Uterus-warming and interior-warming traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a uterus-warming and interior-warming traditional Chinese medicine composition and a preparation method and application thereof. The uterus-warming and interior-warming traditional Chinese medicine composition is prepared from the following components in parts by weight: 45 to 55 parts of Qi folium artemisiae argyi, 5 to 10 parts of fructus anisi stellati, 5 to 10 parts of fructus foeniculi, 8 to 15 parts of flos caryophylli, 8 to 15 parts of cortex cinnamomi, 1 to 3 parts of agilawood and 1 to 3 parts of rhizoma zingiberis recens. The traditional Chinese medicine composition prepared by the invention can relieve a series of symptoms caused by cold in uterus, and has the effects of strengthening the body and warming and invigorating kidney yang.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a uterus-warming and interior-warming traditional Chinese medicine composition and a preparation method and application thereof. Background Art

[0002] Uterine coldness refers to the coldness of the uterus caused by insufficient kidney yang in women, which is manifested as lower abdominal distension, pain, fear of cold limbs, excessive leucorrhea, dysmenorrhea, and menstrual disorders. Uterine coldness can cause problems such as irregular menstruation and dysmenorrhea, such as: lower abdominal distension before menstruation, increased leucorrhea, back pain, breast pain, nausea and vomiting in a few cases, abdominal pain during menstruation, dark menstruation with blood clots, etc. According to traditional Chinese medicine theory, cold is a yin evil that can easily damage yang; coldness can cause blood circulation and blockage. People with uterine coldness have problems such as insufficient yang, cold pain, and low immune function. Long-term uterine coldness can further lead to serious gynecological diseases and discomfort, which can trouble women's normal lives.

[0003] Warming the uterus is a maintenance method for women to repair their injured and cold uterus. Warming the uterus can regulate menstruation, nourish blood, warm the uterus, play an anti-inflammatory repair, scientifically regulate the uterine environment, and effectively protect the health and fertility of the body. Warming the uterus can also promote blood circulation and remove blood stasis, and replenish qi and blood. Because if the blood stasis is not removed, new blood will not be produced. It is necessary to clear the blood first and then replenish it, and to introduce the old and introduce the new. If the blood stasis is removed, new blood will be produced, and the stagnation in the body will be cleared. If the blood stasis is removed, there will be no pain, and the menstruation will be regulated. Replenishing qi and blood, harmonizing the liver and spleen, warming yang and nourishing the kidney, the five internal organs are safe, and diseases cannot breed, the body's resistance is improved, it is not easy to get sick, and the source of disease cannot invade.

[0004] For example, Chinese patent CN107789484B discloses a Chinese medicine composition for treating irregular menstruation and its preparation method, the Chinese medicine composition includes 8-12 parts of donkey-hide gelatin, 18-22 parts of polygonatum, 18-22 parts of red dates, 8-12 parts of wolfberry, 10-14 parts of tuckahoe, 8-12 parts of cinnamon bark, 10-14 parts of orange peel and 8-12 parts of liquorice. Although the Chinese medicine composition of the invention has the effects of nourishing blood and regulating menstruation, tonifying the liver and kidney, and warming the uterus, it can effectively treat and regulate irregular menstruation, improve insomnia symptoms, and improve the quality of life of patients, but the invention is not effective for irregular menstruation caused by spleen and stomach deficiency and cold, and the ingredients are complex, the cost is high, and the effect of improving immunity is not good.

[0005] For example, Chinese patent CN113952396A discloses a uterine warming patch with the function of warming the uterus and the interior, comprising a non-woven magnetic film layer, a Chinese medicine coating layer, a heating element and a non-woven adhesive layer; the non-woven magnetic film layer comprises magnetic powder and non-woven fabric, and the magnetic powder is evenly distributed on the non-woven fabric in a star shape; the Chinese medicine coating layer comprises the following Chinese medicine fillers: 40 parts of Artemisia argyi leaves; 10 parts of fennel; 10 parts of fennel; 10 parts of cloves; 3 parts of costus root; 1 part of agarwood; the heating element comprises a non-woven bag and a heating element filler, the heating element filler is located in the non-woven bag, and the heating element filler comprises iron powder, activated carbon, water and inorganic salt; the uterine warming patch is composed of a non-woven magnetic film layer, a Chinese medicine coating layer, a heating element and a non-woven adhesive layer from top to bottom. Although the invention has the functions of warming the uterus and regulating the spleen and stomach, the preparation method of the invention cannot give full play to the pharmacological activity of the drug, and there are problems such as loss of the active ingredients of the drug.

[0006] Therefore, there is an urgent need to study a Chinese medicine composition that has the functions of warming the uterus and the interior, improving immunity, and is suitable for both men and women, and the preparation method of the composition can fully exert the pharmacological activity of the drug and improve the activity of the drug. Summary of the invention

[0007] Based on the deficiencies in the prior art, the present invention aims to provide a preparation method and application of a Chinese medicine composition for warming the uterus and the interior. The preparation method of the Chinese medicine composition provided by the present invention can fully exert the pharmacological activity of the drug.

[0008] The raw material effects of the present invention are:

[0009] Qi Ai Ye: It enters the liver, spleen, and kidney meridians, can warm the meridians and stop bleeding, dispel cold and relieve pain, dredge meridians, and can remove dampness and relieve itching when used externally.

[0010] Fennel: It enters the liver, spleen, and kidney meridians. It is warm in nature, sweet and spicy in taste, and has a strong aroma. It can be used to improve symptoms such as nausea and vomiting, cold pain in the stomach, and cold pain in the abdomen. It can stimulate the gastrointestinal nerves and blood vessels, promote the secretion of digestive juices, increase gastrointestinal motility, and has the effects of strengthening the stomach and promoting qi, which helps to relieve spasms and reduce pain.

[0011] Fennel: It belongs to the liver, spleen and kidney meridians, and has the functions of regulating liver qi, warming the kidney and liver, promoting qi and relieving pain, and dispelling wind and removing phlegm. It can relieve problems such as liver qi stagnation, insufficient kidney meridian, and poor stomach qi. It is often used to treat symptoms such as cold hernia abdominal pain, kidney deficiency low back pain, and stomach cold vomiting. In addition, fennel has many functions and effects, including dispelling cold and relieving pain, regulating qi and stomach, helping digestion, relieving cough and reducing phlegm, relieving spasms, and sterilizing and anti-inflammatory.

[0012] Clove: Clove is pungent and warm in nature. It enters the spleen, stomach, lung and kidney meridians and has the effects of warming the middle and lowering adverse reactions, nourishing the kidney and supporting yang. It is often used for spleen and stomach deficiency and cold, hiccups and vomiting, poor appetite, vomiting and diarrhea, cold pain in the heart and abdomen, and relieving kidney deficiency and impotence.

[0013] Agarwood: Agarwood is pungent and bitter, warm in nature, and belongs to the spleen, stomach, and kidney meridians. Agarwood can promote qi and relieve pain; at the same time, agarwood is bitter and warm, and can enter the spleen and stomach meridians, so it can also treat symptoms of stomach cold vomiting, hiccups, and other stomach qi upward symptoms, and has the effect of lowering the reverse and stopping vomiting; at the same time, agarwood enters the kidney meridian, and its qi is good at descending, and can also treat kidney deficiency caused by kidney failure to receive qi and cough, asthma, or treat symptoms of waist and knee cold pain, so agarwood also has the effect of warming the kidney and receiving qi.

[0014] Cinnamon: Cinnamon is pungent, sweet and hot in nature. It mainly enters the kidney meridian, spleen meridian, heart meridian and liver meridian. It has the effects of replenishing fire and yang, dispersing cold and relieving pain, warming and unblocking meridians, and guiding fire back to the origin.

[0015] Ginger: Ginger is hot in nature and pungent in taste. It enters the spleen, stomach, heart, and lung meridians and moves but does not stay. Ginger is yellow-brown or gray-yellow in color, has a dry and hard texture, and tastes spicy. It is the pungent flavor among the five flavors of traditional Chinese medicine. It has the effects of dispelling cold evil, boosting yang, warming the middle and dispersing cold. Since ginger is hot in nature and can easily boost yang and generate heat, it can be used to relieve cold symptoms, open the heart and boost yang to restore the pulse, and warm the spleen and kidney to reverse the cold.

[0016] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0017] On the one hand, the present invention provides a Chinese medicine composition for warming the uterus and the interior, comprising the following ingredients by weight: 45-55 parts of Artemisia argyi leaves, 5-10 parts of fennel, 5-10 parts of cumin, 8-15 parts of cloves, 8-15 parts of cinnamon, 1-3 parts of agarwood and 1-3 parts of ginger.

[0018] Preferably, the Chinese medicine composition for warming the uterus and the interior comprises the following components by weight: 48-52 parts of Artemisia argyi leaves, 6-9 parts of fennel, 6-9 parts of cumin, 9-12 parts of cloves, 9-12 parts of cinnamon, 2-3 parts of agarwood and 2-3 parts of ginger.

[0019] As some preferred embodiments, the mass ratio of cloves to cinnamon is 0.5-2:1; preferably 1:1.

[0020] As some preferred implementation schemes, the mass ratio of agarwood to ginger is 0.3-1.5:1; preferably 1:1.

[0021] As a preferred embodiment, the Chinese medicine composition for warming the uterus and the interior comprises the following components by weight: 50 parts of Artemisia argyi leaves, 8 parts of fennel, 8 parts of cumin, 10 parts of cloves, 10 parts of cinnamon, 2 parts of agarwood and 2 parts of ginger.

[0022] On the other hand, the present invention provides a method for preparing a uterus-warming and interior-warming Chinese medicine composition, comprising the following steps:

[0023] (1) Mix the formulated amounts of Artemisia argyi leaf, fennel and cumin, crush them, and sieve them to obtain a mixed powder 1;

[0024] (2) Mix the formulated amounts of cloves, cinnamon, agarwood and ginger, crush them, and sieve them to obtain a mixed powder 2;

[0025] (3) adding ethanol to the mixed powder 1 obtained in step (1), performing reflux extraction, and filtering to obtain a filtrate A and a filter residue A;

[0026] (4) adding ethanol to the mixed powder 2 obtained in step (2), refluxing and extracting, filtering, and obtaining a filtrate B and a filter residue B;

[0027] (5) The filtrates A and B obtained in step (3) and step (4) are mixed, concentrated, and dried to obtain the Chinese medicine composition.

[0028] Preferably, the sieving mesh number in step (1) is 30-40 mesh, preferably 35 mesh.

[0029] Preferably, the sieving mesh number in step (2) is 100-200 mesh, preferably 150 mesh.

[0030] Preferably, the volume fraction of ethanol in step (3) is 85%-95%, the volume of ethanol is 4-6 times the total weight of Artemisia argyi, fennel and cumin, and the reflux extraction time is 1-2h;

[0031] More preferably, the volume fraction of ethanol in step (3) is 90%, the volume of ethanol is 5 times the total weight of Artemisia argyi, fennel and cumin, and the reflux extraction time is 1.5 h.

[0032] Preferably, the volume fraction of ethanol in step (4) is 65%-75%, the volume of ethanol is 4-6 times the total weight of cloves, cinnamon, agarwood and ginger, and the reflux extraction time is 1-3h;

[0033] More preferably, the volume fraction of ethanol in step (4) is 70%, the volume of ethanol is 5 times the total weight of cloves, cinnamon, agarwood and ginger, and the reflux extraction time is 2h.

[0034] Preferably, the concentration in step (5) is carried out under reduced pressure, the temperature of the reduced pressure concentration is 40-60° C., and the reduced pressure concentration is carried out to a solid content of 60-80%;

[0035] More preferably, the temperature of the reduced pressure concentration in step (5) is 55° C., and the reduced pressure concentration is performed to a solid content of 75%.

[0036] Preferably, the drying in step (5) is reduced pressure drying, and the drying time is 4-6 hours.

[0037] Secondly, the present invention also provides the use of the uterus-warming Chinese medicine composition prepared by the above preparation method in the preparation of a uterus-warming pharmaceutical preparation, wherein the uterus-warming pharmaceutical preparation is a uterus-warming patch.

[0038] Finally, the present invention also provides a uterine warming patch with the function of warming the uterus and the interior, comprising a non-woven magnetic film layer, the above-mentioned uterine warming and interior warming Chinese medicine composition layer, a heating element and a non-woven adhesive layer.

[0039] The present invention also provides a method for preparing the above-mentioned uterine warming patch having the function of warming the uterus and the interior, comprising the following steps:

[0040] S1. Preparation of non-woven fabric magnetic film layer: evenly apply magnetic powder on non-woven fabric through glue, and make 250×80mm non-woven fabric magnetic film layer after drying for standby use;

[0041] S2, preparation of the Chinese medicine composition layer: the Chinese medicine composition for warming the uterus and the interior obtained above;

[0042] S3, preparation of the heating element: the heating element fillers are mixed in proportion and put into a non-woven bag, the four sides are pressed and sealed, and one side of the non-woven bag is pasted with glue and a sticker to make the heating element for use;

[0043] S4, adhesive: brush medical pressure-sensitive adhesive on non-woven fabric to make long strip adhesive for later use;

[0044] S5. Take the spare non-woven magnetic film layer, apply glue evenly around it and stick it on one side of the heating element, leaving a 60mm gap for filling the medicine at one edge of the heating element;

[0045] S6, filling the Chinese medicine filler of the Chinese medicine composition layer along the gap between the heating element and the non-woven magnetic film layer;

[0046] S7, sealing the gap filled in step S6 by pressing glue;

[0047] S8. Glue the adhesive to the other side of the heating element, and finally glue release paper on both sides to prepare a uterus warming patch.

[0048] Compared with the prior art, the present invention has the following beneficial effects:

[0049] (1) The Chinese medicine composition provided by the present invention uses Artemisia argyi leaf as the main drug, aniseed and cloves as the auxiliary drugs, and fennel, cinnamon, agarwood and ginger as the guiding drugs. Cloves warm the middle burner, and aniseed warms the lower burner. It can relieve a series of symptoms caused by uterine cold in women. It has the effects of strengthening the body and warming and nourishing kidney yang when used by men, and is suitable for both men and women.

[0050] (2) The Chinese medicine composition provided by the present invention has better effects after heating, and has broad application prospects in the preparation of products such as warming uterus patches. DETAILED DESCRIPTION

[0051] The technical scheme of the present invention is clearly and completely described below with specific implementation methods. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present invention. The materials, reagents, etc. used, if not otherwise specified, are reagents and materials available from commercial sources.

[0052] Qi Ai leaves were purchased from Nanyang Chengshantang Biotechnology Co., Ltd.; fennel and cumin were purchased from Anhui Guihe Pharmaceutical Co., Ltd.; cloves and agarwood were purchased from Anhui Kangweifu Pharmaceutical Co., Ltd.; ginger was purchased from Bozhou Boyuantong Chinese Medicinal Materials Planting Co., Ltd.; cinnamon was purchased from Bozhou Huozhengtang Pharmaceutical Co., Ltd.

[0053] Embodiment 1 A kind of Chinese medicine composition for warming the uterus and the interior

[0054] It is composed of the following raw materials:

[0055] 50 parts of Artemisia argyi leaves, 8 parts of fennel, 8 parts of cumin, 10 parts of cloves, 10 parts of cinnamon, 2 parts of agarwood and 2 parts of ginger.

[0056] The preparation method is:

[0057] (1) Mix the formulated amounts of Artemisia argyi leaf, fennel and cumin, grind them, and sieve through 35 mesh to obtain a mixed powder 1;

[0058] (2) Mix the formulated amounts of cloves, cinnamon, agarwood and ginger, crush them, and sieve through 150 mesh to obtain mixed powder 2;

[0059] (3) adding ethanol in an amount of 5 times the total weight of Artemisia argyi, fennel and cumin and having a volume fraction of 90% to the mixed powder 1 obtained in step (1), reflux extraction for 2 hours, and filter to obtain filtrate A1 and residue A1;

[0060] (4) adding 70% ethanol in an amount of 5 times the total weight of cloves, cinnamon, agarwood and ginger to the mixed powder 2 obtained in step (2), reflux extraction for 2 hours, and filter to obtain filtrate B1 and residue B1;

[0061] (5) The filtrates A1 and B1 obtained in step (3) and step (4) are mixed, concentrated under reduced pressure at 55° C. to a solid content of 75%, and dried under reduced pressure for 5 h to obtain the traditional Chinese medicine composition.

[0062] Embodiment 2 A kind of Chinese medicine composition for warming the uterus and the interior

[0063] It is composed of the following raw materials:

[0064] 45 parts of Artemisia argyi leaves, 10 parts of fennel, 5 parts of cumin, 8 parts of cloves, 12 parts of cinnamon, 1 part of agarwood and 3 parts of ginger.

[0065] The preparation method is:

[0066] (1) Mix the formulated amounts of Artemisia argyi leaf, fennel and cumin, grind them, and sieve through 30 meshes to obtain a mixed powder 1;

[0067] (2) Mix the formulated amounts of cloves, cinnamon, agarwood and ginger, crush them, and sieve through 100 mesh to obtain mixed powder 2;

[0068] (3) adding ethanol in an amount of 85% by volume that is 6 times the total weight of Artemisia argyi, fennel and cumin to the mixed powder 1 obtained in step (1), reflux extraction for 1 hour, and filter to obtain filtrate A2 and residue A2;

[0069] (4) adding 65% ethanol in an amount of 6 times the total weight of cloves, cinnamon, agarwood and ginger to the mixed powder 2 obtained in step (2), reflux extraction for 1 hour, and filter to obtain filtrate B2 and residue B2;

[0070] (5) The filtrates A2 and B2 obtained in step (3) and step (4) are mixed, concentrated under reduced pressure at 55° C. to a solid content of 60%, and dried under reduced pressure for 6 h to obtain the traditional Chinese medicine composition.

[0071] Embodiment 3 A kind of Chinese medicine composition for warming the uterus and the interior

[0072] It is composed of the following raw materials:

[0073] 55 parts of Qi Artemisia argyi leaves, 10 parts of fennel, 10 parts of cumin, 15 parts of cloves, 8 parts of cinnamon, 3 parts of agarwood and 2 parts of ginger.

[0074] The preparation method is:

[0075] (1) Mix the formulated amounts of Artemisia argyi leaf, fennel and cumin, grind them, and sieve through 40 mesh to obtain a mixed powder 1;

[0076] (2) Mix the formulated amounts of cloves, cinnamon, agarwood and ginger, crush them, and sieve through 200 mesh to obtain mixed powder 2;

[0077] (3) adding 95% ethanol in an amount of 4 times the total weight of Artemisia argyi, fennel and cumin to the mixed powder 1 obtained in step (1), refluxing for 2 h, filtering to obtain a filtrate A3 and a residue A3;

[0078] (4) adding 75% ethanol in an amount of 4 times the total weight of cloves, cinnamon, agarwood and ginger to the mixed powder 2 obtained in step (2), reflux extraction for 3 hours, and filter to obtain filtrate B3 and residue B3;

[0079] (5) The filtrates A3 and B3 obtained in step (3) and step (4) are mixed, concentrated under reduced pressure at 55° C. to a solid content of 80%, and dried under reduced pressure for 4 h to obtain the traditional Chinese medicine composition.

[0080] Comparative Example 1 A Chinese medicine composition for warming the uterus and the interior

[0081] The difference from Example 1 is that the mass ratio of cloves to cinnamon is 4:1; the mass ratio of agarwood to ginger is 1:7, i.e. 16 parts of cloves, 4 parts of cinnamon, 0.5 parts of agarwood and 3.5 parts of ginger, and the rest is the same as Example 1.

[0082] Comparative Example 2: A Chinese medicine composition for warming the uterus and the interior

[0083] The difference from Example 1 is that the preparation method is different, and the Chinese medicines in step (1) and step (2) of Example 1 are mixed and sieved together. The rest is the same as Example 1.

[0084] The preparation method is:

[0085] (1) Mix the formulated amounts of Artemisia argyi leaf, fennel, cumin, cinnamon, ginger, cloves and agarwood, grind them, and sieve through 150 mesh to obtain a mixed powder 1;

[0086] (2) adding ethanol in an amount of 5 times the total amount of the medicinal materials in step (1) and having a volume fraction of 90% to the mixed powder 1 obtained in step (1), reflux extraction for 2 hours, and filtering to obtain filtrate A4 and filter residue A4;

[0087] (3) The filtrate A4 obtained in step (2) is concentrated under reduced pressure at 55° C. to a solid content of 75%, and then dried under reduced pressure for 5 hours to obtain the traditional Chinese medicine composition.

[0088] Comparative Example 3: A Chinese medicine composition for warming the uterus and the interior

[0089] The difference from Example 1 is that 8 parts of aniseed are replaced by 8 parts of fennel, namely: 50 parts of Artemisia argyi leaves, 16 parts of fennel, 10 parts of cloves, 10 parts of cinnamon, 2 parts of agarwood and 2 parts of ginger.

[0090] The preparation method is:

[0091] (1) Mix the formulated amounts of Artemisia argyi leaf and fennel, grind them, and sieve through 35 mesh to obtain a mixed powder 1;

[0092] (2) Mix the formulated amounts of cloves, cinnamon, agarwood and ginger, crush them, and sieve through 150 mesh to obtain mixed powder 2;

[0093] (3) adding ethanol in an amount of 5 times the total weight of Artemisia argyi and fennel and having a volume fraction of 90% to the mixed powder 1 obtained in step (1), reflux extraction for 2 hours, and filter to obtain filtrate A5 and residue A5;

[0094] (4) adding 70% ethanol in an amount of 5 times the total weight of cloves, cinnamon, agarwood and ginger to the mixed powder 2 obtained in step (2), reflux extraction for 2 hours, and filter to obtain filtrate B5 and residue B5;

[0095] (5) The filtrates A5 and B5 obtained in step (3) and step (4) are mixed, concentrated under reduced pressure at 55° C. to a solid content of 75%, and dried under reduced pressure for 5 h to obtain the traditional Chinese medicine composition.

[0096] Comparative Example 4: A Chinese medicine composition for warming the uterus and the interior

[0097] The difference from Example 1 is that 10 parts of cinnamon are replaced by 10 parts of cloves, that is, 50 parts of Artemisia argyi leaves, 8 parts of fennel, 8 parts of cumin, 20 parts of cloves, 2 parts of agarwood and 2 parts of ginger.

[0098] The preparation method is:

[0099] (1) Mix the formulated amounts of Artemisia argyi leaf, fennel and cumin, grind them, and sieve through 35 mesh to obtain a mixed powder 1;

[0100] (2) Mix the formulated amounts of cloves, agarwood and ginger, crush them, and sieve through 150 mesh to obtain mixed powder 2;

[0101] (3) adding 90% ethanol in an amount of 5 times the total weight of Artemisia argyi, fennel and cumin to the mixed powder 1 obtained in step (1), refluxing for 2 h, filtering to obtain a filtrate A6 and a residue A6;

[0102] (4) adding 70% ethanol in an amount of 5 times the total weight of cloves, agarwood and ginger to the mixed powder 2 obtained in step (2), reflux extraction for 2 hours, and filter to obtain filtrate B6 and residue B6;

[0103] (5) The filtrates A6 and B6 obtained in step (3) and step (4) are mixed, concentrated under reduced pressure at 55° C. to a solid content of 75%, and dried under reduced pressure for 5 h to obtain the traditional Chinese medicine composition.

[0104] Comparative Example 5: A Chinese medicine composition for warming the uterus and the interior

[0105] The difference from Example 1 is that 2 parts of ginger are replaced by 2 parts of aniseed, that is, 50 parts of Artemisia argyi leaves, 10 parts of aniseed, 8 parts of cumin, 10 parts of cloves, 10 parts of cinnamon and 2 parts of agarwood.

[0106] The preparation method is:

[0107] (1) Mix the formulated amounts of Artemisia argyi leaf, fennel and cumin, grind them, and sieve through 35 mesh to obtain a mixed powder 1;

[0108] (2) Mix the formulated amounts of cloves, cinnamon and agarwood, crush them, and sieve through 150 mesh to obtain mixed powder 2;

[0109] (3) adding 90% ethanol in an amount of 5 times the total weight of Artemisia argyi, fennel and cumin to the mixed powder 1 obtained in step (1), refluxing for 2 h, filtering to obtain a filtrate A7 and a residue A7;

[0110] (4) adding 70% ethanol in an amount of 5 times the total weight of cloves, cinnamon and agarwood to the mixed powder 2 obtained in step (2), reflux extraction for 2 hours, and filter to obtain filtrate B7 and residue B7;

[0111] (5) The filtrates A7 and B7 obtained in step (3) and step (4) are mixed, concentrated under reduced pressure at 55° C. to a solid content of 75%, and dried under reduced pressure for 5 h to obtain the traditional Chinese medicine composition.

[0112] Comparative Example 6

[0113] According to the formula in patent CN113952396A, a Chinese medicine composition for warming the uterus and the interior is prepared, which is composed of the following raw materials:

[0114] 40 parts of Artemisia argyi leaves, 10 parts of fennel, 10 parts of cumin, 10 parts of cloves, 3 parts of costusroot and 1 part of agarwood.

[0115] The preparation method is:

[0116] (1) Mix the formulated amounts of Artemisia argyi leaf, fennel and cumin, grind them, and sieve through 35 mesh to obtain a mixed powder 1;

[0117] (2) Mix the formulated amounts of cloves, costusroot and agarwood, grind them, and sieve through 150 mesh to obtain mixed powder 2;

[0118] (3) adding 90% ethanol in an amount of 5 times the total weight of Artemisia argyi, fennel and cumin to the mixed powder 1 obtained in step (1), refluxing for 2 h, filtering to obtain a filtrate A8 and a residue A8;

[0119] (4) adding 70% ethanol in an amount of 5 times the total weight of cloves, costusroot and agarwood to the mixed powder 2 obtained in step (2), reflux extraction for 2 h, and filter to obtain filtrate B8 and residue B8;

[0120] (5) The filtrates A8 and B8 obtained in step (3) and step (4) are mixed, concentrated under reduced pressure at 55° C. to a solid content of 75%, and dried under reduced pressure for 5 h to obtain the traditional Chinese medicine composition.

[0121] Effect Experiment

[0122] 1. Application of Chinese medicine composition for warming the uterus and the interior in regulating immunity

[0123] (1) Experimental samples

[0124] The Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-7 were prepared into 10 mg / mL sample solutions with sterile water (40° C.) for later use.

[0125] (2) Experimental animals

[0126] Balb / c mice (18-22 g) were purchased from Beijing Weitonglihua Experimental Animal Technology Co., Ltd. and were raised in an experimental animal environment with an optimal temperature of 20-26°C and an environmental relative humidity of 50%-60%. The mice were allowed to eat freely.

[0127] (3) Experimental methods

[0128] 110 Balb / c mice were grouped and adaptively raised for 7 days. The mice were randomly divided into a model group, a normal control group, Example 1-3 groups (200 mg / kg / day), and Comparative Example 1-6 groups (200 mg / kg / day), with 10 mice in each group.

[0129] Processing: Example and comparative example group were given a sample solution of a specified dose by gavage, and the sample was given by gavage for 18 weeks continuously, once a day, and the control group and model group were given an equal amount of sterile water by gavage, once a day. Except for the normal control group, from the 3rd day, the remaining groups of mice were injected with cyclophosphamide 30mg / kg (the normal control group was given an equal volume of normal saline) every other day, and injected 4 times in total to prepare an animal model of immunodeficiency. Mice were killed 24 hours after the last gavage treatment, and the eyeballs were removed for blood collection, and the circulating blood T lymphocyte subtypes and ratios were detected by flow cytometry. The results obtained are shown in Table 1.

[0130] Table 1

[0131]

[0132] Note: Compared with the model group *p<0.05, **p<0.01; compared with the control group # p<0.01.

[0133] As shown in Table 1, compared with the control group, the CD3 + 、CD4 + and CD8+ Compared with the model group and the control group, the proportion of CD3 T cells in the peripheral blood of mice in each embodiment group was significantly reduced. +、 CD4 + and CD8 + The proportion of T cells increased significantly, which shows that the Chinese medicine composition provided by the present invention can improve the immunity of mice and regulate the function of the body's immune system while warming the uterus and the body.

[0134] 2. Effects of the Chinese herbal medicine composition for warming the uterus and the interior on mice with kidney yang deficiency

[0135] (1) Experimental animals

[0136] ICR male mice, 18-22 g, were purchased from Beijing Weitonglihua Experimental Animal Technology Co., Ltd. and were raised in an experimental animal environment with an optimal temperature of 20-26°C and an environmental relative humidity of 50%-60%. The mice were allowed to eat freely.

[0137] (2) Experimental methods

[0138] 100 mice were randomly divided into 10 groups, 10 mice in each group, including normal control group: distilled water (20 ml / kg by intragastric administration); Yang deficiency syndrome model group: hydrocortisone (25 ml / kg by intragastric administration); Example 1 and comparative example 1-7 group: (2 g / kg by intragastric administration); positive control drug commercially available Funingkang tablet group: (2 g / kg by intragastric administration), each group was intragastrically administered once a day, and hydrocortisone was injected intramuscularly at the same time, for a total of 3 days. On the 4th day, 1 hour after the drug administration, the body temperature, number of spontaneous activities (10 min) and low temperature swimming survival time of each group of animals were recorded. The results are shown in Table 2.

[0139] Table 2

[0140]

[0141] Note: Compared with the Yin deficiency model group *p<0.05, **p<0.01; compared with the control group # p<0.05.

[0142] It can be seen from the data in Table 2 that the Chinese medicine composition provided by the present invention can significantly prolong the swimming survival time of hypothermic mice, and increase the weight and number of autonomous activities of mice, which further illustrates that the Chinese medicine composition prepared by the present invention has a good warming effect, can strengthen the body, and warm and nourish the kidney yang.

[0143] In summary, the Chinese medicine composition provided by the present invention has a good effect of warming the uterus and the interior, can improve the body's immunity, and warm and nourish the kidney yang.

Claims

1. A Chinese medicine composition for warming the uterus and the interior, characterized in that: The invention comprises the following components by weight: 45-55 parts of Artemisia argyi leaves, 5-10 parts of aniseed, 5-10 parts of cumin, 8-15 parts of cloves, 8-15 parts of cinnamon, 1-3 parts of agarwood and 1-3 parts of ginger.

2. The uterus-warming and interior-warming Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following components by weight: 50 parts of Artemisia argyi leaves, 8 parts of aniseed, 8 parts of cumin, 10 parts of cloves, 10 parts of cinnamon, 2 parts of agarwood and 2 parts of ginger.

3. The uterus-warming and interior-warming Chinese medicine composition according to claim 1, characterized in that: The mass ratio of the cloves to the cinnamon is 0.5-2:1; the mass ratio of the agarwood to the ginger is 0.3-1.5:

1.

4. The method for preparing the uterus-warming and interior-warming Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The steps include: (1) Mix the formulated amounts of Artemisia argyi leaf, fennel and cumin, crush them, and sieve them to obtain a mixed powder 1; (2) Mix and grind the formulated amounts of cloves, cinnamon, agarwood and ginger, and sieve to obtain mixed powder 2; (3) adding ethanol to the mixed powder 1 obtained in step (1), extracting by reflux, and filtering to obtain filtrate A and residue A; (4) adding ethanol to the mixed powder 2 obtained in step (2), refluxing and extracting, filtering, and obtaining a filtrate B and a filter residue B; (5) The filtrates A and B obtained in step (3) and step (4) are mixed, concentrated, and dried to obtain the Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that: The mesh size of the sieve in step (1) is 30-40 meshes; the mesh size of the sieve in step (2) is 100-200 meshes.

6. The preparation method according to claim 4, characterized in that: The volume fraction of the ethanol in step (3) is 85%-95%, the volume of the ethanol is 4-6 times the total weight of the Artemisia argyi leaves, fennel and cumin, and the reflux extraction time is 1-2h.

7. The preparation method according to claim 4, characterized in that: The volume fraction of ethanol in step (4) is 65%-75%, the volume of ethanol is 4-6 times the total weight of cloves, cinnamon, agarwood and ginger, and the reflux extraction time is 1-3h.

8. The preparation method according to claim 4, characterized in that: The concentration in step (5) is carried out under reduced pressure, the temperature of the reduced pressure concentration is 40-60° C., and the reduced pressure concentration is carried out to a solid content of 60-80%.

9. Use of the uterus-warming Chinese medicine composition according to any one of claims 1 to 3 or the uterus-warming Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 8 in the preparation of a uterus-warming pharmaceutical preparation.

10. A uterine warming patch having the function of warming the uterus, characterized in that: It includes a non-woven magnetic film layer, a Chinese medicine composition layer, a heating element and a non-woven adhesive layer; the Chinese medicine composition layer includes the uterus-warming Chinese medicine composition described in any one of claims 1-3 or the uterus-warming Chinese medicine composition prepared by the preparation method of any one of claims 4-8.

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