific embodiments of this application are analytical grade. Additionally, polycresolsulfonate was purchased from Hubei Changxinsheng Chemical Co., Ltd., product number: CS02266, with a purity of 99%.

[0015] Example 1 A method for preparing a uterine inflammation clearing solution includes the following steps: S1. Mix 0.8g benzyl alcohol and 40g propylene glycol (80rpm) for 5min, then heat to 55℃, then add 30g polycresolsulfonate and stir (250rpm) for 15min, add 30g purified water, and adjust the pH to 3.0 with 0.1mol / hydrochloric acid to obtain the semi-finished Gongyanqing solution. S2. Filter the semi-finished Gongyanqing solution through a 0.45μm filter, fill, seal and package to obtain Gongyanqing solution.

[0016] Example 2 A method for preparing a uterine inflammation clearing solution includes the following steps: S1. Mix 1g benzyl alcohol and 45g propylene glycol (80rpm) for 5min, then heat to 60℃, add 35g polycresolsulfonate and stir (280rpm) for 15min, add 25g purified water, and adjust the pH to 3.3 with 0.1mol / L hydrochloric acid to obtain the semi-finished Gongyanqing solution. S2. Filter the semi-finished Gongyanqing solution through a 0.45μm filter, fill, seal and package to obtain Gongyanqing solution.

[0017] Example 3 A method for preparing a uterine inflammation clearing solution includes the following steps: S1. Mix 1.2g benzyl alcohol and 50g propylene glycol (80rpm) for 5min, then heat to 65℃, then add 40g polycresolsulfonate and stir (300rpm) for 15min, add 20g purified water, and adjust the pH to 3.5 with 0.1mol / L hydrochloric acid to obtain the semi-finished Gongyanqing solution. S2. Filter the semi-finished Gongyanqing solution through a 0.45μm filter, fill, seal and package to obtain Gongyanqing solution.

[0018] Compare with Example 1 A method for preparing a uterine inflammation clearing solution includes the following steps: S1. Mix 1.2g benzyl alcohol and 50g propylene glycol (80rpm) for 5min, then heat to 65℃, then add 40g polycresolsulfonate and stir (300rpm) for 15min, add 20g purified water, and adjust the pH to 4.5 with 0.1mol / L hydrochloric acid to obtain the semi-finished Gongyanqing solution. S2. Filter the semi-finished Gongyanqing solution through a 0.45μm filter, fill, seal and package to obtain Gongyanqing solution.

[0019] Performance testing The quality of the Gongyanqing solution prepared in Examples 1-3 and Control Example 1 was tested.

[0020] Stability test: The uterine inflammation clear solution prepared in Examples 1-3 and Control Example 1 was placed at 40±2℃ and 75±5%RH for 6 months. The appearance of the solution was observed and the pH value was measured with a pH meter.

[0021] Antibacterial test: The antibacterial properties of the Gongyanqing solution prepared in Examples 1-3 and Control Example 1 were tested against Staphylococcus aureus using the agar diffusion method, and the diameter (mm) of the inhibition zone was measured. The results are shown in Table 1.

[0022] Table 1: Performance Test Results ; As shown in Table 1, the embodiments of this application still have good stability after being stored for 6 months. The appearance is reddish-brown and clear, and the pH only changes slightly. The antibacterial effect is very good. Compared with Example 3, the pH of Control Example 1 was adjusted to 4.5, which resulted in a darker color, a cloudy solution, and a significant decrease in pH after being stored for 6 months. The stability was not as good as that of Example 3.

[0023] In summary, the Gongyanqing solution prepared in the embodiments of this application has good stability and good antibacterial effect.

[0024] The above description is merely an example and illustration of the concept of this application. Those skilled in the art can make various modifications or additions to the specific embodiments described or use similar methods to replace them, as long as they do not deviate from the inventive concept or exceed the scope defined in the claims, they should all fall within the protection scope of this application.

Claims

1. A Gongyanqing solution, characterized in that, The Gongyanqing solution is composed of the following raw materials by mass fraction: 30-40 parts of policresulen, 40-50 parts of cosolvent, 0.8-1.2 parts of preservative, and 5-30 parts of purified water.

2. The Gongyanqing solution according to claim 1, characterized in that, The cosolvent is propylene glycol or ethanol.

3. The Gongyanqing solution according to claim 1, characterized in that, The preservative is benzyl alcohol or potassium sorbate.

4. A method for preparing Gongyanqing solution as claimed in any one of claims 1-3, characterized in that, The method comprises the following steps: S1, mixing benzyl alcohol and propylene glycol, heating, adding policresulen and stirring, adding purified water, adjusting the pH value to be acidic, and obtaining a semi-finished Gongyanqing solution; S2, filtering, filling, sealing, and packaging the semi-finished Gongyanqing solution to obtain the Gongyanqing solution.

5. The preparation method of Gongyanqing solution according to claim 4, characterized in that, The heating is to 55-65 DEG C.

6. The preparation method of Gongyanqing solution according to claim 4, characterized in that, The stirring is at a speed of 250-300 rpm for 15 min.

7. The preparation method of Gongyanqing solution according to claim 4, characterized in that, The pH value is adjusted to 3.0-3.

5.

8. The preparation method of Gongyanqing solution according to claim 4, characterized in that, The filtration is at a pore size of ≤0.45 μm.