Traditional Chinese medicine composition for treating gynecological tumors as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for treating gynecologic tumor and a preparation method and application thereof, and relates to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition for treating gynecologic tumor comprises the following raw materials by weight: 55-70 parts of welted thistle, 30-48 parts of limonium bicolor, 10-20 parts of Chinese angelica, 15-25 parts of sculellaria barbata, 5-10 parts of cape jasmine and 2-7 parts of licorice. The traditional Chinese medicine composition provided by the invention takes welted thistle and limonium bicolor as main functional raw materials and takes a proper amount of angelica sinensis, sculellaria barbata, cape jasmine and liquorice as auxiliary materials, and animal experiments show that the traditional Chinese medicine composition has a remarkable inhibiting effect on tumor growth of a transplanted human ovarian cancer cell Skov-3 mouse model, can up-regulate the expression quantity of Caspase-3 in tumor tissues, and has a remarkable inhibiting effect on tumor growth of a transplanted human ovarian cancer cell Skov-3 mouse model. The compound can be applied to preparation of drugs for treating gynecological tumors such as ovarian cancer, and opens up a new path for treatment of gynecological tumors, especially ovarian cancer.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating gynecological tumors, and a preparation method and application thereof. Background Art

[0002] Gynecological tumors are a major challenge in the field of women's health. Their incidence rate is increasing year by year and is showing a trend of younger people. Common gynecological tumors include vulvar tumors, vaginal tumors, uterine tumors, ovarian tumors and fallopian tube tumors. Among them, uterine tumors and ovarian tumors are particularly common, and malignant tumors such as vulvar cancer, vaginal cancer, cervical cancer, endometrial cancer, ovarian cancer, etc. seriously threaten women's life and health.

[0003] At present, the treatment strategies for gynecological tumors mainly rely on surgical resection, radiotherapy and chemotherapy. However, these traditional therapies are accompanied by many limitations. Although surgical resection can directly remove the lesions, it causes irreversible damage to the patient's organ tissues, has a heavy economic burden, and the risk of postoperative recurrence cannot be ignored. Although radiotherapy and chemotherapy can effectively inhibit or kill cancer cells, they also affect normal tissues, causing a series of local and systemic toxic side effects, which seriously impair the patient's quality of life. In addition, these treatments may also damage the patient's immune system and increase susceptibility to infection and other complications.

[0004] In contrast, traditional Chinese medicine has shown unique advantages in the treatment of gynecological tumors. Its core concept is to regulate the whole body, and to achieve the purpose of curing the root cause by harmonizing qi and blood, balancing yin and yang, and enhancing the body's immune function. Traditional Chinese medicine treatment not only has mild side effects, but also can comprehensively improve the patient's physical condition and improve the quality of life. It is particularly worth mentioning that the essence of Chinese medicine compatibility lies in the interaction between drugs. Through clever combination, synergistic enhancement and reduced toxicity can be achieved. For example, the combination of Lithospermum officinale and Smilax glabra can not only clear away heat and cool blood, but also activate blood circulation and detoxify; the combination of Trillium and Curcuma zedoaria is good at breaking blood and promoting qi, and dissipating blood stasis, becoming an important prescription for the treatment of gynecological tumors with qi stagnation and blood stasis.

[0005] However, although traditional Chinese medicine has shown certain advantages in the treatment of gynecological tumors, the existing traditional Chinese medicine formulas for the treatment of gynecological tumors still have some shortcomings, such as unstable efficacy, uneven efficacy, and complex preparation process. Therefore, it is of great significance to develop a traditional Chinese medicine composition with definite efficacy, simple preparation process, and good efficacy for the treatment of gynecological tumors. Summary of the invention

[0006] To solve the above problems, the present invention provides a Chinese medicine composition for treating gynecological tumors, and a preparation method and application thereof.

[0007] In a first aspect, the present invention provides a Chinese medicine composition for treating gynecological tumors, wherein the Chinese medicine composition for treating gynecological tumors comprises the following raw materials in parts by weight:

[0008] 55-70 parts of Radix Achyranthis Bidentatae, 30-48 parts of Limonium bicolor, 10-20 parts of Radix Angelicae Sinensis, 15-25 parts of Scutellaria barbata, 5-10 parts of Gardenia jasminoides and 2-7 parts of Licorice.

[0009] Furthermore, the Chinese medicine composition for treating gynecological tumors comprises the following raw materials in parts by weight:

[0010] There were 62.5 parts of Radix Achyranthis Bidentatae, 37 parts of Herba Limoniae Bicolor, 16 parts of Radix Angelicae Sinensis, 20 parts of Scutellariae Barbatae, 8 parts of Fructus Gardeniae and 5 parts of Radix Glycyrrhizae.

[0011] In a second aspect, the present invention provides a method for preparing the Chinese medicine composition for treating gynecological tumors according to any one of the first aspects, the preparation method comprising the following steps:

[0012] Adding Achyranthes bidentata to ethanol for a first reflux extraction, then adding the obtained alcohol extract to a solvent for dissolution and extracting with petroleum ether to obtain a first extract;

[0013] Adding Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to water for ultrasonic-assisted extraction, and then performing a second reflux extraction to obtain a second extract;

[0014] The first extract and the second extract are crushed and sieved to obtain the traditional Chinese medicine composition for treating gynecological tumors.

[0015] Furthermore, the weight ratio of the Achyranthes bidentata to the ethanol is 1:(8-12), the volume fraction of the ethanol is 75-95%; the weight ratio of the total weight of the Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to the water is 1:(10-15).

[0016] Furthermore, the working condition parameters of the first reflux extraction include: temperature of 80-90° C., time of 1-2 hours, and number of times of 1-3 times.

[0017] Furthermore, the solvent is water.

[0018] Furthermore, the working condition parameters of the ultrasonic-assisted extraction include: ultrasonic power of 300 to 500 W and time of 3 to 6 hours.

[0019] Furthermore, the working condition parameters of the second reflux extraction include: temperature of 105-110° C., time of 2-3 hours, and number of times of 1-3 times.

[0020] In a third aspect, the present invention provides a use of a traditional Chinese medicine composition for treating gynecological tumors as described in any one of the first aspects and / or a traditional Chinese medicine composition for treating gynecological tumors obtained by the preparation method described in any one of the second aspects in the preparation of drugs for treating gynecological tumor diseases.

[0021] Furthermore, the treatment of gynecological tumor diseases includes ovarian tumors, and the dosage form of the drug includes tablets, capsules, powders, mixtures, pills or granules.

[0022] The above technical solution provided by the embodiment of the present invention has at least the following advantages compared with the prior art:

[0023] The Chinese medicine composition provided by the present invention uses Achyranthes bidentata and Limonium bicolor as the main effective raw materials and is supplemented with appropriate amounts of Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice. Animal experiments have shown that the Chinese medicine composition has a significant inhibitory effect on the tumor growth of the Skov-3 mouse model transplanted with human ovarian cancer cells, and can upregulate the expression of Caspase-3 in tumor tissues. It can be used to prepare drugs for treating gynecological tumors such as ovarian cancer, opening up a new path for the treatment of gynecological tumors, especially ovarian cancer. Specifically:

[0024] 1. Main medicine: Achyranthes bidentata, Limonium bicolor

[0025] The Chinese angelica contains a variety of active ingredients such as flavonoids and terpenoids, which have the effects of clearing away heat and detoxifying, cooling blood and stopping bleeding, inhibiting the proliferation of gynecological tumor cells, reducing the inflammatory response caused by gynecological tumors, and controlling the bleeding symptoms related to gynecological tumors; the two-color limonium is rich in polysaccharides, flavonoids, saponins and other active substances, which have the effects of replenishing blood and qi, enhancing immunity, etc. By improving the patient's immunity, it helps to promote the inhibition of the growth and spread of gynecological tumor cells. The two together serve as the main medicine, complement each other, and play a major anti-tumor role.

[0026] 2. Assistant medicine: Angelica sinensis, Scutellaria barbata

[0027] Angelica sinensis is an important medicine for nourishing blood, regulating menstruation, promoting blood circulation and relieving pain. It can improve the blood deficiency state of patients with gynecological tumors, promote blood circulation, relieve pain, and enhance the body's tolerance to treatment; Scutellaria barbata has the effects of reducing swelling and dispersing nodules, and relieves the symptoms of heat and toxicity caused by tumors. The two can synergize with the main medicine to further enhance the inhibitory effect on the proliferation and spread of gynecological tumor cells, enhance the overall efficacy, and treat the symptoms associated with tumors at the same time.

[0028] 3. Adjuvant drugs: Gardenia, Licorice

[0029] Gardenia has the effects of purging fire and relieving restlessness, clearing away heat and removing dampness, and can relieve the discomfort symptoms such as irritability, thirst, constipation, etc. in patients with gynecological tumors; licorice harmonizes various medicines, relieves pain, reduces adverse reactions between drugs, reduces drug stimulation to the gastrointestinal tract, improves patients' medication compliance, and provides a stable internal environment for the entire treatment process.

[0030] In summary, the Chinese medicine composition of the present invention can act on multiple links of tumor occurrence and development through the clever combination of monarch, minister, assistant and envoy, through the various active ingredients in the Chinese medicine composition (such as flavonoids, terpenes, polysaccharides, saponins, etc.), including multi-target mechanisms such as inhibiting tumor cell proliferation, promoting tumor cell apoptosis, and enhancing the body's immunity. It not only exerts the pharmacological effects of each drug when used alone, but also enhances the overall anti-tumor effect through the mutual synergy between drugs. In particular, by upregulating the expression of Caspase-3 (apoptosis execution protein) in tumor tissues, it promotes the apoptosis of tumor cells and inhibits their growth and spread, providing a new and effective means for the treatment of gynecological tumors. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0032] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0033] Figure 1 A schematic flow chart of a method for preparing a traditional Chinese medicine composition for treating gynecological tumors provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0036] In a first aspect, the present invention provides a Chinese medicine composition for treating gynecological tumors, wherein the Chinese medicine composition for treating gynecological tumors comprises the following raw materials in parts by weight:

[0037] 55-70 parts of Radix Achyranthis Bidentatae, 30-48 parts of Limonium bicolor, 10-20 parts of Radix Angelicae Sinensis, 15-25 parts of Scutellaria barbata, 5-10 parts of Gardenia jasminoides and 2-7 parts of Licorice.

[0038] The traditional Chinese medicine composition provided by the present invention uses Achyranthes bidentata and Limonium bicolor as main effective raw materials and is supplemented with appropriate amounts of Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice. Animal experiments show that the traditional Chinese medicine composition has a significant inhibitory effect on tumor growth in a Skov-3 mouse model transplanted with human ovarian cancer cells, and can upregulate the expression of Caspase-3 in tumor tissues. The traditional Chinese medicine composition can be used to prepare drugs for treating gynecological tumors such as ovarian cancer, thus opening up a new path for the treatment of gynecological tumors, especially ovarian cancer.

[0039] In the present invention, the cardamom is cardamom (CarduuscrispusL.) and Tibetan cardamom (C.acanthoidesL.) of the genus Carduus of the Asteraceae family, and the whole herb is used as medicine; the two-color blood-replenishing grass is the two-color blood-replenishing grass (Limoniumbicolor(Bag.)Kuntze) of the family Plumbago, and the whole herb is used as medicine; the angelica is the angelica sinensis (Oliv.)Diels of the family Umbelliferae, and the root is used as medicine; the barbata is the barbata (ScutellariabarbataD.Don) of the family Lamiaceae, and the whole herb is used as medicine; the gardenia is the gardenia (GardeniajasminoidesEllis) of the family Rubiaceae, and the dried mature fruit is used as medicine; the licorice is the licorice (Glycyrrhiza uralensisFisch.), the inflated fruit licorice (Glycyrrhiza inflataBat.) or the glabra (GlycyrrhizaglabraL.) of the family Leguminosae, and the root is used as medicine.

[0040] In some specific embodiments, the Chinese medicine composition for treating gynecological tumors comprises the following raw materials in parts by weight:

[0041] There were 62.5 parts of Radix Achyranthis Bidentatae, 37 parts of Herba Limoniae Bicolor, 16 parts of Radix Angelicae Sinensis, 20 parts of Scutellariae Barbatae, 8 parts of Fructus Gardeniae and 5 parts of Radix Glycyrrhizae.

[0042] In a second aspect, based on the same inventive concept, the present invention provides a method for preparing a Chinese medicine composition for treating gynecological tumors as described in any one of the first aspects, such as Figure 1 As shown, the preparation method comprises the following steps:

[0043] Adding Achyranthes bidentata to ethanol for a first reflux extraction, then adding the obtained alcohol extract to a solvent for dissolution and extracting with petroleum ether to obtain a first extract;

[0044] Adding Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to water for ultrasonic-assisted extraction, and then performing a second reflux extraction to obtain a second extract;

[0045] The first extract and the second extract are crushed and sieved to obtain the traditional Chinese medicine composition for treating gynecological tumors.

[0046] The preparation method provided by the present invention is simple to operate, has mature technology, does not require additional specific equipment, and is suitable for industrial mass production; at the same time, the preparation method is realized based on the Chinese medicine composition described in any one of the first aspects, and therefore has at least the beneficial effects described in any one of the first aspects, which will not be repeated here one by one.

[0047] In some specific embodiments, the weight ratio of the Achyranthes bidentata to the ethanol is 1:(8-12), and the volume fraction of the ethanol is 75-95%; the weight ratio of the total weight of the Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to the water is 1:(10-15).

[0048] In some specific embodiments, the working condition parameters of the first reflux extraction include: temperature of 80-90° C., time of 1-2 hours, and number of times of 1-3 times.

[0049] In some specific embodiments, the solvent is water.

[0050] In some specific embodiments, the working condition parameters of the ultrasonic-assisted extraction include: ultrasonic power of 300-500W, and time of 3-6 hours.

[0051] In some specific embodiments, the working condition parameters of the second reflux extraction include: temperature of 105-110° C., time of 2-3 hours, and number of times of 1-3 times.

[0052] In the third aspect, based on the same inventive concept, the present invention provides a Chinese medicine composition for treating gynecological tumors as described in any one of the first aspects and / or a Chinese medicine composition for treating gynecological tumors obtained by the preparation method described in any one of the second aspects in the preparation of drugs for treating gynecological tumor diseases.

[0053] The Chinese medicine composition provided by the present invention has a significant inhibitory effect on the tumor growth of the Skov-3 mouse model transplanted with human ovarian cancer cells, and can upregulate the expression of Caspase-3 in tumor tissues. It can be used to prepare drugs for treating gynecological tumors such as ovarian cancer, and opens up a new path for the treatment of gynecological tumors, especially ovarian cancer.

[0054] In some specific embodiments, the treatment of gynecological tumor diseases includes ovarian tumors, and the dosage form of the drug includes tablets, capsules, powders, mixtures, pills or granules.

[0055] It should be noted that the raw material components involved in the Chinese medicine composition for treating gynecological tumors and its preparation method and application provided in the embodiments of the present invention, unless otherwise specified or described, can be directly purchased from the market or made by oneself according to the existing preparation method; at the same time, the operation steps involved, unless otherwise specified or described, can be carried out according to the preparation method and condition parameters disclosed in the prior art or by using existing equipment and referring to the instructions for use, and the present invention document will not repeat them one by one.

[0056] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples that do not specify specific conditions are usually measured according to national standards. If there is no corresponding national standard, then the conditions recommended by the manufacturer are followed.

[0057] Example 1

[0058] This example provides a Chinese medicine composition for treating gynecological tumors. The Chinese medicine composition for treating gynecological tumors comprises the following raw materials in parts by weight:

[0059] There were 62.5 parts of Radix Achyranthis Bidentatae, 37 parts of Herba Limoniae Bicolor, 16 parts of Radix Angelicae Sinensis, 20 parts of Scutellariae Barbatae, 8 parts of Fructus Gardeniae and 5 parts of Radix Glycyrrhizae.

[0060] The preparation method of the above-mentioned Chinese medicine composition for treating gynecological tumors comprises the following steps:

[0061] Step (1): adding the crushed Achyranthes bidentata to 85% ethanol by volume for a first reflux extraction, wherein the weight ratio of Achyranthes bidentata to the ethanol is 1:10, the temperature is 85° C., the time is 1.5 hours, the number of times is 2 times, combining the obtained first extracts and concentrating under reduced pressure to obtain an alcohol extract; then adding the alcohol extract to water for dissolution and extracting with petroleum ether for 3 times, combining the extracts from the upper petroleum ether part, concentrating under reduced pressure and drying to constant weight to obtain a first extract;

[0062] Step (2): adding the mixed and crushed Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to water for ultrasonic-assisted extraction, wherein the weight ratio of the total weight of the Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to the water is 1:12, the ultrasonic power is 400 W, and the extraction time is 5 hours; then performing a second reflux extraction at a temperature of 108° C. for 2.5 hours, twice, combining the obtained second extracts, concentrating under reduced pressure, and drying to constant weight to obtain a second extract;

[0063] Step (3): The first extract obtained in step (1) and the second extract obtained in step (2) are mixed and crushed, and the mixture is passed through a 100-mesh sieve to obtain the traditional Chinese medicine composition for treating gynecological tumors.

[0064] Example 2

[0065] This example provides a Chinese medicine composition for treating gynecological tumors. The Chinese medicine composition for treating gynecological tumors comprises the following raw materials in parts by weight:

[0066] 70 parts of Radix Achyranthis Bidentatae, 48 parts of Herba Limoniae Bicolor, 20 parts of Radix Angelicae Sinensis, 25 parts of Scutellariae Barbatae, 10 parts of Fructus Gardeniae and 7 parts of Radix Glycyrrhizae.

[0067] The preparation method of the above-mentioned Chinese medicine composition for treating gynecological tumors comprises the following steps:

[0068] Step (1): adding the crushed Achyranthes bidentata to 95% ethanol by volume for a first reflux extraction, wherein the weight ratio of Achyranthes bidentata to the ethanol is 1:8, the temperature is 80° C., the time is 1 hour, and the number of times is 2 times, combining the obtained first extracts and concentrating under reduced pressure to obtain an alcohol extract; then adding the alcohol extract to water for dissolution and extracting with petroleum ether for 3 times, combining the extracts from the upper petroleum ether part, concentrating under reduced pressure and drying to constant weight to obtain a first extract;

[0069] Step (2): adding the mixed and crushed Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to water for ultrasonic-assisted extraction, wherein the weight ratio of the total weight of the Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to the water is 1:15, the ultrasonic power is 500 W, and the extraction time is 3 hours; then performing a second reflux extraction at a temperature of 110° C. for 2 hours, the number of times is 2 times, combining the obtained second extracts, concentrating under reduced pressure and drying to constant weight, to obtain a second extract;

[0070] Step (3): The first extract obtained in step (1) and the second extract obtained in step (2) are mixed and crushed, and the mixture is passed through a 100-mesh sieve to obtain the traditional Chinese medicine composition for treating gynecological tumors.

[0071] Example 3

[0072] This example provides a Chinese medicine composition for treating gynecological tumors. The Chinese medicine composition for treating gynecological tumors comprises the following raw materials in parts by weight:

[0073] 55 parts of Radix Achyranthis Bidentatae, 30 parts of Herba Limoniae Bicolor, 10 parts of Radix Angelicae Sinensis, 15 parts of Scutellariae Barbatae, 5 parts of Fructus Gardeniae and 2 parts of Radix Glycyrrhizae.

[0074] The preparation method of the above-mentioned Chinese medicine composition for treating gynecological tumors comprises the following steps:

[0075] Step (1): adding the crushed Achyranthes bidentata to 75% ethanol by volume for a first reflux extraction, wherein the weight ratio of Achyranthes bidentata to the ethanol is 1:12, the temperature is 90° C., the time is 2 hours, the number of times is 2 times, the first extract obtained is combined and concentrated under reduced pressure to obtain an alcohol extract; then the alcohol extract is added to water for dissolution and extracted with petroleum ether for 3 times, the extracts from the upper petroleum ether part are combined, concentrated under reduced pressure and dried to constant weight to obtain a first extract;

[0076] Step (2): adding the mixed and crushed Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to water for ultrasonic-assisted extraction, wherein the weight ratio of the total weight of the Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to the water is 1:10, the ultrasonic power is 300 W, and the extraction time is 6 hours; then performing a second reflux extraction at a temperature of 105° C. for 3 hours, the number of times is 2, combining the obtained second extracts, concentrating under reduced pressure and drying to constant weight, to obtain a second extract;

[0077] Step (3): The first extract obtained in step (1) and the second extract obtained in step (2) are mixed and crushed, and the mixture is passed through a 100-mesh sieve to obtain the traditional Chinese medicine composition for treating gynecological tumors.

[0078] Comparative Example 1

[0079] This example provides a traditional Chinese medicine composition for treating gynecological tumors and a preparation method thereof. The only difference from Example 1 is that the amount of Radix Achyranthis Bidentatae is adjusted to 0 parts (i.e., Radix Achyranthis Bidentatae is not added and the corresponding preparation process steps are omitted); the remaining steps and parameters are the same.

[0080] Comparative Example 2

[0081] This example provides a Chinese medicine composition for treating gynecological tumors and a preparation method thereof. The only difference from Example 1 is that the amount of Limonium bicolor used is adjusted to 0 parts (i.e., Limonium bicolor is not added); the remaining steps and parameters are the same.

[0082] Comparative Example 3

[0083] This example provides a Chinese medicine composition for treating gynecological tumors and a preparation method thereof. The only difference from Example 1 is that the amount of Achyranthes bidentata is adjusted to 37 parts and the amount of Limonium bicolor is adjusted to 62.5 parts; the remaining steps and parameters are the same.

[0084] Comparative Example 4

[0085] This example provides a Chinese medicine composition for treating gynecological tumors and a preparation method thereof. The only difference from Example 1 is that the amount of Achyranthes bidentata is adjusted to 20 parts and the amount of Scutellaria barbata is adjusted to 62.5 parts; the remaining steps and parameters are the same.

[0086] Test Case

[0087] In this example, the therapeutic effect of the Chinese medicine composition obtained in Examples 1 to 3 and Comparative Examples 1 to 4 on the Skov-3 mouse model transplanted with human ovarian cancer cells was investigated according to the test method disclosed in the prior art.

[0088] The test method is as follows:

[0089] 1. Experimental Materials

[0090] Experimental animals: Female Balb / C nude mice weighing between 18-22 grams were selected.

[0091] Reagents and cells: Caspase-3 immunohistochemistry detection kit and human ovarian cancer cell line Skov-3 in logarithmic growth phase.

[0092] 2. Animal Model Establishment

[0093] Preparation of cell suspension: Human ovarian cancer cells Skov-3 in logarithmic growth phase were taken and adjusted to a concentration of 2×10 10 L -1 .

[0094] Inoculation and modeling: Under sterile conditions, the cell suspension was injected subcutaneously into the right back of nude mice, with an inoculation volume of 0.2 ml per mouse. Seven days after inoculation, the size of the subcutaneous nodules was observed and measured. When the nodule volume exceeded 100 mm 3 The modeling was considered successful.

[0095] 3. Grouping and Dosing

[0096] Model control group: 1 group was set up, with 10 mice in each group after successful modeling, and an equal volume of normal saline was gavaged as a control, once every other day, for a total of 5 times.

[0097] Positive control group: 1 group was set up, with 10 mice in each group after successful modeling, and cisplatin was administered by gavage at a dose of 2 mg / kg body weight, once every other day, for a total of 5 times.

[0098] Dosing experimental group: A total of 7 groups were set up, with 10 mice in each group after successful modeling, and the Chinese medicine composition obtained from Example 1 (recorded as Example 1 dosing group), Example 2 (recorded as Example 2 dosing group), Example 3 (recorded as Example 3 dosing group), Comparative Example 1 (recorded as Comparative Example 1 dosing group), Comparative Example 2 (recorded as Comparative Example 2 dosing group), Comparative Example 3 (recorded as Comparative Example 3 dosing group) and Comparative Example 4 (recorded as Comparative Example 4 dosing group) were gavage treated, with a unified dose of 80 mg / kg body weight, once every other day, for a total of 5 times.

[0099] 4. Data detection and statistical analysis

[0100] Sample collection: 24 hours after the last oral administration, the mice were killed by cervical dislocation, and the tumor tissues were removed and weighed.

[0101] Calculation of tumor inhibition rate: The tumor inhibition rate was calculated according to the formula: Tumor inhibition rate (%) = (average tumor weight of the model control group - average tumor weight of the drug-administered experimental group) / average tumor weight of the model control group × 100%, or tumor inhibition rate (%) = (average tumor weight of the model control group - average tumor weight of the positive control group) / average tumor weight of the model control group × 100%.

[0102] Histological analysis: The tumor tissues were fixed in 4% paraformaldehyde solution, embedded in paraffin, and sectioned. The expression of Caspase-3 protein was detected using an immunohistochemical detection kit, and then a semi-quantitative analysis was performed: 6 fields of view were randomly selected from each stained section, and the average optical density was determined using BI2000 medical image analysis software.

[0103] Data statistics: SPSS software was used for data analysis. The test results are shown in Tables 1 and 2.

[0104] Table 1 Statistical results of tumor inhibition rate in each group

[0105] Test Group Tumor inhibition rate (%) Model control group - Positive control group 56.9 Example 1 Dosage Group 85.4 Example 2 Dosage Group 70.7 Example 3 Dosage Group 74.2 Comparative Example 1: Drug administration group 31.6 Comparative Example 2: Drug administration group 37.5 Comparative Example 3: Administration Group 46.1 Comparative Example 4: Administration Group 40.8

[0106] Table 2 Average optical density of Caspase-3 protein expression in tumor tissues of each group

[0107] Test Group Caspase-3 Model control group 0.09 Positive control group 0.19 Example 1 Dosage Group 0.47 Example 2 Dosage Group 0.28 Example 3 Administration Group 0.34 Comparative Example 1: Drug administration group 0.12 Comparative Example 2: Drug administration group 0.13 Comparative Example 3: Administration Group 0.16 Comparative Example 4: Administration Group 0.15

[0108] As shown in Table 1 and Table 2, compared with the model control group, the experimental groups administered with the Chinese medicine composition provided in Examples 1 to 3 of the present invention can significantly inhibit the growth of the tumor, and the inhibitory effect is significantly better than that of Comparative Examples 1 to 4; at the same time, the experimental groups administered with the Chinese medicine composition provided in Examples 1 to 3 of the present invention can significantly upregulate the expression of Caspase-3 in tumor tissues, and the expression and activity of Caspase-3 are generally positively correlated with the degree of cell apoptosis. Therefore, the detection of a significant increase in the expression of Caspase-3 in tumor tissues means that more tumor cells are undergoing apoptosis, indicating that the Chinese medicine composition provided in the embodiment of the present invention can inhibit the growth and spread of tumor cells through the apoptosis pathway mediated by Caspase-3.

[0109] In summary, the embodiments of the present invention provide a traditional Chinese medicine composition for treating gynecological tumors, and a preparation method and application thereof. The traditional Chinese medicine composition provided by the present invention uses Achyranthes bidentata and Limonium bicolor as main effective raw materials and is supplemented with appropriate amounts of Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice. Animal experiments have shown that the traditional Chinese medicine composition has a significant inhibitory effect on tumor growth in a Skov-3 mouse model transplanted with human ovarian cancer cells, and can upregulate the expression of Caspase-3 in tumor tissues. The traditional Chinese medicine composition can be used to prepare drugs for treating gynecological tumors such as ovarian cancer, opening up a new path for the treatment of gynecological tumors, especially ovarian cancer.

[0110] Various embodiments of the present invention may be presented in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be understood as a rigid limitation on the scope of the present invention; therefore, the range description should be considered to have specifically disclosed all possible sub-ranges and single numerical values ​​within the range. For example, the range description from 1 to 6 should be considered to have specifically disclosed sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as single numbers within the range, such as 1, 2, 3, 4, 5 and 6, which apply regardless of the range. In addition, whenever a numerical range is indicated herein, it is meant to include any cited number (fractional or integer) within the indicated range.

[0111] The foregoing is merely a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A Chinese medicine composition for treating gynecological tumors, characterized in that: The Chinese medicine composition for treating gynecological tumors comprises the following raw materials in parts by weight: 55-70 parts of Radix Achyranthis Bidentatae, 30-48 parts of Herba Limoniae Bicolor, 10-20 parts of Radix Angelicae Sinensis, 15-25 parts of Scutellariae Barbatae, 5-10 parts of Gardeniae Jasminoides and 2-7 parts of Radix Glycyrrhizae.

2. The Chinese medicine composition for treating gynecological tumors according to claim 1, characterized in that: The Chinese medicine composition for treating gynecological tumors comprises the following raw materials in parts by weight: There were 62.5 parts of Radix Achyranthis Bidentatae, 37 parts of Herba Limoniae Bicolor, 16 parts of Radix Angelicae Sinensis, 20 parts of Scutellariae Barbatae, 8 parts of Fructus Gardeniae and 5 parts of Radix Glycyrrhizae.

3. A method for preparing the Chinese medicine composition for treating gynecological tumors according to claim 1 or 2, characterized in that: The preparation method comprises the following steps: Adding Achyranthes bidentata to ethanol for a first reflux extraction, then adding the obtained alcohol extract to a solvent for dissolution and extracting with petroleum ether to obtain a first extract; Adding Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to water for ultrasonic-assisted extraction, and then performing a second reflux extraction to obtain a second extract; The first extract and the second extract are crushed and sieved to obtain the traditional Chinese medicine composition for treating gynecological tumors.

4. The method for preparing the Chinese medicine composition for treating gynecological tumors according to claim 3, characterized in that: The weight ratio of the Achyranthes bidentata to the ethanol is 1:(8-12), and the volume fraction of the ethanol is 75-95%; the weight ratio of the total weight of the Limonium bicolor, Angelica sinensis, Scutellaria barbata, Gardenia jasminoides and Licorice to the water is 1:(10-15).

5. The method for preparing the Chinese medicine composition for treating gynecological tumors according to claim 3, characterized in that: The working condition parameters of the first reflux extraction include: temperature of 80-90° C., time of 1-2 hours, and number of times of 1-3 times.

6. The method for preparing the Chinese medicine composition for treating gynecological tumors according to claim 3, characterized in that: The solvent is water.

7. The method for preparing the Chinese medicine composition for treating gynecological tumors according to claim 3, characterized in that: The working condition parameters of the ultrasonic assisted extraction include: ultrasonic power of 300-500W and time of 3-6 hours.

8. The method for preparing the Chinese medicine composition for treating gynecological tumors according to claim 3, characterized in that: The working condition parameters of the second reflux extraction include: temperature of 105-110° C., time of 2-3 hours, and number of times of 1-3 times.

9. Use of a Chinese medicinal composition for treating gynecological tumors as claimed in claim 1 or 2 and / or a Chinese medicinal composition for treating gynecological tumors obtained by the preparation method according to any one of claims 3 to 8 in the preparation of drugs for treating gynecological tumor diseases.

10. The use according to claim 9, wherein the treatment of gynecological tumor diseases includes ovarian tumors, and the dosage form of the drug includes tablets, capsules, powders, mixtures, pills or granules.

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