Ointment for treating senile vulva lichen sclerosus and preparation method thereof

Abstract

The invention relates to an ointment for treating senile vulva lichen sclerosus and a preparation method thereof, and belongs to the technical field of medicines.The preparation method of the ointment comprises the steps that 1, astragalus membranaceus, herba epimedii, radix paeoniae rubra, fructus cnidii and fructus psoraleae are decocted with water; (2) adding ethanol into the water decoction clarified liquid for extraction, and removing ethanol from the extract to obtain thick paste; (3) mixing the thick paste with the molten wool fat; (4) mixing vaseline and borneol to obtain an oily matrix; (5) mixing the oily matrix with the mixture obtained in the step (3). The external ointment obtained by the invention has an obvious treatment effect on senile vulva lichen sclerosus, and is quick in effect, convenient to use, low in price, free of toxic and side effects and easy to popularize.

Description

Technical Field

[0001] The present invention belongs to the field of pharmaceutical technology. Specifically, it relates to an ointment for treating senile vulvar lichen sclerosus and a preparation method thereof. Background Art

[0002] Vulvar lichen sclerosus, also known as sclerosing atrophic lichen, is a chronic disease in which the skin and mucosal tissues of the female vulva undergo degeneration and pigment changes. It is a stubborn and refractory gynecological disease with unknown causes. The International Society for the Study of the Vulva defines it as chronic vulvar dystrophy. Vulvar lichen sclerosus is a skin disease mainly characterized by atrophy and thinning of the vulvar and perianal skin. Since skin atrophy is the main feature of this disease, dermatologists still call this disease "sclerosing atrophic lichen" to this day. It is particularly common in menopausal and elderly women. The lesions mainly involve the clitoris and its prepuce, the labia minora, the posterior commissure of the labia, and the perianal area, and it is the most common white lesion of the vulva. A preliminary diagnosis can be made based on the clinical manifestations. Biopsy is the only final diagnostic method. Based on the patient's vulvar pruritus, typical affected sites, clinical manifestations, local depigmentation and white patches, and the pathological examination showing hyperkeratosis, atrophy of the spinous cell layer, dermal edema, and collagen fiber degeneration, the diagnosis is not difficult. Due to unknown causes, long course of disease, and unbearable itching, it brings great pain to patients, and there is currently no effective treatment drug. Summary of the Invention

[0003] In order to overcome the problems in the background art, the present invention provides an ointment for treating senile vulvar lichen sclerosus and a preparation method thereof. The ointment provided by the present invention has a quick effect, is convenient to use, has a low price, and has no toxic and side effects.

[0004] To achieve the above object, the present invention is realized through the following technical solutions: The preparation method of the ointment for treating senile vulvar lichen sclerosus includes the following steps: S1. Take astragalus membranaceus, epimedium brevicornu, red peony root, fructus cnidii, and psoralea corylifolia, decoct with water and filter to obtain a filtrate; S2. Add ethanol to the filtrate in step S1, stir well, let it stand until the precipitation is complete, then take the supernatant, and obtain a thick paste after recovering the ethanol; S3. Take lanolin and melt it in a water bath, add the thick paste in step S2 to the melted lanolin to obtain medicinal lanolin; S4. Take vaseline and melt it in a water bath, then remove it from the water bath and let it cool. At the same time, take borneol and add it to stir until it melts to obtain an oily matrix; S5. Add the medicinal lanolin in step S3 to the oily matrix in step S4, stir well, let it stand, and cool to obtain the traditional Chinese medicine external ointment of the present invention.

[0005] Further, the ethanol concentration described in step S2 is greater than 90%.

[0006] Further, in the materials used in the above preparation method, by mass parts, there are 4 - 6 parts of Astragalus membranaceus, 2 - 4 parts of Epimedium brevicornu, 2 - 4 parts of Paeonia lactiflora, 2 - 4 parts of Cnidium monnieri, 2 - 4 parts of Psoralea corylifolia, 1 - 3 parts of lanolin, 10 - 14 parts of vaseline, and 0.5 - 3 parts of borneol.

[0007] Further, in the materials used in the above preparation method, by mass parts, there are 5 parts of Astragalus membranaceus, 3 parts of Epimedium brevicornu, 3 parts of Paeonia lactiflora, 3 parts of Cnidium monnieri, 3 parts of Psoralea corylifolia, 12 parts of vaseline, 1 part of lanolin, and 1 part of borneol.

[0008] The present invention provides an ointment for treating senile vulvar lichen sclerosus obtained by the above preparation method.

[0009] The present invention also provides an ointment for treating senile vulvar lichen sclerosus, which, by weight parts, includes the following components: 5 parts of Astragalus membranaceus, 3 parts of Epimedium brevicornu, 3 parts of Paeonia lactiflora, 3 parts of Cnidium monnieri, 3 parts of Psoralea corylifolia, 12 parts of vaseline, 1 part of lanolin, and 1 part of borneol.

[0010] Advantages of the present invention: The ointment of the present invention is for external use. Through actual use, it has a good therapeutic effect on vulvar lichen sclerosus. After 1 to 2 months of use, the vulvar skin of the patient has obvious new growth, the leukoplakia disappears, and the edema and itching disappear. There is no discomfort during the use process; the present invention is prepared with traditional Chinese medicine ingredients, is safe, has no toxic and side effects, and during the use process by the patient, there are no toxic and side effects and discomfort, and it is easy to be accepted by the patient. Description of the drawings

[0011] Figure 1 is a schematic flow chart of the preparation method of the ointment of the present invention. Detailed implementation manners

[0012] In order to make the objectives, technical solutions, and advantages of the present invention clearer, the technical solutions of the present invention will be described in detail below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, other embodiments obtained by those skilled in the art without creative efforts all fall within the scope of protection of the present invention.

[0013] The ointment for treating senile vulvar sclerosis lichen of the present invention is prepared by extracting effective ingredients from astragalus, epimedium, red peony root and cnidium monnieri, using psoralea corylifolia and borneol as adjuvant drugs, and using vaseline and lanolin as drug carriers. The drugs used are respectively as follows by weight: 4-6 parts of astragalus, 2-4 parts of epimedium, 2-4 parts of red peony root, 2-4 parts of cnidium monnieri, 2-4 parts of psoralea corylifolia, 1-3 parts of lanolin, 10-14 parts of vaseline and 0.5-3 parts of borneol.

[0014] Astragalus is sweet in taste and warm in nature. It enters the spleen and lung meridians. It has the effects of invigorating qi and raising yang, strengthening the body's defense system, promoting toxins and promoting tissue regeneration, and promoting diuresis and reducing swelling. It is mainly used to treat qi deficiency and fatigue, poor appetite and loose stools, sinking of qi in the middle, chronic diarrhea and prolapse of the anus, blood in the stool and metrorrhagia, spontaneous perspiration due to deficiency of the surface, edema due to qi deficiency, carbuncle that is difficult to ulcerate, long-term ulceration that does not heal, blood deficiency and jaundice, internal heat and thirst, chronic nephritis, proteinuria, and diabetes. Modern pharmacology proves that Astragalus has the effects of enhancing the body's immune function, protecting the liver, diuresis, anti-aging, anti-stress, blood pressure reduction, and a wide range of antibacterial effects. It is the monarch drug in this prescription.

[0015] Epimedium is a plant of the Berberidaceae family. The main effects of the dried leaves of Epimedium are to tonify kidney yang, strengthen bones and tendons, and eliminate rheumatism. It is mainly used to treat kidney deficiency, impotence, infertility, frequent urination, weakness of bones and tendons, and also has effects on wind-cold-dampness arthralgia or limb numbness. Modern research has confirmed that this product has the effects of enhancing immune function, improving sexual function, resisting myocardial ischemia, lowering blood pressure, lowering blood sugar, and delaying aging. It is the ministerial drug in this prescription.

[0016] Red peony root belongs to the category of heat-clearing and blood-cooling medicine, which is slightly cold in nature and bitter in taste. It enters the liver meridian and spleen meridian, has the effects of clearing heat and cooling blood, dispersing blood stasis and relieving pain, and is used to treat fever-induced rash, vomiting blood and epistaxis, eye swelling and pain, liver depression and hypochondrium pain, amenorrhea and dysmenorrhea, abdominal pain due to lumps and masses, injuries from falls, carbuncles and ulcers.

[0017] Cnidium monnieri is an insecticide and antipruritic drug, and also a yang-tonifying drug under the category of tonic drugs. It is warm in nature, pungent and bitter in taste, and enters the kidney meridian. It has the effects of warming the kidney and strengthening yang, drying dampness, dispelling wind, and killing insects. It is mainly used to treat fever and toxicity, vomiting blood and epistaxis, eye swelling and pain, liver depression and hypochondria, amenorrhea and dysmenorrhea, abdominal pain due to lumps and masses, injuries from falls, carbuncles, sores, impotence, cold uterus, cold and damp leucorrhea, and dampness and arthralgia and low back pain. It is used as an adjuvant with red peony root in this prescription.

[0018] Psoralea corylifolia belongs to the category of yang-tonifying medicine. It is pungent, bitter and warm in nature. It belongs to the kidney and spleen meridians. It has the functions of tonifying the kidney and supporting yang, consolidating essence and reducing urine, warming the spleen and stopping diarrhea, relieving qi and relieving asthma, and eliminating wind and removing spots. Modern pharmacology has proved that it can be used to treat leukopenia, dysmenorrhea, dysfunctional uterine bleeding, breast hyperplasia, coronary heart disease, hyperlipidemia, prolapse of the anus in children, senile constipation, nephrotic syndrome, cervical spondylosis, vitiligo, urinary stones and many other diseases.

[0019] Borneol is a commonly used traditional Chinese medicine for resuscitation in clinical practice. Its properties are pungent, bitter, slightly cold, and it pertains to the heart, spleen, and lung meridians. It has the effects of resuscitating the consciousness, clearing heat and relieving pain, removing nebula and improving eyesight, and detumescence and relieving pain. It is mainly used to treat heat-blocked coma, phlegm-heat internal blockage, sudden syncope due to summer heat, infantile convulsions, and various sores and boils with swelling and pain, non-healing after ulceration, scalds and burns, sore throat, throat obstruction, red and swollen eyes, and oral ulcers. Clinically, borneol is mainly used for diseases such as delirium caused by phlegm turbidity blocking the clear orifices; it can also be used for diseases such as red and swollen eyes and throat, oral ulcers, and carbuncles, furuncles, and sores; in addition, borneol can also be used to treat burns and scalds. It and Psoralea corylifolia are used as assistant drugs in this formula.

[0020] Vaseline and lanolin have the effects of moisturizing and hydrating, and are used as drug carriers.

[0021] To illustrate the present invention more clearly, the following examples are used for detailed description.

[0022] Example 1

[0023] A method for preparing an external ointment for treating vulvar lichen sclerosus, comprising the following steps: (1) 0.5 kg of Astragalus membranaceus, 0.3 kg of Epimedium brevicornu, 0.3 kg of Paeonia lactiflora, 0.3 kg of Cnidium monnieri, 0.3 kg of Psoralea corylifolia, decoct twice with water for one hour each time, combine the decoction liquids, filter, and obtain a filtrate; (2) Measure the volume of the filtrate in step (1), add 95% ethanol according to the proportion of the filtrate volume so that the ethanol content in the filtrate reaches 60%, stir well, let stand for 2 hours until the precipitation is complete, then take the supernatant, and obtain a thick paste after recovering ethanol; (3) Take 0.1 kg of lanolin and melt it in a water bath, add the thick paste in step (2) to the melted lanolin to obtain medicated lanolin; (4) Take 1.2 kg of vaseline and melt it in a water bath, then remove it from the water bath and cool it to 45 °C. At the same time, take 0.1 kg of borneol and add it thereto and stir to melt it to obtain an oily matrix; (5) Add the medicated lanolin in step (3) to the oily matrix in step (4), stir well, let stand, and cool, then package to obtain the traditional Chinese medicine external ointment of the present invention.

[0024] Example 2

[0025] A method for preparing an external ointment for treating vulvar lichen sclerosus, comprising the following steps: (1) 0.4 kg of Astragalus membranaceus, 0.2 kg of Epimedium brevicornu, 0.2 kg of Paeonia lactiflora, 0.2 kg of Cnidium monnieri, 0.2 kg of Psoralea corylifolia, decoct twice with water for one hour each time, combine the decoction liquids, filter, and obtain a filtrate; (2)Measure the volume of the filtrate in step (1), add 95% ethanol according to the proportion of the filtrate volume to make the ethanol content in the filtrate reach 60%, stir well, let it stand for 2 hours until the precipitation is complete, then take the supernatant, and obtain a thick paste after recovering ethanol; (3)Take 0.1 kg of lanolin and melt it in a water bath. Add the thick paste in step (2) to the melted lanolin to obtain medicinal lanolin; (4)Take 1.2 kg of vaseline and melt it in a water bath, then remove it from the water bath and let it cool to 45 °C. At the same time, take 0.1 kg of borneol and add it to stir and melt it to obtain an oily matrix; (5)Add the medicinal lanolin in step (3) to the oily matrix in step (4), stir well, let it stand, cool, and then subpackage to obtain the traditional Chinese medicine external ointment of the present invention.

[0026] Example 3

[0027] A preparation method of an external ointment for treating vulvar lichen sclerosus, comprising the following steps: (1)Take 0.6 kg of Astragalus membranaceus, 0.4 kg of Epimedium brevicornu, 0.4 kg of Paeonia lactiflora, 0.4 kg of Cnidium monnieri, and 0.4 kg of Psoralea corylifolia, decoct twice with water for 1 hour each time, combine and filter the decoction liquid to obtain a filtrate; (2)Measure the volume of the filtrate in step (1), add 95% ethanol according to the proportion of the filtrate volume to make the ethanol content in the filtrate reach 60%, stir well, let it stand for 2 hours until the precipitation is complete, then take the supernatant, and obtain a thick paste after recovering ethanol; (3)Take 0.1 kg of lanolin and melt it in a water bath. Add the thick paste in step (2) to the melted lanolin to obtain medicinal lanolin; (4)Take 1.2 kg of vaseline and melt it in a water bath, then remove it from the water bath and let it cool to 45 °C. At the same time, take 0.3 kg of borneol and add it to stir and melt it to obtain an oily matrix; (5)Add the medicinal lanolin in step (3) to the oily matrix in step (4), stir well, let it stand, cool, and then subpackage to obtain the traditional Chinese medicine external ointment of the present invention.

[0028] Comparative Example 1 Others are the same as in Example 1, without using Astragalus membranaceus.

[0029] Comparative Example 2 Others are the same as in Example 1, without using Astragalus membranaceus and Epimedium brevicornu.

[0030] Comparative Example 3 Others are the same as in Example 1, without using Cnidium monnieri and Paeonia lactiflora.

[0031] Comparative Example 4 Others are the same as in Example 1, without using Psoralea corylifolia and borneol.

[0032] Comparison of application effects: The ointment of the present invention was distributed free of charge to patients in the First People's Hospital of Yunnan Province from May 2024 to March 2025. 50 patients who had already started to have obvious itching were randomly selected. According to the order of seeing a doctor, the ointments prepared in Examples 1 to 3 and Comparative Examples 1 to 4 were used respectively (the first 3 patients seeing a doctor used the ointments of Examples 1 to 3, the 4th to 7th patients used the ointments of Comparative Examples 1 to 4; the 8th to 10th patients used the ointments of Examples 1 to 3, and so on). After two months of use, the use effects were compared.

[0033] Clinical efficacy scoring criteria: The scoring criteria and efficacy determination criteria were formulated with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines" revised and promulgated by the National Health Commission: ① Pigmentation loss of vulvar skin and mucosa: According to the percentage of the skin lesion area in the total vulvar area: less than 30% is 1 point; 30% - 70% is 2 points; more than 70% is 3 points. ② Vulvar pruritus: Mild (occasionally itchy) is 1 point; Moderate (often itchy, does not affect sleep) is 2 points; Severe (severe vulvar pruritus, affects sleep) is 3 points. ③ Vulvar dryness: Mild (slightly dry) is 1 point; Moderate (obvious dryness, sometimes need to wash, less than 3 times a day) is 2 points; Severe (severe dryness, more than 4 times a day) is 3 points. ④ Thickening of vulvar skin: Mild (slightly obvious skin texture) is 1 point; Moderate (coarse skin, obvious texture) is 2 points; Severe (leathery change of skin) is 3 points. ⑤ Skin atrophy and thinning: Mild (slightly atrophied and thinned skin) is 1 point; Moderate (atrophied and thinned skin, small labia minora visible) is 2 points; (atrophied and thinned skin, small labia minora disappeared) is 3 points.

[0034] Follow-up recurrence criteria ① No recurrence: No persistent or paroxysmal vulvar pruritus occurred within 3 months after the end of the patient's treatment course. ② Recurrence: Vulvar pruritus reappeared within 3 months after the end of the patient's treatment course, or the area of vulvar leukoplakia increased, or the vulvar skin color and texture deteriorated. 1. Therapeutic effect:

[0035] 2. Comparison of clinical efficacy scores before and after treatment in each group of cases (points; x ± s)

[0036] In order to further verify the use effect of the ointment of the present invention, the ointment prepared by the method of Example 1 was continuously used for clinical use and was officially distributed free of charge to the patients seeing a doctor since May 2024.

[0037] The inventor conducted a large number of clinical trials on the topical ointment prepared in Example 1 for the treatment of senile vulvar lichen sclerosus. The specific case situations are as follows: 1. Ning XX, female, 65 years old, suffered from the disease for 27 years. It occurred occasionally, but was extremely itchy during attacks and often scratched. Examination showed that the vulvar lesion was in an eczematoid change, with pink color mixed with clearly demarcated white patches, belonging to the hyperplastic type of vulva. The patient applied the medicine three times a day, the white patch shrank, and the pruritus disappeared. She was completely cured in two months.

[0038] 2. Li XX, female, 74 years old, suffered from the disease for 26 years and failed to seek treatment everywhere. Examination showed atrophic vulvar leukoplakia. After continuous use, the vulvar pruritus, vulvar color, vulvar elasticity, and lesion area were all improved to varying degrees, and the symptoms disappeared in two months.

[0039] 3. Lei XX, female, 74 years old, suffered from the disease for more than 1 year. Examination showed atrophic vulvar leukoplakia. It continuously occurred with extremely itchy and occasionally scratched and ulcerated. After continuous medication for two months, the recovery was good, and the clinical efficacy score showed that the patient had been cured.

[0040] 4. Liu XX, female, 62 years old, suffered from the disease for more than three years. Examination showed atrophic vulvar leukoplakia. The patient applied the medicine three times a day, the white patch shrank, and the pruritus disappeared. She was completely cured in two months.

[0041] 5. Huang XX, female, 69 years old, suffered from the disease for nearly 30 years. Examination showed atrophic vulvar leukoplakia. After continuous medication for two months, the recovery was good, and the vulvar pruritus, vulvar color, vulvar elasticity, and lesion area were all improved to varying degrees.

[0042] It can be clearly seen from the vulvar conditions of the patients before and after using the ointment of the present invention: there are obvious new growths on the vulvar skin, the white patches disappear, and the edema and pruritus disappear.

[0043] Finally, it should be noted that the above are only the preferred embodiments of the present invention and are not used to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements for some of the technical features. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A preparation method of an ointment for treating senile vulvar lichen sclerosus, characterized in that It includes the following steps: S1. Take astragalus membranaceus, epimedium brevicornum, radix paeoniae rubra, fructus cnidii and psoralea corylifolia, decoct with water and filter to obtain a filtrate; S2. Add ethanol to the filtrate in step S1, stir well, let it stand until the precipitation is complete, then take the supernatant, recover the ethanol to obtain a thick paste; S3. Take lanolin and melt it in a water bath, add the thick paste in step S2 to the melted lanolin to obtain medicinal lanolin; S4. Take vaseline and melt it in a water bath, then remove it from the water bath to cool it. At the same time, take borneol and add it to stir until it melts to obtain an oily matrix; S5. Add the medicinal lanolin in step S3 to the oily matrix in step S4, stir well, let it stand and cool to obtain the traditional Chinese medicine external ointment of the present invention.

2. The preparation method according to claim 1, characterized in that, The ethanol concentration in step S2 is greater than 90%.

3. The preparation method according to claim 1, wherein By mass fraction, astragalus membranaceus 4 - 6 parts, epimedium brevicornum 2 - 4 parts, radix paeoniae rubra 2 - 4 parts, fructus cnidii 2 - 4 parts, psoralea corylifolia 2 - 4 parts, lanolin 1 - 3 parts, vaseline 10 - 14 parts, borneol 0.5 - 3 parts.

4. An external ointment obtained by the preparation method according to any one of claims 1 to 3.

5. The ointment for treating senile vulvar lichen sclerosus according to claim 4, characterized in that, By weight fraction, it includes the following components: astragalus membranaceus 5 parts, epimedium brevicornum 3 parts, radix paeoniae rubra 3 parts, fructus cnidii 3 parts, psoralea corylifolia 3 parts, vaseline 12 parts, lanolin 1 part, borneol 1 part.

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