A gynecological compound traditional Chinese medicine composition, an external lotion and a preparation method thereof

Abstract

The application discloses a gynecological compound traditional Chinese medicine composition, an external lotion and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The oral composition of the application takes gentiana scabra and smilax glabra as monarchs, and is supplemented with various traditional Chinese medicine components such as alisma, phellodendron, sophora flavescens, isatis leaf, radix isatidis and salvia miltiorrhiza, and has the effects of clearing heat and removing dampness, resisting viruses and promoting blood circulation and repair; the external lotion takes earth snake bed and sophora flavescens as monarchs, and is matched with components such as radix stachy, paris polyphylla, borneol and radix dictamni, and directly reaches the disease site to kill insects and relieve itching; the two form a combined medication scheme, and treat diseases from inside and outside. The oral preparation of the application adopts an alcohol precipitation refining combined spray drying process, and the external lotion adopts a special preparation process of borneol ethanol dissolution and dispersion of fine powder of copper vitriol, so that the quality of the product is controllable and the stability is improved. Experiments show that the total effective rate of the internal and external combined treatment reaches more than 90%, and is significantly better than a single medication scheme.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically referring to a gynecological compound traditional Chinese medicine composition, an external wash, and its preparation method. Background Technology

[0002] Vulvar pruritus, condyloma acuminata (caused by HPV infection), and vulvar leukoplakia are common and difficult-to-treat gynecological diseases. Currently, Western medicine treatments often employ antibiotics, antiviral drugs, hormonal creams, or physical therapies (such as laser and cryotherapy), which have drawbacks such as high recurrence rates, drug resistance, and significant side effects (such as local irritation and skin atrophy).

[0003] Traditional Chinese medicine believes that the fundamental pathogenesis of this type of disease is "damp-heat descending to the liver meridian, accompanied by parasitic toxins and blood stasis." Dampness tends to descend, and heat scorches the body. Damp-heat accumulates in the genital area along the liver meridian, hence the itching and erosion. Prolonged damp-heat can breed parasitic toxins, which can be seen in condyloma acuminata. Damp-heat stagnation obstructs the flow of qi and blood, and the skin becomes malnourished, resulting in leukoderma.

[0004] Several traditional Chinese medicine formulas are currently used to treat gynecological diseases. For example, Formula A (Gentiana Detoxifying and Insecticidal Formula) focuses on internal administration to clear damp-heat in the liver and gallbladder. In this formula, gentian root, phellodendron bark, and sophora flavescens are bitter and cold, drying dampness; smilax glabra and artemisia capillaris promote diuresis and detoxification; chinaberry fruit and peony bark cool the blood and invigorate blood circulation; and cnidium monnieri and dryopteris crassirhizoma kill parasites. Formula B (washing formula) is for external use, using cnidium monnieri, sophora flavescens, and stemona japonica to powerfully kill parasites and relieve itching. However, existing technologies have the following shortcomings: First, the combination of internal and external treatment is not systematic; Formulas A and B are relatively independent and do not form a complete treatment plan that integrates internal and external treatments and addresses both the symptoms and the root cause. Second, while the original formulas address pathogens such as HPV and their tissue repair effects on vulvar leukoplakia, the effects are insufficient. Third, traditional decoction and external washing methods are inconvenient to use, have low drug utilization, and are not conducive to standardized production and widespread application.

[0005] Therefore, it is necessary to develop a traditional Chinese medicine regimen that combines internal and external treatments, optimizes components, and employs modern pharmaceutical processes. Summary of the Invention

[0006] In view of the above situation and to overcome the defects of the prior art, the present invention provides a gynecological compound Chinese medicine composition, external wash and its preparation method, which effectively solves the problems of slow onset of action, short-lasting effect and high recurrence rate when using oral prescriptions or external washes alone to treat gynecological diseases such as vulvar pruritus, condyloma acuminata and vulvar leukoplakia.

[0007] This invention provides a gynecological compound traditional Chinese medicine composition and a topical wash.

[0008] The oral composition is made from the following raw materials in parts by weight: 6-9 parts of Gentiana scabra, 20-30 parts of Smilax glabra, 10-15 parts of Dioscorea hypoglauca, 10-12 parts of Phellodendron chinense, 6-9 parts of Sophora flavescens, 10-15 parts of Isatis indigotica, 10-15 parts of Isatis tinctoria, 10-15 parts of Salvia miltiorrhiza, 8-12 parts of Melia toosendan, 8-12 parts of Gynostemma pentaphyllum, 8-12 parts of Dryopteris crassirhizoma, 8-12 parts of Artemisia capillaris, 8-12 parts of Lonicera japonica, and 8-12 parts of Paeonia suffruticosa.

[0009] The external wash is made from the following raw materials in parts by weight: 25-35 parts of Cnidium monnieri, 25-35 parts of Sophora flavescens, 25-35 parts of Stemona japonica, 12-18 parts of Phellodendron chinense, 12-18 parts of Paris polyphylla, 8-12 parts of alum, 5-7 parts of Zanthoxylum bungeanum, 12-18 parts of Dryopteris crassirhizoma, 2-4 parts of borneol, and 15-25 parts of Dictamnus dasycarpus.

[0010] Furthermore, the weight ratio of Isatis tinctoria leaf to Isatis tinctoria root in the oral composition is 1:0.8-1.2.

[0011] Furthermore, the weight ratio of borneol to alum in the external wash is 1:2.5-4.0.

[0012] Furthermore, the oral composition is formulated into capsules, granules, or tablets.

[0013] Furthermore, the external wash is a concentrated liquid preparation.

[0014] This invention also proposes a method for preparing a gynecological compound traditional Chinese medicine composition, specifically including the following steps:

[0015] (1) Take the raw material of the oral composition, add water and decoct 2-3 times, combine the decoctions, filter and obtain filtrate; (2) Concentrate the filtrate to a clear paste with a relative density of 1.10-1.15, add ethanol to make the alcohol content reach 60%-70%, let stand, filter, recover the ethanol and obtain a refined liquid; (3) Concentrate the refined liquid into a thick paste, dry it, add pharmaceutically acceptable excipients and make an oral preparation.

[0016] Furthermore, the drying described in step (3) is spray drying.

[0017] This invention also proposes a method for preparing a gynecological compound traditional Chinese medicine external wash, specifically including the following steps:

[0018] (1) Take Cnidium monnieri, Sophora flavescens, Stemona japonica, Phellodendron chinense, Paris polyphylla, Zanthoxylum bungeanum, Dryopteris crassirhizoma, and Dictamnus dasycarpus, add water and decoct, filter and obtain concentrated liquid; (2) Crush alum into fine powder and dissolve borneol in ethanol; (3) Add the alum powder and borneol ethanol solution obtained in step (2) to the concentrated liquid obtained in step (1), stir, add water to make up the volume, stir well, dispense and sterilize.

[0019] Furthermore, the sterilization described in step (3) is steam sterilization.

[0020] The beneficial effects achieved by this invention are as follows:

[0021] 1. Treating both internal and external ailments, addressing both the root cause and symptoms. Internal medication clears heat from the liver meridian, while external application treats the symptoms (directly killing parasites, relieving itching, and fighting viruses), forming a comprehensive treatment plan that is more effective than single-method therapies.

[0022] 2. Scientifically formulated with strong targeting. The oral formula adds Isatis tinctoria leaf and Isatis indigotica root to enhance anti-HPV virus capabilities; it also adds Salvia miltiorrhiza to target blood stasis pathogenesis and promote repair. The external wash formula adds borneol to promote transdermal absorption; and it also adds Dictamnus dasycarpus root bark to enhance its drying and detoxifying effects.

[0023] 3. Advanced technology and controllable quality. Modern refining techniques such as alcohol precipitation and spray drying are employed to improve the concentration and stability of active ingredients in oral preparations. External washes utilize a scientific formulation method, with alum dispersed in the system as a fine powder suspension, avoiding the loss of active ingredients due to filtration; borneol is pre-dissolved in ethanol before addition, ensuring uniformity and efficacy.

[0024] 4. Convenient to use and with good compliance. Traditional decoctions have been improved into capsules / granules, and external washes have been made into ready-to-use concentrated solutions, making them convenient for patients and for clinical promotion. Attached Figure Description

[0025] Figure 1 A comparison of monotherapy and combination therapy for vulvar pruritus;

[0026] Figure 2 This is a comparative example of therapeutic efficacy.

[0027] Figure 3 For observation of the treatment efficacy for condyloma acuminata;

[0028] Figure 4 To observe the therapeutic effects of vulvar leukoplakia.

[0029] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof. Detailed Implementation

[0030] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0031] Example 1

[0032] Take 800g of gentian root, 2500g of smilax glabra, 1200g of dioscorea hypoglauca, 1200g of phellodendron bark, 800g of sophora flavescens, 1200g of indigo leaf, 1200g of isatis root, 1200g of salvia miltiorrhiza, 1000g of Sichuan pepper, 1000g of gentian root, 1000g of dryopteris crassirhizoma, 1000g of artemisia capillaris, 1000g of honeysuckle, and 1000g of peony bark.

[0033] The above fourteen herbs were decocted three times with water: 2 hours for the first decoction, and 1.5 hours each for the second and third. The decoctions were combined, filtered, and concentrated to a clear extract with a relative density of 1.12 (60℃). Ethanol was added to bring the alcohol content to 65%, stirred well, and allowed to stand for 24 hours. The extract was then filtered, the ethanol was recovered, and the filtrate was concentrated to a thick extract with a relative density of 1.32 (80℃). The thick extract was then spray-dried at an inlet air temperature of 180℃ and an outlet air temperature of 90℃ to obtain a dry extract powder. 10% by weight of microcrystalline cellulose was added to the dry extract powder, mixed well, and filled into 1000 capsules to obtain the final product.

[0034] Example 2

[0035] Take 700g of gentian root, 2200g of smilax glabra, 1100g of dioscorea hypoglauca, 1100g of phellodendron bark, 700g of sophora flavescens, 1000g of indigo leaf, 1200g of isatis root, 1100g of salvia miltiorrhiza, 900g of Sichuan pepper, 900g of gentian root, 900g of dryopteris crassirhizoma, 900g of artemisia capillaris, 900g of honeysuckle, and 900g of peony bark.

[0036] The dry extract powder was prepared according to the method described in Example 1. 5% starch and 5% dextrin by weight of the dry extract powder were added to the dry extract powder, mixed well, granulated with ethanol, dried, and sized to form granules.

[0037] Example 3

[0038] Take 300g of *Cnidium monnieri*, 300g of *Sophora flavescens*, 300g of *Stemona japonica*, 150g of *Phellodendron chinense*, 150g of *Paris polyphylla*, 60g of *Zanthoxylum bungeanum*, 150g of *Dryopteris crassirhizoma*, and 200g of *Dictamnus dasycarpus*. Add water to the above eight ingredients and decoct twice, 1.5 hours each time. Combine the decoctions, filter, concentrate the filtrate to approximately 1000ml, and let cool.

[0039] Take another 100g of alum and grind it into a fine powder. Dissolve 30g of borneol in 100ml of ethanol. Slowly add the alum powder and borneol ethanol solution to the above concentrated solution while stirring. Add water to adjust the total volume to 1500ml, stir thoroughly, fill into 50ml plastic bottles, and sterilize with circulating steam for 30 minutes.

[0040] Example 4

[0041] Take 280g of *Cnidium monnieri*, 280g of *Sophora flavescens*, 280g of *Stemona japonica*, 140g of *Phellodendron chinense*, 140g of *Paris polyphylla*, 56g of *Zanthoxylum bungeanum*, 140g of *Dryopteris crassirhizoma*, and 180g of *Dictamnus dasycarpus*. Add water to the above eight ingredients and decoct twice, 1.5 hours each time. Combine the decoctions, filter, concentrate the filtrate to approximately 950ml, and let cool.

[0042] Separately, take 80g of alum and grind it into a fine powder. Dissolve 32g of borneol in 100ml of ethanol. Slowly add the alum powder and borneol ethanol solution to the above concentrated solution while stirring. Add water to adjust the total volume to 1400ml, stir thoroughly, fill into 50ml plastic bottles, and sterilize with circulating steam for 30 minutes.

[0043] Comparative Example 1

[0044] The preparation method of Example 1 is the same, except that: the oral composition does not contain Isatis tinctoria leaves and Isatis tinctoria root, and the amount of honeysuckle is adjusted to 2400g.

[0045] Take 800g of gentian root, 2500g of smilax glabra, 1200g of dioscorea hypoglauca, 1200g of phellodendron chinense, 800g of sophora flavescens, 2400g of honeysuckle, 1200g of salvia miltiorrhiza, 1000g of melia azedarach, 1000g of dryopteris crassirhizoma, 1000g of artemisia capillaris, and 1000g of peony bark. Prepare capsules according to the method in Example 1.

[0046] Comparative Example 2

[0047] The preparation method of Example 1 is the same, except that Danshen is not added to the oral composition, and the amount of Danpi is adjusted to 2200g.

[0048] Take 800g of gentian root, 2500g of smilax glabra, 1200g of dioscorea hypoglauca, 1200g of phellodendron bark, 800g of sophora flavescens, 1200g of isatis leaf, 1200g of isatis root, 1000g of Sichuan chinaberry, 1000g of gentian root, 1000g of dryopteris crassirhizoma, 1000g of artemisia capillaris, 1000g of honeysuckle, and 2200g of peony bark. Prepare capsules according to the method in Example 1.

[0049] Comparative Example 3

[0050] The preparation method of Example 3 is the same, except that borneol and Dictamnus dasycarpus are not added to the external wash.

[0051] Take 300g of *Cnidium monnieri*, 300g of *Sophora flavescens*, 300g of *Stemona japonica*, 150g of *Phellodendron chinense*, 150g of *Paris polyphylla*, 60g of *Zanthoxylum bungeanum*, and 150g of *Dryopteris crassirhizoma*. Decoct twice with water, 1.5 hours each time. Combine the decoctions, filter, and concentrate the filtrate to approximately 1000ml. Let cool. Separately, take 100g of dried alum and grind it into a fine powder. Add the dried alum powder to the concentrated liquid, stir, add water to adjust the total volume to 1500ml, stir thoroughly, fill and seal, and sterilize with circulating steam for 30 minutes.

[0052] Comparative Example 4

[0053] Traditional decoction preparation methods

[0054] Take 8g of Gentiana scabra, 25g of Smilax glabra, 12g of Dioscorea hypoglauca, 12g of Phellodendron chinense, 8g of Sophora flavescens, 12g of Isatis indigotica, 12g of Isatis tinctoria, 12g of Salvia miltiorrhiza, 10g of Melia toosendan, 10g of Smilax china, 10g of Dryopteris crassirhizoma, 10g of Artemisia capillaris, 10g of Lonicera japonica, and 10g of Paeonia suffruticosa. Add water to cover the above fourteen herbs, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter the liquid, add water to the dregs again, and simmer for another 20 minutes. Combine the two decoctions and take in two divided doses.

[0055] Synergistic effect of combined drug use experiment

[0056] Forty-two cases meeting the diagnostic criteria for vulvar pruritus were randomly divided into three groups of 14 each. Group A received the oral capsules prepared in Example 1 of this invention in combination with the topical wash prepared in Example 3; Group B received the oral capsules prepared in Example 1 alone; and Group C received the topical wash prepared in Example 3 alone. The treatment period for all groups was four weeks.

[0057] The results showed that the total effective rate in group A was 92.9% (13 / 14), including 7 cured cases, 4 cases with significant improvement, 2 cases with improvement, and 1 case with no effect; the total effective rate in group B was 71.4% (10 / 14); and the total effective rate in group C was 78.6% (11 / 14). The total effective rate of group A was significantly better than that of groups B and C (P<0.05), indicating that the combined oral and topical treatment regimen had a significant synergistic effect.

[0058] Comparison of therapeutic effects between the examples and the comparative examples

[0059] One hundred cases meeting the diagnostic criteria for vulvar pruritus were randomly divided into eight groups: groups 1-5 each had 14 cases, and groups 6 and 7 each had 15 cases. All groups received a treatment regimen combining oral and topical medication. The oral medication consisted of 3-5 capsules twice daily, while the topical medication was 30-50ml diluted with warm water for sitz baths once or twice daily. The treatment cycle was four weeks. The only difference was the preparation used. The treatment regimens for each group are as follows:

[0060] Group 1: For internal use, the capsules prepared in Example 1 are used; for external use, the lotion prepared in Example 3 is used (preferred embodiment of the present invention).

[0061] Group 2: For internal use, the granules prepared in Example 2 were used; for external use, the lotion prepared in Example 4 was used.

[0062] Group 3: For internal use, the capsules prepared in Example 1 were used; for external use, the lotion prepared in Example 4 was used.

[0063] Group 4: For internal use, capsules prepared in Comparative Example 1 (lacking Isatis tinctoria leaf and Isatis tinctoria root) were used; for external use, lotion prepared in Example 3 was used.

[0064] Group 5: For internal use, capsules prepared in Comparative Example 2 (without Salvia miltiorrhiza) were used; for external use, lotion prepared in Example 3 was used.

[0065] Group 6: For internal use, the capsules prepared in Example 1 were used; for external use, the lotion prepared in Comparative Example 3 (lacking borneol and Dictamnus dasycarpus root bark) was used.

[0066] Group 7: Oral administration used the decoction prepared in Comparative Example 4 (traditional decoction), and external application used the lotion prepared in Example 3. The efficacy results of each group are shown in Table 1.

[0067] Table 1. Comparison of therapeutic effects between the examples and comparative examples

[0068] Group Number of examples Overall efficiency cure rate Relapse rate (4 weeks after discontinuation of medication) Group 1 14 92.9%（13 / 14） 50.0%（7 / 14） 7.1%（1 / 14） Group 2 14 85.7%（12 / 14） 42.9%（6 / 14） 14.3%（2 / 14） Group 3 14 92.9%（13 / 14） 50.0%（7 / 14） 7.1%（1 / 14） Group 4 14 64.3%（9 / 14） 21.4%（3 / 14） 28.6%（4 / 14） Group 5 14 71.4%（10 / 14） 28.6%（4 / 14） 21.4%（3 / 14） Group 6 15 66.7%（10 / 15） 20.0%（3 / 15） 33.3%（5 / 15） Group 7 15 60.0%（9 / 15） 13.3%（2 / 15） 40.0%（6 / 15）

[0069] The results showed that Group 1 (preferred formula) had a total effective rate of 92.9%, significantly better than the control groups. Group 4 (lacking Isatis tinctoria leaf and Isatis indigotica root) had a total effective rate of 64.3%, indicating that the addition of Isatis tinctoria leaf and Isatis indigotica root significantly enhanced antiviral capabilities, resulting in more thorough elimination of the pathogen and a substantial reduction in recurrence rate. Group 5 (lacking Salvia miltiorrhiza root) had a total effective rate of 71.4%, indicating that Salvia miltiorrhiza's effects of promoting blood circulation and removing blood stasis, and improving local microcirculation, are significant in promoting tissue repair and reducing recurrence. Group 6 (lacking Borneol and Dictamnus dasycarpus root bark) had a total effective rate of 71.4%, indicating that the synergistic effect of Borneol promoting transdermal absorption and Dictamnus dasycarpus root bark enhancing drying and detoxification significantly improved the efficacy of the external wash. Group 7 (traditional decoction) had a total effective rate of 60.0%, indicating that the modern pharmaceutical processes of this invention, such as alcohol precipitation and spray drying, significantly improved the concentration and bioavailability of the active ingredients. The total effective rate of Group 2 (granules) was 85.7%, slightly lower than that of the capsules (92.9%), but there was no statistically significant difference (P>0.05), indicating that the two dosage forms were of comparable efficacy. The total effective rate of Groups 1 and 3 (different ratios) was 92.9%, indicating that both had stable therapeutic effects within the ratio range defined in the claims.

[0070] Clinical observation of the treatment of condyloma acuminata

[0071] Thirty cases clinically and pathologically diagnosed with condyloma acuminata (HPV6 / 11 positive) were randomly divided into two groups of 15 each. Group A received the oral capsules prepared in Example 1 of this invention in combination with the topical wash prepared in Example 3. The oral capsules were taken 3-5 times daily, and the topical wash (30-50 ml diluted with warm water) was applied to the warts and surrounding skin twice daily. Group B received only the topical wash, used in the same manner as Group A. The treatment period was 6 weeks.

[0072] The results showed that in group A, the complete wart shedding rate was 73.3% (11 / 15), the HPV negative conversion rate was 53.3% (8 / 15), and the recurrence rate within 6 months was 20.0% (3 / 15); in group B, the complete wart shedding rate was 46.7% (7 / 15), the HPV negative conversion rate was 26.7% (4 / 15), and the recurrence rate within 6 months was 46.7% (7 / 15). Group A was significantly better than group B in terms of wart shedding rate, HPV negative conversion rate, and recurrence rate (P<0.05), indicating that the antiviral effects of Isatis tinctoria leaf and Isatis indigotica root in the oral composition and the local corrosive and insecticidal effects of the external lotion have a synergistic effect.

[0073] Clinical observation of vulvar leukoplakia

[0074] Twenty-eight clinically diagnosed cases of vulvar leukoplakia (lichen sclerosus type) were randomly divided into two groups of 14 each. Group A received the oral capsules prepared in Example 1 of this invention in combination with the topical wash prepared in Example 3. The oral capsules were taken 3-5 times daily, and the topical wash was diluted with warm water and used for sitz baths 1-2 times daily. Group B received only the topical wash for sitz baths, using the same method as Group A. The treatment period was 8 weeks.

[0075] The results showed that in group A, the pruritus relief rate was 85.7% (12 / 14), the skin lesion improvement rate (reduction of leukoplakia area ≥30%) was 64.3% (9 / 14), and the skin elasticity recovery rate was 57.1% (8 / 14). In group B, the pruritus relief rate was 64.3% (9 / 14), the skin lesion improvement rate was 35.7% (5 / 14), and the skin elasticity recovery rate was 28.6% (4 / 14). Group A was significantly better than group B in both pruritus relief and skin lesion repair (P<0.05), indicating that the effects of Danshen in the oral formula in promoting blood circulation, removing blood stasis, and improving local microcirculation have an important promoting effect on the tissue repair of vulvar leukoplakia.

[0076] 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.

[0077] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention; the actual structure is not limited thereto. In conclusion, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the spirit of the invention, such designs should fall within the protection scope of the present invention.

Claims

1. A gynecological compound traditional Chinese medicine composition and external wash, characterized in that: This product comprises an oral composition and a topical wash; the oral composition is made from the following raw materials in parts by weight: 6-9 parts Gentiana scabra, 20-30 parts Smilax glabra, 10-15 parts Dioscorea hypoglauca, 10-12 parts Phellodendron chinense, 6-9 parts Sophora flavescens, 10-15 parts Isatis indigotica, 10-15 parts Isatis tinctoria, 10-15 parts Salvia miltiorrhiza, 8-12 parts Melia toosendan, 8-12 parts Smilax glabra, 8-12 parts Dryopteris crassirhizoma, and Artemisia capillaris. The external wash is made from the following raw materials in parts by weight: 25-35 parts of *Cnidium monnieri*, 25-35 parts of *Sophora flavescens*, 25-35 parts of *Stemona japonica*, 12-18 parts of *Phellodendron chinense*, 12-18 parts of *Paris polyphylla*, 8-12 parts of dried alum, 5-7 parts of Sichuan pepper, 12-18 parts of *Dryopteris crassirhizoma*, 2-4 parts of borneol, and 15-25 parts of *Dictamnus dasycarpus*.

2. The gynecological compound traditional Chinese medicine composition according to claim 1, characterized in that: The weight ratio of Isatis tinctoria leaf to Isatis tinctoria root in the oral composition is 1:0.8-1.

2.

3. The gynecological compound traditional Chinese medicine external wash according to claim 1, characterized in that: The weight ratio of borneol to alum in the external lotion is 1:2.5-4.

0.

4. The gynecological compound traditional Chinese medicine composition according to claim 1, characterized in that: The oral composition is formulated as capsules, granules, or tablets.

5. A gynecological compound traditional Chinese medicine external wash according to claim 1, characterized in that: The external wash is a concentrated liquid preparation.

6. The method for preparing a gynecological compound traditional Chinese medicine composition according to claim 1, characterized in that, Includes the following steps: (1) Take the raw material of the oral composition, add water and decoct 2-3 times, combine the decoctions, filter and obtain filtrate; (2) Concentrate the filtrate to a clear paste with a relative density of 1.10-1.15, add ethanol to make the alcohol content reach 60%-70%, let stand, filter, recover ethanol and obtain refined liquid; (3) Concentrate the refined liquid into a thick paste, dry it, add pharmaceutically acceptable excipients and make an oral preparation.

7. The method for preparing a gynecological compound traditional Chinese medicine composition according to claim 6, characterized in that: The drying process described in step (3) is spray drying.

8. The preparation method of a gynecological compound traditional Chinese medicine external wash according to claim 1, characterized in that, The steps include: (1) Take Cnidium monnieri, Sophora flavescens, Stemona japonica, Phellodendron chinense, Paris polyphylla, Zanthoxylum bungeanum, Dryopteris crassirhizoma, and Dictamnus dasycarpus, add water and decoct, filter and obtain concentrated liquid; (2) Crush alum into fine powder and dissolve borneol in ethanol; (3) Add the alum powder and borneol ethanol solution obtained in step (2) to the concentrated liquid obtained in step (1), stir, add water to make up the volume, stir well, dispense and sterilize.

9. The method for preparing a gynecological compound traditional Chinese medicine external wash according to claim 8, characterized in that: The sterilization described in step (3) is steam sterilization.

10. Use of the gynecological compound traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament for treating vulvar pruritus, condyloma acuminata and / or vulvar leukoplakia.

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