Traditional Chinese medicine composition for treating gynecological inflammation and preparation method thereof

By using croton and licorice as the principal ingredients, combined with other traditional Chinese medicine ingredients such as frankincense and myrrh, a pill is prepared, which solves the problem of incomplete treatment of gynecological inflammation with existing medications, and achieves the effects of treating both the symptoms and the root cause, as well as drug stability.

CN120960323APending Publication Date: 2025-11-18栗喜仁
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Patent Information

Application Number
CN202511351082.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-09-22
Publication Date
2025-11-18

AI Technical Summary

Technical Problem

Existing gynecological inflammation medications directly inhibit or kill pathogenic microorganisms by using antibiotics or antifungal drugs, which is insufficient to address complex pathogenesis such as mixed infections and tissue stagnation and blood and qi imbalance caused by inflammation, leading to easy recurrence and incomplete symptom improvement after treatment.

Method used

Using croton and licorice as the principal ingredients, combined with other traditional Chinese medicine ingredients such as frankincense, myrrh, and realgar, the pills are prepared by combining the comprehensive effects of clearing heat and detoxifying, promoting blood circulation and removing blood stasis, and drying dampness and stopping leukorrhea. Honey is added as a binder, and the particle size and moisture content are controlled to prepare a powder preparation.

Benefits of technology

It achieves both symptomatic and root-cause treatment, improving common gynecological inflammation symptoms such as leukorrhea, lower abdominal pain, and lumbosacral soreness, enhancing drug bioavailability and patient compliance, and ensuring the stability and safety of the drug's efficacy.

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Abstract

The invention relates to the technical field of gynecological medicines, and particularly discloses a traditional Chinese medicine composition for treating gynecological inflammation and a preparation method thereof. The invention discloses a traditional Chinese medicine composition for treating gynecological inflammation. The traditional Chinese medicine composition comprises croton, liquorice, frankincense, myrrh, realgar, stiff silkworm, rheum officinale, rhizoma cyperi, pericarpium citri reticulatae, safflower carthamus, pinellia ternate, almond and cinnamon. The preparation method comprises the following steps: S1, pretreating the raw materials; s2, mixing the raw materials treated in the step S1, performing coarse crushing and fine grinding, and then performing sieving to obtain traditional Chinese medicine mixed fine powder; s3, pelleting: adding honey accounting for 20-40% of the total weight of the traditional Chinese medicine mixed fine powder into the traditional Chinese medicine mixed fine powder obtained in the step S2, and uniformly stirring and mixing to obtain a soft material; rubbing the soft material into strips, and pelleting to obtain traditional Chinese medicine pills; and S4, drying and packaging. The traditional Chinese medicine composition for treating gynecologic inflammation can be used for treating leukorrheal diseases, chronic pelvic inflammation and other gynecologic inflammatory diseases caused by damp-heat stasis, and has the advantages of taking effect at multiple targets, treating both symptoms and root causes and being small in side effect.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of gynecological drugs, more particularly, it relates to a traditional Chinese medicine composition for treating gynecological inflammation and a preparation method thereof. BACKGROUND

[0002] Gynecological drugs refer to drugs specially used for preventing, diagnosing and treating diseases of the female reproductive system, which are widely used in hospital gynecology, maternal and child health institutions and pharmacies, and need to be used under the guidance of doctors or pharmacists, and self-medication is strictly prohibited. The applicable diseases include infectious diseases, menstrual disorders, gynecological tumors, reproductive endocrine diseases, pregnancy-related diseases and contraceptive-related drugs, etc. From the aspect of drug dosage forms, common ones include external preparations, oral preparations, injections and local external patches, ointments, etc. From the aspect of drug types, they can be divided into chemical drugs and traditional Chinese medicines.

[0003] Related gynecological inflammation drugs directly inhibit or kill pathogenic microorganisms by using antibiotics or antifungal drugs, but such a treatment method is often aimed at a single cause and is difficult to cope with complex pathogenesis such as mixed infection and inflammation-induced tissue stasis and blood disorder, thereby leading to easy recurrence after treatment and incomplete improvement of symptoms. SUMMARY

[0004] In order to solve the problem of easy recurrence after treatment and incomplete improvement of symptoms caused by related gynecological inflammation drugs by using antibiotics or antifungal drugs to directly inhibit or kill pathogenic microorganisms, the present application provides a traditional Chinese medicine composition for treating gynecological inflammation and a preparation method thereof.

[0005] In the first aspect, the present application provides a traditional Chinese medicine composition for treating gynecological inflammation, which adopts the following technical solution:

[0006] A traditional Chinese medicine composition for treating gynecological inflammation is made from raw materials containing the following weight parts: 18-22 parts of croton, 18-22 parts of licorice, 1.5-2.5 parts of frankincense, 1.5-2.5 parts of myrrh, 1.5-2.5 parts of realgar, 1.5-2.5 parts of silkworm chrysalis, 1.5-2.5 parts of rhubarb, 1.5-2.5 parts of cyperus rotundus, 1.5-2.5 parts of dried tangerine or orange peel, 1.5-2.5 parts of safflower, 1.5-2.5 parts of pinellia ternate, 1.5-2.5 parts of apricot kernel and 1.5-2.5 parts of cassia.

[0007] By adopting the technical scheme, the prescription takes both croton and licorice as monarch drugs, combines the warm purgative and blood stasis-removing effect of croton with the regulating and emergency-relieving effect of licorice, protects the spleen and stomach while removing accumulation and reducing swelling; and the combination of frankincense, myrrh and realgar plays the roles of activating blood, relieving pain and detoxification, aiming at the common pathogenesis of damp-heat and blood stasis in gynecological inflammation; the combination of silkworm chrysalis and rhubarb can clear heat, resolve stagnation, promote defecation and clear away fire; and cyperus rotundus and tangerine peel can regulate qi, assisting safflower in activating blood and unblocking channels; pinellia ternata and apricot kernel can resolve phlegm and reverse adverse flow, and cinnamon can warm kidney and assist yang, so that the comprehensive effects of clearing away heat and toxic material, activating blood and resolving stasis, and drying dampness and stopping leucorrhea can be achieved, and common symptoms of gynecological inflammation such as red and white leucorrhea, hypogastrium pain and lumbosacral soreness can be improved, and the balance of qi and blood in human body can be regulated through multi-target effect, so as to achieve the effect of treating both symptoms and root causes.

[0008] Preferably, the composition is prepared into a powder preparation with a particle size range of 80-120 mesh.

[0009] By adopting the technical scheme, grinding the medicinal materials into fine powder within the range of 80-120 mesh helps to improve bioavailability, the particle size ensures the dissolution rate of active ingredients, avoids caking or poor flowability caused by too fine powder, and thus facilitates the subsequent process.

[0010] Preferably, the dosage form of the composition is a pill with a pill weight of 3-6 g / pill.

[0011] By adopting the technical scheme, since the pill type has the characteristics of slow drug release and long-lasting effect, it is suitable for the treatment of chronic gynecological inflammation, and controlling the pill weight within 3-6 g facilitates the patient to take the pill in several times, which is conducive to maintaining stable blood drug concentration.

[0012] Preferably, the content of amygdalin in apricot kernel is not less than 3.0%, and the content of cinnamyl aldehyde in cinnamon is not less than 1.5%.

[0013] By adopting the technical scheme, amygdalin as the main active ingredient of apricot kernel, with a content of not less than 3.0%, can ensure the play of the effects of moistening dryness, resolving phlegm and immune regulation; and cinnamyl aldehyde is the component of cinnamon for warming meridian and promoting blood circulation, and the specified content of not less than 1.5% ensures the effects of warming yang and activating blood of the pill.

[0014] Preferably, honey is further added as a binder, and the addition amount of the honey is 20%-40% of the total weight of the powder of the traditional Chinese medicine composition.

[0015] By adopting the technical scheme, honey has the functions of adhesion and flavoring, and the addition amount controlled within 20%-40% can ensure the pill formability while avoiding too soft or too hard pill; honey also has the effects of moistening dryness and regulating the center, which can moderate the properties of the raw materials such as croton and realgar in the prescription.

[0016] Preferably, the moisture content of the composition product is ≤9.0% and the total ash content is ≤6.0%.

[0017] By adopting the above technical solution, the moisture content is controlled to be not more than 9.0%, which can prevent the pills from mildewing or deteriorating during storage, while maintaining the hardness and stability of the pills; and the total ash content is limited to be not more than 6.0%, which reflects that the raw materials are relatively pure, and the inorganic impurities and residual sand are less.

[0018] In a second aspect, the application provides a preparation method of a traditional Chinese medicine composition for treating gynecological inflammation, which adopts the following technical solution:

[0019] A preparation method of a traditional Chinese medicine composition for treating gynecological inflammation, comprising the following steps:

[0020] S1, raw material pretreatment: according to the prescription, the croton, licorice, frankincense, myrrh, realgar, silkworm chrysalis, rhubarb, cyperus rotundus, dried tangerine or orange peel, safflower, pinellia ternata, apricot kernel and cassia are weighed and cleaned and dried respectively, and the water content of each raw material is controlled to be ≤12%;

[0021] S2, crushing and grinding: after the raw materials treated in S1 are mixed, they are put into a crusher for rough crushing to obtain coarse powder; and then the coarse powder is transferred into a grinding machine for fine grinding, and sieved to obtain 80-200 mesh traditional Chinese medicine mixed fine powder;

[0022] S3, pill making: 20%-40% of the total weight of the traditional Chinese medicine mixed fine powder obtained in S2 is added with honey, and stirred and mixed uniformly to obtain soft material; the soft material is rolled into strips and made into pills to obtain traditional Chinese medicine pills;

[0023] S4, drying and packaging: the traditional Chinese medicine pills obtained in S3 are dried, and then sealed and packaged to obtain the traditional Chinese medicine composition product.

[0024] By adopting the above technical solution, the water content of each medicinal material is controlled to be less than 12% in the raw material pretreatment step, which helps to avoid the breeding of microorganisms and ensure the smooth progress of the subsequent crushing process; in the crushing and grinding process, the plant tissue structure is first broken by rough crushing, and then the cell wall is broken by fine grinding to promote the dissolution of effective ingredients; after sieving, the 80-200 mesh mixed fine powder can meet the basic requirements of the pill for the particle size of the raw material, and provide a uniform material basis for the subsequent pill making process; at the same time, honey is added as a binder during pill making, which utilizes its adhesion and drying properties to make the powder easy to form, and the honey can also moderate the properties of some components in the composition; the subsequent drying and packaging steps gradually reduce the moisture content of the pills, and combined with sealed packaging, prevent moisture absorption and pollution, and finally ensure that the product quality is stable and meets the storage requirements.

[0025] Preferably, in the S2 step, the fine grinding temperature is 25-40℃, and the grinding time is 30-60min.

[0026] By controlling the fine grinding temperature in the range of 25-40℃, the loss of volatile components can be effectively reduced, and the degradation of heat-sensitive substances in the medicinal materials caused by excessively high temperature can be avoided; and by controlling the grinding time in the range of 30-60min, the material can be fully pulverized to a standard particle size of 100 meshes, which is beneficial to the release and absorption of active ingredients, and facilitates the subsequent uniform mixing with honey, thereby avoiding the difficulty in pill formation or uneven content distribution caused by uneven particle size.

[0027] Preferably, in the S3 step, the stirring and mixing temperature is 50-70℃, and the stirring time is 15-30min, until the soft material has uniform color and moderate hardness.

[0028] By adopting the above technical solution, the stirring and mixing temperature in the range of 50-70℃ helps to reduce the viscosity of honey and improve the uniformity of mixing with the medicinal powder, and this temperature range can also promote the Maillard reaction between honey and part of the medicinal powder, thereby enhancing the flavor and stability of the pills; and by controlling the stirring time in the range of 15-30min, the soft material can reach the ideal state of uniform color and moderate hardness, thereby ensuring the smooth progress of the subsequent rolling and pill-making processes, and finally obtaining pills with smooth surface and small weight difference.

[0029] Preferably, in the S4 step, the drying temperature is 45-60℃, and the drying time is 120-180min.

[0030] By adopting the above technical solution, the drying temperature in the range of 45-60℃ can gradually remove the internal and external moisture of the pills, thereby avoiding the hardening or cracking of the pill surface caused by excessively high temperature, and preventing the prolongation of drying time caused by excessively low temperature; and by controlling the drying time in the range of 120-180min, the moisture content of the pills can be reduced, thereby facilitating storage.

[0031] In summary, the present application has the following beneficial effects:

[0032] 1、The present application selects both croton and licorice as monarch drugs, utilizes the synergistic effect of the heat-clearing and blood-activating functions of croton and the regulating and relieving properties of licorice, protects the function of the spleen and stomach while removing stagnation and reducing swelling; at the same time, the synergistic effect of frankincense, myrrh and realgar plays the roles of blood-activating and pain-relieving and detoxification, thereby achieving the comprehensive effects of clearing heat and detoxifying, activating blood and resolving stasis, and drying dampness and stopping leucorrhea, improving gynecological inflammation symptoms such as leucorrhagia, hypogastrium pain and lumbosacral soreness, and regulating the balance of qi and blood in the human body through multi-target action, thereby achieving the effect of treating both symptoms and root causes.

[0033] 2, The application preferably adopts a pill dosage form and combines honey as a binder to adapt to the treatment needs of chronic diseases by the slow release characteristics of the pill, and the addition of honey not only improves the drug taste and promotes molding, but also moderates the medicinal properties of some components in the composition, thereby improving patient medication compliance and ensuring the stability and safety of the drug.

[0034] 3, In the application, by controlling the water content of the raw materials, adjusting the grinding particle size and mixing temperature, the dissolution and uniform mixing of the active ingredients are promoted while the volatile components and heat-sensitive substances are retained, thereby ensuring the integrity of the medicinal ingredients and improving the consistency between batches and the reliability of the clinical efficacy. BRIEF DESCRIPTION OF DRAWINGS

[0035] Figure 1 A flowchart of a preparation method of a traditional Chinese medicine composition for treating gynecological inflammation is provided in the application. DETAILED DESCRIPTION

[0036] The application will be further described in detail below in combination with examples and comparative examples.

[0037] Technical concept:

[0038] Related drugs for gynecological inflammation directly inhibit or kill pathogenic microorganisms by using antibiotics or antifungal drugs, but this treatment method often targets a single cause and is difficult to deal with complex pathogenesis such as mixed infection and inflammation-induced tissue stasis, blood stasis, etc., thereby leading to easy recurrence and incomplete improvement of symptoms after treatment.

[0039] Referring to the accompanying Figure 1 The traditional Chinese medicine composition for treating gynecological inflammation disclosed in the application comprises croton, licorice, frankincense, myrrh, realgar, silkworm, rhubarb, cyperus rotundus, dried tangerine or orange peel, safflower, pinellia ternata, apricot kernel and cassia; the preparation method comprises the following steps: S1, pretreatment of raw materials; S2, coarse crushing and fine grinding of the raw materials after step S1, followed by sieving to obtain traditional Chinese medicine mixed fine powder; S3, pill making: adding 20% to 40% of the total weight of honey to the traditional Chinese medicine mixed fine powder obtained in step S2, stirring and mixing uniformly to obtain soft material; rolling the soft material into strips and making pills to obtain traditional Chinese medicine pills; S4, drying and packaging.

[0040] The application selects croton and licorice as the monarch drug, utilizes the synergistic effect of the warm purgative and stasis-removing efficacy of croton and the property of regulating acute and chronic conditions of licorice to protect the function of the spleen and stomach while breaking up and reducing swelling; at the same time, it is assisted by frankincense, myrrh and realgar to synergistically play the roles of promoting blood circulation for stopping pain and detoxification, thereby achieving the comprehensive effects of clearing heat and detoxifying, promoting blood circulation for removing blood stasis and drying dampness for stopping leucorrhea, improving gynecological inflammation symptoms such as red and white leucorrhea, lower abdominal pain and lumbosacral soreness, and regulating the balance of qi and blood in the human body through multi-target action, thereby achieving the effect of treating both the symptoms and the root cause.

[0041] Example 1

[0042] The present example provides a traditional Chinese medicine composition for treating gynecological inflammation, which is made of raw materials including the following components by weight: Croton Tiglium 18 parts, Glycyrrhiza 18 parts, Olibanum 1.5 parts, Myrrh 1.5 parts, Realgar 1.5 parts, Strychnos Ignatii 1.5 parts, Rheum Palmatum 1.5 parts, Cyperus Rotundus 1.5 parts, Citrus Reticulata 1.5 parts, Carthamus Tinctorius 1.5 parts, Pinellia 1.5 parts, Prunus Armeniaca 1.5 parts, and Cinnamomum Cassia 1.5 parts.

[0043] The preparation method of the traditional Chinese medicine composition for treating gynecological inflammation is as follows:

[0044] S1, raw material pretreatment: according to the prescription, Croton Tiglium, Glycyrrhiza, Olibanum, Myrrh, Realgar, Strychnos Ignatii, Rheum Palmatum, Cyperus Rotundus, Citrus Reticulata, Carthamus Tinctorius, Pinellia, Prunus Armeniaca and Cinnamomum Cassia are weighed and cleaned and dried respectively, and the water content of each raw material is controlled to be 10%;

[0045] Among them, the content of amygdaloside in the selected raw material Prunus Armeniaca is 3.2%, and the content of cinnamyl aldehyde in Cinnamomum Cassia is 1.6%;

[0046] S2, crushing and grinding: after mixing all the raw materials treated in step S1, put them into the crusher for coarse crushing to obtain coarse powder; then transfer the coarse powder into the grinding machine for fine grinding, sieve and obtain 80 mesh traditional Chinese medicine mixed fine powder;

[0047] Among them, the fine grinding temperature in step S2 is 25℃, and the grinding time is 30min;

[0048] S3, pill making: add 20% of the total weight of honey to the traditional Chinese medicine mixed fine powder obtained in step S2, stir and mix uniformly to obtain soft material; roll the soft material into strips and make pills to obtain traditional Chinese medicine pills;

[0049] Among them, the stirring and mixing temperature of step S3 is 50℃, the stirring time is 15min, and the pill weight of traditional Chinese medicine pills is controlled to be 3g / pill;

[0050] S4, drying and packaging: dry the traditional Chinese medicine pills obtained in step S3, then seal and package to obtain the finished traditional Chinese medicine composition;

[0051] Among them, the water content of the finished composition is 4%, and the total ash content is 3%.

[0052] Example 2

[0053] The present example provides a traditional Chinese medicine composition for treating gynecological inflammation, which is made of raw materials including the following components by weight: Croton Tiglium 18 parts, Glycyrrhiza 18 parts, Olibanum 1.5 parts, Myrrh 1.5 parts, Realgar 1.5 parts, Strychnos Ignatii 1.5 parts, Rheum Palmatum 1.5 parts, Cyperus Rotundus 1.5 parts, Citrus Reticulata 1.5 parts, Carthamus Tinctorius 1.5 parts, Pinellia 1.5 parts, Prunus Armeniaca 1.5 parts, and Cinnamomum Cassia 1.5 parts.

[0054] The preparation method of the above-mentioned traditional Chinese medicine composition for treating gynecological inflammation is as follows:

[0055] S1, raw material pretreatment: according to the formula, take the raw materials of croton, licorice, frankincense, myrrh, realgar, silkworm chrysalis, rhubarb, cyperus rotundus, dried tangerine or orange peel, safflower, pinellia ternata, apricot kernel and cassia bark, and control the water content of each raw material to be 9%;

[0056] Among them, the content of amygdalin in apricot kernel selected is 3.5%, and the content of cinnamyl aldehyde in cassia bark is 1.8%;

[0057] S2, crushing and grinding: after mixing all the raw materials treated in step S1, put them into a crusher for rough crushing to obtain coarse powder; then transfer the coarse powder into a grinding machine for fine grinding, and sieve to obtain 100 mesh traditional Chinese medicine mixed fine powder;

[0058] Among them, the fine grinding temperature in step S2 is 30℃, and the grinding time is 35min;

[0059] S3, pill making: add 25% of the total weight of honey to the traditional Chinese medicine mixed fine powder obtained in step S2, stir and mix uniformly to obtain soft material; roll the soft material into strips and make pills to obtain traditional Chinese medicine pills;

[0060] Among them, the stirring and mixing temperature in step S3 is 55℃, the stirring time is 20min, and the pill weight of the traditional Chinese medicine pills is controlled to be 4g / pill;

[0061] S4, drying and packaging: dry the traditional Chinese medicine pills obtained in step S3, then seal and package to obtain the finished traditional Chinese medicine composition;

[0062] Among them, the moisture content of the composition finished product is 6%, and the total ash content is 5%.

[0063] Example 3

[0064] The present embodiment provides a traditional Chinese medicine composition for treating gynecological inflammation, which is made of raw materials containing the following weight parts: croton 22 parts, licorice 22 parts, frankincense 2.5 parts, myrrh 2.5 parts, realgar 2.5 parts, silkworm chrysalis 2.5 parts, rhubarb 2.5 parts, cyperus rotundus 2.5 parts, dried tangerine or orange peel 2.5 parts, safflower 2.5 parts, pinellia ternata 2.5 parts, apricot kernel 2.5 parts and cassia bark 2.5 parts.

[0065] The preparation method of the above-mentioned traditional Chinese medicine composition for treating gynecological inflammation is as follows:

[0066] S1, raw material pretreatment: according to the formula, take the raw materials of croton, licorice, frankincense, myrrh, realgar, silkworm chrysalis, rhubarb, cyperus rotundus, dried tangerine or orange peel, safflower, pinellia ternata, apricot kernel and cassia bark, and control the water content of each raw material to be 11%;

[0067] The content of amygdalin in the selected almond raw material is 3.2%, and the content of cinnamaldehyde in the cinnamon is 1.6%;

[0068] S2, crushing and grinding: after mixing all the raw materials treated in the S1 step, put them into a crusher for rough crushing to obtain coarse powder; then transfer the coarse powder into a grinding machine for fine grinding, and sieve to obtain 120-mesh mixed fine powder of traditional Chinese medicine;

[0069] In the S2 step, the fine grinding temperature is 35°C, and the grinding time is 25 min;

[0070] S3, pill making: add 30% of the total weight of honey to the mixed fine powder of traditional Chinese medicine obtained in the S2 step, mix uniformly, and obtain soft material; roll the soft material into strips and make pills to obtain traditional Chinese medicine pills;

[0071] In the S3 step, the mixing temperature is 60°C, the mixing time is 12 min, and the pill weight of the traditional Chinese medicine pills is controlled to be 5 g / pill;

[0072] S4, drying and packaging: dry the traditional Chinese medicine pills obtained in the S3 step, and then seal and package to obtain the finished product of the traditional Chinese medicine composition;

[0073] In the composition finished product, the moisture content is 9%, and the total ash content is 6%.

[0074] Comparative Example 1

[0075] This comparative example refers to the contents of Example 1, except that the amount of croton is 12 parts, the amount of licorice is 12 parts, the ratio of the remaining components is unchanged, and the remaining contents are the same as Example 1.

[0076] Comparative Example 2

[0077] This comparative example refers to the contents of Example 1, except that the amount of frankincense, myrrh, realgar, silkworm chrysalis, rhubarb, cyperus, dried tangerine or orange peel, safflower, pinellia, almond and cinnamon is 1.0 part, the ratio of croton and licorice is unchanged, and the remaining contents are the same as Example 1.

[0078] Comparative Example 3

[0079] This comparative example refers to the contents of Example 1, except that the grinding fineness is 50 mesh, and the remaining process parameters are the same as Example 1.

[0080] Comparative Example 4

[0081] This comparative example refers to the contents of Example 1, except that the amount of added honey is 10% of the total weight of the mixed fine powder of traditional Chinese medicine, and the remaining process parameters are the same as Example 1.

[0082] Comparative Example 5

[0083] The comparative example refers to the content of Example 1, the difference is that realgar is omitted, and the rest of the components are the same as Example 1.

[0084] Comparative Example 6

[0085] The comparative example refers to the content of Example 1, the difference is that the content of amygdalin in the selected raw material almond is 2.2%, and the content of cinnamyl aldehyde in cinnamon is 1.1%, and the rest is the same as Example 1.

[0086] Performance test

[0087] Sample preparation: according to the formula and preparation method described in Examples 1-3 and Comparative Examples 1-6, the corresponding traditional Chinese medicine pill samples are prepared respectively as test samples for subsequent performance detection.

[0088] Pharmacodynamic detection: female experimental animals are selected, and a chronic pelvic inflammatory disease model is prepared by injecting phenol paste; after modeling, the animals are randomly divided into several groups, and the corresponding sample solutions of the examples and comparative examples are administered orally, once a day, and after continuous administration for a specified number of days, the uterine tissue is taken for pathological examination, the endometrial hyperemia and edema, inflammatory cell infiltration and connective tissue hyperplasia are observed, and histopathological scoring is performed to comprehensively evaluate the anti-inflammatory, blood-activating and stasis-removing and tissue repair ability of each sample, and the higher the score, the better the anti-inflammatory effect.

[0089] Dissolution test: by adopting the slurry method, using artificial intestinal fluid as the dissolution medium, maintaining the medium temperature at 37°C, and rotating at 75 revolutions per minute; at the specified time points, i.e. 1 hour, 2 hours, 4 hours, 6 hours and 8 hours, samples are taken and simultaneously supplemented with equal amount of fresh dissolution medium; after filtering the sample solution, the characteristic active ingredients are determined by high performance liquid chromatography.

[0090] Active ingredient content detection: high performance liquid chromatography is used to determine the content of amygdalin and cinnamyl aldehyde in the sample, and then the measured results are compared with the theoretical values calculated according to the raw material feeding amount and content to obtain the transfer rate.

[0091] Sensory evaluation and compliance detection: to evaluate the effect of the addition of honey on the taste of the pills and the willingness of patients to take the medicine, a sensory evaluation group is organized; different samples are randomly provided to the subjects, and the smell, entry bitterness intensity, pungency, sweet and smooth feeling of honey and aftertaste of the pills are tracked and scored in multiple dimensions, and the higher the score, the better the compliance.

[0092] The performance parameters of the products obtained in Examples 1-3 and Comparative Examples 1-6 are shown in Tables 1 and 2.

[0093] Table 1:

[0094]

[0095]

[0096] Table 2

[0097]

[0098]

[0099] Conclusion of the example:

[0100] It can be seen from the combination of Examples 1-3 and Comparative Example 1 and Table 1 that the insufficient use of croton and licorice as the monarch drug reduces the comprehensive efficacy of anti-inflammatory and blood-activating and stasis-removing, confirming the synergistic effect of the two in warming and purging stasis and regulating acute and chronic, thereby affecting the overall curative effect and the effect of treating both the symptoms and the root cause;

[0101] It can be seen from the combination of Examples 1-3 and Comparative Example 2 and Table 1 that the insufficient use of frankincense, myrrh and realgar as auxiliary drugs weakens the synergistic effect of blood-activating and pain-relieving and detoxification, leading to a decrease in the efficacy of heat-clearing and detoxification and dryness-wetting and leucorrhea-stopping, thereby affecting the ability to regulate qi and blood balance at multiple targets;

[0102] It can be seen from the combination of Examples 1-3 and Comparative Example 3 and Table 1 and Table 2 that the insufficient crushing particle size is not conducive to the release and uniform mixing of active ingredients, affecting the integrity and bioavailability of the medicinal ingredients, thereby reducing the consistency between product batches and the reliability of clinical efficacy;

[0103] It can be seen from the combination of Examples 1-3 and Comparative Example 4 and Table 1 that the insufficient use of honey reduces the taste and sweet and moistening feeling of the pill, affecting the willingness of patients to take medicine and the compliance of patients, although the medicinal ingredients are maintained, the effect of moderating the medicinal properties and improving the medicinal taste is weakened;

[0104] It can be seen from the combination of Examples 1-3 and Comparative Example 5 and Table 1 that the absence of realgar destroys the synergistic effect of blood-activating and pain-relieving and detoxification, leading to a decrease in anti-inflammatory and detoxification efficacy, thereby affecting the comprehensive treatment effect;

[0105] It can be seen from the combination of Examples 1-3 and Comparative Example 6 and Table 1 that the insufficient content of active ingredients in the raw materials leads to a decrease in the transfer rate of effective ingredients in the final product, affecting the stability and consistency of the medicinal efficacy.

[0106] The specific embodiments are merely an explanation of the present application, which is not a limitation of the present application. Those skilled in the art can make modifications to the embodiments without creative contribution after reading the specification, but as long as the modifications are within the scope of the claims of the present application, they are protected by the patent law.

Claims

1. A traditional Chinese medicine composition for treating gynecological inflammation, characterized in that, It is made from the following ingredients in parts by weight: 18-22 parts croton seed, 18-22 parts licorice root, 1.5-2.5 parts frankincense, 1.5-2.5 parts myrrh, 1.5-2.5 parts realgar, 1.5-2.5 parts silkworm, 1.5-2.5 parts rhubarb, 1.5-2.5 parts cyperus rhizome, 1.5-2.5 parts dried tangerine peel, 1.5-2.5 parts safflower, 1.5-2.5 parts pinellia tuber, 1.5-2.5 parts apricot kernel, and 1.5-2.5 parts cinnamon.

2. The traditional Chinese medicine composition for treating gynecological inflammation according to claim 1, characterized in that, The composition is prepared into a powder formulation with a particle size range of 80-120 mesh.

3. The traditional Chinese medicine composition for treating gynecological inflammation according to claim 1, characterized in that, The composition is in the form of pills, with a pill weight of 3-6g / pill.

4. The traditional Chinese medicine composition for treating gynecological inflammation according to claim 1, characterized in that, The amygdalin content in the raw almonds is not less than 3.0%, and the cinnamon content in the cinnamon is not less than 1.5%.

5. The traditional Chinese medicine composition for treating gynecological inflammation according to claim 1, characterized in that, Honey was also added as a binder, and the amount of honey added was 20% to 40% of the total weight of the Chinese herbal medicine composition powder.

6. The traditional Chinese medicine composition for treating gynecological inflammation according to claim 1, characterized in that, The moisture content and total ash content of the finished product of the composition are ≤9.0% and ≤6.0%.

7. A method for preparing a traditional Chinese medicine composition for treating gynecological inflammation, characterized in that, The traditional Chinese medicine composition for treating gynecological inflammation according to any one of claims 1-6 comprises the following steps: S1. Raw material pretreatment: Weigh out croton, licorice, frankincense, myrrh, realgar, silkworm, rhubarb, cyperus, tangerine peel, safflower, pinellia, apricot kernel and cinnamon according to the formula, and clean and dry them respectively, controlling the moisture content of each raw material to ≤12%; S2. Crushing and Grinding: Mix all the raw materials processed in step S1 and put them into a crusher for coarse crushing to obtain coarse powder; then transfer the coarse powder into a grinder for fine grinding, and sieve to obtain a fine powder of Chinese medicine mixture with a mesh size of 80-200. S3. Making pills: Add 20% to 40% of the total weight of honey to the fine powder of traditional Chinese medicine obtained in step S2, stir and mix evenly to obtain a soft material; roll the soft material into strips and make pills to obtain traditional Chinese medicine pills; S4. Drying and Packaging: The Chinese medicine pills obtained in step S3 are dried and then sealed and packaged to obtain the finished Chinese medicine composition.

8. The method for preparing a traditional Chinese medicine composition for treating gynecological inflammation according to claim 7, characterized in that, In step S2, the fine grinding temperature is 25℃~40℃ and the grinding time is 30~60min.

9. A method for preparing a traditional Chinese medicine composition for treating gynecological inflammation according to claim 7, characterized in that, In step S3, the mixing temperature is 50℃~70℃, and the mixing time is 15~30min, until the soft material has a uniform color and moderate softness and hardness.

10. A method for preparing a traditional Chinese medicine composition for treating gynecological inflammation according to claim 7, characterized in that, In step S4, the drying temperature is 45℃~60℃ and the drying time is 120~180min.