Gynecological external traditional Chinese medicine lotion as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of gynecological external-use lotion products, and particularly relates to gynecological external-use traditional Chinese medicine lotion as well as a preparation method and application thereof. The external traditional Chinese medicine lotion for gynecology is prepared from the following components in parts by weight: 2-5 parts of dried ethanol solution extract of traditional Chinese medicinal materials, 0.1-0.5 part of coenzyme Q10, 1-3 parts of calcium gluconate and 500 parts of water, wherein the traditional Chinese medicinal materials are prepared by mixing radix sophorae flavescentis and rhizoma cibotii according to the mass ratio of 1: (0.5-1). The traditional Chinese medicinal materials only contain the radix sophorae flavescentis and the rhizoma cibotii, the formula is simple, the adopted coenzyme Q10 and calcium gluconate are substances with definite components, and allergic reactions such as skin itch, erythema and swelling are avoided. The external traditional Chinese medicine lotion for gynecology provided by the invention has a good inhibition effect on staphylococcus aureus, escherichia coli and candida albicans.

Description

Technical Field

[0001] The invention belongs to the technical field of gynecological external-use lotion products, and particularly relates to a gynecological external-use traditional Chinese medicine lotion and a preparation method and application thereof. Background Art

[0002] Gynecological washes are often formulated with a combination of various Chinese medicinal herbs, with different formulations targeting specific symptoms. Common ingredients include Sophora flavescens and Phellodendron amurense for clearing heat and dampness, Cnidium monnieri and Kochia scoparia for killing insects and relieving itching, and Coptis chinensis and Scutellaria baicalensis for purging heat and detoxifying. Some formulas also incorporate herbs like alum for astringency, and Curcuma zedoaria for promoting blood circulation and removing blood stasis. For example, Fuyanjie Wash contains Senecio chinensis, Sophora flavescens, Phellodendron amurense, and Stemona tuberosa, effectively combating fungal infections, Trichomonas, and bacterial vaginosis. Fujieshu Wash, on the other hand, is composed of Sophora flavescens, Phellodendron amurense, Coptis chinensis, Scutellaria baicalensis, and Smilax glabra. These ingredients work synergistically to achieve anti-inflammatory, antipruritic, and vaginal microecological benefits.

[0003] Common preparation methods for gynecological herbal washes include water extraction to obtain an aqueous extract, distillation to obtain a volatile oil, or a mixture of an aqueous extract and a volatile oil. The primary goal is to extract the active ingredients from various Chinese medicinal herbs, discarding the solid residue, to create a liquid preparation with antibacterial and other medicinal properties.

[0004] Despite the extraction of active ingredients, the numerous Chinese medicinal herbs used to make washes—often more than five—are often used. For example, the aforementioned Fuyanjie Wash and Fujieshu Wash, as well as Chinese Patent CN107737330A, which discloses a Chinese medicinal wash for treating postpartum body pain, and Chinese Patent CN114617837B, which discloses a gynecological Chinese medicinal wash and its preparation method, can lead to complex compositions and potentially cause allergic reactions such as itching, rashes, and swelling. Summary of the Invention

[0005] In order to solve the above technical problems, the present invention provides a gynecological external use Chinese medicine lotion and its preparation method and application.

[0006] The present invention aims to provide a gynecological external use Chinese medicine lotion, which uses Chinese medicinal materials including Sophora flavescens and Cibotium barometz. The gynecological external use Chinese medicine lotion is composed of the following ingredients in parts by weight:

[0007] 2 to 5 parts of dried ethanol extract of traditional Chinese medicine, 0.1 to 0.5 parts of coenzyme Q10, 1 to 3 parts of calcium gluconate, and 500 parts of water;

[0008] The Chinese medicinal material is a mixture of Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5 to 1.

[0009] Sophora flavescens is a common traditional Chinese medicine ingredient in gynecological washes, demonstrating its antibacterial properties. Existing wash products often contain Sophora flavescens, but these products combine Sophora flavescens with multiple other Chinese medicinal ingredients, resulting in complex formulations and the potential for allergic reactions such as itching, rashes, and swelling. The present invention utilizes only two Chinese medicinal ingredients, Sophora flavescens and Cibotium barometz, mixed in a mass ratio of 1:0.5 to 1. This simplifies the formulation and reduces the risk of allergic reactions such as itching, rashes, and swelling.

[0010] To offset the negative impact of weakened antibacterial effects caused by simplified Chinese herbal medicine formulas, the gynecological external use Chinese herbal lotion of the present invention incorporates coenzyme Q10 and calcium gluconate. Coenzyme Q10 and calcium gluconate are used to enhance the antibacterial effects of Sophora flavescens and Cibotium barometz, particularly significantly enhancing the antibacterial effect of Cibotium barometz. Calcium gluconate can also enhance the pharmacodynamic stability of the gynecological external use Chinese herbal lotion of the present invention. For example, alkaloids such as matrine and oxymatrine in Sophora flavescens are the main antibacterial components of Sophora flavescens, but their structures are affected by high temperatures and change. The present invention's research results show that when the extraction temperature is greater than 80°C, the extraction rates of matrine and oxymatrine decrease. However, in the presence of calcium gluconate, the extraction rates of matrine and oxymatrine do not decrease, indicating that calcium gluconate can enhance the stability of Sophora flavescens extracts at high temperatures.

[0011] Preferably, in the above-mentioned gynecological external use Chinese medicine lotion, the volume fraction of the ethanol solution is 60% to 70%.

[0012] Preferably, the above-mentioned gynecological external use Chinese medicinal lotion and the dried product of the ethanol solution extract of the Chinese medicinal materials are prepared according to the following method:

[0013] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5-1 to obtain a mixed material;

[0014] Add 8 to 10 times the mass of the mixed material to the ethanol solution and 0.05 to 0.15 times the mass of the mixed material to the calcium gluconate solution, and extract at 80 to 90° C. for 1 to 2 hours;

[0015] The medicinal residue is removed by filtration, and the obtained filtrate is dried to obtain a dry product of the ethanol solution extract of the Chinese medicinal material.

[0016] Preferably, the above-mentioned gynecological external use Chinese medicine lotion further comprises 0.1 to 0.5 parts of pharmaceutically acceptable excipients.

[0017] Preferably, in the above-mentioned gynecological external use Chinese medicine lotion, the pharmaceutically acceptable excipients include at least one of a dispersant, an emulsifier, a stabilizer and a moisturizer.

[0018] Preferably, the moisturizing agent of the above-mentioned gynecological external herbal lotion is propylene glycol, glycerol or sodium hyaluronate; wherein, propylene glycol has the advantages of good moisturizing properties, strong solubility, strong permeability and high safety, glycerol has the advantages of strong moisturizing properties, mild and non-irritating, good stability, wide source and low cost, and sodium hyaluronate has super moisturizing properties, can repair the skin barrier, has good biocompatibility and can improve skin texture. Therefore, the present invention preferably uses propylene glycol, glycerol or sodium hyaluronate as a moisturizing agent. However, it should be noted that if a person skilled in the art replaces the moisturizing agent with other common moisturizing substances, it is a conventional replacement within the inventive concept of the present invention.

[0019] The stabilizer is a phosphate buffer solution, which is used to stabilize the pH. Since the wash solution contacts the vulva and may also penetrate into the vagina, and the pH has a great influence on the growth, metabolism and physiological activity of the vaginal flora, the present invention uses a phosphate buffer solution as a pH stabilizer.

[0020] The emulsifier is Tween 80. When used as an emulsifier, Tween 80 can reduce surface tension and is suitable for a variety of emulsification systems. It has high chemical stability, thermal stability, and safety.

[0021] The present invention provides a method for preparing a gynecological external-use Chinese medicinal lotion, comprising:

[0022] (1) Preparation of dried products of ethanol solution extracts of Chinese medicinal materials

[0023] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5-1 to obtain a mixed material;

[0024] Add 8 to 10 times the mass of the mixed material to the ethanol solution and 0.05 to 0.15 times the mass of the mixed material to the calcium gluconate solution, and extract at 80 to 90° C. for 1 to 2 hours;

[0025] The medicinal residue is removed by filtration, and the obtained filtrate is dried to obtain a dry product of the ethanol solution extract of the Chinese medicinal material;

[0026] (2) Mix the materials according to the following weight parts:

[0027] 2 to 5 parts of dried ethanol extract of traditional Chinese medicine, 0.1 to 0.5 parts of coenzyme Q10, 1 to 3 parts of calcium gluconate, and 500 parts of water;

[0028] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0029] The invention provides an application of a gynecological external-use Chinese medicinal lotion, which is used for inhibiting the growth of Staphylococcus aureus, Escherichia coli and Candida albicans.

[0030] The present invention provides the use of coenzyme Q10 and calcium gluconate in preparing a gynecological external Chinese medicinal lotion. The formula of the gynecological external Chinese medicinal lotion is the formula of the external Chinese medicinal lotion.

[0031] Preferably, coenzyme Q10 is used to enhance the antibacterial effect of Sophora flavescens and Cibotium barometz.

[0032] Preferably, calcium gluconate is used to enhance the antibacterial effect of Sophora flavescens and Cibotium barometz, and to improve the stability of matrine and oxymatrine at 80°C to 90°C.

[0033] Compared with the prior art, the present invention has the following beneficial effects:

[0034] The present invention provides a gynecological external use Chinese medicinal lotion, which is formulated with 2 to 5 parts of a dried ethanol solution extract of a Chinese medicinal material, 0.1 to 0.5 parts of coenzyme Q10, 1 to 3 parts of calcium gluconate, and 500 parts of water; the Chinese medicinal materials are Sophora flavescens and Cibotium barometz mixed in a mass ratio of 1:0.5 to 1. The Chinese medicinal materials contain only Sophora flavescens and Cibotium barometz, resulting in a simple formula. The coenzyme Q10 and calcium gluconate used are both substances with clear ingredients, and there are no allergic reactions such as itching, rashes, or swelling. The gynecological external use Chinese medicinal lotion provided by the present invention has a good inhibitory effect on Staphylococcus aureus, Escherichia coli, and Candida albicans.

[0035] According to the research results of the present invention, in the gynecological external Chinese medicine lotion of the present invention, coenzyme Q10 can enhance the antibacterial effect of Sophora flavescens and Cibotium barometz; calcium gluconate can not only enhance the antibacterial effect of Sophora flavescens and Cibotium barometz, but also improve the stability of matrine and oxymatrine at 80°C to 90°C. DETAILED DESCRIPTION

[0036] In order to enable those skilled in the art to better understand and implement the technical solution of the present invention, the present invention is further described below with reference to specific embodiments.

[0037] In the description of the present invention, unless otherwise specified, all reagents used are commercially available, and all methods used are conventional techniques in the art. For example, Sophora flavescens and Cibotium barometz were purchased from a pharmacy.

[0038] Next, some specific examples and control groups are provided to illustrate the effects of the gynecological external use Chinese medicinal lotion of the present invention.

[0039] Example 1

[0040] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0041] 2 parts of dried extract of ethanol solution of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 1 part of calcium gluconate, 500 parts of water;

[0042] Among them, the Chinese medicinal materials are Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5.

[0043] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0044] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5 to obtain a mixed material;

[0045] Add ethanol solution equivalent to 8 times the mass of the mixed material and calcium gluconate equivalent to 0.1 times the mass of the mixed material, and extract at 80°C for 1 hour;

[0046] The residue is removed by filtration, and the obtained filtrate is dried to obtain a dry product of the extract of the ethanol solution of the Chinese medicinal material;

[0047] Mix the materials according to the following weight parts:

[0048] 2 parts of dried extract of ethanol solution of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 1 part of calcium gluconate, 500 parts of water;

[0049] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0050] Example 2

[0051] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0052] 5 parts of dried ethanol extract of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 1 part of calcium gluconate, and 500 parts of water;

[0053] Among them, the Chinese medicinal materials are a mixture of Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5.

[0054] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0055] (1) Preparation of dried products of ethanol solution extracts of Chinese medicinal materials

[0056] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5 to obtain a mixed material;

[0057] Add ethanol solution equivalent to 8 times the mass of the mixed material and calcium gluconate equivalent to 0.05 times the mass of the mixed material to the mixed material, and extract at 80°C for 1 hour;

[0058] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of the Chinese medicinal material;

[0059] (2) Mix the materials according to the following weight parts:

[0060] 5 parts of dried ethanol extract of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 1 part of calcium gluconate, and 500 parts of water;

[0061] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0062] Example 3

[0063] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0064] 2 parts of dried ethanol extract of Chinese medicinal materials, 0.5 parts of coenzyme Q10, 1 part of calcium gluconate, 500 parts of water;

[0065] Among them, the Chinese medicinal materials are a mixture of Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5.

[0066] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0067] (1) Preparation of dried products of ethanol solution extracts of Chinese medicinal materials

[0068] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5 to obtain a mixed material;

[0069] Add ethanol solution equivalent to 8 times the mass of the mixed material and calcium gluconate equivalent to 0.05 times the mass of the mixed material to the mixed material, and extract at 80°C for 1 hour;

[0070] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of the Chinese medicinal material;

[0071] (2) Mix the materials according to the following weight parts:

[0072] 2 parts of dried ethanol extract of Chinese medicinal materials, 0.5 parts of coenzyme Q10, 1 part of calcium gluconate, 500 parts of water;

[0073] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0074] Example 4

[0075] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0076] 2 parts of dried ethanol extract of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 3 parts of calcium gluconate, and 500 parts of water;

[0077] Among them, the Chinese medicinal materials are a mixture of Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5.

[0078] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0079] (1) Preparation of dried products of ethanol solution extracts of Chinese medicinal materials

[0080] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5 to obtain a mixed material;

[0081] Add ethanol solution equivalent to 8 times the mass of the mixed material and calcium gluconate equivalent to 0.05 times the mass of the mixed material to the mixed material, and extract at 80°C for 1 hour;

[0082] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of the Chinese medicinal material;

[0083] (2) Mix the materials according to the following weight parts:

[0084] 2 parts of dried ethanol extract of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 3 parts of calcium gluconate, and 500 parts of water;

[0085] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0086] Example 5

[0087] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0088] 2 parts of dried ethanol extract of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 1 part of calcium gluconate, 500 parts of water;

[0089] Among them, the Chinese medicinal materials are Sophora flavescens and Cibotium barometz in a mass ratio of 1:1.

[0090] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0091] (1) Preparation of dried products of ethanol solution extracts of Chinese medicinal materials

[0092] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:1 to obtain a mixed material;

[0093] Add ethanol solution equivalent to 8 times the mass of the mixed material and calcium gluconate equivalent to 0.05 times the mass of the mixed material to the mixed material, and extract at 80°C for 1 hour;

[0094] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of the Chinese medicinal material;

[0095] (2) Mix the materials according to the following weight parts:

[0096] 2 parts of dried ethanol extract of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 1 part of calcium gluconate, 500 parts of water;

[0097] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0098] Example 6

[0099] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0100] 2 parts of dried ethanol extract of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 1 part of calcium gluconate, 500 parts of water;

[0101] Among them, the Chinese medicinal materials are a mixture of Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5.

[0102] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0103] (1) Preparation of dried products of ethanol solution extracts of Chinese medicinal materials

[0104] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5 to obtain a mixed material;

[0105] Add ethanol solution equivalent to 8 times the mass of the mixed material and calcium gluconate equivalent to 0.05 times the mass of the mixed material to the mixed material, and extract at 90°C for 1 hour;

[0106] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of the Chinese medicinal material;

[0107] (2) Mix the materials according to the following weight parts:

[0108] 2 parts of dried ethanol extract of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 1 part of calcium gluconate, 500 parts of water;

[0109] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0110] Example 7

[0111] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0112] 2 parts of dried ethanol extract of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 1 part of calcium gluconate, 500 parts of water;

[0113] Among them, the Chinese medicinal materials are a mixture of Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5.

[0114] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0115] (1) Preparation of dried products of ethanol solution extracts of Chinese medicinal materials

[0116] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5 to obtain a mixed material;

[0117] Add ethanol solution equivalent to 10 times the mass of the mixed material and calcium gluconate equivalent to 0.05 times the mass of the mixed material to the mixed material, and extract at 80°C for 2h;

[0118] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of the Chinese medicinal material;

[0119] (2) Mix the materials according to the following weight parts:

[0120] 2 parts of dried ethanol extract of Chinese medicinal materials, 0.1 parts of coenzyme Q10, 1 part of calcium gluconate, 500 parts of water;

[0121] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0122] Control group 1

[0123] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0124] 2 parts of dried ethanol extract of Chinese herbal medicine, 500 parts of water;

[0125] Among them, the Chinese medicinal materials are a mixture of Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5.

[0126] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0127] (1) Preparation of dried products of ethanol solution extracts of Chinese medicinal materials

[0128] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5 to obtain a mixed material;

[0129] Add ethanol solution equivalent to 8 times the mass of the mixed material to the mixed material and extract at 80℃ for 1h;

[0130] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of the Chinese medicinal material;

[0131] (2) Mix the materials according to the following weight parts:

[0132] 2 parts of dried ethanol extract of Chinese herbal medicine, 500 parts of water;

[0133] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0134] Control group 2

[0135] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0136] 2 parts of dried ethanol extract of Chinese herbal medicine, 500 parts of water;

[0137] Among them, the Chinese medicinal materials are a mixture of Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5.

[0138] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0139] (1) Preparation of dried products of ethanol solution extracts of Chinese medicinal materials

[0140] Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5 to obtain a mixed material;

[0141] Add ethanol solution equivalent to 8 times the mass of the mixed material and calcium gluconate equivalent to 0.05 times the mass of the mixed material to the mixed material, and extract at 80°C for 1 hour;

[0142] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of the Chinese medicinal material;

[0143] (2) Mix the materials according to the following weight parts:

[0144] 2 parts of dried ethanol extract of Chinese herbal medicine, 500 parts of water;

[0145] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0146] Control group 3

[0147] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0148] 2 parts of dry product of ethanol solution extract of Sophora flavescens, 500 parts of water.

[0149] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0150] Add ethanol solution equivalent to 8 times the mass of Sophora flavescens to Sophora flavescens and extract at 80℃ for 1h;

[0151] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of Sophora flavescens;

[0152] Mix the materials according to the following weight parts:

[0153] 2 parts of dry product of ethanol solution extract of Sophora flavescens, 500 parts of water;

[0154] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0155] Control group 4

[0156] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0157] 2 parts of dry product of ethanol solution extract of Sophora flavescens, 500 parts of water.

[0158] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0159] Add ethanol solution equivalent to 8 times the mass of Sophora flavescens and calcium gluconate equivalent to 0.05 times the mass of Sophora flavescens, and extract at 80℃ for 1h;

[0160] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of Sophora flavescens;

[0161] Mix the materials according to the following weight parts:

[0162] 2 parts of dry product of ethanol solution extract of Sophora flavescens, 500 parts of water;

[0163] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0164] Control group 5

[0165] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0166] 2 parts of dried product of ethanol solution extract of Dog Cibotium, 500 parts of water.

[0167] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0168] Add 8 times the weight of ethanol solution and 0.05 times the weight of calcium gluconate to the Cibotium barometz and extract at 80°C for 1 hour.

[0169] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of Cibotium barometz;

[0170] Mix the materials according to the following weight parts:

[0171] 2 parts of dried product of ethanol solution extract of Cibotium barometz, 500 parts of water;

[0172] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0173] Control group 6

[0174] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0175] 2 parts of dry product of ethanol solution extract of Sophora flavescens, 0.1 parts of coenzyme Q10, and 500 parts of water.

[0176] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0177] (1) Preparation of dried ethanol extract of Sophora flavescens

[0178] Add ethanol solution equivalent to 8 times the mass of Sophora flavescens and calcium gluconate equivalent to 0.05 times the mass of Sophora flavescens to Sophora flavescens, and extract at 80°C for 1 hour;

[0179] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of Sophora flavescens;

[0180] (2) Mix the materials according to the following weight parts:

[0181] 2 parts of dry ethanol extract of Sophora flavescens, 0.1 parts of coenzyme Q10, 500 parts of water;

[0182] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0183] Control group 7

[0184] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0185] 2 parts of dry product of ethanol solution extract of Sophora flavescens, 1 part of calcium gluconate, and 500 parts of water.

[0186] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0187] (1) Preparation of dried ethanol extract of Sophora flavescens

[0188] Add ethanol solution equivalent to 8 times the mass of the mixed materials and calcium gluconate equivalent to 0.05 times the mass of Sophora flavescens to the Sophora flavescens, and extract at 80°C for 1 hour;

[0189] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of Sophora flavescens;

[0190] (2) Mix the materials according to the following weight parts:

[0191] 2 parts of dry product of ethanol solution extract of Sophora flavescens, 1 part of calcium gluconate, 500 parts of water;

[0192] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0193] Control group 8

[0194] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0195] 2 parts of dried product of ethanol solution extract of dog spine, 0.1 parts of coenzyme Q10, and 500 parts of water.

[0196] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0197] (1) Preparation of dried ethanol extract of Sophora flavescens

[0198] Add 8 times the weight of Sophora flavescens and 0.05 times the weight of calcium gluconate to the Rhizoma Cibotii and extract at 80°C for 1 hour.

[0199] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of Cibotium barometz;

[0200] (2) Mix the materials according to the following weight parts:

[0201] 2 parts of dried ethanol extract of Cibotium barometz, 0.1 parts of coenzyme Q10, and 500 parts of water;

[0202] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0203] Control group 9

[0204] A gynecological external use Chinese medicine lotion, composed of the following ingredients in parts by weight:

[0205] 2 parts of dried product of ethanol solution extract of Cibotium barometz, 1 part of calcium gluconate, and 500 parts of water.

[0206] The preparation method of gynecological external use Chinese medicine lotion is as follows:

[0207] (1) Preparation of dried product of ethanol solution extract of dog spine

[0208] Add ethanol solution equivalent to 8 times the mass of the mixed materials and calcium gluconate equivalent to 0.05 times the mass of the dog spine, and extract at 80℃ for 1 hour;

[0209] The residue was removed by filtration through a 100-mesh filter cloth, and the obtained filtrate was concentrated to 1 / 10 of the original volume, and freeze-dried at -20°C to obtain a dry product of the ethanol solution extract of Cibotium barometz;

[0210] (2) Mix the materials according to the following weight parts:

[0211] 2 parts of dried ethanol extract of Cibotium barometz, 1 part of calcium gluconate, 500 parts of water;

[0212] After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

[0213] The differences between the above examples and the control group are shown in Table 1.

[0214] Table 1 Differences between the embodiment and the control group

[0215]

[0216] Note: “-” in Table 1 means no corresponding substance was added.

[0217] 1. The antibacterial experiment is as follows.

[0218] (1) Preparation of bacterial suspension

[0219] Materials: Prepare fresh cultures of Staphylococcus aureus, Escherichia coli, and Candida albicans. S. aureus (ATCC 25923), a strain commonly used in clinical medicine and microbiology; E. coli (BNCC 336902); and Candida albicans (ATCC 10231), a strain of Candida albicans.

[0220] Prepare sterile water.

[0221] After Staphylococcus aureus, Escherichia coli, and Candida albicans were activated, the concentration of the bacterial suspension of each strain was adjusted to 1.0×10 5 cfu / mL.

[0222] (2) Testing process: It is carried out in a clean bench, which provides a sterile environment.

[0223] The concentration is 1.0×10 5 1 mL of bacterial suspension with a concentration of cfu / mL was added to 5 mL of the liquid to be tested, which was any of the gynecological external Chinese medicine lotions in Examples 1 to 7 and Control Groups 1 to 7. The mixture was allowed to stand at room temperature of 25°C for 20 minutes. At the same time, a 1.0×10 5 The bacterial suspension with 0.1 cfu / mL was used as the blank control group.

[0224] The number of viable bacteria in each group was counted and the inhibition rate was calculated according to the following formula.

[0225]

[0226] The antibacterial test results are shown in Table 2.

[0227] Table 2 Statistical results of antibacterial rate

[0228]

[0229]

[0230] Examples 1 and 2 compared the effect of the dosage of dried ethanol extracts of different Chinese medicinal materials on their antibacterial efficacy. As shown in Table 2, Example 2 achieved a higher inhibition rate against Staphylococcus aureus than Example 1, indicating that a higher dosage of dried ethanol extracts slightly improved the antibacterial effect. There was little difference in inhibition rates against Escherichia coli and Candida albicans.

[0231] Examples 1 and 3 compared the effects of different Coenzyme Q10 dosages on antibacterial efficacy. Table 2 shows that Example 3 achieved a higher inhibition rate against Staphylococcus aureus than Example 1, indicating that a higher Coenzyme Q10 dosage slightly improved the antibacterial effect. There was little difference in inhibition rates against Escherichia coli and Candida albicans.

[0232] Examples 1 and 4 compared the effects of different calcium gluconate dosages on antibacterial efficacy. As shown in Table 2, Example 4 exhibited a slightly higher inhibition rate against Staphylococcus aureus than Example 1, indicating that increasing the calcium gluconate dosage significantly improved inhibition. There was little difference in inhibition rates against Escherichia coli and Candida albicans.

[0233] Examples 1 and 5 compared the effects of different Sophora flavescens to Cibotium barometz mass ratios on antibacterial efficacy. The Sophora flavescens in Example 1 had a higher mass fraction in the Chinese medicinal material. Table 2 shows that there was no significant difference in the inhibition rates against Staphylococcus aureus, Escherichia coli, and Candida albicans between Examples 1 and 5, indicating that a Sophora flavescens to Cibotium barometz mass ratio of 1:0.5 to 1 achieved comparable antibacterial efficacy.

[0234] The comparison between Example 1 and Example 6 and Example 7 is based on different extraction processes. As can be seen from the results in Table 2, there is little difference in the antibacterial effect between Example 1 and Example 6 and Example 7.

[0235] Control 1 consisted of the Chinese herbal medicine components alone, extracted with ethanol. Control 2 consisted of the Chinese herbal medicine components alone, extracted with ethanol and calcium gluconate. Compared to the antibacterial rate in Example 1, the antibacterial effect of the Chinese herbal medicine components, which consisted of only two herbs, decreased significantly. However, the antibacterial effect of Control 2, which included the calcium gluconate extraction step, increased, indicating that calcium gluconate helps maintain the antibacterial effect of the Chinese herbal medicines.

[0236] Control group 3 uses Sophora flavescens as the only Chinese herbal medicine ingredient. Although it has an antibacterial effect, due to the single ingredient, the antibacterial effect is significantly lower than that of the examples.

[0237] Control group 4 used Sophora flavescens as the sole Chinese medicinal ingredient, but added a calcium gluconate extraction step, resulting in improved antibacterial efficacy compared to control group 3. Furthermore, testing showed that the total amounts of matrine and oxymatrine in control group 4 increased by 35.2% and 24.5%, respectively, compared to control group 3, indicating that calcium gluconate can improve the stability of matrine and oxymatrine at 80°C.

[0238] The control group 5 used Cibotium barometz as the only Chinese medicinal ingredient, and the antibacterial effect was significantly different from that of Example 1.

[0239] The results of control groups 4 and 5 show that the antibacterial effect of a single Chinese herbal ingredient is relatively poor.

[0240] Control group 6 combined Sophora flavescens with coenzyme Q10, and control group 7 combined Sophora flavescens with calcium gluconate. Compared with control group 4, these two control groups added coenzyme Q10 or calcium gluconate, and the antibacterial effects were significantly improved, indicating that coenzyme Q10 and calcium gluconate can enhance the antibacterial effect of Sophora flavescens.

[0241] In addition, the present application also combines coenzyme Q10 with Cibotium barometz as control group 8, and combines calcium gluconate with Cibotium barometz as control group 9. Compared with control group 5, these two control groups have added coenzyme Q10 or calcium gluconate, and the antibacterial effects are significantly improved, indicating that coenzyme Q10 and calcium gluconate can enhance the antibacterial effect of Sophora flavescens.

[0242] The present invention also places the products of each group at 80℃~90℃ for 4h, and then tests the total amount of matrine and oxymatrine. There is no significant difference in the total amount of matrine and oxymatrine before and after the samples of Examples 1 to 7 are treated at 80℃~90℃, indicating that the gynecological external Chinese medicine lotion provided by the present invention has good thermal stability.

[0243] In addition, after allergy testing, the gynecological external use Chinese medicine lotions prepared in various embodiments of the present invention did not cause allergic reactions such as skin itching, rash, and swelling.

[0244] It should be noted that when numerical ranges are involved in the present invention, it should be understood that both endpoints of each numerical range and any value between the two endpoints can be selected. Since the steps and methods used are the same as those in the embodiments, in order to avoid redundancy, the present invention describes preferred embodiments. Although preferred embodiments of the present invention have been described, those skilled in the art may make additional changes and modifications to these embodiments once they understand the basic inventive concept, and such changes and modifications fall within the scope of the present invention.

[0245] Obviously, those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. If these modifications and variations of the present invention fall within the scope of the equivalent technology of the present invention, the present invention is intended to include these modifications and variations.

Claims

1. A gynecological external use Chinese medicine lotion, characterized in that: It is composed of the following ingredients in parts by weight: 2 to 5 parts of dried ethanol extract of traditional Chinese medicine, 0.1 to 0.5 parts of coenzyme Q10, 1 to 3 parts of calcium gluconate, and 500 parts of water; The Chinese medicinal material is a mixture of Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5 to 1.

2. The gynecological external use Chinese medicinal lotion according to claim 1, characterized in that The volume fraction of the ethanol solution is 60% to 70%.

3. The gynecological external use Chinese medicinal lotion according to claim 1, characterized in that The dried product of the ethanol solution extract of the Chinese medicinal material is prepared according to the following method: Mixing Sophora flavescens and Cibotium barometz in a mass ratio of 1:0.5-1 to obtain a mixed material; Add 8 to 10 times the mass of the mixed material to the ethanol solution and 0.05 to 0.15 times the mass of the mixed material to the calcium gluconate solution, and extract at 80 to 90° C. for 1 to 2 hours; The medicinal residue is removed by filtration, and the obtained filtrate is dried to obtain a dry product of the ethanol solution extract of the Chinese medicinal material.

4. The gynecological external use Chinese medicinal lotion according to claim 1, characterized in that The invention also includes 0.1 to 0.5 parts of pharmaceutically acceptable excipients.

5. The gynecological external use Chinese medicinal lotion according to claim 4, characterized in that The pharmaceutically acceptable excipients include at least one of a dispersant, an emulsifier, a stabilizer and a humectant.

6. The gynecological external use Chinese medicinal lotion according to claim 5, characterized in that The moisturizer is propylene glycol, glycerin, or sodium hyaluronate; The stabilizer is phosphate buffer; The emulsifier is Tween 80.

7. The method for preparing the gynecological external use Chinese medicinal lotion according to claim 1, wherein: include: Preparation of dried products of ethanol solution extracts of Chinese medicinal materials; Mix the materials according to the following weight parts: 2 to 5 parts of dried ethanol extract of traditional Chinese medicine, 0.1 to 0.5 parts of coenzyme Q10, 1 to 3 parts of calcium gluconate, and 500 parts of water; After mixing the materials, a gynecological external-use Chinese medicinal lotion is obtained.

8. The use of the gynecological external use Chinese medicinal lotion according to claim 1, characterized in that: The application refers to inhibiting the growth of Staphylococcus aureus, Escherichia coli and Candida albicans.

9. The use according to claim 8, characterized in that Coenzyme Q10 is used to enhance the antibacterial effect of Sophora flavescens and Cibotium barometz.

10. The use according to claim 8, characterized in that Calcium gluconate is used to enhance the antibacterial effect of Sophora flavescens and Cibotium barometz, and to improve the stability of matrine and oxymatrine at 80°C to 90°C.

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