CN114652800A

CN114652800A - External bacteriostatic lotion containing liquorice total flavonoids and preparation method thereof

Info

Publication number: CN114652800A
Application number: CN202210250133.9A
Authority: CN
Inventors: 冀祖恩; 李文慧; 张薇; 罗恒磊; 孙琰琴; 李玉薇; 于水莲
Original assignee: Xinjiang Quanan Pharmaceutical Co ltd
Current assignee: Xinjiang Quanan Pharmaceutical Co ltd
Priority date: 2022-03-14
Filing date: 2022-03-14
Publication date: 2022-06-24

Abstract

The invention provides an external bacteriostatic lotion containing licorice total flavonoids and a preparation method thereof; the bacteriostatic lotion comprises the following components in percentage by weight: 20 to 60 percent of radix sophorae flavescentis, 30 to 55 percent of radix stemonae, 1 to 35 percent of phellodendron, 1 to 35 percent of fructus cnidii, 0.1 to 3 percent of liquorice total flavone dissolved solution and 0.01 to 0.3 percent of chlorhexidine acetate stock solution. The invention relates to an antibacterial lotion prepared by compounding radix sophorae flavescentis, radix stemonae, cortex phellodendri, fructus cnidii, chlorhexidine acetate and liquorice total flavonoids; the product prepared by the preparation method has high safety, good stability and strong bacteriostatic effect, and has strong bacteriostatic action on staphylococcus aureus, escherichia coli and candida albicans.

Description

External bacteriostatic lotion containing liquorice total flavonoids and preparation method thereof

Technical Field

The invention relates to the technical field of personal care disinfection products, in particular to an external bacteriostatic lotion containing licorice total flavonoids and a preparation method thereof.

Background

The Glycyrrhrizae radix is dry root and rhizome of Glycyrrhiza uralensis Fisch, Glycyrrhiza inflata Bat or Glycyrrhiza glabra L of Glycyrrhiza of Leguminosae, has effects of invigorating spleen and replenishing qi, eliminating phlegm and relieving cough, relieving spasm and pain, clearing heat and detoxicating, has good effects of resisting Staphylococcus aureus and Candida albicans, resisting inflammation, killing parasite, resisting tumor, and harmonizing all drugs, and is an important drug in all generations. The main bioactive substances of the liquorice are triterpenoid saponins and flavonoids, wherein the licoflavone has wide pharmacological actions such as bacteriostasis, antifungal activity, antiviral immunity, antitumor activity, antioxidant activity and the like, the licoflavone extract can be extracted from the liquorice and can also be extracted from liquorice residues, the high-efficiency utilization of resources is facilitated, waste is turned into wealth, new values are created, and the liquorice total flavone is increasingly paid attention to by people in the characteristics of pure nature, high activity, quick response, wide action and the like.

The gynecological disease is a common clinical disease, and female reproductive organs are easily interfered by in-vivo and in-vitro adverse factors due to the special physiological structure of the female reproductive organs, so that the gynecological disease of vaginitis is easily caused and is not easy to heal quickly. Under normal conditions, the immune defense system of the female reproductive system can fully defend and resist external bacteria and protect the health of the vagina, but when the system is damaged, bacteria (such as staphylococcus aureus, escherichia coli), fungi (candida albicans) and other bacteria can propagate in large quantities to cause uncomfortable symptoms of vaginitis. Currently oral administration and vaginal topical treatment are the primary methods of clinical treatment for vaginitis. Because of the long treatment time and high recurrence rate of vaginitis, vaginal irrigation is one of the important methods for treating vaginitis. Therefore, the development of the mild external bacteriostatic lotion for inhibiting mass propagation of bacteria and fungi and maintaining the ecological balance of flora in the vagina has important significance.

At present, western medicine therapy mainly adopts antibiotics, but the generation of drug resistance of strains, ecological imbalance of flora in vagina and weakening of self defense function can be caused by long-term use of a large amount of antibiotics, so that the condition of the disease is aggravated, and in addition, the generation of drug resistance of bacteria and fungi also brings great problems to treatment. Can effectively inhibit staphylococcus aureus, escherichia coli and candida albicans, and has the advantages of high safety, wide applicability and the like.

Disclosure of Invention

The invention aims to provide an external bacteriostatic lotion containing licorice total flavonoids and a preparation method thereof.

The invention is realized by the following technical scheme:

the invention relates to an external bacteriostatic lotion containing licorice total flavonoids, which comprises lightyellow sophora root, sessile stemona root, amur corktree bark, common cnidium fruit, licorice total flavonoids and chlorhexidine acetate.

Preferably, the composition comprises the following components in percentage by weight: 20 to 60 percent of radix sophorae flavescentis, 30 to 55 percent of radix stemonae, 1 to 35 percent of phellodendron, 1 to 35 percent of fructus cnidii, 0.1 to 3 percent of liquorice total flavone dissolved solution and 0.01 to 0.3 percent of chlorhexidine acetate stock solution.

Flavescent sophora root: matrine and oxymatrine in radix Sophorae Flavescentis have wide bioactivity, and the research on the effects of resisting tumor, bacteria, mold, parasite, inflammation, immunity regulation, cell protection and fibrosis is also popularized in the gynecological field.

Stemona root: the traditional Chinese medicine stemona root is a traditional cough-relieving and insecticidal medicine, mainly contains stemona alkaloid, and has pharmacological effects of relieving cough, eliminating phlegm, killing insects, resisting bacteria and the like.

Phellodendron bark: cortex phellodendri is commonly used in clinic as a traditional Chinese medicine, has the effects of eliminating dampness and clearing heat, detoxifying and purging intense heat, and removing putrefaction and diminishing swelling, has main chemical components of flavonoids and alkaloids, and has various pharmacological effects of reducing blood sugar, reducing blood pressure, suppressing immunity and the like.

Fructus cnidii: the coumarin compound mainly containing osthole as active component has antiinflammatory, analgesic, antibacterial, antipruritic, antioxidant and neuroprotective effects.

Dissolving liquorice total flavonoids: has antibacterial, antifungal, antiviral, antitumor, and antioxidant effects.

Chlorhexidine acetate stock solution: the disinfectant is a common disinfectant, and is clinically used for disinfecting skin and mucous membranes due to the characteristics of good stability, low corrosivity, good sterilization effect and the like.

The invention also relates to a preparation method of the external bacteriostatic lotion containing the licorice total flavonoids, which comprises the following steps:

step 1, processing medicinal materials: cleaning radix Sophorae Flavescentis, radix Stemonae, cortex Phellodendri, and fructus Cnidii;

step 2, the extraction process of the medicinal materials: weighing the processed medicinal materials according to the prescription amount, soaking for 1-3 hours, extracting twice with a solvent, filtering, and combining the filtrates to obtain a traditional Chinese medicine extracting solution;

step 3, preparing a chlorhexidine acetate stock solution: weighing a solvent for chlorhexidine acetate powder, preparing a 10g/L chlorhexidine acetate solution, and storing in dark for later use;

step 4, preparing a liquorice total flavone dissolved solution: weighing 1g of licorice total flavonoids, adding a proper amount of propylene glycol to dissolve at room temperature, stirring, standing, and taking supernatant for later use to obtain a solution with the concentration of 0.1-5%;

step 5, standing and centrifuging the medicinal material clarified liquid: standing the Chinese medicinal extractive solution overnight, and centrifuging the supernatant at low speed to obtain Chinese medicinal clarified solution;

step 6, mixing treatment: taking the traditional Chinese medicine clarified liquid, the chlorhexidine acetate stock solution and the licorice total flavone dissolved solution according to the proportion, and stirring and mixing the traditional Chinese medicine clarified liquid, the chlorhexidine acetate stock solution and the licorice total flavone dissolved solution uniformly;

and 7, filling and storing: placing in shade after filling.

Preferably, in step 2, the two-time extraction process specifically includes: the first extraction with 5-15 times of water for 1-5 hours and the second extraction with 5-20 times of water for 1-3 hours.

Preferably, in step 2, the solvent used for the extraction is ethanol, propanol or purified water.

Preferably, the solvent used for the extraction is purified water.

Preferably, step 3 further comprises: the screening of the licorice extract comprises the following specific steps: in vitro bacteriostatic experiments are respectively carried out on staphylococcus aureus, escherichia coli and candida albicans by using monoammonium glycyrrhizinate, dipotassium glycyrrhizinate and licorice total flavonoids, and finally the licorice total flavonoids with the optimal bacteriostatic effect are three extracts.

Preferably, the final concentration of the licorice total flavonoids is 0.1-3%, and the concentration of the chlorhexidine solution is 0.01-0.3%.

The externally applied bacteriostatic lotion containing licorice total flavone prepared by the invention overcomes the defects and shortcomings of the existing gynecological lotion, and aims at solving the problems that gynecological medicines destroy vaginal flora, are easy to relapse and have drug resistance in the using process of antibiotic chemicals. The invention is prepared by taking the liquorice extract with strong bacteriostatic action and other four traditional Chinese medicinal materials as raw materials and compounding with chlorhexidine acetate disinfectant, so that the gynecological lotion has strong bacteriostatic action, reduces the generation of drug-resistant flora and maintains the acidic environment of vagina.

The invention has the following advantages:

(1) the invention relates to an antibacterial lotion prepared by compounding radix sophorae flavescentis, radix stemonae, cortex phellodendri, fructus cnidii, chlorhexidine acetate and liquorice total flavonoids; according to the results of repeated experiments on the amount of added decoction and the amount of liquid medicine received, the invention develops experimental research on the decoction process and determines the decoction endpoint so as to determine the decoction time. According to the single-dose decoction process, extraction time, added water amount and the like determined by examination, the diameter of the bacteriostatic zone is taken as an evaluation index, the process is amplified, the production process of a material standard is determined, and key production process steps are determined; the product prepared by the preparation method has high safety, good stability and strong bacteriostatic effect, and has strong bacteriostatic action on staphylococcus aureus, escherichia coli and candida albicans.

(2) The invention takes the licorice extract with bacteriostasis and other traditional Chinese medicine components as raw materials to combine with a chemical disinfectant to play a role; the finally prepared bacteriostatic lotion can effectively inhibit pudendum infection caused by staphylococcus aureus, escherichia coli and candida albicans.

Drawings

FIG. 1 is a graph showing the bacteriostatic effect of Staphylococcus aureus in comparison with Fuyanjie, Jieeryin and Hongju lotion in example 4 (actual concentration is prepared according to the usage amount in the specification);

FIG. 2 is a graph showing the effect of the bacteriostatic test on Escherichia coli in comparison with Fuyanjie lotion, Jieeryin lotion and Hongyao lotion in example 4 (actual concentrations are prepared according to the usage amounts in the specification);

FIG. 3 is a graph showing the effect of example 4 in comparison with Fuyanjie, Jieeryin and Hongyao washing liquid in Candida albicans bacteriostasis experiments (actual concentration is prepared according to the usage amount in the specification).

Detailed Description

The present invention will be described in detail with reference to specific examples. It should be noted that the following examples are only illustrative of the present invention, but the scope of the present invention is not limited to the following examples.

Comparison of antibacterial effects

Example 1

The embodiment relates to an antibacterial lotion for female vulva, which is prepared by mixing the following components: 10 to 20 percent of liquorice, 20 to 25 percent of radix sophorae flavescentis, 10 to 20 percent of phellodendron, 5 to 10 percent of radix stemonae, 10 to 15 percent of fructus cnidii, 6 to 12 percent of gallnut, 1.5 percent of vitamin E and 0.05 percent of chlorhexidine acetate.

The preparation method comprises the following steps:

(1) treatment of medicinal materials: cleaning the medicinal materials. The method comprises the following steps: false, inferior, worm, mildew and rot and the like cannot be caused, and medicinal materials are clean and the like.

(2) The extraction operation process comprises the following steps: weighing the treated medicinal materials according to the production process, soaking for two hours, extracting with water twice, wherein the first time is 5-10 times of water for 1-5 hours, the second time is 8-10 times of water for 1-3 hours, and then concentrating into 50-80% of liquid medicine.

(3) Standing: standing overnight, collecting supernatant, centrifuging, filtering, adding chlorhexidine to obtain 0.05% -0.25% solution, detecting chlorhexidine acetate concentration, and establishing quality standard.

(4) Filling, and placing in shade.

Example 2

The embodiment relates to an antibacterial lotion for female vulva, which is prepared by mixing the following components: 20 to 25 percent of radix sophorae flavescentis, 15 to 25 percent of phellodendron, 10 to 15 percent of radix stemonae, 10 to 15 percent of fructus cnidii, 10 to 15 percent of gallnut, 0.05 to 0.1 percent of chlorhexidine acetate and 0.05 to 0.1 percent of dipotassium glycyrrhizinate.

The preparation method comprises the following steps:

(1) treatment of medicinal materials: cleaning and selecting the medicinal materials, and requiring: false, inferior, worm, mildew and rot and the like can not be generated.

(2) The extraction and concentration process comprises the following steps: weighing the processed medicinal materials according to the prescription, soaking for two hours, extracting with water twice, the first extraction with 5-10 times of water for 2-3 hours, the second extraction with 5-8 times of water for 1-5 hours, and then concentrating to 1/5-1/8 of the liquid medicine extract.

(3) Standing and centrifuging: standing overnight, collecting supernatant, centrifuging, filtering, adding 0.05-2% chlorhexidine and 1-3% dipotassium glycyrrhizinate, and mixing.

(4) Filling and storing: placing in shade after filling.

Example 3

The embodiment relates to an antibacterial lotion for female vulva, which is prepared by mixing the following components: 20 to 30 percent of radix sophorae flavescentis, 20 to 25 percent of phellodendron, 10 to 15 percent of radix stemonae, 10 to 20 percent of fructus cnidii, 10 to 15 percent of gallnut, 0.01 to 0.1 percent of chlorhexidine acetate and 0.5 to 0.1 percent of dipotassium glycyrrhizinate.

The preparation method comprises the following steps:

(2) The extraction and concentration process comprises the following steps: weighing the processed medicinal materials according to the formula amount, soaking for two hours, extracting with water twice, extracting for 1-3 hours by 5-15 times of water for the first time and 1-3 hours by 5-20 times of water for the second time, filtering and concentrating to obtain an extracting solution.

Example 4

The embodiment relates to a bacteriostatic lotion for female vulva, which comprises the following components: 20 to 60 percent of radix sophorae flavescentis, 30 to 55 percent of radix stemonae, 1 to 35 percent of phellodendron, 1 to 35 percent of fructus cnidii and 0.1 to 3 percent of liquorice total flavone dissolved solution and 0.01 to 0.3 percent of chlorhexidine acetate stock solution which are dissolved by propanedione are added after the traditional Chinese medicine clarified solution is prepared.

The preparation method comprises the following steps:

1. treatment of medicinal materials: cleaning and selecting lightyellow sophora root, sessile stemona root, amur corktree bark and common cnidium fruit, and requiring that: false, inferior, worm, mildew and rot and the like can not be generated.

2. The extraction process of the medicinal materials comprises: weighing the treated medicinal materials according to the formula amount, soaking for 1-3 hours, extracting with water twice, extracting with 5-15 times of water for 1-5 hours for the first time and extracting with 5-20 times of water for 1-3 hours for the second time, filtering, and mixing the filtrates.

3. Preparing a chlorhexidine acetate stock solution: weighing chlorhexidine acetate powder, dissolving with purified water solution to obtain chlorhexidine acetate solution, and storing in dark place.

4. Preparing a liquorice total flavone dissolved solution: weighing Glycyrrhrizae radix total flavone, dissolving with appropriate amount of propylene glycol at room temperature, stirring for several minutes, standing, and collecting supernatant for use.

5. Standing and centrifuging the medicinal material clarified liquid: standing the Chinese medicinal extractive solution overnight, and centrifuging the supernatant at low speed to obtain Chinese medicinal clarified solution.

6. Mixing process: taking a proper amount of Chinese medicinal clarified solution, adding chlorhexidine acetate stock solution and Glycyrrhrizae radix total flavone dissolved solution according to the given ratio, and mixing well.

7. Filling and storing: filling in dark place in shade.

Contrast case of antibacterial effect of antibacterial lotion production process

The antibacterial lotion prepared in the embodiment 1-4 is compared with the antibacterial efficacy of Fuyanjie (F), Jieeryin (J) and Hongnuclear lotion (H) in experiments (actual concentration is prepared according to the usage amount of the specification):

test strains: staphylococcus aureus (CMCC (B)26003), Escherichia coli (CMCC (B)44102) and Candida albicans (CMCC (F)98001), and is prepared into 1 × 10⁸CFU/mL～5×10⁸CFU/mL test bacterial suspension.

(1) Preparation of a sterile filter paper sheet: cutting Xinhua I qualitative filter paper into 6mm diameter, sterilizing with pressure steam, oven drying at 120 deg.C for 2 hr, and storing.

(2) Preparation of actual use concentration bacteriostatic agent solution (actual concentration is prepared according to the usage amount in the specification): the usage amount of Fuyanjie (number: F) and case four (number: Q) is to take the stock solution for direct use, i.e. to take the stock solution without dilution; the Jieeryin lotion (number: J) and the Hongyao Fujie lotion (number: H) are prepared by taking 10ml of liquid medicine in a dilution bottle, heating boiled water to 100ml, shaking up for use, and taking the stock solution to dilute 10 times for later use.

(3) The preparation of the bacteriostatic tablet comprises taking sterile and dry filter paper for liquid bacteriostatic agent. Each filter paper is dripped with 20 mu L of bacteriostatic agent solution with actual use concentration, then the filter paper is horizontally placed in a clean sterile plate, and the plate is uncovered and placed in an incubator (37 ℃) to be baked for later use.

(4) And (3) preparing a negative control sample sheet, namely taking a sterile dry filter paper sheet, dropwise adding 20 mu L of sterile distilled water into each sheet, and drying for later use.

(5) Inoculation of test bacteria withThe concentration of dipped bacterial cotton swab is 5 multiplied by 10⁵cfu/ml～5×10⁶cfu/ml test bacterial suspension was evenly spread on the surface of nutrient agar medium plate for 3 times. For each application 1 time, the plate should be rotated 60 °, and finally the cotton swab is applied around the edge of the plate for one revolution. The plate was covered and dried at room temperature for 5 min.

(6) And (3) sticking bacteriostatic agent sample sheets, namely sticking 1 bacteriostatic flat plate on each test, sticking 4 test sample sheets and 1 negative control sample sheet on each flat plate, and sticking 5 negative control sample sheets. A sample piece was attached to the surface of the plate using sterile forceps. The distance between the centers of the various pieces is more than 25mm, and the distance between the centers of the various pieces and the periphery of the flat plate is more than 15 mm. After the sample is placed, the sample is lightly pressed by using sterile tweezers to be tightly attached to the surface of the flat plate. The plate is covered, the plate is placed in an incubator at 37 ℃, and the result is observed after the plate is cultured for 16 to 18 hours. The diameter of the antibacterial ring (including the patch) was measured with a vernier caliper and recorded. The test was repeated 3 times.

Evaluation of the bacteriostatic action

(1) Judgment of the bacteriostasis, namely insensitivity (no bacteriostasis) is judged when the diameter is less than 6 mm; low sensitivity (slight bacteriostasis) is achieved when the thickness is 6-10 mm; 11-20mm is moderately sensitive (moderately bacteriostatic); and the sensitivity is high (severe bacteriostasis) when the thickness is more than 20 mm.

(2) And 3 times of repeated tests show that the product has the bacteriostatic effect, and the product is judged to be qualified. The negative control group should have no bacteriostatic ring. Otherwise the test is invalid.

The experimental results and conclusions are shown in table 1:

TABLE 1

From the results of the diameter of the inhibition zone, the in-vitro inhibition effect of example 4 on staphylococcus aureus and escherichia coli is strongest, and the inhibition effect on candida albicans is not much different from that of the gynecological inflammation cleaning stock solution. It was found that the bacteriostatic effect of example 4 is relatively better than that of the red-nucleus gynecological lotion and the Jieeryin lotion which are obtained by diluting the solution by 10 times under the use concentration specified in the specification according to the use method, and reference can be provided for the practical application of the bacteriostatic lotion.

The foregoing description of specific embodiments of the present invention has been presented. It is to be understood that the present invention is not limited to the specific embodiments described above, and that various changes or modifications may be made by one skilled in the art within the scope of the appended claims without departing from the spirit of the invention.

Claims

1. An external bacteriostatic lotion containing licorice total flavonoids is characterized by comprising the following components: radix Sophorae Flavescentis, radix Stemonae, cortex Phellodendri, fructus Cnidii, Glycyrrhrizae radix total flavone, and chlorhexidine acetate.

2. The external bacteriostatic lotion containing licorice total flavonoids according to claim 1, which is characterized by comprising the following components in percentage by weight: 20 to 60 percent of radix sophorae flavescentis, 30 to 55 percent of radix stemonae, 1 to 35 percent of phellodendron, 1 to 35 percent of fructus cnidii, 0.1 to 3 percent of liquorice total flavone dissolved solution and 0.01 to 0.3 percent of chlorhexidine acetate stock solution.

3. The preparation method of the external bacteriostatic lotion containing licorice total flavonoids according to claim 1 or 2, which is characterized by comprising the following steps:

step 3, preparing a chlorhexidine acetate stock solution: weighing chlorhexidine acetate powder and solvent, preparing into 5-20g/L chlorhexidine acetate solution, and storing in dark for use;

and 7, filling and storing: placing in shade after filling.

4. The method for preparing an external bacteriostatic lotion containing licorice total flavonoids according to claim 3, wherein in step 2, the two extraction processes are specifically as follows: the first extraction with 5-15 times of water for 1-5 hours and the second extraction with 5-20 times of water for 1-3 hours.

5. The method for preparing an antibacterial lotion for external use containing licorice total flavonoids according to claim 3, wherein in the step 2, the solvent used for extraction is ethanol, propanol or purified water.

6. The method for preparing an antibacterial lotion for external use containing licorice total flavonoids according to claim 3, wherein the solvent used for the extraction is purified water.

7. The external bacteriostatic lotion containing licorice total flavonoids according to claim 1, wherein the final concentration of licorice total flavonoids is 0.1-3%, and the concentration of chlorhexidine solution is 0.01-0.3%.