Gel composition for treating cervical erosion and preparation method thereof

Abstract

The invention discloses a gel composition for treating cervical erosion and a preparation method thereof. The gel composition is prepared from the following components in parts by weight: a sophora flavescens total extract, a lithospermum extract, a pseudo-ginseng extract, a fructus cnidii extract, a felwort extract, a sea buckthorn seed oil extract, a golden cypress extract, a gelatinizing agent, glycerol, tween-80, a pH regulator and purified water. The invention relates to the technical field of medicines. According to the gel composition for treating cervical erosion and the preparation method thereof, in the gel composition, the total sophora flavescens extract, the fructus cnidii extract and the seabuckthorn seed oil extract have a synergistic effect, cervical erosion is effectively treated, and cervical tissue repair is promoted. Matrine and sophoridine in the sophora flavescens total extract have the effects of resisting bacteria, diminishing inflammation and promoting cell regeneration; cnidium lactone in the fructus cnidii extract has anti-inflammatory and antifungal effects; the sea buckthorn seed oil extract is rich in vitamin E and unsaturated fatty acid, and has the effects of promoting tissue repair and enhancing local immunity.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, specifically to a gel composition for treating cervical erosion and its preparation method. Background Technology

[0002] Cervical erosion (cervical columnar epithelial ectopia) is a common gynecological disease, mainly manifested as erosion, congestion, and contact bleeding on the surface of the cervix. Currently, clinical treatments for cervical erosion primarily include medication, physical therapy (such as laser, cryotherapy, and electrocautery), and surgery. Among these, medication is the preferred treatment method due to its safety, simplicity, and non-invasiveness.

[0003] Traditional medications for treating cervical erosion are mostly lotions, suppositories, films, sprays, or effervescent tablets. However, these preparations have many problems: 1) Insufficient drug release, making it difficult to achieve an effective drug concentration in the cervix; 2) Inconvenient to use, requiring patients to administer them themselves; 3) Some medications inhibit beneficial vaginal flora, potentially leading to vaginal microecological imbalance and increasing the risk of infection; 4) Unstable efficacy and high recurrence rate.

[0004] Existing traditional Chinese medicine preparations, such as the gel for treating cervicitis and cervical erosion disclosed in patent CN104510767A, although containing total extracts of Sophora flavescens and catechu, use 8-16 parts by weight of polymeric adhesive material and 150-500 parts by weight of dilute acid in their formulation, resulting in insufficiently precise pH adjustment and potentially causing drug stability issues. Similarly, the traditional Chinese medicine composition for treating cervical erosion disclosed in patent CN107213177A, while containing matrine, osthol, and sea buckthorn seed oil, uses only 1-1.2 parts by weight of carbomer-940 in its formulation, and the wide range of humectants and solubilizers may affect drug stability and efficacy.

[0005] Therefore, developing a novel gel composition for treating cervical erosion, with better drug stability, superior local efficacy, and no interference with the vaginal microecology, has significant clinical importance and market value. Summary of the Invention

[0006] (a) Technical problems to be solved To address the shortcomings of existing technologies, this invention provides a gel composition for treating cervical erosion and its preparation method. This composition contains a specific ratio of traditional Chinese medicine extracts and excipients, and is characterized by rapid onset of action, definite curative effect, and no inhibitory effect on beneficial vaginal flora. The gel composition of this invention can form a long-lasting protective film on the cervical surface, promoting cervical tissue repair without disrupting the vaginal microecological balance.

[0007] (II) Technical Solution To achieve the above objectives, the present invention is implemented through the following technical solution: a gel composition for treating cervical erosion, comprising the following components in parts by weight: 15-25 parts of total extract of Sophora flavescens, 5-10 parts of extract of Lithospermum erythrorhizon, 5-10 parts of extract of Panax notoginseng, 0.5-1.5 parts of extract of Cnidium monnieri, 5-10 parts of extract of Gentiana scabra, 8-15 parts of extract of Hippophae rhamnoides seed oil, 5-10 parts of extract of Phellodendron chinense, 1.2-1.5 parts of gelling agent, 10-15 parts of glycerin, 6-8 parts of Tween-80, 0.5-1 parts of pH adjuster, and 40-80 parts of purified water.

[0008] Preferably, it is composed of the following components in parts by weight: 20 parts total extract of Sophora flavescens, 7 parts extract of Lithospermum erythrorhizon, 7 parts extract of Panax notoginseng, 1 part extract of Cnidium monnieri, 7 parts extract of Gentiana scabra, 11 parts extract of Hippophae rhamnoides seed oil, 7 parts extract of Phellodendron chinense, 1.3 parts gelling agent, 13 parts glycerin, 7 parts Tween-80, 0.7 parts pH adjuster and 60 parts purified water.

[0009] Preferably, it is composed of the following components in parts by weight: 15 parts total extract of Sophora flavescens, 5 parts extract of Lithospermum erythrorhizon, 5 parts extract of Panax notoginseng, 0.5 parts extract of Cnidium monnieri, 5 parts extract of Gentiana scabra, 8 parts extract of Hippophae rhamnoides seed oil, 5 parts extract of Phellodendron chinense, 1.2 parts gelling agent, 10 parts glycerin, 6 parts Tween-80, 0.5 parts pH adjuster and 40 parts purified water.

[0010] Preferably, it is composed of the following components in parts by weight: 25 parts total extract of Sophora flavescens, 10 parts extract of Lithospermum erythrorhizon, 10 parts extract of Panax notoginseng, 1.5 parts extract of Cnidium monnieri, 10 parts extract of Gentiana scabra, 15 parts extract of Hippophae rhamnoides seed oil, 10 parts extract of Phellodendron chinense, 1.5 parts gelling agent, 15 parts glycerin, 8 parts Tween-80, 1 part pH adjuster and 80 parts purified water.

[0011] Preferably, the total extract of Sophora flavescens contains matrine and sophoridine.

[0012] Preferably, the gelling agent is at least one selected from carbomer-940, gelatin, gum arabic, alginate, hyaluronic acid, starch, or agar.

[0013] Preferably, the pH adjuster is one of citric acid, malic acid, or acetic acid.

[0014] This invention also provides a method for preparing a gel composition for treating cervical erosion, specifically comprising the following steps: S1. Add the gelling agent to an appropriate amount of purified water and stir until completely dispersed to form a preliminary gel. S2. Dissolve the total extract of Sophora flavescens, extract of Lithospermum erythrorhizon, extract of Panax notoginseng, extract of Cnidium monnieri, extract of Gentiana scabra, extract of Hippophae rhamnoides seed oil, and extract of Phellodendron chinense in an appropriate amount of ethanol and mix well. S3. Add the mixture from step S2 to the gel from step S1 and stir until homogeneous. S4. Add glycerin and Tween-80, and continue stirring; S5. Adjust the pH to 6.5-7.0 using a pH adjuster; S6. Add purified water to the total volume, stir thoroughly to obtain the gel composition for treating cervical erosion.

[0015] (III) Beneficial Effects This invention provides a gel composition for treating cervical erosion and its preparation method. Compared with the prior art, it has the following advantages: (1) The gel composition for treating cervical erosion and its preparation method. In the gel composition of the present invention, the total extract of Sophora flavescens, the extract of Cnidium monnieri, and the extract of Hippophae rhamnoides seed oil work synergistically to effectively treat cervical erosion and promote cervical tissue repair. Matrine and sophoridine in the total extract of Sophora flavescens have antibacterial, anti-inflammatory, and cell regeneration-promoting effects; osthol in the extract of Cnidium monnieri has anti-inflammatory and antifungal effects; and the extract of Hippophae rhamnoides seed oil is rich in vitamin E and unsaturated fatty acids, which can promote tissue repair and enhance local immunity.

[0016] (2) The gel composition for treating cervical erosion and its preparation method. The gel has good adhesion and can form a long-lasting protective film on the cervical surface, prolonging the drug action time and increasing the local drug concentration. The drug has no inhibitory effect on the beneficial bacteria in the vagina and will not disrupt the vaginal microecological balance, thus avoiding the problem of vaginal flora imbalance that may be caused by traditional drugs.

[0017] (3) The gel composition for treating cervical erosion and its preparation method are simple to prepare, have stable quality, are easy to use, and have high patient compliance. The pH value of the gel composition of the present invention is controlled at 6.5-7.0, which is close to the pH value of the vaginal environment, which is conducive to drug absorption and efficacy. The gel composition of the present invention has stable drug properties, takes effect quickly, and has a definite curative effect. It is suitable for the treatment of cervical erosion of different degrees, especially mild to moderate cervical erosion, and can be used as a first-line treatment drug. Attached Figure Description

[0018] Figure 1 This is a flowchart of the preparation method of the present invention. Detailed Implementation

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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 skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] Please see Figure 1 The present invention provides six technical solutions: a gel composition for treating cervical erosion and its preparation method, specifically including the following embodiments: Example 1: A gel composition for treating cervical erosion, comprising the following components in parts by weight: 20 parts total extract of Sophora flavescens, 7 parts extract of Lithospermum erythrorhizon, 7 parts extract of Panax notoginseng, 1 part extract of Cnidium monnieri, 7 parts extract of Gentiana scabra, 11 parts extract of Hippophae rhamnoides seed oil, 7 parts extract of Phellodendron chinense, 1.3 parts gelling agent, 13 parts glycerin, 7 parts Tween-80, 0.7 parts pH adjuster, and 60 parts purified water. The total extract of Sophora flavescens contains matrine and sophoridine, the gelling agent is carbomer-940, and the pH adjuster is citric acid.

[0021] This invention also provides a method for preparing a gel composition for treating cervical erosion, specifically including the following steps: S1. Add the gelling agent to an appropriate amount of purified water and stir until completely dispersed to form a preliminary gel. S2. Dissolve the total extract of Sophora flavescens, extract of Lithospermum erythrorhizon, extract of Panax notoginseng, extract of Cnidium monnieri, extract of Gentiana scabra, extract of Hippophae rhamnoides seed oil, and extract of Phellodendron chinense in an appropriate amount of ethanol and mix well. S3. Add the mixture from step S2 to the gel from step S1 and stir until homogeneous. S4. Add glycerin and Tween-80, and continue stirring; S5. Adjust the pH to 6.8 using a pH adjuster; S6. Add purified water to the total volume, stir thoroughly to obtain the gel composition for treating cervical erosion.

[0022] Example 2: A gel composition for treating cervical erosion, comprising the following components in parts by weight: 15 parts total extract of Sophora flavescens, 5 parts extract of Lithospermum erythrorhizon, 5 parts extract of Panax notoginseng, 0.5 parts extract of Cnidium monnieri, 5 parts extract of Gentiana scabra, 8 parts extract of Hippophae rhamnoides seed oil, 5 parts extract of Phellodendron chinense, 1.2 parts gelling agent, 10 parts glycerin, 6 parts Tween-80, 0.5 parts pH adjuster, and 40 parts purified water. The total extract of Sophora flavescens contains matrine and sophoridine, the gelling agent is gelatin, and the pH adjuster is malic acid.

[0023] This invention also provides a method for preparing a gel composition for treating cervical erosion, specifically including the following steps: S1. Add the gelling agent to an appropriate amount of purified water and stir until completely dispersed to form a preliminary gel. S2. Dissolve the total extract of Sophora flavescens, extract of Lithospermum erythrorhizon, extract of Panax notoginseng, extract of Cnidium monnieri, extract of Gentiana scabra, extract of Hippophae rhamnoides seed oil, and extract of Phellodendron chinense in an appropriate amount of ethanol and mix well. S3. Add the mixture from step S2 to the gel from step S1 and stir until homogeneous. S4. Add glycerin and Tween-80, and continue stirring; S5. Adjust the pH to 6.5 using a pH adjuster; S6. Add purified water to the total volume, stir thoroughly to obtain the gel composition for treating cervical erosion.

[0024] Example 3: A gel composition for treating cervical erosion, comprising the following components in parts by weight: 25 parts total extract of Sophora flavescens, 10 parts extract of Lithospermum erythrorhizon, 10 parts extract of Panax notoginseng, 1.5 parts extract of Cnidium monnieri, 10 parts extract of Gentiana scabra, 15 parts extract of Hippophae rhamnoides seed oil, 10 parts extract of Phellodendron chinense, 1.5 parts gelling agent, 15 parts glycerin, 8 parts Tween-80, 1 part pH adjuster, and 80 parts purified water. The total extract of Sophora flavescens contains matrine and sophoridine, the gelling agent is agar, and the pH adjuster is acetic acid.

[0025] This invention also provides a method for preparing a gel composition for treating cervical erosion, specifically including the following steps: S1. Add the gelling agent to an appropriate amount of purified water and stir until completely dispersed to form a preliminary gel. S2. Dissolve the total extract of Sophora flavescens, extract of Lithospermum erythrorhizon, extract of Panax notoginseng, extract of Cnidium monnieri, extract of Gentiana scabra, extract of Hippophae rhamnoides seed oil, and extract of Phellodendron chinense in an appropriate amount of ethanol and mix well. S3. Add the mixture from step S2 to the gel from step S1 and stir until homogeneous. S4. Add glycerin and Tween-80, and continue stirring; S5. Adjust the pH to 7.0 using a pH adjuster; S6. Add purified water to the total volume, stir thoroughly to obtain the gel composition for treating cervical erosion.

[0026] Example 4: A gel composition for treating cervical erosion, comprising the following components in parts by weight: total extract of Sophora flavescens: 20 parts by weight, extract of Cnidium monnieri: 1 part by weight, extract of Hippophae rhamnoides seed oil: 10 parts by weight, carbomer-940: 1.3 parts by weight, glycerin: 12 parts by weight, Tween-80: 7 parts by weight, triethanolamine: 0.7 parts by weight, and purified water: balance.

[0027] Preparation method: (1) Add carbomer-940 to an appropriate amount of purified water (about 50 parts by weight), stir until completely dispersed, and form a preliminary gel; (2) Dissolve the total extract of Sophora flavescens, the extract of Cnidium monnieri and the extract of Hippophae rhamnoides seed oil in an appropriate amount of ethanol (about 10 parts by weight of ethanol for each extract) and mix well; (3) Add the mixture from step (2) to the gel from step (1) and stir until homogeneous; (4) Add glycerin and Tween-80, and continue stirring; (5) Adjust the pH to 6.8 with triethanolamine; (6) Add purified water to the total volume and stir thoroughly to obtain the gel composition for treating cervical erosion.

[0028] Example 5: A gel composition for treating cervical erosion, comprising the following components in parts by weight: total extract of Sophora flavescens: 15 parts by weight, extract of Cnidium monnieri: 0.5 parts by weight, extract of Hippophae rhamnoides seed oil: 8 parts by weight, carbomer-940: 1.2 parts by weight, glycerin: 10 parts by weight, Tween-80: 6 parts by weight, triethanolamine: 0.5 parts by weight, and purified water: balance.

[0029] Preparation method: The preparation method is the same as in Example 4.

[0030] Example 6: A gel composition for treating cervical erosion, comprising the following components in parts by weight: total extract of Sophora flavescens: 25 parts by weight, extract of Cnidium monnieri: 1.5 parts by weight, extract of Hippophae rhamnoides seed oil: 15 parts by weight, carbomer-940: 1.5 parts by weight, glycerin: 15 parts by weight, Tween-80: 8 parts by weight, triethanolamine: 1 part by weight, and purified water: balance. Preparation method: The preparation method is the same as in Example 4. In summary, the gel composition of this invention, with the synergistic effect of total extract of Sophora flavescens, extract of Cnidium monnieri, and extract of Hippophae rhamnoides seed oil, effectively treats cervical erosion and promotes cervical tissue repair. Matrine and sophoridine in the total extract of Sophora flavescens have antibacterial, anti-inflammatory, and cell regeneration-promoting effects; osthol in the extract of Cnidium monnieri has anti-inflammatory and antifungal effects; sea buckthorn seed oil extract is rich in vitamin E and unsaturated fatty acids, which can promote tissue repair and enhance local immunity. This gel has good adhesion and can form a long-lasting protective film on the cervical surface, prolonging the drug's action time and increasing the local drug concentration. The drug does not inhibit the beneficial bacteria in the vagina and will not disrupt the vaginal microecological balance, avoiding the vaginal flora imbalance that may be caused by traditional drugs. The preparation process is simple, the quality is stable, it is convenient to use, and the patient compliance is high. The pH value of the gel composition of this invention is controlled at 6.5-7.0, which is close to the pH value of the vaginal environment, which is conducive to drug absorption and efficacy. The gel composition of this invention has stable drug properties, rapid onset of action, and definite curative effect. It is suitable for the treatment of cervical erosion of different degrees, especially mild to moderate cervical erosion, and can be used as a first-line treatment drug.

[0031] Furthermore, any content not described in detail in this specification is existing technology known to those skilled in the art.

[0032] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0033] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A gel composition for treating cervical erosion, characterized in that: It is composed of the following components in parts by weight: 15-25 parts total extract of Sophora flavescens, 5-10 parts extract of Lithospermum erythrorhizon, 5-10 parts extract of Panax notoginseng, 0.5-1.5 parts extract of Cnidium monnieri, 5-10 parts extract of Gentiana scabra, 8-15 parts extract of Hippophae rhamnoides seed oil, 5-10 parts extract of Phellodendron chinense, 1.2-1.5 parts gelling agent, 10-15 parts glycerin, 6-8 parts Tween-80, 0.5-1 part pH adjuster, and 40-80 parts purified water.

2. The gel composition for treating cervical erosion according to claim 1, characterized in that: It consists of the following components in parts by weight: 20 parts total extract of Sophora flavescens, 7 parts extract of Lithospermum erythrorhizon, 7 parts extract of Panax notoginseng, 1 part extract of Cnidium monnieri, 7 parts extract of Gentiana scabra, 11 parts extract of Hippophae rhamnoides seed oil, 7 parts extract of Phellodendron chinense, 1.3 parts gelling agent, 13 parts glycerin, 7 parts Tween-80, 0.7 parts pH adjuster and 60 parts purified water.

3. The gel composition for treating cervical erosion according to claim 1, characterized in that: It consists of the following components in parts by weight: 15 parts total extract of Sophora flavescens, 5 parts extract of Lithospermum erythrorhizon, 5 parts extract of Panax notoginseng, 0.5 parts extract of Cnidium monnieri, 5 parts extract of Gentiana scabra, 8 parts extract of Hippophae rhamnoides seed oil, 5 parts extract of Phellodendron chinense, 1.2 parts gelling agent, 10 parts glycerin, 6 parts Tween-80, 0.5 parts pH adjuster and 40 parts purified water.

4. The gel composition for treating cervical erosion according to claim 1, characterized in that: It consists of the following components in parts by weight: 25 parts total extract of Sophora flavescens, 10 parts extract of Lithospermum erythrorhizon, 10 parts extract of Panax notoginseng, 1.5 parts extract of Cnidium monnieri, 10 parts extract of Gentiana scabra, 15 parts extract of Hippophae rhamnoides seed oil, 10 parts extract of Phellodendron chinense, 1.5 parts gelling agent, 15 parts glycerin, 8 parts Tween-80, 1 part pH adjuster and 80 parts purified water.

5. A gel composition for treating cervical erosion according to any one of claims 1-4, characterized in that: The total extract of Sophora flavescens contains matrine and sophoridine.

6. A gel composition for treating cervical erosion according to any one of claims 1-4, characterized in that: The gelling agent is at least one of carbomer-940, gelatin, gum arabic, alginate, hyaluronic acid, starch, or agar.

7. A gel composition for treating cervical erosion according to any one of claims 1-4, characterized in that: The pH adjuster is one of citric acid, malic acid, or acetic acid.

8. A method for preparing a gel composition for treating cervical erosion as described in any one of claims 1-4, characterized in that, Specifically, the following steps are included: S1. Add the gelling agent to an appropriate amount of purified water and stir until completely dispersed to form a preliminary gel. S2. Dissolve the total extract of Sophora flavescens, extract of Lithospermum erythrorhizon, extract of Panax notoginseng, extract of Cnidium monnieri, extract of Gentiana scabra, extract of Hippophae rhamnoides seed oil, and extract of Phellodendron chinense in an appropriate amount of ethanol and mix well. S3. Add the mixture from step S2 to the gel from step S1 and stir until homogeneous. S4. Add glycerin and Tween-80, and continue stirring; S5. Adjust the pH to 6.5-7.0 using a pH adjuster; S6. Add purified water to the total volume, stir thoroughly to obtain the gel composition for treating cervical erosion.

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