CN111388634A

CN111388634A - Composition used in combination with fumigation instrument and used for treating dysmenorrhea

Info

Publication number: CN111388634A
Application number: CN201811645670.3A
Authority: CN
Inventors: 郑继宇; 马振元; 周书繁; 苑鹏翀; 杨玉; 汪巍; 李国栋
Original assignee: Liaoning Herbpex Pharmaceutical Group Co ltd
Current assignee: Liaoning Herbpex Pharmaceutical Group Co ltd
Priority date: 2018-12-29
Filing date: 2018-12-29
Publication date: 2020-07-10

Abstract

The invention relates to the field of traditional Chinese medicine extracts, in particular to a composition for treating dysmenorrhea by combining a fumigation instrument. Aiming at the technical problem of fumigation treatment of dysmenorrhea in the prior art, the application is prepared from red ginseng, ginger, folium artemisiae argyi, angelica sinensis, acanthopanax senticosus, ligusticum wallichii, red paeony root, moutan bark, radix ophiopogonis, fructus evodiae, cassia twig, liquorice, fennel, pepper, radix bupleuri, rhizoma cyperi, trogopterus dung, radix achyranthis bidentatae, rhizoma corydalis, caulis spatholobi and other medicines through the processes of extraction, squeezing, nano homogenization and the like. Aiming at the drugs such as radix ophiopogonis, trogopterus dung and folium artemisiae argyi which are not suitable for being added into the medicated bath, the drugs can be added into the medicated bath for treatment through a certain processing technology, the active ingredients of the drugs are retained to the maximum extent, the application efficiency of the drugs is remarkably improved, the prepared nanoemulsion is stable in property, aromatic and comfortable, and the compliance of patients in use is greatly improved.

Description

Composition used in combination with fumigation instrument and used for treating dysmenorrhea

Technical Field

The invention relates to the field of plant extracts, in particular to a preparation method and application of a nanoemulsion dispersion liquid used for treating dysmenorrhea by combining a traditional Chinese medicine fumigation instrument.

Background

Dysmenorrhea, also known as menstrual pain, is one of the common clinical diseases of gynecological diseases. Periodic dysmenorrhea occurs mainly in women's menstrual cycle and is clinically manifested as abdominal cramps accompanied by lower back pain, headache, nausea, vomiting or diarrhea. Drug treatment can produce side effects and cause damage to the patient's body. Dysmenorrhea belongs to the category of abdominal pain during menstruation in Chinese traditional medicine, and the lesion position is in Chong and ren uterus. The pathogenesis is that the patient is influenced by various factors to cause unsmooth thoroughfare and conception vessels, qi stagnation and blood stasis, and pain caused by obstruction.

The fumigation method of traditional Chinese medicine integrates the effects of physiotherapy, massage, medicinal moxibustion, acupoint application and the like, has strong medicine permeability, and can directly reach the focus of a disease through acupoints and channels. Subjective pain perception is reduced as the warm stimulus reduces the excitability of the sensory nerve. Meanwhile, a large amount of traditional Chinese medicine ions are generated in the decoction of the medicine and act on the skin by the ionic characteristic, so that local capillaries are expanded, the blood flow is accelerated, the tissue temperature is raised, the nutrition supply of blood circulation and lymphatic circulation is promoted, and the removal of local metabolic waste, inflammatory exudates and pain-causing substances is accelerated. Thereby relieving the tension pressure of local tissues, relieving the tension of muscles, tendons and ligaments and obtaining good pain relieving effect.

The application of the traditional Chinese medicine fumigation method for treating gynecological chronic diseases has a long history, and the descriptions of 'hot of cold part', 'scattered of stasis', 'visible' and sweat-like 'are available in Huangdi' Nei Jing. The atomized vapor generated by the traditional Chinese medicine vapor therapy apparatus under the physical warming effect of the medicine contains alkaloid, a plurality of amino acids, glycosides, plant antibiotics, tannin, various trace elements and strong volatile oily substances such as aromatic ketone, aldehyde, phenol alcohol and the like, and can directly penetrate into interstitial spaces, viscera and the like through skin, orifices, channels, penetration, absorption, diffusion, radiation and other ways of the whole body to achieve the effects of dispelling wind, dredging collaterals, dispelling cold, relieving pain, resisting inflammation, relieving swelling, reducing phlegm, removing blood stasis, strengthening body resistance, consolidating constitution and the like. Secondly, the balance of yin and yang of the organism can be promoted or adjusted by the dual functions of physical warming and heating of the medicated atomized steam, and the immune function is enhanced; the warming function of the drug-containing atomized steam can adjust the higher nerve center and the whole body physiological process, reduce the excitability of nerve endings, relax smooth muscles and the like, and achieve the effects of relieving pain and the like quickly; the atomized vapor containing medicine has great amount of medicine ions acting on skin for absorption, and the medicine has warming effect, so that the hair follicle and sweat gland of skin are opened, the blood capillary is expanded, the blood flow is accelerated, the tissue temperature is raised, the blood circulation is promoted or accelerated, the metabolism is vigorous, the regeneration capacity of the tissue is accelerated, the phagocytic activity of leucocytes is enhanced, the absorption of inflammation and metabolites is promoted or the absorption of bioactive substances along with the warming effect can make pathogenic toxin go out, or the release of bioactive substances such as 5-hydroxytryptamine, oxygen free radical, histamine, prostaglandin, kininogen and the like is inhibited and reduced, or inflammatory mediators are eliminated or foreign matters are excreted along with sweat, so that the symptoms such as pain and the like are eliminated or improved rapidly. The traditional Chinese medicine is absorbed through skin without wound, thereby avoiding the influence of a plurality of factors such as enzyme, digestive juice, pH value and the like in the gastrointestinal tract of the medicine and the first pass effect of the liver of the medicine, improving the utilization rate of the medicine and reducing the toxic and side effect of the combined application of a plurality of medicines. And the drug effect is quickly exerted, the operation is simple and convenient, the safety is realized, and no adverse reaction is caused.

In the traditional Chinese medicine prescription for treating dysmenorrhea by fumigation, kusnezoff monkshood root and other components are mostly adopted, and the decomposition product of aconitine in the prescription has the paralysis effect on various peripheral nerves and central nerves to obtain the pain-stopping effective component, but chronic poisoning can be caused by long-term use of aconitine. In addition, the fumigation medicine contains volatile oil components which are dissolved out under the action of hot water, but the volatile oil components have poor capability of penetrating through the skin, and the skin surface has heavy sticky feeling after the medicated bath is finished; traditional medicated bath needs to put medicines into hot water to volatilize potency of the medicines, but many medicines cause special properties of the medicines and are not suitable for dissolving out of the hot water, for example, radix ophiopogonis and trogopterus dung are sticky in properties, sticky feeling can be brought after the medicines are dissolved in water, and bad smell can be generated; the inula flower, the oriental wormwood, the acanthopanax and the like have a plurality of villi and small thorns on the surfaces, and the small thorns are scattered in water in hot water and adhered to the skin, and even easily cause scratches and allergy.

Along with the improvement of modern living standard, the demand of people on medicated bath is also improved, the medicated bath has certain advantages for treating dysmenorrhea, the medicine is provided in a form suitable for fumigation, and a medicine formula suitable for treating dysmenorrhea after long-term use is developed, so that the medicated bath has important significance.

Disclosure of Invention

Aiming at the technical problems, the application is to prepare the traditional Chinese medicine nano dispersion bath lotion with the function of treating dysmenorrheal by extracting, squeezing, nano homogenizing and other processes of red ginseng, ginger, folium artemisiae argyi, angelica sinensis, acanthopanax root, ligusticum wallichii, red peony root, moutan bark, radix ophiopogonis, fructus evodiae, cassia twig, liquorice, fennel, pepper, radix bupleuri, rhizoma cyperi, trogopterus dung, radix achyranthis bidentatae, rhizoma corydalis, caulis spatholobi and other medicines. The traditional Chinese medicine nanoemulsion is used with a fumigation instrument for treating the dysmenorrhea, does not need to be taken or injected, and has high use safety. Aiming at the drugs such as radix ophiopogonis, trogopterus dung and acanthopanax senticosus which are not suitable for being added into a medicated bath, the drugs can be added into the medicated bath for treatment through a certain processing technology, the active ingredients of the drugs are retained to the maximum extent, the application efficiency of the drugs is remarkably improved, the prepared nanoemulsion is stable in property and aromatic and pleasant, and the use compliance of patients is greatly improved.

In order to achieve the technical effects, the application provides the following technical scheme:

the invention provides a traditional Chinese medicine composition for treating dysmenorrhea, which comprises the following raw material medicines: red ginseng, ginger, folium artemisiae argyi, acanthopanax, angelica sinensis, ligusticum wallichii, radix paeoniae rubra, moutan bark, radix ophiopogonis, fructus evodiae, cassia twig, liquorice, fennel, pepper, radix bupleuri, rhizoma cyperi, trogopterus dung, radix achyranthis bidentatae, rhizoma corydalis and caulis spatholobi.

Red ginseng: has the effects of invigorating primordial qi, restoring pulse, relieving depletion, invigorating qi, and regulating blood. Ginseng is a tonic drug with many functions such as treatment, health care, nourishing and strengthening the body, and is the most precious natural tonic. Red ginseng is warmer than ginseng, has the characteristics of large and powerful fire and strong efficacy, and is good at tonifying primordial qi, restoring yang and rescuing from collapse, and tonifying qi and controlling blood. Has effects in invigorating qi, nourishing yin, tonifying blood, promoting salivation, tonifying heart, invigorating stomach, tranquilizing mind, and tranquilizing mind. Is a good tonifying product for people with deficiency of qi and blood and yang deficiency. Ginseng radix Rubri contains saponin, polysaccharide, polypeptide, enzyme, microelement, volatile oil, vitamins, amino acids, etc. The traditional medicated bath for treating dysmenorrhea adopts nerve paralysis medicines to relieve pain, and is used for a long time to be unfavorable for health.

Ginger: volatile oil components in the ginger are rich in fragrance, have lemon flavor, have fragrance of fresh flowers, are spicy and thick, have certain physiological activity and skin nutritive value, can play a role in relaxing bodies and nerves, and are beneficial to relieving emotional dysphoria of patients caused by dysmenorrhea. The special gingerol can stimulate gastrointestinal mucosa, promote intestinal congestion, enhance digestion, and relieve abdominal distention, abdominal pain, diarrhea, emesis, etc. caused by cold and cool. Has good relieving effect on soreness of waist and knees, abdominal pain and diarrhea accompanied with dysmenorrhea.

Folium artemisiae argyi: the folium artemisiae argyi has the effects of warming channels, stopping bleeding, dispelling cold, relieving pain, preventing miscarriage and relieving itching, and can regulate qi and blood and expel cold and dampness. The traditional Chinese medicine composition is mainly used for treating irregular menstruation, cold pain in lower abdomen, congealing cold in meridians, miscarriage prevention, killing parasites and relieving itching in clinic and the like. The chemical components of the folium artemisiae argyi mainly comprise volatile oil, flavone, tannin, triterpene, eudesmane, polysaccharide, trace elements and the like. The folium Artemisiae Argyi volatile oil has effects of relieving pain, inhibiting bacteria, enhancing immunity, and killing parasite.

The red ginseng, the ginger and the folium artemisiae argyi are used as monarch drugs, the drugs for consolidating the constitution and consolidating the constitution, tonifying qi and controlling blood, and warming the middle-jiao and dispelling cold are used as monarch drugs, so that the traditional Chinese medicine has a good relieving effect on abdominal pain, diarrhea and vexation and dysphoria during dysmenorrhea, and can be used for a long time without nerve paralysis drugs, so that the injury to the body of a patient is avoided.

Chinese angelica: sweet and mild in taste and warm in nature, and has the effects of enriching and activating blood, regulating menstruation and relieving pain, and relaxing bowel. The angelica volatile oil is one of the main active ingredients of angelica. In contrast research on analgesic and anti-inflammatory effects of angelica essential oil obtained by different extraction processes, scholars such as Wangzhiwang select 60 rats with arthritis as experimental objects, and apply different doses of angelica to treatment of rat joint inflammation, so that the angelica essential oil has obvious analgesic and anti-inflammatory effects, has obvious relieving effects on both acetic acid-induced pain symptoms of mice and oxytocin-induced dysmenorrheal reaction of the mice, and can improve inflammatory reaction caused by xylene and carrageenan. The formula in the application adjusts the dosage of the angelica, and the angelica is used as a ministerial drug to reduce the dosage of the nerve paralysis drug and has good pertinence to pain caused by uterine contraction.

Ligusticum wallichii: has effects in promoting blood circulation, activating qi-flowing, dispelling pathogenic wind, and relieving pain; the main components comprise volatile oil (mainly phthalides), phenolic acids, alkaloids, etc., and the phthalides are the main active components of rhizoma Ligustici Chuanxiong; modern pharmacological research proves that the ligusticum wallichii volatile oil has the effects of improving microcirculation, reducing blood pressure, increasing cerebral blood flow, easing pain, regulating cardiovascular function, resisting coagulation and the like; in addition, researches show that the ligusticum wallichii volatile oil can relieve spasm of capillaries, increase the number of open capillaries, accelerate blood flow speed and depolymerize aggregated erythrocytes, wherein the depolymerization effect of the erythrocytes is particularly obvious and is consistent with the action mechanism of activating blood and dissolving stasis of the ligusticum wallichii.

The cyperus rotundus has the effects of soothing liver, relieving depression, regulating qi, relieving epigastric distention, regulating menstruation and relieving pain, and the main components are volatile oil, flavonoid, terpenes, phenols, alkaloids and other compounds, wherein the content of the cyperus rotundus volatile oil is about 1 percent, the cyperus rotundus volatile oil mainly contains various monoterpenes, sesquiterpenes and oxides thereof and is a main drug effect part of the cyperus rotundus, modern research proves that the cyperus rotundus has the pharmacological effects of resisting bacteria, relieving pain, resisting cancer, reducing blood sugar, resisting ascorbic acid and the like, the main component α -cyperone of the volatile oil has stronger antipyretic and analgesic effects, the analgesic effects of the fresh volatile oil and the volatile oil part on mice are studied by transportation and the like, and compared with a blank group, the cyperus rotu.

Red peony root: bitter taste and slightly cold nature, entering liver meridian, and has effects of clearing heat, cooling blood, removing blood stasis and relieving pain. Peony was originally from Shen nong Ben Cao Jing and listed as a high-quality product.

Moutan bark: cortex moutan has bitter, pungent and slightly cold taste, and has effects of clearing heat, cooling blood, promoting blood circulation and relieving fatigue, and can be used for treating heat entering nutrient blood, warm toxic macula, night heat, morning cool, blood of blood-vomiting girl, anhidrosis, amenorrhea dysmenorrhea, carbuncle, swelling, sore and pain, etc. Modern researches have shown that the pharmacological activity of cortex moutan is mainly focused on paeonol, cortex moutan total glycosides, cortex moutan polysaccharide, etc.

The ophiopogon root has the main effects of nourishing yin, promoting the secretion of saliva or body fluid, moistening lung and clearing heart, and is used for treating dry cough due to lung dryness, tuberculosis cough due to yin deficiency, sore throat, thirst due to body fluid, internal heat, diabetes, vexation, insomnia and constipation due to intestinal dryness.

The radix ophiopogonis contains more polysaccharides, so that the radix ophiopogonis is difficult to break in the preparation process, and the radix ophiopogonis is dissolved in hot water, so that the solution contains more polysaccharides, becomes sticky and is difficult to break. According to the application, the beneficial components of the radix ophiopogonis are prepared into the emulsion after the radix ophiopogonis is crushed by adopting a colloid mill, and the sticky feeling of the dispersion liquid obtained by the preparation is well eliminated, so that the use feeling is improved.

The evodia rutaecarpa has the effects of dispelling cold and relieving pain, calming the adverse-rising energy and preventing vomiting and supporting yang and stopping diarrhea, and is used for treating jueyin headache, cold hernia and abdominal pain, cold-dampness beriberi, menstrual abdominal pain, abdominal distending pain, vomiting and acid regurgitation and diarrhea before dawn, modern researches prove that the main component of the evodia rutaecarpa is various alkaloids and has stronger analgesic effect, the main material base is rutaecarpine which can inhibit the generation of PGD2 and the conversion of exogenous arachidonic acid into PGE2, the evodia rutaecarpa has analgesic effect on writhing reaction caused by acetic acid and has inhibitory effect on the later stage of foot licking behavior but has no influence on the early stage, ② has anti-inflammatory effect, namely the evodia rutaecarpa has an improvement effect on the pain threshold of inflammatory toes but has no influence on the pain threshold of noninflammatory toes, the acetic acid has inhibitory effect on the increase of vascular permeability but has no influence on carrageenan edema, hot plate test pain and motility.

Cassia twig: cassia twig, a dry twig of Cinnamomum cassia Presl of Lauraceae, is pungent and sweet in flavor and warm in nature, and has the effects of dispelling cold, relieving exterior syndrome, warming and dredging channels and collaterals, activating yang and regulating qi. Clinically, it is indicated for wind-cold type common cold, abdominal psychroalgia, amenorrhea due to blood cold, arthralgia, phlegm and fluid retention, edema, palpitation, and galloping. Pharmacological research shows that the cassia twig has various physiological activities of relieving gastrointestinal irritation, strengthening heart, improving microcirculation, resisting inflammation, resisting platelet aggregation and the like. Modern researches also show that the main active substances in the cassia twig are volatile oils, wherein the main component is cinnamaldehyde; further contains organic acids, polysaccharides, coumarins and tannin.

Fennel: pungent flavor and warm nature. It enters liver, kidney, spleen and stomach meridians. Has effects of dispelling cold, relieving pain, regulating qi-flowing and regulating stomach. The salt fructus Foeniculi has effects of warming kidney, dispelling cold, and relieving pain. Can be used for treating cold hernia with abdominal pain, testis tenesmus, dysmenorrhea, cold pain of lower abdomen, abdominal distention and pain, anorexia, vomiting and diarrhea. Modern pharmacological research proves that: fennel has the obvious functions of bacteriostasis, regulating gastrointestinal function, promoting urination, etc. and also has the functions of benefiting gallbladder, protecting liver, resisting cancer, resisting mutation, resisting diabetes, etc. The volatile oil has good broad-spectrum antibacterial effect on food-borne pathogenic bacteria and putrefying fungi, and also has effects of dispelling pathogenic wind, dispelling cold, relieving pain and invigorating spleen, and can be used for treating diseases such as stomach qi weakness distending pain, dyspepsia, lumbago, emesis, etc. In addition, the fennel also has the functions of warming the kidney, dispelling cold, harmonizing the stomach and regulating qi, and also has certain effect on abdominal distension and female dysmenorrhea caused by excessive diet.

Chinese prickly ash: the main components of the composition comprise volatile oil, alkaloid, amide, coumarin, lignin, flavone, triterpene, sterol, hydrocarbon, fatty acid and the like. The pericarpium Zanthoxyli volatile oil and water soluble extract have effects on impulse conduction and excitability of Bufo siccus in vitro sciatic nerve, i.e. reversibly blocking impulse conduction of nerve trunk and reducing excitability of nerve trunk. These effects may be the physiological basis for local anesthesia of zanthoxylum bungeanum. The pricklyash peel volatile oil and the pricklyash peel water-soluble substance have local anesthetic action similar to that of procaine, the action of the water-soluble substance is stronger than that of the volatile oil, and the time required by the 20 percent of pricklyash peel volatile oil and the 20 percent of pricklyash peel water-soluble substance for blocking impulse is close to that of 5 percent of procaine. The anaesthetic effect of zanthoxylum bungeanum may be related to the relaxant effect of the water-soluble alkaloid on the striated muscle. The water extract of fructus Zanthoxyli has analgesic effect.

Bupleurum root: is bitter and pungent in flavor and slightly cold in property, enters liver, gallbladder and lung channels, and has the effects of relieving exterior syndrome, relieving fever, lifting yang qi, dispersing stagnated liver qi, and relieving qi stagnation. Bupleurum root is recorded in Shen nong Ben Cao Jing (Shen nong's herbal): bupleurum root, radix bupleuri, possessing the function of heart and abdomen, removes the pathogenic factors in stomach and intestine, accumulates food and drink, and promotes the aging to become new. It can be taken for a long time to lighten body, improve vision and replenish vital essence. The bupleurum has been widely applied to cold fever, chills fever, chest pain, irregular menstruation, uterine prolapse and the like, and modern pharmacological studies prove that the bupleurum has the effects of relieving fever, calming, easing pain, resisting inflammation, bacteria, enhancing immunity, resisting depression, resisting tumors and the like. Clinical observation shows that the pain level of patients can be reduced by the Bupleurum and Xiaochaihu decoction. Researches of the Dushimin and the like show that the water extract and the ethanol extract of the bupleurum have analgesic effect on an acetic acid writhing experiment; however, in the hot plate experiment, the aqueous extract of bupleurum has analgesic effect, but the ethanol extract has no analgesic effect. Under acidic condition, saikosaponin can generate glycosidic bond and glycogenin when meeting water, and the substance has effect of improving analgesic effect of bupleuri radix.

Trogopterus dung: as a traditional Chinese medicine, trogopterus dung has the effects of promoting blood circulation to remove blood stasis, relieving pain and the like, and is mainly used for treating symptoms such as dysmenorrheal, angina and the like caused by blood stasis. Promoting blood circulation to remove blood stasis, namely promoting blood circulation, promoting blood circulation and dissipating blood stasis. The influence of the cattail pollen-trogopterus dung on the rheological properties of the serum by 2 extracts with different usages is evaluated by indexes such as rat acute blood stasis models, rabbit in-vitro platelet aggregation, blood coagulation time and the like in Zhongwei and Hovenia dulcis et al, and the results show that the extracts can obviously improve the pathological characteristics such as whole blood viscosity, plasma viscosity, blood sedimentation, erythrocyte pressure and the like of the rat acute blood stasis models. The clinical application of the trogopterus dung and other traditional Chinese medicines has some successful examples in the aspects of treating pelvic inflammation, chronic atrophic gastritis, gynecological diseases, metrorrhagia and metrostaxis and the like.

Achyranthes root: it is bitter and sour in taste and neutral in nature. Enters liver and kidney meridians, and has effects of nourishing liver and kidney, strengthening tendons and bones, promoting blood circulation, dredging channels, inducing diuresis, and treating stranguria. It is clinically indicated for amenorrhea, dysmenorrhea, irregular menstruation, traumatic injury, soreness and edema of waist and knees, dysuria, etc. The analgesic effect of different processed achyranthes bidentata products is compared by Lublin and the like by a mouse writhing method and a hot plate method. Different processed products have certain analgesic effect, wherein the effect of radix achyranthis bidentatae processed with wine is strong and lasting. Studies on the anti-inflammatory and antibacterial effects of achyranthes bidentata by Shiyufen and the like find that the antibacterial effect of achyranthes bidentata is not obvious, but has stronger anti-inflammatory and detumescence effects.

Rhizoma corydalis: contains multiple chemical components, mainly tertiary amine and quaternary amine alkaloids, and also contains a large amount of non-alkaloid components. The corydalis tuber has obvious analgesic, sedative and hypnotic effects and has better clinical effects on various diseases such as arrhythmia, gastric ulcer and the like. The alkaloid component is the main component of rhizoma corydalis with analgesic effect. The rhizoma corydalis water extract can effectively weaken acute inflammation and neuropathic pain; the analgesic effect on acute nociceptive pain and neuropathic pain shows remarkable dopamine receptor antagonist property. Wherein the tetrahydropalmatine has stronger analgesic effect than corydaline A. The pain-relieving effect of vinegar-baked corydalis tuber is stronger than that of raw products.

Caulis spatholobi: caulis Spatholobi is a Chinese medicinal material with effects of promoting blood circulation and removing blood stasis, and can enrich blood, promote blood circulation, and dredging collaterals; can be used for treating menoxenia, blood deficiency, sallow complexion, numbness, paralysis, and rheumatalgia. Ancient herbal monograph records that caulis Spatholobi has the effects of removing blood stasis and promoting blood generation, and is called as "Sheng Yao of blood system". Modern pharmacological research also proves that the water extract of the suberect spatholobus stem has the activity of enriching and activating blood.

Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 7-13 parts of red ginseng, 12-17 parts of ginger, 8-11 parts of folium artemisiae argyi, 5-7 parts of acanthopanax, 5-7 parts of angelica sinensis, 5-7 parts of ligusticum wallichii, 5-7 parts of red paeony root, 5-7 parts of moutan bark, 5-7 parts of radix ophiopogonis, 5-7 parts of fructus evodiae, 5-7 parts of cassia twig, 5-7 parts of liquorice, 12-17 parts of fennel, 9-11 parts of pepper, 12-17 parts of radix bupleuri, 9-11 parts of rhizoma cyperi, 9-11 parts of trogopterus dung, 12-17 parts of radix achyranthis bidentatae, 12-17 parts of rhizoma corydalis and 12-17 parts of caulis spatholobi.

Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 8-10 parts of red ginseng, 14-16 parts of ginger, 8-10 parts of folium artemisiae argyi, 5-7 parts of acanthopanax, 5-7 parts of angelica sinensis, 5-7 parts of ligusticum wallichii, 5-7 parts of red peony root, 5-7 parts of moutan bark, 5-7 parts of radix ophiopogonis, 5-7 parts of fructus evodiae, 5-7 parts of cassia twig, 5-7 parts of liquorice, 14-17 parts of fennel, 9-11 parts of pepper, 14-16 parts of radix bupleuri, 9-11 parts of rhizoma cyperi, 9-11 parts of trogopterus dung, 14-16 parts of radix achyranthis bidentatae, 14-16 parts of rhizoma corydalis and 14-16 parts of caulis spatholobi.

The traditional Chinese medicine formula teaches the compatibility of medicines, the collocation of the medicines can influence the embodiment of the final efficacy, the dosage of the medicines can also influence the efficacy of the medicines, and the traditional Chinese medicine composition with the dosage ratio can show good pain relieving effect.

In a second aspect of the invention, a traditional Chinese medicine nanoemulsion for treating dysmenorrhea is provided, and is prepared from the traditional Chinese medicine composition and one or more pharmaceutically acceptable auxiliary materials.

In a third aspect of the present invention, a preparation method of the above traditional Chinese medicine nanoemulsion for treating dysmenorrhea is provided, which comprises the following steps:

(1) crushing Ginseng radix Rubri, adding steamed Ginseng radix water, grinding to obtain Ginseng radix Rubri slurry, adding Ginseng radix volatile oil, and homogenizing to obtain Ginseng radix Rubri nanometer dispersion;

(2) crushing ginger, adding water, grinding, filtering to obtain a slurry, and homogenizing the slurry to obtain a ginger nano dispersion liquid;

(3) directly introducing folium Artemisiae Argyi, radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, ramulus Cinnamomi, fructus Foeniculi, fructus Zanthoxyli, and rhizoma Cyperi into water vapor for extracting volatile oil, collecting volatile oil obtained by distillation to obtain volatile oil A, filtering extractive solution, and concentrating to obtain soft extract A;

(4) taking the folium artemisiae argyi, the angelica sinensis, the ligusticum wallichii, the cassia twig, the fennel, the pepper and the rhizoma cyperi residues which are extracted in the step (3), adding acanthopanax, the red peony root, the moutan bark, the radix ophiopogonis, the evodia rutaecarpa, the liquorice, the radix bupleuri, the trogopterus dung, the achyranthes bidentata, the corydalis tuber and the caulis spatholobi, adding water, extracting for a period of time, filtering to obtain an extracting solution, concentrating to obtain a thick paste B, mixing the two thick pastes A and B, adding the volatile oil A, and homogenizing;

(5) mixing the red ginseng nano dispersion liquid, the ginger nano dispersion liquid and the mixed nano dispersion liquid to obtain the traditional Chinese medicine nano dispersion liquid.

Preferably, in the step (1), the red ginseng rootlets are crushed for a period of time by a chopper mixer, 2-3 times of steamed ginseng water is added, then the mixture is ground by a colloid mill, squeezed and filtered to obtain slurry, the slurry is added with the ginseng volatile oil, and the slurry is treated by a dynamic ultrahigh pressure micro-jet homogenizer to obtain the red ginseng nano dispersion liquid.

Steaming ginseng water is used as a byproduct in the red ginseng cooking process, contains more effective components, and is ground with drug residues after red ginseng crushing, so that the grinding efficiency is higher, and the obtained red ginseng nano dispersion liquid is more stable.

Preferably, in the step (2), ginger is crushed by a chopper mixer, 2-3 times of purified water is added, the mixture is ground by a colloid mill, squeezed and filtered to obtain slurry, and the slurry is treated by a dynamic ultrahigh pressure micro-jet homogenizer to obtain the ginger nano-dispersion.

Further preferably, the crushing time is 2-4 min; the grinding time of the colloid mill is 30-50 min.

In the process of grinding the medicine, the progress of the grinding of the solid particles is continuously reduced, the crushing degree of the plant cells is improved, and the corresponding effective components can be quickly dissolved out in the crushing process. However, ginger contains not only volatile oil components, but also anti-oxidation and easily-deteriorated components such as partial flavone and phenols, and when the crushing time is too long, the corresponding easily-deteriorated components are dissolved out, so that the quality of the dispersion liquid is influenced.

Preferably, in the step (3), the folium artemisiae argyi, the angelica sinensis, the ligusticum wallichii, the cassia twig, the fennel, the pepper and the rhizoma cyperi are directly introduced with water vapor for 5-8 hours to extract volatile oil.

Preferably, in the step (3), the temperature of the water vapor is 100-120 ℃.

Preferably, the folium artemisiae argyi, the angelica sinensis, the ligusticum wallichii, the cassia twig, the fennel, the pepper and the rhizoma cyperi residues extracted in the step (4) are added with acanthopanax, the red peony root, the moutan bark, the ophiopogon japonicus, the evodia rutaecarpa, the liquorice, the radix bupleuri, the trogopterus dung, the achyranthes bidentata, the corydalis tuber and the caulis spatholobi and water for extraction twice, 9-11 times of water is added for the first time for 1-3 hours, and 7-9 times of water is added for the second time for 1-2.

The surfaces of the argyi leaf and the acanthopanax are not suitable for direct hot water soaking due to the small thorns and villi, and the organic acid dissolved out from the medicines can soften the small thorns and the villi in the extraction process by mixing the medicines, so that the components which are easy to cause allergy are prevented from entering the filtrate.

Preferably, the thick paste A in the step (4): and (3) thick paste B: the mixing proportion of the volatile oil A is 1-1.2 g: 2-2.5 g: 0.5-0.6 ml.

The traditional Chinese medicine nano-emulsion is in a mixed state of an oil phase and a water phase, and when the thick paste and the volatile oil are mixed according to a certain proportion, the prepared emulsion is in a stable state.

In a fourth aspect of the present application, a gel preparation for treating dysmenorrhea is provided, wherein the gel preparation is prepared from the nano dispersion liquid and one or more pharmaceutically acceptable auxiliary materials.

Preferably, the gel preparation is prepared from the nano dispersion liquid, carbomer 940, tween-80, glycerol, triethanolamine aqueous solution and water.

Further preferably, the preparation method of the gel preparation is as follows: grinding 2-5g of carbomer 940, 50-160ml of water, 1-5g of tween 80 and 10-30g of glycerol in a mortar for swelling for 2-3h, and mixing uniformly to obtain a transparent product; dropwise adding triethanolamine water solution, neutralizing to obtain transparent gel matrix with pH of 6-7, adding 5-15g nanometer dispersion, and stirring.

In a fifth aspect of the present invention, a combination pack having an effect of treating dysmenorrhea is provided, which comprises the above gel preparation and a nanodispersion, wherein the gel preparation is applied to the lower abdomen before fumigating with the nanodispersion.

Preferably, the gel preparation is applied to the lower abdomen and gently massaged to allow the gel to be absorbed.

According to research of the application, the gel preparation is coated on an affected part, and the nano dispersion emulsion is regularly used for fumigation, so that the conditions of dysmenorrheal and menstrual blood stasis can be effectively relieved.

The invention has the advantages of

1. The application provides a new medicine composition idea aiming at the form of treating dysmenorrhea by medicated bath, and the traditional medicines mostly adopt the components of aconitine, angelica essential oil and the like for relieving pain or inhibiting uterine contraction, so that neurotoxicity can be caused by long-term application. The traditional Chinese medicine composition takes the medicines for strengthening body resistance and reinforcing primordial qi and warming channel and dispelling cold as monarch medicines, on the basis of warming middle-jiao and dispelling cold, relieves stagnation, regulates menstruation and relieves pain, and also comprises the components for calming and relieving restlessness, such as corydalis tuber, ophiopogon root and the like, aiming at the mood depression caused by dysmenorrhea.

2. Aiming at the drugs of dwarf lilyturf tuber, trogopterus dung, folium artemisiae argyi and the like which can bring bad feelings when being added into a medicated bath because of sticky and greasy aqueous solution or fluff, the application provides a form of a nano-emulsion of the drugs, which can reserve the effective components in the drugs to the maximum extent and overcome the bad feelings of the drugs when being applied.

3. The traditional Chinese medicine nano-emulsion prepared by the preparation method has good stability and aromatic and pleasant smell, is applied to medicated bath, effectively reduces the sticky feeling on the surface of the skin, and increases the compliance of a patient in use.

Detailed Description

It should be noted that the following detailed description is exemplary and is intended to provide further explanation of the disclosure. Unless defined otherwise, 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.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.

Steaming ginseng water: water obtained in the process of steaming Ginseng radix to obtain Ginseng radix Rubri is called steamed Ginseng radix water, and contains organic components such as saccharide, saponin, organic acid, protein, and phenols.

As introduced in the background art, aconitine, angelica essential oil and the like are mostly adopted as main analgesic ingredients in the prior art, and are not suitable for long-term use, and in addition, radix ophiopogonis, trogopterus dung, folium artemisiae argyi and the like are not suitable for the traditional medicated bath form due to sticky property or fluff. In view of the above-mentioned defects in the prior art, the present application provides a traditional Chinese medicine composition more suitable for a medicated bath form, the drug of analgesic component is used as ministerial drug or conductant drug, and the drug is taken as a main idea for treating dysmenorrhea by strengthening the basis and consolidating the origin, warming the channel and dispelling cold as a whole. In addition, the medicine is prepared into the form of the nanoemulsion, so that the technical problem that the medicated bath is not suitable for the medicated bath is solved, and the traditional Chinese medicine nanoemulsion prepared by the method has stable property and pleasant smell, and has a good effect when being matched with fumigation for use.

In order to make the technical solutions of the present application more clearly understood by those skilled in the art, the technical solutions of the present application will be described in detail below with reference to specific examples and comparative examples.

Example 1

1) Taking 9g of red ginseng rootlets, crushing by a chopper mixer for 3min, adding 18g of steamed ginseng water, grinding by a colloid mill for 40min, squeezing, filtering to obtain 23.6g of slurry, adding 0.02ml of volatile oil into the slurry, and treating by a dynamic ultrahigh pressure micro-jet homogenizer to obtain the red ginseng nano dispersion liquid.

2) Taking 15g of ginger, crushing for 3min by using a chopper mixer, adding 30g of purified water, grinding for 30min by using a colloid mill, squeezing, filtering to obtain 31.2g of slurry, and treating the slurry by using a dynamic ultrahigh pressure micro-jet homogenizer to obtain the ginger nano dispersion liquid.

3) Taking 9g of folium artemisiae argyi, 6g of angelica sinensis, 6g of ligusticum wallichii, 6g of cassia twig, 6g of fennel, 6g of pepper and 6g of rhizoma cyperi, directly introducing high-temperature water vapor at 120 ℃ to extract volatile oil (the valve opening degree is 0.2 percent), extracting for 6 hours, collecting the volatile oil to obtain 2.5ml of volatile oil for later use, concentrating the extracting solution to 22.5g for later use,

4) adding 6g of acanthopanax, 6g of red paeony root, 6g of tree peony bark, 6g of dwarf lilyturf tuber, 6g of evodia rutaecarpa, 6g of liquorice, 15g of radix bupleuri, 10g of trogopterus dung, 15g of achyranthes root, 15g of corydalis tuber and 15g of suberect spatholobus stem into dregs after volatile oil extraction, adding 10 times of water for the first time, extracting for 2 hours, adding 8 times of water for the second time, extracting for 1.5 hours, concentrating the extracting solution to 53g, mixing the two thick pastes, adding 0.55ml of volatile oil, and treating by using a dynamic ultrahigh pressure micro-jet homogenizer to obtain a mixed.

5) Mixing the obtained Ginseng radix Rubri nanometer dispersion, rhizoma Zingiberis recens nanometer dispersion, and mixed nanometer dispersion to obtain Chinese medicinal nanometer dispersion bath liquid.

Example 2

1) Taking 13g of red ginseng rootlets, crushing for 4min by using a chopper mixer, adding 26g of steamed ginseng water, grinding for 50min by using a colloid mill, squeezing, filtering to obtain 24.7g of slurry, adding 0.03ml of volatile oil into the slurry, and treating by using a dynamic ultrahigh pressure micro-jet homogenizer to obtain the red ginseng nano dispersion liquid.

2) Crushing 17g of ginger by using a chopper mixer for 3min, adding 34g of purified water, grinding by using a colloid mill for 35n, squeezing and filtering to obtain 32.1g of slurry, and treating by using a dynamic ultrahigh-pressure micro-jet homogenizer to obtain the ginger nano dispersion liquid.

3) Taking 10g of folium artemisiae argyi, 7g of angelica sinensis, 7g of ligusticum wallichii, 7g of cassia twig, 7g of fennel, 7g of pepper and 7g of rhizoma cyperi, directly introducing high-temperature water vapor at 100 ℃ to extract volatile oil (the valve opening degree is 0.2 percent), extracting for 8 hours, collecting the volatile oil to obtain 2.8ml of volatile oil for later use, concentrating the extracting solution to 22.8g for later use,

4) adding 6g of acanthopanax, 6g of red paeony root, 6g of tree peony bark, 6g of dwarf lilyturf tuber, 6g of evodia rutaecarpa, 6g of liquorice, 15g of radix bupleuri, 10g of trogopterus dung, 15g of achyranthes root, 15g of corydalis tuber and 15g of suberect spatholobus stem into dregs after volatile oil extraction, adding 11 times of water for the first time, extracting for 2.5 hours, adding 8 times of water for the second time, extracting for 2 hours, concentrating the extracting solution to 54g, mixing the two thick pastes, adding 0.65ml of volatile oil, and treating by using a dynamic ultrahigh pressure micro-jet homogenizer to obtain a mixed.

Example 3

1) Taking 8g of red ginseng rootlets, crushing for 2min by using a chopper mixer, adding 16g of steamed ginseng water, grinding for 35min by using a colloid mill, squeezing, filtering to obtain 23.8g of slurry, adding 0.02ml of volatile oil into the slurry, and treating by using a dynamic ultrahigh pressure micro-jet homogenizer to obtain the red ginseng nano dispersion liquid.

2) Crushing 12g of ginger by using a chopper mixer for 3min, adding 24g of purified water, grinding for 29min by using a colloid mill, squeezing and filtering to obtain 30.8g of slurry, and treating by using a dynamic ultrahigh-pressure micro-jet homogenizer to obtain the ginger nano dispersion liquid.

3) Directly introducing high temperature water vapor of 105 deg.C into folium Artemisiae Argyi 10, radix Angelicae sinensis 5g, rhizoma Ligustici Chuanxiong 5g, ramulus Cinnamomi 5g, fructus Foeniculi 5g, fructus Zanthoxyli 5g, and rhizoma Cyperi 5 to extract volatile oil (valve opening degree 0.2%), extracting for 6 hr, collecting volatile oil to obtain volatile oil 2.5ml, concentrating the extractive solution to 22.1g,

4) adding 5g of acanthopanax, 5g of red peony root, 5g of moutan bark, 5g of dwarf lilyturf tuber, 5g of evodia, 5g of liquorice, 14g of radix bupleuri, 8g of trogopterus dung, 14g of achyranthes root, 12g of corydalis tuber and 14g of suberect spatholobus stem into the dregs after volatile oil extraction, adding 10 times of water for the first time, extracting for 2.5 hours, adding 8 times of water for the second time, extracting for 2 hours, concentrating the extracting solution to 51g, mixing the two thick pastes, adding 0.58ml of volatile oil, and treating by using a dynamic ultrahigh pressure micro-jet homogenizer to obtain a mixed nano dispersion liquid.

Example 4

Grinding 5g of carbomer 940, 160ml of water, 5g of tween 80 and 30g of glycerol in a mortar for swelling for 3 hours, and fully and uniformly mixing to obtain a transparent product; and dropwise adding triethanolamine aqueous solution, neutralizing to obtain a transparent gel matrix with the pH value of 7, adding 15g of the traditional Chinese medicine nano dispersion liquid in the embodiment 1, and uniformly stirring to obtain the traditional Chinese medicine nano dispersion gel for relieving dysmenorrheal.

Example 5

2g of carbomer 940, 50ml of water, 1g of tween 80 and 10g of glycerol are taken to be ground and swelled in a mortar for 2 hours, so that the carbomer 940, the water and the tween 80 are fully and uniformly mixed and are transparent; and dropwise adding triethanolamine aqueous solution, neutralizing to obtain a transparent gel matrix with pH of 6, adding 5g of the traditional Chinese medicine nano dispersion liquid in the embodiment 1, and uniformly stirring to obtain the traditional Chinese medicine nano dispersion gel for relieving dysmenorrhea.

Example 6

3g of carbomer 940, 110ml of water, 2g of tween 80 and 15g of glycerol are taken to be ground and swelled in a mortar for 2.8 hours, so that the carbomer 940, the water, the tween 80 and the glycerol are fully and uniformly mixed and are transparent; and dropwise adding triethanolamine aqueous solution, neutralizing to obtain a transparent gel matrix with the pH value of 6.8, adding 14g of the traditional Chinese medicine nano dispersion liquid in the embodiment 1, and uniformly stirring to obtain the traditional Chinese medicine nano dispersion gel for relieving dysmenorrheal.

Example 7

The process route comprises the following steps:

1. directly extracting volatile oil from folium Artemisiae Argyi, radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, ramulus Cinnamomi, fructus Foeniculi, fructus Zanthoxyli and rhizoma Cyperi by steam extraction, collecting volatile oil, filtering medicinal liquid, and collecting residue.

2. Mixing the residues of the 1 items with acanthopanax, red peony root, tree peony bark, dwarf lilyturf tuber, evodia rutaecarpa, liquorice, radix bupleuri, trogopterus dung, achyranthes root, corydalis tuber and suberect spatholobus stem, extracting twice, adding 10 times of water for the first time, extracting for 2 hours, adding 8 times of water for the second time, and extracting for 1.5 hours. Filtering the extractive solution, mixing with the medicinal liquid of item 1, concentrating to obtain soft extract, adding the volatile oil of item 1, and homogenizing with dynamic ultrahigh pressure micro-jet homogenizer to obtain mixed nanometer dispersion.

3. Crushing Ginseng radix Rubri fibrous root, adding steamed Ginseng radix water, grinding, squeezing, filtering, centrifuging to obtain Ginseng radix Rubri fibrous root slurry, adding appropriate amount of volatile oil collected during steaming Ginseng radix Rubri, and homogenizing with dynamic ultrahigh pressure micro jet homogenizer to obtain Ginseng radix Rubri nanometer dispersion;

4. crushing ginger, adding water, grinding, squeezing, filtering and centrifuging to obtain ginger slurry, and homogenizing by using a dynamic ultrahigh-pressure micro-jet homogenizer to obtain ginger nano dispersion liquid;

5. mixing the nanometer dispersion solutions according to a certain proportion to obtain the medicine for treating dysmenorrhea.

Secondly, screening of the preparation process:

1. examining the extraction mode of red ginseng:

taking red ginseng fibrous roots, chopping and mixing by a chopper mixer, adding 6 times of water, extracting for 2 hours, adding 4 times of water for the second time, extracting for 2 hours, combining the obtained extracting solutions, filtering, and filtering to obtain the extracting solution for later use.

Taking red ginseng fibrous roots, chopping and mixing the fibrous roots by a chopper mixer, adding 10 times of pure water, grinding the mixture for 60 minutes by a colloid mill, centrifuging the mixture for 30 minutes to obtain slurry for later use, squeezing the dregs of a decoction by a squeezer, combining the obtained slurry, filtering the combined slurry, and filtering the filtered slurry for later use.

Extraction method	Total saponins yield (%)	Total saponins transfer rate (%)
			Extraction of	0.38	68.77
Beating	0.45	82.05

And (4) conclusion: the experimental result shows that the total saponin yield and the transfer rate are taken as indexes, and the total saponin yield and the transfer rate of the ginseng in the pulping process are obviously higher than those in the traditional extraction process, so the pulping and squeezing process is selected as the extraction mode, and the parameters are further optimized and screened.

2. Inspecting the ginger extraction mode:

taking ginger, chopping and mixing the ginger by a chopper mixer, adding 6 times of water for extraction for 2 hours, adding 4 times of water for the second time for extraction for 2 hours, combining the obtained extracting solutions, filtering, and filtering to obtain the extracting solution for later use.

Taking ginger, chopping and mixing the ginger by a chopper mixer, adding 10 times of pure water, grinding the mixture for 60 minutes by a colloid mill, centrifuging the mixture for 30 minutes to obtain slurry for later use, squeezing the decoction dregs by a squeezer, combining the obtained slurry, filtering the slurry, and filtering the filtered slurry for later use.

Extraction method	Yield of gingerol (%)	Yield of volatile oil (%)
			Extraction of	0.26	0.11
Beating	0.43	0.35

And (4) conclusion: the experimental result shows that the yield of gingerol and volatile oil is used as an index, and the yield of total ginsenoside and volatile oil in the pulping process is obviously higher than that in the traditional extraction process, so the pulping and squeezing process is selected as the extraction mode, and the parameters are further optimized and screened.

3. Investigation of grinding time and water addition

The water adding amount and the grinding time during grinding are considered: the optimal water addition amount and grinding time are respectively inspected by taking the contents of the total ginsenoside and the gingerol as indexes.

3.1 red ginseng grinding time and water addition amount investigation:

note: the grinding effect of 1 time of water is also investigated in the experiment, but the consistency is too high, the colloid mill can discharge materials in a circulating way, and the grinding is not sufficient by naked eyes, so that the important investigation is not carried out.

And (4) conclusion: taking the yield and the transfer rate of the total ginsenoside as indexes, the difference of experiments 6, 7 and 8 is small, the production cost and the grinding effect are considered, and the experiment 6 is selected, namely 2 times of the raw material amount of water is added, and the grinding is carried out for 40 min.

3.2 inspecting the grinding time and water addition amount of the ginger:

And (4) conclusion: taking gingerol and volatile oil yield as indexes, experiments 5 and 6 have small difference, taking into account production cost and grinding effect, selecting experiment 5, namely adding 2 times of water of raw material amount, grinding for 30min

4. Inspecting the time for extracting volatile oil by directly introducing steam into folium artemisiae argyi, angelica sinensis, ligusticum wallichii, cassia twig, fennel, pepper and rhizoma cyperi

And (4) conclusion: the yield of the volatile oil is taken as an index, the yield of the volatile oil is gradually improved along with the increase of time, the content of the volatile oil is slowly increased from 6 hours to 8 hours and 10 hours, and the time for extracting the volatile oil by direct steam is selected to be 6 hours from the production cost.

5. Examination of 18-flavor water extraction conditions of folium artemisiae argyi, angelica sinensis and the like:

and (4) conclusion: extracting for 2 times from the consideration of production cost, yield and tetrahydropalmatine content

The optimal extraction process comprises adding 10 times of water for extraction for 2 hr, adding 8 times of water for extraction for 1.5 hr

6. Nano dispersion process research:

the Chinese medicinal extract or serous fluid and volatile oil obtained by extraction or squeezing need to be homogenized to obtain Chinese medicinal nanometer dispersion bath lotion with stable property and high bioavailability.

6.1 parameters are preferably: the pressure and the number of homogenization are considered, the pressure of the ultrahigh-pressure micro-jet homogenizer is 40 MPa, the pressure of the ultrahigh-pressure micro-jet homogenizer is 80MPa, the number of homogenization is 2, 4, 6 and 8, and the particle size of the homogenized emulsion is observed by a microscope.

6.2 conclusion:

(1) effect of number of homogenizers on particle size: the particle size of the liquid drops is reduced along with the increase of the homogenization times from the whole trend, the particle size of the liquid drops is basically minimized after 6 times of homogenization, and the particle size is not obviously changed after more than 6 times of homogenization, and shows fluctuation change in a small range. From this, it is not necessarily the case that the emulsion prepared with a larger number of homogenization times has a better quality and a smaller particle size. Excessive times waste resources and exacerbate wear on the homogenizing valve spool and the homogenizing ring. The number of homogenisations was chosen to be 6.

(2) Effect of homogenization pressure on droplet size: when the pressure is less than 80MPa, the particle size decreases with the increase of the pressure, and when the pressure is more than 80MPa, the larger the homogenizing pressure is, the larger the particle size liquid is. Therefore, the homogenization pressure was 80 MPa.

Third, product evaluation

The intuitive property and the use comfort level of the product are adopted as indexes, and the nanoemulsion bath lotion is compared with the bath lotion prepared by the traditional method.

The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Fourth, application

The method is used for trial in a health-care shop, 15 female subjects with blood stasis physique, dysmenorrhea and abdominal discomfort are invited, 0.5g of nano-dispersion gel is smeared on the lower abdomen, gentle massage is carried out to enable the gel to be absorbed quickly, 15g of nano-dispersion medicine bath liquid is poured into a fumigation instrument, then fumigation is carried out in a traditional Chinese medicine fumigation cabin for 15-30min, once every 2-3 days (fumigation is not carried out in the menstrual period), after 30 days, comprehensive scoring is carried out on the traditional Chinese medicine nano-dispersion gel and the nano-dispersion medicine bath liquid, the skin comfort degree in the fumigation process, the dysmenorrhea relieving condition after fumigation and the improvement condition of menstrual blood stasis are respectively scored, 100 scores are full, one highest score is removed from each score, one lowest score is removed, and the average value is calculated to be the final score. The results are shown in the following table.

And (4) conclusion:

as can be seen from the above table, the nano-dispersion traditional Chinese medicine bath lotion can relieve dysmenorrheal and reduce blood stasis in menstrual period, and the nano-dispersion traditional Chinese medicine bath lotion has good skin comfort in use.

The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. The traditional Chinese medicine composition for treating dysmenorrhea is characterized by comprising the following raw material medicines: radix Ginseng Rubra, rhizoma Zingiberis recens, folium Artemisiae Argyi, radix Acanthopanacis Senticosi, radix Angelicae sinensis, rhizoma Ligustici Chuanxiong, radix Paeoniae Rubra, cortex moutan, radix Ophiopogonis, fructus evodiae, ramulus Cinnamomi, Glycyrrhrizae radix, fructus Foeniculi, fructus Zanthoxyli, bupleuri radix, rhizoma Cyperi, Oletum Trogopterori, Achyranthis radix, rhizoma corydalis, and caulis Spatholobi; preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 7-13 parts of red ginseng, 12-17 parts of ginger, 8-11 parts of folium artemisiae argyi, 5-7 parts of acanthopanax, 5-7 parts of angelica sinensis, 5-7 parts of ligusticum wallichii, 5-7 parts of red paeony root, 5-7 parts of moutan bark, 5-7 parts of radix ophiopogonis, 5-7 parts of fructus evodiae, 5-7 parts of cassia twig, 5-7 parts of liquorice, 12-17 parts of fennel, 9-11 parts of pepper, 12-17 parts of radix bupleuri, 9-11 parts of rhizoma cyperi, 9-11 parts of trogopterus dung, 12-17 parts of radix achyranthis bidentatae, 12-17 parts of rhizoma corydalis and 12-17 parts of caulis spatholobi.

2. The traditional Chinese medicine composition for treating dysmenorrhea according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw medicines in parts by weight: 8-10 parts of red ginseng, 14-16 parts of ginger, 8-10 parts of folium artemisiae argyi, 5-7 parts of acanthopanax, 5-7 parts of angelica sinensis, 5-7 parts of ligusticum wallichii, 5-7 parts of red peony root, 5-7 parts of moutan bark, 5-7 parts of radix ophiopogonis, 5-7 parts of fructus evodiae, 5-7 parts of cassia twig, 5-7 parts of liquorice, 14-17 parts of fennel, 9-11 parts of pepper, 14-16 parts of radix bupleuri, 9-11 parts of rhizoma cyperi, 9-11 parts of trogopterus dung, 14-16 parts of radix achyranthis bidentatae, 14-16 parts of rhizoma corydalis and 14-16 parts of caulis spatholobi.

3. A traditional Chinese medicine nanoemulsion for treating dysmenorrhea, which is prepared from the traditional Chinese medicine composition of any one of claims 1-2 and one or more pharmaceutically acceptable auxiliary materials.

4. The method for preparing a traditional Chinese medicine nanoemulsion according to claim 3, comprising the following steps:

5. The method according to claim 4, wherein in the step (1), the red ginseng rootlets are crushed for a period of time by a chopper mixer, 2 to 3 times of steamed ginseng water is added, then the ground ginseng rootlets are ground by a colloid mill, pressed and filtered to obtain a slurry, the volatile oil of the ginseng is added to the slurry, and the slurry is treated by a dynamic ultrahigh pressure micro-jet homogenizer to obtain the red ginseng nano-dispersion.

6. The preparation method according to claim 4, wherein the ginger in the step (2) is crushed by a chopper mixer, 2-3 times of purified water is added, the mixture is ground by a colloid mill, squeezed and filtered to obtain slurry, and the slurry is treated by a dynamic ultrahigh pressure micro-jet homogenizer to obtain ginger nano-dispersion; preferably, the crushing time is 2-4 min; the grinding time of the colloid mill is 30-50 min.

7. The preparation method according to claim 4, wherein in the step (3), the folium artemisiae argyi, the angelica sinensis, the ligusticum wallichii, the cassia twig, the fennel, the pepper and the rhizoma cyperi are directly introduced with water vapor for 5-8 hours to extract volatile oil; preferably, the temperature of the water vapor is 100-.

8. The preparation method of claim 4, wherein the folium artemisiae argyi, the angelica sinensis, the ligusticum wallichii, the cassia twig, the fennel, the pepper and the rhizoma cyperi residues which are extracted in the step (4) are added with acanthopanax, the red peony root, the moutan bark, the radix ophiopogonis, the evodia rutaecarpa, the liquorice, the radix bupleuri, the trogopterus dung, the achyranthes bidentata, the corydalis tuber and the caulis spatholobi and are extracted with water twice, 9-11 times of water is added for the first time for 1-3 hours, and 7-9 times of water is added for the second time for 1-2 hours; preferably, the thick paste A in the step (4): and (3) thick paste B: the mixing proportion of the volatile oil A is 1-1.2 g: 2-2.5 g: 0.5-0.6 ml.

9. A gel preparation for treating dysmenorrhea, which is prepared from the nanodispersion solution according to claim 3 and one or more pharmaceutically acceptable adjuvants; preferably, the gel preparation is prepared from the nano dispersion liquid, carbomer 940, tween-80, glycerol, triethanolamine aqueous solution and water; or the gel formulation of claim 9, prepared by the following process: grinding 2-5g of carbomer 940, 50-160ml of water, 1-5g of tween 80 and 10-30g of glycerol in a mortar for swelling for 2-3h, and mixing uniformly to obtain a transparent product; dropwise adding triethanolamine water solution, neutralizing to obtain transparent gel matrix with pH of 6-7, adding 5-15g nanometer dispersion, and stirring.

10. A combination pack for treating dysmenorrhea, which comprises the gel preparation of claim 9 and the nanodispersion of claim 3, and is applied to an affected part before fumigating the affected part.