Traditional Chinese medicine composition for relieving dysmenorrhea as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for relieving dysmenorrhea and a preparation method and application thereof, and relates to the technical field of medicine preparation. The invention provides a novel traditional Chinese medicine composition for relieving dysmenorrhea. The traditional Chinese medicine composition specifically comprises cinnamon, baked ginger, angelica sinensis, radix paeoniae alba, honey-fried licorice root, ligusticum wallichii, corydalis tuber and prepared rhizoma cyperi. Components of the traditional Chinese medicine composition are divided into a slow release group and a quick release group according to medicine characteristics and treatment principles, different processes are adopted for processing, the traditional Chinese medicine patch capable of effectively relieving dysmenorrhea is prepared, and the quick release layer can warm channels and dispel cold, quickly relieve spasm pain, nourish and activate blood and improve ischemia and hypoxia states in a short time; the sustained-release layer can promote qi to activate blood, improve menstrual cycle disorder, strongly relieve pain and prolong action time, and through the synergistic effect of warming meridians, promoting blood circulation and relieving pain of the quick-release layer and promoting qi circulation, regulating menstruation and consolidating foundation of the sustained-release layer, the medicine effect is exerted to the maximum extent, and a new medicine form is provided for relieving and treating dysmenorrhea.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medicine preparation, in particular to a traditional Chinese medicine composition for relieving dysmenorrhea and a preparation method and application thereof. BACKGROUND

[0002] Dysmenorrhea is one of the most common gynecological symptoms. It refers to the occurrence of lower abdominal pain, distension, accompanied by lumbago or other discomfort symptoms before and after menstruation or during menstruation, which seriously affects the quality of life. The TCM syndrome types of dysmenorrhea mainly include qi stagnation and blood stasis type, cold coagulation and blood stasis type, damp-heat and blood stasis type, qi and blood deficiency type, and kidney qi deficiency type. Among them, dysmenorrhea of cold coagulation and blood stasis type and qi stagnation and blood stasis type is the most common. Dysmenorrhea of cold coagulation and blood stasis type is caused by cold evil coagulating in the uterus, poor blood circulation, and blood stasis, which is manifested as cold pain in the lower abdomen during menstruation, dark blood with blood clots, and pain relief after warming. Dysmenorrhea of qi stagnation and blood stasis type is caused by stagnation of liver qi due to improper emotions, blood stasis, and blockage of the uterus, which is manifested as premenstrual breast pain, blood clots, and rib distension.

[0003] The navel is a "high-efficiency channel" for drug transdermal absorption due to its anatomical characteristics of thin keratin layer and rich blood vessels. It is convenient, safe, and suitable for a wide range of people, and has safety and convenience, but there are few studies on navel patches for treating dysmenorrhea.

[0004] Currently, for dysmenorrhea, the usual practice of Western medicine is to take painkillers, but this method treats the symptoms rather than the root cause, and frequent use of painkillers can lead to drug resistance in the human body. Traditional Chinese medicine has thousands of years of clinical practice in the field of dysmenorrhea prevention and treatment, and has unique advantages. However, although there are many oral preparations for treating dysmenorrhea in traditional Chinese medicine, there are problems such as single administration route and obvious gastrointestinal irritation. SUMMARY

[0005] In view of the above problems, the purpose of the present application is to provide a new traditional Chinese medicine composition for relieving dysmenorrhea and a preparation method and application thereof. The present application innovatively uses an external navel patch with better safety, good efficacy, and convenient administration, instead of the traditional oral administration, and the process is simple and controllable, the production cost is low, and it has the advantage of industrialized mass production.

[0006] In one aspect, the present application provides a traditional Chinese medicine composition for relieving dysmenorrhea, which comprises 1-3 parts of cassia, 3-12 parts of processed ginger, 6-15 parts of angelica, 4-9 parts of white peony root, 3-10 parts of fried licorice, 3-12 parts of chuanxiong, 3-12 parts of rhizoma corydalis, and 12-24 parts of prepared cyperus rotundus.

[0007] Optionally, the traditional Chinese medicine composition comprises a sustained-release layer material and an immediate-release layer material.

[0008] Further, the sustained release layer material comprises: Cinnamon 1-3 parts, Zingiber officinale 3-12 parts, Angelica 6-15 parts, Radix Paeoniae Alba 4-9 parts, and Radix Glycyrrhizae 3-10 parts.

[0009] Wherein, Cinnamon can be selected from any one of 1, 2, 3 parts; Zingiber officinale can be selected from any one of 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 parts; Angelica can be selected from any one of 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 parts; Radix Paeoniae Alba can be selected from any one of 4, 5, 6, 7, 8, 9 parts; and Radix Glycyrrhizae can be selected from any one of 3, 4, 5, 6, 7, 8, 9, 10 parts.

[0010] Further, the immediate release layer material comprises: Chuanxiong 3-12 parts, Rhizoma Corydalis 3-12 parts, and Radix Cyperi 12-24 parts.

[0011] Wherein, Chuanxiong can be selected from any one of 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 parts; Rhizoma Corydalis can be selected from any one of 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 parts; and Radix Cyperi can be selected from any one of 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 parts.

[0012] In a preferred embodiment, the traditional Chinese medicine composition comprises: Cinnamon 2 parts, Zingiber officinale 10 parts, Angelica 12 parts, Radix Paeoniae Alba 8 parts, Radix Glycyrrhizae 6 parts, Chuanxiong 8 parts, Rhizoma Corydalis 12 parts, and Radix Cyperi 24 parts.

[0013] The present application can also add adjuvants, which can be appropriate solvents, propellants, solubilizers, cosolvents, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, flow aids, flavorings, preservatives, suspending agents, coating materials, fragrances, anti-adhesion agents, integrating agents, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, foaming agents, antifoaming agents, thickening agents, inclusion agents, humectants, absorbents, diluents, flocculants and deflocculants, filtration aids, release retardants, and the like.

[0014] The composition of the present application can be prepared by a general method, in which one or more diluents or carriers can be added.

[0015] One aspect of the present application relates to a composition, which can achieve the effects described in the present application, and the composition includes but is not limited to simultaneous use or sequential use of each component. The “simultaneous use” includes use together in the same preparation or use separately in different preparations. The “sequential use” includes sequential use in different preparations, and there is no limitation on the order of sequential use.

[0016] In another aspect, the application also provides a preparation method of the traditional Chinese medicine composition for relieving dysmenorrhea, which comprises the following steps:

[0017] Step one, take honey and refine it into medium honey, add cinnamon powder, processed ginger powder, angelica powder, white peony root powder, and honey-fried licorice powder into the medium honey and mix them evenly to obtain a sustained-release layer material;

[0018] Step two, soak and decoct Szechuan lovage rhizome, corydalis, and processed cyperus rotundus with water, filter the filtrate, and reduce the pressure to concentrate to obtain a quick-release layer material;

[0019] Step three, adhere the quick-release layer material to the surface of the sustained-release layer material to obtain the traditional Chinese medicine composition.

[0020] In the preparation method, the refining standard of the medium honey is the current standard, and specifically, the temperature of the honey is 116-118°C, the water content is 14-16%, the relative density is about 1.37, the medium honey appears light yellow and shiny, and uniform and fine bubbles appear, and the medium honey has stickiness and no white silk appears when two fingers are separated.

[0021] In a preferred embodiment, the refining method of the medium honey comprises the following steps: taking an appropriate amount of honey, refining it at 117°C with small fire until light yellow and shiny bubbles appear, and the honey is refined into medium honey. The specific refining time is determined according to the amount and quality of the honey.

[0022] Further, the traditional Chinese medicine composition comprises 1-3 parts of cinnamon, 3-12 parts of processed ginger, 6-15 parts of angelica, 4-9 parts of white peony root, 3-10 parts of honey-fried licorice, 3-12 parts of Szechuan lovage rhizome, 3-12 parts of corydalis, and 12-24 parts of processed cyperus rotundus.

[0023] Further, the sustained-release layer material comprises 1-3 parts of cinnamon, 3-12 parts of processed ginger, 6-15 parts of angelica, 4-9 parts of white peony root, and 3-10 parts of honey-fried licorice.

[0024] Further, the quick-release layer material comprises 3-12 parts of Szechuan lovage rhizome, 3-12 parts of corydalis, and 12-24 parts of processed cyperus rotundus.

[0025] Further, in step one, the mesh number of the cinnamon powder, the processed ginger powder, the angelica powder, the white peony root powder, and the honey-fried licorice powder is 80-150 mesh.

[0026] Alternatively, the mesh number can be any of 80 mesh, 90 mesh, 100 mesh, 110 mesh, 120 mesh, 130 mesh, 140 mesh, and 150 mesh.

[0027] Further, in step one, the mass ratio of the cinnamon powder, the processed ginger powder, the angelica powder, the white peony root powder, and the honey-fried licorice powder to the medium honey is 1:1-1.2.

[0028] Optionally, the mass ratio can be any of 1:1, 1:1.11, 1:1.12, 1:1.13, 1:1.14, 1:1.15, 1:1.16, 1:1.17, 1:1.18, 1:1.19, 1:1.2.

[0029] Further, in the second step, the mass ratio of Chuanxiong Rhizoma, Rhizoma Corydalis, and Dried Zedoary Turmeric to water is 1:(5-20).

[0030] Optionally, the mass ratio of Chuanxiong Rhizoma, Rhizoma Corydalis, and Dried Zedoary Turmeric to water can be any of 1:5, 1:6, 1:7, 1:8, 1:9, 1:10, 1:11, 1:12, 1:13, 1:14, 1:15, 1:16, 1:17, 1:18, 1:19, 1:20.

[0031] Further, the soaking time in the second step is 10-60 min.

[0032] Optionally, the soaking time in the second step can be any of 10 min, 20 min, 30 min, 40 min, 50 min, 60 min.

[0033] Further, the decoction in the second step includes three decoctions, the first decoction for 0.5-1 h, the second decoction for 0.5-1 h, and the third decoction for 0.5-1 h.

[0034] The decoction time can be any of 0.5 h, 0.6 h, 0.7 h, 0.8 h, 0.9 h, 1 h.

[0035] Further, the density of the thick paste obtained by vacuum concentration in the second step is 1.30-1.40.

[0036] The density of the thick paste can be any of 1.30, 1.31, 1.32, 1.33, 1.34, 1.35, 1.36, 1.37, 1.38, 1.39, 1.40.

[0037] The skilled person can use known methods to vacuum concentrate the filtrate, which will not be described in detail here.

[0038] Further, in the third step, the mass ratio of the slow-release layer to the immediate-release layer is (1-2):1.

[0039] Preferably, the mass ratio of the slow-release layer material to the immediate-release layer material is 2:1.

[0040] Further, the method further comprises the steps of drying and polishing to prepare the navel pills.

[0041] In a preferred embodiment, the umbilical pill can be fixed on a blank umbilical patch to obtain a traditional Chinese medicine umbilical patch for relieving dysmenorrhea.

[0042] The traditional Chinese medicine umbilical patch takes advantage of high transdermal absorption efficiency of the umbilical part, so that the active ingredients in the traditional Chinese medicine quickly enter the systemic circulation, directly relieve the pathological basis of pain by inhibiting uterine smooth muscle spasm, reducing the synthesis of pain-causing substances such as prostaglandin, and improving pelvic blood circulation, and ultimately achieve the improvement of dysmenorrhea symptoms.

[0043] On the other hand, the application also provides the use of the traditional Chinese medicine composition or the method in the preparation of a medicine for treating and / or relieving dysmenorrhea.

[0044] On the other hand, the application also provides a traditional Chinese medicine composition prepared by the traditional Chinese medicine composition or the method for treating dysmenorrhea.

[0045] Further, the medicine is an external medicine.

[0046] Further, the external preparation includes liniment, ointment, plaster, hot melt adhesive patch, tincture, lotion, oil, emulsion, paste, plaster, film coating agent, gel, aerosol, patch, etc. Preferably, the patch; more preferably, the umbilical patch.

[0047] The properties and effects of each component of the traditional Chinese medicine composition for relieving dysmenorrhea are as follows:

[0048] Cassia is the dried bark of Cinnamomum cassia Presl of Lauraceae; it is peeled off in autumn and dried in the shade; it tastes bitter and sweet, and is hot; it belongs to kidney, spleen, heart and liver channels; it has the effects of tonifying fire and yang, guiding fire to the origin, dispelling cold and relieving pain, and warming meridians; it is used for impotence and cold uterus, cold pain in waist and knees, asthma due to kidney deficiency, dizziness and red eyes due to deficiency of yang, cold pain in heart and abdomen, cold vomiting and diarrhea, cold abdominal pain, and dysmenorrhea.

[0049] Peeled ginger is a processed product of dried ginger; it tastes pungent and is hot; it belongs to spleen, stomach and kidney channels; it has the effects of warming the meridians to stop bleeding and warming the middle to stop pain; it is used for blood loss due to yang deficiency, vomiting and metrorrhagia due to spleen deficiency, abdominal pain and diarrhea due to cold.

[0050] Angelica sinensis (Oliv.) Diels is the dried root of Angelica sinensis (Oliv.) Diels of Umbelliferae; it is harvested in late autumn, and the roots and mud are removed, then it is bundled into small bundles and slowly smoked with smoke and fire in the shed; it tastes sweet and pungent, and is warm; it belongs to liver, heart and spleen channels; it has the effects of tonifying blood, activating blood, regulating menstruation and relieving pain, moistening the intestines and relieving constipation; it is used for blood deficiency and yellowish complexion, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, cold abdominal pain, rheumatism and pain due to injury, carbuncle and sore, and dry intestines and constipation.

[0051] White Peony Root is the dried root of Paeonia lactiflora Pall. of Ranunculaceae. It is harvested in summer and autumn, washed, and cleaned of the head, tail and fine roots. It is then boiled in water, peeled, dried, bitter and sour in taste, and cold in nature. It is attributed to the liver and spleen meridians. It has the functions of nourishing blood, regulating menstruation, astringing yin and stopping sweating, soothing the liver and relieving pain, and suppressing liver yang. It is used for blood deficiency, irregular menstruation, spontaneous sweating, night sweating, hypochondriac pain, abdominal pain, and pain in the limbs and head.

[0052] Radix Glycyrrhizae Praeparata is a processed product of Radix Glycyrrhizae. It is sweet in taste and neutral in nature. It is attributed to the heart, lung, spleen and stomach meridians. It has the functions of tonifying the spleen and stomach, and benefiting qi and restoring pulse. It is used for weakness of the spleen and stomach, listlessness, palpitation, and pulse blockage.

[0053] Chuanxiong Rhizome is the dried rhizome of Ligusticum chuanxiong Hort. of Umbelliferae. It is harvested in summer when the node disc on the stem is prominent and slightly purple, cleaned of mud and sand, dried, and then dried again after removing the root hairs. It is pungent in taste and warm in nature. It is attributed to the liver, gallbladder and pericardium meridians. It has the functions of activating blood and qi, dispelling wind and relieving pain. It is used for chest pain, chest and hypochondriac pain, contusion and swelling, irregular menstruation, amenorrhea and painful menstruation, abdominal mass, and headache and rheumatic pain.

[0054] Corydalis is the dried tuber of Corydalis yanhusuo W.T.Wang of Papaveraceae. It is harvested in early summer when the stems and leaves wither, cleaned of root hairs, washed, boiled or steamed until the white core is just gone, and then dried. It is pungent and bitter in taste and warm in nature. It is attributed to the liver and spleen meridians. It has the functions of activating blood, regulating qi and relieving pain. It is used for chest and abdominal pain, chest pain, amenorrhea and painful menstruation, postpartum blood stasis, and contusion and swelling.

[0055] Cyperus is the dried rhizome of Cyperus rotundus L. of Cyperaceae. It is harvested in autumn, singed to remove the hairs, slightly boiled or steamed in water, dried, or directly dried after singeing. It is pungent, bitter and slightly sweet in taste and neutral in nature. It is attributed to the liver, spleen and triple energ meridians. It has the functions of soothing the liver, resolving stagnation, regulating qi, and relieving pain. It is used for liver stagnation, chest and hypochondriac pain, scrotal swelling, breast distending pain, spleen and stomach qi stagnation, abdominal distending pain, irregular menstruation, and amenorrhea and painful menstruation.

[0056] Explanation:

[0057] The prescription is mainly to warm the meridians and dissipate cold, regulate qi and activate blood, regulate menstruation and relieve pain. Cinnamon and fried ginger are used together. Cinnamon is very hot and enters the kidney, directly supplementing the fire of the conception vessel and warming the uterus. Fried ginger warms the middle-jiao spleen and stomach, dissipates cold and stops abdominal pain. The two are used together to warm the spleen and stomach, warm the liver and kidney, internally dissipate cold of viscera and externally unblock stagnation of meridians, and are the monarch herbs. Prepared Cyperus rotundus regulates the liver and regulates qi, and resolves stagnation of the liver. Chuanxiong activates blood and regulates qi, unblocks qi and blood, and is the ministerial herb. Corydalis increases the pain-relieving effect of Chuanxiong and prepared Cyperus rotundus, and is the auxiliary herb. Angelica and white peony are used together. Angelica nourishes blood and activates blood, and white peony nourishes blood and astringe yin. They are complementary, supplement yin blood deficiency, prevent yin blood from being consumed by warm and dry drugs, and are the auxiliary herbs. Licorice root supplements the spleen and tonifies qi, coordinates all drugs, relieves the dryness of cinnamon and fried ginger, and relieves acute pain, and is the ministerial herb. The prescription is based on warming yang and dissipating cold, and is the core of regulating qi, activating blood and relieving pain, and takes into account nourishing blood, tonifying deficiency and regulating liver and spleen, and is suitable for dysmenorrhea caused by cold coagulation, blood stasis, qi stagnation and blood stasis.

[0058] In view of the problem that western medicine does not treat the root cause, the traditional Chinese medicine composition provided by the application can not only significantly relieve the clinical symptoms caused by dysmenorrhea, such as premenstrual breast distending pain, cold pain in the lower abdomen during menstruation, dark and clotted menstrual blood, pain relief after warming, clotted menstrual blood, and costal distending pain, thereby significantly improving the quality of life of female patients, but also helps patients to warm the meridians and dissipate cold, regulate qi and activate blood, regulate menstruation and relieve pain, and fundamentally improve the pathological state of dysmenorrhea. Through this comprehensive treatment method, patients not only feel relief in a short period of time, but also obtain more stable and long-lasting effects in the long term, thereby achieving the effect of treating both the symptoms and the root cause.

[0059] In order to maximize the efficacy, the application provides two processing methods of crushing and concentrating for the traditional Chinese medicine composition, which are divided into two parts of slow-release layer and immediate-release layer. The immediate-release layer can warm the meridians and dissipate cold in a short period of time, quickly relieve spasm pain, nourish blood and activate blood, and improve ischemia and hypoxia; the slow-release layer can regulate qi and activate blood, improve menstrual cycle disorder, effectively relieve pain, and prolong the action time. Through the synergistic effect of “immediate-release layer warming the meridians and activating blood to relieve pain, and slow-release layer regulating qi, regulating menstruation and consolidating the root”, the efficacy is maximized.

[0060] The application has the following beneficial effects:

[0061] 1. A new traditional Chinese medicine composition for relieving dysmenorrhea is provided in the application, which specifically includes cinnamon, fried ginger, angelica, white peony, licorice root, chuanxiong, corydalis, and prepared Cyperus rotundus.

[0062] 2. In the present application, the ingredients of the traditional Chinese medicine composition are divided into sustained-release group and immediate-release group according to their drug properties and therapeutic principles, and are processed by different processes to prepare a traditional Chinese medicine patch capable of effectively relieving dysmenorrhea. The immediate-release layer can activate blood circulation to remove blood stasis, and the sustained-release layer can warm the meridians and nourish the blood, improve the basic pathogenesis, regulate endocrine and immune function, and maximize the drug efficacy, thereby providing a new drug form for relieving and treating dysmenorrhea. BRIEF DESCRIPTION OF DRAWINGS

[0063] The drawings described herein are used to provide further understanding of the present application, and form a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application, and do not constitute an improper limitation on the present application. In the drawings:

[0064] Figure 1 A is a torsion frequency statistical chart, and B is a torsion latency statistical chart;

[0065] Figure 2 A is a torsion frequency statistical chart, and B is a torsion latency statistical chart;

[0066] Figure 3 A is a torsion frequency statistical chart, and B is a torsion latency statistical chart; DETAILED DESCRIPTION

[0067] In order to more clearly illustrate the overall concept of the present application, the following will be described in detail in the form of embodiments in conjunction with the drawings of the specification. In the following description, a large number of specific details are given in order to provide a more complete understanding of the present application. However, it is obvious to those skilled in the art that the present application can be implemented without one or more of these details. In other examples, some technical features known in the art are not described in order not to obscure the present application.

[0068] Before further describing the specific embodiments of the present application, it should be understood that the scope of protection of the present application is not limited to the following specific embodiments; it should also be understood that the terms used in the embodiments of the present application are for the purpose of describing the specific embodiments, and are not intended to limit the scope of protection of the present application. The test methods in the following examples are not specified, and are usually performed according to the conventional conditions or the conditions recommended by the manufacturers.

[0069] It should be noted that the terms used herein are only for the purpose of describing the specific embodiments, and are not intended to limit the exemplary embodiments according to the present application. As used herein, the singular form is intended to include the plural form, unless the context clearly indicates otherwise, and furthermore, it should be understood that when the terms "comprise" and / or "include" are used in the specification, they indicate the presence of a feature, step, operation, device, component and / or combination thereof.

[0070] When the embodiments give numerical ranges, it is understood that unless the application indicates otherwise, every numerical range's two endpoints, and any number that falls between the two endpoints, can be selected. Unless otherwise defined, all technical and scientific terms used in the application have the same meaning as commonly understood by one of ordinary skill in the art. Except in the Examples, or where otherwise explicitly indicated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. Any method, device, material, or the like that is similar in principle to those described in the Examples of the application and that is known to be employable in the art can be used in place of those that are described in the Examples of the application, in accordance with the knowledge of the skilled person in the art and the description of the application.

[0071] Unless otherwise specified, in the following embodiments, the reagents or instruments used without the manufacturer noted are all conventional products that can be obtained by commercial purchase.

[0072] Unless otherwise specified, the experimental methods, detection methods, and preparation methods disclosed in the application all use conventional techniques in the fields of pharmacy, traditional Chinese medicine, analytical chemistry, medicine, and related fields.

[0073] In addition, the "water" described in the application includes deionized water, distilled water, ion exchange water, double distilled water, high-purity water, and any feasible water that can be used in the field.

[0074] In the following embodiments, if no other specific description, % means wt%, i.e. weight percentage.

[0075] In a preferred embodiment,

[0076] A prescription of a traditional Chinese medicine navel patch for relieving dysmenorrhea, in mass parts, includes: cassia 1-3 parts, processed ginger 3-12 parts, angelica 6-15 parts, white peony root 4-9 parts, fried licorice 3-10 parts, Szechuan lovage 3-12 parts, corydalis 3-12 parts, and prepared cyperus 12-24 parts.

[0077] A preparation method of a traditional Chinese medicine navel patch for relieving dysmenorrhea, including the following steps:

[0078] Step one, grinding cassia, processed ginger, angelica, white peony root, and fried licorice into fine powder, and passing through an 80-150 mesh sieve;

[0079] Step two, taking an appropriate amount of honey, and refining at a small fire of 116-118 ℃ until light yellow and lustrous uniform fine bubbles appear, which is refined into medium honey, and then adding the cassia, processed ginger, angelica, white peony root, and fried licorice fine powder into the medium honey according to a mass ratio of 1:1-1.2 of the medicinal powder to the medium honey, mixing uniformly, and preparing into honey pills (weight: 0.3 g) to obtain the sustained-release layer material;

[0080] Step three, add 5-20 times of water (m / m) to Rhizoma Chuanxiong, Rhizoma Corydalis, Rhizoma Cyperi, soak for 10-60 min, decoct for three times, decocting time is 0.5-1h, 0.5-1h, 0.5-1h respectively, combine the decoction, filter, filter the filtrate under reduced pressure to a thick paste with a relative density of 1.30-1.40, and then obtain the immediate-release layer material (weight: 0.15g);

[0081] Step four, uniformly adhere the immediate-release layer material to the surface of the sustained-release layer material (the mass ratio of the sustained-release layer to the immediate-release layer is 2:1), dry, polish, and then obtain the traditional Chinese medicine navel pill (weight: 0.45g), and fix the navel pill on the blank navel patch to obtain the traditional Chinese medicine navel patch for relieving dysmenorrhea.

[0082] The blank navel patch adopts a commercially available blank navel patch, and the external fixing material is a material harmless to the human body, and a material for preventing drug liquid leakage is padded around the tablet.

[0083] Example 1

[0084] A prescription of a traditional Chinese medicine navel patch for relieving dysmenorrhea, in terms of mass parts, comprises: 3 parts of Cortex Cinnamomi, 6 parts of Rhizoma Zingiberis Praeparatum, 10 parts of Radix Angelicae Sinensis, 9 parts of Radix Paeoniae Alba, 6 parts of Radix Glycyrrhizae Praeparata, 6 parts of Rhizoma Chuanxiong, 10 parts of Rhizoma Corydalis, and 12 parts of Rhizoma Cyperi.

[0085] A preparation method of a traditional Chinese medicine navel patch for relieving dysmenorrhea, comprising the following steps:

[0086] Step one, grind Cortex Cinnamomi, Rhizoma Zingiberis Praeparatum, Radix Angelicae Sinensis, Radix Paeoniae Alba, and Radix Glycyrrhizae Praeparata into fine powder, and pass through a 120-mesh sieve;

[0087] Step two, take an appropriate amount of honey, and prepare it at 117℃ under small fire until uniform fine bubbles with light yellow color and luster appear, and then the honey is prepared, and the fine powder of Cortex Cinnamomi, Rhizoma Zingiberis Praeparatum, Radix Angelicae Sinensis, Radix Paeoniae Alba, and Radix Glycyrrhizae Praeparata is added into the prepared honey at a mass ratio of 1:1.17, mixed uniformly, and then honeyed pills (weight: 0.3g) are prepared to obtain the sustained-release layer material;

[0088] Step three, add 10 times of water (m / m) to Rhizoma Chuanxiong, Rhizoma Corydalis, and Rhizoma Cyperi, soak for 40 min, decoct for three times, decocting time is 1h, 1h, 1h respectively, combine the decoction, filter, and filter the filtrate under reduced pressure to a thick paste with a relative density of 1.40, and then obtain the immediate-release layer material (weight: 0.15g);

[0089] Step four, uniformly adhere the immediate-release layer material to the surface of the sustained-release layer material (the mass ratio of the sustained-release layer to the immediate-release layer is 2:1), dry, polish, and then obtain the traditional Chinese medicine navel pill (weight: 0.45g), and fix the navel pill on the blank navel patch to obtain the traditional Chinese medicine navel patch for relieving dysmenorrhea.

[0090] The blank navel patch can adopt a commercially available blank navel patch, and the external fixing material is a material harmless to human body, and a material for preventing drug liquid from leaking is padded around the tablet.

[0091] Example 2

[0092] A prescription of a traditional Chinese medicine navel patch for relieving dysmenorrhea, including, in mass parts, cassia 2 parts, processed ginger 10 parts, angelica 12 parts, white peony root 8 parts, prepared licorice 6 parts, Szechuan lovage 8 parts, corydalis 12 parts, and rhizoma cyperi 24 parts.

[0093] A preparation method of a traditional Chinese medicine navel patch for relieving dysmenorrhea, including the following steps:

[0094] Step one, grinding cassia, processed ginger, angelica, white peony root, and prepared licorice into fine powder and passing through a 120-mesh sieve;

[0095] Step two, taking an appropriate amount of honey, and refining at 117℃ small fire until light yellow and glossy uniform fine bubbles appear, which is refined into medium honey, and then adding the fine powder of cassia, processed ginger, angelica, white peony root, and prepared licorice into the medium honey according to a mass ratio of 1:1.17 of the powder and the medium honey, mixing uniformly, and preparing into honey pills (weight: 0.3g) to obtain a sustained-release layer material;

[0096] Step three, soaking Szechuan lovage, corydalis, and rhizoma cyperi in 10 times of water (m / m) for 40 minutes, decocting three times with a decocting time of 1h, 1h, and 1h respectively, combining the decoction, filtering, and reducing pressure to concentrate the filtrate into a thick paste with a relative density of 1.40 to obtain a quick-release layer material (weight: 0.15g);

[0097] Step four, uniformly adhering the quick-release layer material to the surface of the sustained-release layer material (mass ratio of the sustained-release layer to the quick-release layer: 2:1), drying, and polishing to obtain a traditional Chinese medicine navel pill (weight: 0.45g), and fixing the navel pill on a blank navel patch to obtain a traditional Chinese medicine navel patch for relieving dysmenorrhea.

[0098] The blank navel patch adopts a commercially available blank navel patch, and the external fixing material is a material harmless to human body, and a material for preventing drug liquid from leaking is padded around the tablet.

[0099] Example 3

[0100] A prescription of a traditional Chinese medicine navel patch for relieving dysmenorrhea, including, in mass parts, cassia 1 part, processed ginger 5 parts, angelica 8 parts, white peony root 6 parts, prepared licorice 6 parts, Szechuan lovage 5 parts, corydalis 8 parts, and rhizoma cyperi 12 parts.

[0101] A preparation method of a traditional Chinese medicine navel patch for relieving dysmenorrhea, including the following steps:

[0102] Step one, grinding cassia, processed ginger, angelica, white peony root, and prepared licorice into fine powder and passing through a 120-mesh sieve;

[0103] Step two, take the appropriate amount of honey, 117 ℃ small fire refining, until the appearance of light yellow with luster of uniform fine bubbles, namely refining into the middle honey, cinnamon, dried ginger, angelica, white peony root, honeyed licorice powder according to the quality ratio of 1:1.17 of the proportion of drug powder and the middle honey into the middle honey mixed evenly, made into honeyed pill (weight: 0.3g), obtain the sustained release layer material;

[0104] Step three, Sichuan Lovage Rhizome, Corydalis, prepared Cyperus rotundus add 10 times the amount of water (m / m), soak 40 min, decoct three times, decocting time is 1h, 1h, 1h, respectively, combined decoction, filtration, filter liquor reduced pressure concentration to the relative density 1.40 thick paste, namely the rapid release layer material (weight 0.15g);

[0105] Step four, the rapid release layer material is evenly adhered to the surface of the sustained release layer material (the mass ratio of sustained release layer to rapid release layer is 2:1), dried, polished, and the traditional Chinese medicine navel pill (weight 0.45g) is obtained. The navel pill is fixed on the blank navel patch to obtain a traditional Chinese medicine navel patch for relieving dysmenorrhea.

[0106] The blank navel patch uses a commercially available blank navel patch. The external fixing material is a material harmless to the human body. The material around the tablet is used to prevent drug leakage.

[0107] Example 4

[0108] A traditional Chinese medicine navel patch for relieving dysmenorrhea includes, in mass parts, 2 parts of cinnamon, 10 parts of dried ginger, 12 parts of angelica, 8 parts of white peony root, 6 parts of honeyed licorice, 8 parts of Sichuan Lovage Rhizome, 12 parts of Corydalis, and 24 parts of prepared Cyperus rotundus.

[0109] A preparation method of a traditional Chinese medicine navel patch for relieving dysmenorrhea includes the following steps:

[0110] Step one, grind the cinnamon, dried ginger, angelica, white peony root, and honeyed licorice into fine powder and pass through an 80-mesh sieve;

[0111] Step two, take the appropriate amount of honey, 117 ℃ small fire refining, until the appearance of light yellow with luster of uniform fine bubbles, namely refining into the middle honey, cinnamon, dried ginger, angelica, white peony root, honeyed licorice powder according to the quality ratio of 1:1.10 of the proportion of drug powder and the middle honey into the middle honey mixed evenly, made into honeyed pill (weight: 0.3g), obtain the sustained release layer material;

[0112] Step three, Sichuan Lovage Rhizome, Corydalis, prepared Cyperus rotundus add 5 times the amount of water (m / m), soak 30 min, decoct three times, decocting time is 0.5h, 0.5h, 0.5h, respectively, combined decoction, filtration, filter liquor reduced pressure concentration to the relative density 1.30 thick paste, namely the rapid release layer material (weight 0.15g);

[0113] Step four, the rapid release layer material is evenly adhered to the surface of the slow release layer material (the mass ratio of the slow release layer to the rapid release layer is 2:1), dried, polished, and the traditional Chinese medicine navel pill (the weight is 0.45g) is obtained, and the navel pill is fixed on the blank navel patch to obtain the traditional Chinese medicine navel patch for relieving dysmenorrhea.

[0114] The blank navel patch adopts a commercially available blank navel patch, and the external fixing material is a material harmless to the human body, and a material for preventing drug liquid leakage is padded around the tablet.

[0115] Example 5

[0116] A prescription of a traditional Chinese medicine navel patch for relieving dysmenorrhea, in terms of mass parts, comprises: cassia 2 parts, processed ginger 10 parts, angelica 12 parts, white peony root 8 parts, fried licorice 6 parts, chuanxiong 8 parts, corydalis 12 parts, and prepared cyperus 24 parts.

[0117] A preparation method of a traditional Chinese medicine navel patch for relieving dysmenorrhea, comprising the following steps:

[0118] Step one, cassia, processed ginger, angelica, white peony root, and fried licorice are crushed into fine powder and sieved through a 150-mesh sieve;

[0119] Step two, an appropriate amount of honey is prepared, small fire is refined, 117℃ small fire is refined, and until light yellow and lustrous uniform fine bubbles appear, the honey is refined, the fine powder of cassia, processed ginger, angelica, white peony root, and fried licorice is added into the refined honey according to the mass ratio of 1:1.20 of the powder and the refined honey, mixed uniformly, and the honeyed pill (the weight is 0.3g) is prepared to obtain the slow release layer material;

[0120] Step three, chuanxiong, corydalis, and prepared cyperus are soaked in 20 times of water for 60 minutes, decocted three times, the decoction time is 1h, 1h, and 1h respectively, the decoction liquid is combined, filtered, and concentrated under reduced pressure to a thick paste with a relative density of 1.35, and the rapid release layer material (the weight is 0.15g) is obtained;

[0121] Step four, the rapid release layer material is evenly adhered to the surface of the slow release layer material (the mass ratio of the slow release layer to the rapid release layer is 2:1), dried, polished, and the traditional Chinese medicine navel pill (the weight is 0.45g) is obtained, and the navel pill is fixed on the blank navel patch to obtain the traditional Chinese medicine navel patch for relieving dysmenorrhea.

[0122] The blank navel patch adopts a commercially available blank navel patch, and the external fixing material is a material harmless to the human body, and a material for preventing drug liquid leakage is padded around the tablet.

[0123] Comparative example 1

[0124] A prescription of a traditional Chinese medicine navel patch for relieving dysmenorrhea, in terms of mass parts, comprises: cassia 2 parts, processed ginger 10 parts, angelica 12 parts, white peony root 8 parts, and fried licorice 6 parts.

[0125] A preparation method of a traditional Chinese medicine navel patch for relieving dysmenorrhea, comprising the following steps:

[0126] Step one, grind cassia, prepared ginger, angelica, white peony root, and fried licorice into fine powder, and pass through a 120-mesh screen;

[0127] Step two, take an appropriate amount of honey, and prepare it at 117 ℃ with small fire until uniform fine bubbles with light yellow luster appear, which is the prepared medium honey; add the fine powder of cassia, prepared ginger, angelica, white peony root, and fried licorice into the medium honey according to a mass ratio of 1:1.17 of the powder and the medium honey, mix uniformly, and prepare into honey pills (weight: 0.3 g) to obtain the sustained-release layer material;

[0128] Step three, dry and polish the sustained-release layer material to obtain the traditional Chinese medicine navel pill (weight: 0.3 g), and fix the navel pill on a blank navel patch to obtain the traditional Chinese medicine navel patch for relieving dysmenorrhea.

[0129] The blank navel patch is a commercially available blank navel patch, and the external fixing material is a material harmless to the human body and a material for preventing the leakage of medicinal liquid around the medicine tablet.

[0130] Comparative example 2

[0131] A prescription of a traditional Chinese medicine navel patch for relieving dysmenorrhea, comprising, in terms of mass parts, 8 parts of chuanxiong rhizome, 12 parts of corydalis, and 24 parts of prepared cyperus rotundus.

[0132] A preparation method of a traditional Chinese medicine navel patch for relieving dysmenorrhea, comprising the following steps:

[0133] Step one, soak 10 times the amount of water in chuanxiong rhizome, corydalis, and prepared cyperus rotundus for 40 min, and decoct three times with a decocting time of 1 h, 1 h, and 1 h respectively, filter, and combine all the filtrates to reduce pressure and concentrate to obtain a thick paste with a relative density of 1.40, which is the immediate-release layer material (weight: 0.15 g);

[0134] Step two, uniformly adhere the immediate-release layer material to a blank navel patch to obtain the traditional Chinese medicine navel patch for relieving dysmenorrhea.

[0135] The blank navel patch is a commercially available blank navel patch, and the external fixing material is a material harmless to the human body and a material for preventing the leakage of medicinal liquid around the medicine tablet.

[0136] Test example

[0137] The traditional Chinese medicine navel patches obtained in the above examples and comparative examples are used as samples for efficacy testing.

[0138] 1. Experimental method

[0139] 1.1 Construction of a dysmenorrhea mouse model:

[0140] The estradiol benzoate combined with oxytocin was used to prepare the dysmenorrhea mouse model. After 7 days of adaptive feeding, the mice were subcutaneously injected with estradiol benzoate for 10 days (10 mg·kg -1 on the 1st and 10th day, and 5 mg·kg -1 on the 2nd to 9th day). During this period, the blank group was injected with the same amount of distilled water. 10 min after the last administration, oxytocin (20 U·kg -1 ) was injected intraperitoneally to induce dysmenorrhea. The mice were immediately observed for 30 min to see if they had writhing reactions. The number of writhing reactions of the mice except the blank group increased, and the main manifestations were abdominal contraction, inward concave, body distortion, hind limb extension, and hip lifting. The above behaviors were judged as successful modeling.

[0141] 1.2 Animal grouping

[0142] The female non-pregnant mice were randomly divided into 10 groups, 8 mice each, which were blank control group, model group, positive drug group, examples 1-5 group, comparative example 1 group and comparative example 2 group. Among them, the blank group was healthy mice, and the model group was successfully modeled mice without treatment. From the 3rd day to the 10th day of modeling, examples 1-5 group and comparative examples 1-2 group were administered according to the above corresponding process, one dose of prepared navel pill was pasted on the navel every day, and the daily replacement was performed. The positive drug group was administered ibuprofen (200 mg·kg -1 ) every day.

[0143] 2 Index evaluation

[0144] 2.1 Apparent index

[0145] 2.1.1 Animal state

[0146] Before modeling, the mice in each group were in good health, with full spirit, bright hair color and active behavior. After modeling, the mice showed decreased body weight, decreased food and water intake, fluffy and dull hair, pale or purple nail, less movement or restlessness, tongue abdomen, clear urine, and loose stool.

[0147] 2.1.2 Wringing reaction

[0148] 10 min after the last administration, oxytocin (20 U·kg -1 ) was injected intraperitoneally to induce dysmenorrhea. The mice were immediately observed for 30 min to see if they had writhing reactions. The number of writhing reactions of the mice except the blank group increased, and the main manifestations were abdominal contraction, inward concave, body distortion, hind limb extension, and hip lifting. The above behaviors were judged as successful modeling. Figure 1

[0149]

[0150] ​

[0151] Note: vs blank group: #### P<0.0001; vs model group: *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.

[0152] As shown in Table 1 and Figure 1 Fig. 1, except the blank group, the rest of the groups intraperitoneally injected oxytocin within 30 min all occurred writhing reaction, compared with the model group, the number of writhing of mice in Example 1 group, Example 2 group, Example 4 group, Example 5 group and Control Example 2 group was significantly reduced (P<0.05; P<0.001), see Figure 1 A; compared with the model group, the latency of writhing of mice in Example 1 group, Example 2 group, Example 4 group, Example 5 group was significantly increased (P<0.01; P<0.001; P<0.0001), see Figure 1 B. The results suggest that the navel pill has an inhibitory effect on dysmenorrhea in mice, and the effect of relieving and inhibiting dysmenorrhea in Example 2 group is particularly outstanding.

[0153] 2.2 Changes in NO content in uterine tissue of mice

[0154] NO regulates vascular tension, platelet function and pain transmission through cGMP-dependent signaling pathway, and plays a key role in cardiovascular homeostasis and pain regulation. Reduction of NO content is one of the mechanisms of dysmenorrhea. In this embodiment, the NO content of mice is further detected.

[0155] After observing the writhing reaction of the animals, blood samples were collected from the eye sockets; then the blood was treated to separate the serum, and the level of nitric oxide (NO) in the serum was determined according to the instructions of the relevant detection kit, and the results are shown in Table 2 and Figure 2 Fig. 2.

[0156]

[0157]

[0158] Note: vs blank group: #### P<0.0001; vs model group: *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.

[0159] As shown in Table 2 and Figure 2As shown in Table 3 and

[0160] 2.3 Comparison of serum PGF2α levels in each group

[0161] It has been shown that dysmenorrhea is related to the increase of prostaglandin (PGE2 and PGF2α) in the body. During menstruation, endometrial cells synthesize and release prostaglandin, and high levels of prostaglandin, especially PGF2α, are closely related to the occurrence of dysmenorrhea, because it can cause strong contraction of uterine smooth muscle and local ischemia, thereby causing dysmenorrhea symptoms.

[0162] The mice were sacrificed by cervical dislocation, and the uterus was taken out. The 10% uterine tissue homogenate was prepared according to the ratio of 1 g of uterus to 9 mL of physiological saline, and the supernatant was separated by centrifugation at 3000 r / min. The PGF2α level was detected by ELISA according to the operating instructions, and the results are shown in Table 3 and Figure 3 .

[0163] Table 3

[0164]

[0165] Note: vs. blank group:####P<0.0001; vs. model group: *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.

[0166] As shown in Table 3 and Figure 3 the results can be seen that compared with the blank group, the NO content of the model group was significantly reduced (P<0.0001); compared with the model group, the uterine NO level of Example 1 group, Example 2 group, Example 4 group, Example 5 group and Control Example 2 group was significantly increased (P<0.05; P<0.01; P<0.001); which proves that the navel pill patch has the effect of relieving dysmenorrhea, and the effect of Example 2 group is particularly significant.

[0167] Conclusion:

[0168] (1) The navel pill patch of the traditional Chinese medicine composition can inhibit the writhing response of the dysmenorrhea model mice and prolong the writhing latency;

[0169] (2) The navel pill patch of the traditional Chinese medicine composition can increase the NO content, regulate vascular tension, platelet function and pain transmission, and achieve analgesic effect;

[0170] (3) The navel pill patch of the traditional Chinese medicine composition can reduce the serum PGF2α level, thereby inhibiting the strong contraction of uterine smooth muscle and relieving local ischemia, and reducing dysmenorrhea symptoms.

[0171] In summary, the traditional Chinese medicine composition navel pill patch has good effect of relieving dysmenorrhea, and the effect of relieving dysmenorrhea of the traditional Chinese medicine composition navel pill patch in Example 2 is particularly remarkable.

[0172] The above only describes the embodiments of the present application and is not intended to limit the present application. Various modifications and changes can be made to the present application by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the scope of claims of the present application.

Claims

1. A Chinese medicine composition for relieving dysmenorrhea, characterized in that: The traditional Chinese medicine composition comprises: 1-3 parts of cinnamon bark, 3-12 parts of roasted ginger, 6-15 parts of angelica sinensis, 4-9 parts of white peony root, 3-10 parts of roasted liquorice root, 3-12 parts of chuanxiong, 3-12 parts of yanhusuo, and 12-24 parts of processed cyperus rotundus.

2. A method for preparing a Chinese medicine composition for relieving dysmenorrhea, characterized in that: The preparation method comprises the following steps: Step 1: Refining honey into medium honey, adding cinnamon powder, roasted ginger powder, angelica powder, white peony powder, and roasted licorice powder into the medium honey and mixing well to obtain a sustained-release layer material; Step 2: soaking and boiling Chuanxiong, Corydalis yanhusuo and incense preparation in water, filtering to obtain a filtrate, and concentrating under reduced pressure to obtain a quick-release layer material; Step 3: Adhere the quick-release layer material to the surface of the sustained-release layer material to obtain a Chinese medicine composition.

3. The method according to claim 2, characterized in that The sustained-release layer material comprises: 1-3 parts of cinnamon bark, 3-12 parts of roasted ginger, 6-15 parts of angelica sinensis, 4-9 parts of white peony root, and 3-10 parts of roasted licorice root.

4. The method according to claim 2, characterized in that The quick-release layer material comprises: 3-12 parts of Chuanxiong, 3-12 parts of Corydalis yanhusuo, and 12-24 parts of processed Cyperus rotundus.

5. The method according to claim 2, characterized in that In the step 1, the mesh size of the cinnamon powder, roasted ginger powder, angelica powder, white peony root powder and roasted licorice powder is 80-150 mesh.

6. The method according to claim 2, characterized in that In the step 1, the mass ratio of the cinnamon bark powder, roasted ginger powder, angelica powder, white peony root powder and roasted liquorice root powder to the honey is 1:1-1.

2.

7. The method according to claim 2, characterized in that In the step 2, the mass ratio of Chuanxiong, Corydalis yanhusuo, processed Cyperus rotundus to water is 1:(5-20), the soaking time is 10-60 minutes, and the decoction includes three decoctions, the first decoction is 0.5-1 hour, the second decoction is 0.5-1 hour, and the third decoction is 0.5-1 hour. The density of the thick paste after reduced pressure concentration is 1.30-1.

40.

8. The method according to claim 2, characterized in that In the step 3, the mass ratio of the sustained-release layer to the immediate-release layer is (1-2):

1.

9. Use of the Chinese medicine composition according to claim 1 or the method according to claims 2-7 in preparing a medicine for treating and alleviating dysmenorrhea.

10. A medicament for dysmenorrhea comprising the traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine composition prepared by the method according to claims 2-7; preferably, the medicament is an external-use medicament.

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