A uterus warming patch and its manufacturing process

Abstract

The present application provides a warming uterus patch and its manufacturing process, which relates to the field of pharmaceutical technology. A warming uterus patch includes: angelica, chuanxiong, red peony root, pollen, aconite, corydalis, myrrh, cinnamon, dried ginger, fennel, wormwood, chuanlianzi, safflower, eucommia and licorice. The warming uterus patch of the present application has the effects of promoting blood circulation and removing blood stasis, warming the meridians and relieving pain, and is mainly used for abdominal pain caused by cold blood stasis in the lower abdomen, which is relieved by warmth; menstrual blood clots, pain under the clots is reduced; the lower abdomen is cold, and warmth is preferred; menstruation is scanty and dark in color; dysmenorrhea, infertility and other symptoms caused by cold blood stasis. The manufacturing process of the present application prepares the patch by crushing the raw materials into nanopowders, so that the bioavailability of the active ingredients of the drug in the patch is high, which is conducive to the percutaneous absorption of the drug, so that the patch takes effect faster, the efficacy is better, and the therapeutic effect is effectively guaranteed.

Description

Technical Field

[0001] The present application relates to the field of pharmaceutical technology, and in particular to a uterine warming patch and a manufacturing process thereof. Background Art

[0002] Dysmenorrhea is one of the most common gynecological diseases in women. Modern medicine believes that the occurrence of dysmenorrhea is related to autonomic dysfunction and prostaglandin release. Traditional Chinese medicine believes that the location of dysmenorrhea is in the uterus and Chong and Ren meridians, and the main pathogenesis is "pain due to obstruction" or "pain due to lack of nourishment". Clinically, abdominal pain during menstruation is mostly caused by cold syndrome and blood stasis syndrome. The treatment of this disease is to warm the meridians and dispel cold, promote blood circulation, and remove blood stasis and relieve pain. Modern pharmacological studies have confirmed that Shaofu Zhuyu Decoction can significantly reduce uterine swelling in rats caused by plastic tubes, and also has a significant inhibitory effect on subcutaneous granulomas in rats caused by cotton balls, suggesting that it has an anti-inflammatory effect. In clinical application, according to the different symptoms of dysmenorrhea, the amount of medicine is increased or decreased according to the symptoms, and the dosage is flexibly adjusted. The combination of various medicines can achieve the effects of warming the meridians and dispelling cold, promoting blood circulation and removing blood stasis, promoting qi and relieving pain, so that the cold can be warmed, the blood stasis can be transformed, and the cause of the disease is removed. Then the meridians and qi and blood can flow smoothly, and the blood and qi of Chong, Ren and uterus can be harmonized. When the flow is smooth, there will be no pain, and there will be no risk of the symptoms recurring cyclically with menstruation.

[0003] At present, there are traditional Chinese medicine decoctions, granules, pills, capsules and plaster preparations in the market. Decoctions can be added or subtracted according to symptoms, which can give full play to the comprehensive efficacy and characteristics of multiple ingredients in prescriptions, and work quickly, but they need to be prepared and taken immediately, and they are prone to mold and deterioration after being left for a long time, have a poor taste, and are complicated to decoct, which is inconvenient to carry. Granules maintain the traditional decoction basis, overcome the difficulties in decoction of traditional Chinese medicine, and are more convenient to carry, store and take than liquid preparations, but they are expensive, easy to deliquesce, have poor mixing performance and easy to stratify when taken with water, and have a high frequency of taking and poor taste. Pills dissolve and release slowly, which can prolong the efficacy, reduce toxicity and irritation, reduce adverse reactions, and are easy to carry, but they are inconvenient to take, and improper production operations can easily cause dissolution and slow disintegration, poor taste, and difficulty in swallowing. Although capsules can cover up the special smell of drugs, improve the stability of drugs, are relatively low in price, and have a fast onset of action and are portable, they have the phenomenon of difficulty in swallowing and a high frequency of taking. Summary of the invention

[0004] The purpose of the present application is to provide a uterus warming patch, which has the effects of promoting blood circulation, removing blood stasis, warming the meridians and relieving pain. It is mainly used for abdominal pain caused by cold blood stasis in the lower abdomen, which is relieved by warmth; menstrual blood clots, and pain under the clots is relieved; the lower abdomen is cold, and warmth is preferred; scanty menstruation with dark color; dysmenorrhea, infertility and other symptoms caused by cold blood stasis.

[0005] Another purpose of the present application is to provide a production process for a uterine warming patch, in which the raw materials are crushed into nanopowders to prepare a patch, so that the bioavailability of the active ingredients of the drug in the patch is high, which is beneficial to the percutaneous absorption of the drug, making the patch take effect faster and have better efficacy, thereby effectively ensuring the therapeutic effect.

[0006] The present application solves the technical problem by adopting the following technical solution.

[0007] The present application proposes a uterus warming patch, which includes the following raw materials by weight: 6-15 parts of angelica, 6-15 parts of chuanxiong, 3-10 parts of red peony root, 5-15 parts of pollen, 5-10 parts of aconite, 5-20 parts of yanhusuo, 6-10 parts of myrrh, 3-9 parts of cinnamon, 3-9 parts of dried ginger, 5-15 parts of fennel, 5-20 parts of mugwort, 5-10 parts of toosendan, 3-10 parts of safflower, 5-15 parts of eucommia and 3-9 parts of licorice.

[0008] The present application proposes a manufacturing process of a uterine warming patch, comprising the following steps:

[0009] The raw materials are crushed by ultrafine nanometer to obtain nano powder; Vaseline is heated into liquid, the Vaseline liquid and the nano powder are stirred and mixed, cooled to obtain ointment, the ointment is added to the blank non-woven fabric patch, and the blank non-woven fabric patch with the ointment added is covered with paper and stored in a refrigerator.

[0010] The embodiments of the present application have at least the following beneficial effects:

[0011] In this application, the warm palace patch has the effects of promoting blood circulation and removing blood stasis, warming meridians and relieving pain. The drug is absorbed into the internal organs and meridians through the local skin transdermal absorption, avoiding the decomposition of the liver and gastrointestinal tract and fully improving the utilization of the drug. In the square, Angelica, Chuanxiong, Pollen Typhae, and Ophiopogon japonicus are the main drugs, which have the effect of promoting blood circulation and removing blood stasis and relieving pain; Cinnamon, dried ginger, fennel, and Artemisia argyi are the ministerial drugs, which have the effect of warming the palace and relieving pain, and safflower is the ministerial drug, which can strengthen the merit of promoting blood circulation and removing blood stasis of the main drug; Corydalis and Toosendan are adjuvants, which can promote qi and relieve pain, and strengthen the analgesic properties of the main drug and ministerial drug; Myrrh is an adjuvant, which can promote blood circulation and relieve pain, and strengthen the analgesic effect; Red peony root is an adjuvant, which can promote blood circulation and remove blood stasis, and prevent the various drugs from being too warm; Eucommia ulmoides is an adjuvant, which is sweet and warm to tonify the kidney, strengthen the waist and relieve pain, and strengthen the property of warming and tonifying; Licorice is a messenger drug, which harmonizes various drugs, and dense roasting can enhance the merit of tonic. The prescription is properly matched, the dosage is accurate, and the clinical efficacy is very significant. It is made into a paste acupoint patch to treat some chronic and refractory diseases. It is especially suitable for female patients with frequent dysmenorrhea. In addition, acupoint patch therapy has a long history of development, a wide range of applications, clear clinical efficacy, safety and reliability, stable medicinal properties, no special odor, easy storage, easy to carry and low cost.

[0012] In the present application, the raw material is crushed into nano powder to form a patch with good absorption performance and high bioavailability, which can be used for long-term treatment or adjuvant treatment of chronic and recurrent dysmenorrhea, making up for the shortcomings of bitter taste, high price and difficulty in decocting Chinese medicine decoction, giving play to the advantages of Chinese medicine acupoint patch, making full use of the drug, maximizing the efficacy, and ensuring the effectiveness of treatment. Solid lipid nanoparticles do not use high-concentration surfactants in their preparation process, can form a film on the skin surface, promote drug absorption through epidermal hydration after local sealing, and increase the contact time and area of ​​the drug with the stratum corneum, thereby facilitating drug percutaneous absorption. DETAILED DESCRIPTION

[0013] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to the conventional conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0014] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present application will be described in detail below with reference to specific embodiments.

[0015] The syndrome of cold and blood stasis in the lower abdomen is blood stasis in the lower abdomen. The lower abdomen includes the liver and kidney. Due to the dysfunction of the liver and kidney, cold stagnation of qi, poor drainage, and blood stasis, blood stasis in the lower abdomen, the symptoms are pain in the lower abdomen, or irregular menstruation and other diseases. The treatment principle is to promote blood circulation and remove blood stasis, regulate qi and relieve pain, and nourish the kidney. The prescription is as follows.

[0016] A uterus warming patch comprises the following raw materials by weight: 6-15 parts of angelica sinensis, 6-15 parts of ligusticum chuanxiong, 3-10 parts of red peony root, 5-15 parts of pollen typhae, 5-10 parts of aconiti lobata, 5-20 parts of yanhusuo, 6-10 parts of myrrh, 3-9 parts of cinnamon bark, 3-9 parts of dried ginger, 5-15 parts of fennel, 5-20 parts of wormwood leaf, 5-10 parts of toosendan fruit, 3-10 parts of safflower, 5-15 parts of eucommia bark and 3-9 parts of liquorice.

[0017] Angelica sinensis belongs to the liver, heart and spleen meridians. It nourishes blood, invigorates blood circulation and regulates menstruation. It is often used with white peony root, cooked rehmannia root, chuanxiong, cyperus rotundus, white peony root, astragalus, etc. Angelica sinensis has a significant effect of inhibiting platelet aggregation, which can reduce blood viscosity, plasma fibrinogen, prolong prothrombin time, and shorten the electrophoresis time of red blood cells and platelets. The ferulic acid in angelica sinensis can inhibit the action of TXA2 synthase, and can also prevent arachidonic acid on the membrane from being freed from phospholipids by inhibiting phospholipase A2, thereby blocking the production of PGs such as TAX2; it can increase the level of platelet cAMP and inhibit the activity of phosphodiesterase to inhibit platelet aggregation.

[0018] Chuanxiong belongs to the liver, gallbladder and pericardium meridians. It can promote blood circulation and qi, dispel wind and relieve pain. It is used to treat irregular menstruation, dysmenorrhea, amenorrhea, postpartum abdominal pain and retained placenta caused by blood stasis and qi stagnation. This product is an important medicine for regulating menstruation in gynecology, and is often used together with Angelica sinensis, White Peony Root, Cyperus rotundus, etc. It is often used together with Bupleurum chinense and Corydalis yanhusuo for chest and flank pain caused by liver depression and qi stagnation. It is often used in combination with Salvia miltiorrhiza and Red Peony Root for coronary heart disease and angina pectoris. Chuanxiong is the first medicine for blood circulation and blood stasis, which is specially used to treat blood stasis in the heart and forms thrombus. The effective ingredients of Chuanxiong mainly include four categories of ingredients: phthalides (ligustilide, butylphthalide, ligustilide A, I, J), phenolic acids (ferulic acid, coniferyl ferulate), alkaloids (ligustrazine), and polysaccharides. Among them, ligustilide has the effects of prolonging prothrombin time, anti-platelet aggregation, and relaxing uterine and tracheal smooth muscles; ferulic acid has the effects of prolonging prothrombin time and replenishing blood; and ligustrazine has the effect of promoting blood circulation and removing blood stasis.

[0019] Red peony root is slightly cold in nature and bitter in taste. It enters the liver meridian and spleen meridian, clears away heat and cools blood, disperses blood stasis and relieves pain. It belongs to the heat-clearing and cooling blood medicine under the category of heat-clearing medicines. It contains paeoniflorin, neopeoniflorin, red peony root A, red peony root B, palmitic acid, dihydroapigenin, paeonol glycoside, red peony root, β-sitosterol, camphor hydrocarbons, vanillic acid, vanillic acid, etc.

[0020] Pollen Typhae, with a flat nature and sweet taste, belongs to the liver meridian and the heart meridian, stops bleeding, dissipates blood stasis and relieves stranguria, and belongs to the blood stasis dissipating and hemostatic drugs under the hemostatic drug classification, mainly containing flavonoids and steroid components. This product has the effects of improving myocardial microcirculation, lowering blood lipids, resisting atherosclerosis, and promoting blood coagulation, exciting uterine smooth muscle, having a spasmolytic effect on intestinal smooth muscle, inhibiting cellular immunity and humoral immunity, and having anti-inflammatory, antibacterial, antiallergic, and hemolytic effects. It can stop bleeding and dissipate blood stasis, and has the characteristics of stopping bleeding without leaving blood stasis, and is suitable for bleeding diseases and signs of blood stasis and blood not flowing through the meridians. In addition, it is light and stagnant, can promote blood circulation and relieve menstruation, and eliminate blood stasis and relieve pain.

[0021] Wulingzhi is warm in nature, salty and sweet in taste, and belongs to the liver meridian. It can promote blood circulation and relieve pain, dissipate blood stasis and stop bleeding, eliminate stagnation and detoxify, and promote qi. It is a blood-activating and analgesic drug under the category of blood-activating and stasis-removing drugs. It contains a large amount of resin, urea, uric acid and vitamin A substances. It is mainly used to treat pain caused by blood stasis in the heart and abdomen, dysmenorrhea, amenorrhea caused by blood stasis, and abdominal pain caused by postpartum blood stasis. This product has antibacterial and anti-inflammatory effects, inhibits platelet aggregation and anti-thrombotic effects, can improve cardiovascular system and microcirculation disorders, and enhance the ability to resist stress damage and the activity of superoxide dismutase.

[0022] Yanhusuo, belongs to the liver, spleen, and heart meridians, promotes blood circulation and dissipates blood stasis, promotes qi and relieves pain. This product is pungent, dispersing, warming, and can "promote qi stagnation in the blood, blood stagnation in the qi, and treats all kinds of pain in the body", and has a good analgesic effect. For the treatment of chest pain and heart pain, it is combined with Danshen, Trichosanthes, etc. For stomach pain, it is combined with white peony root, Citrus aurantium, etc. For the treatment of flank pain, it is combined with Bupleurum, etc. For the treatment of dysmenorrhea and abdominal pain caused by postpartum stasis, it is combined with Cyperus rotundus, Angelica sinensis, Safflower, etc. Yanhusuo can dilate the coronary artery, increase coronary blood flow, inhibit platelet aggregation, and resist thrombosis.

[0023] Myrrh is neutral in nature, pungent and bitter in taste, and belongs to the heart meridian, liver meridian, and spleen meridian. It can dissipate blood stasis, relieve pain, reduce swelling, promote tissue regeneration, and relieve stagnation. It belongs to the blood-activating and analgesic drugs classified under the blood-activating and stasis-removing drugs. It mainly contains α-myrrhic acid, β-myrrhic acid, myrrhonic acid, myrrhol, eugenol, limonene, bisabolene and other ingredients. The blood-activating and analgesic effect of myrrh is to dissipate blood stasis and activate blood circulation. It is matched with drugs that promote qi and activate blood circulation, such as Chuanxiong. One is biased towards qi and the other is biased towards blood. The combination of them complements each other.

[0024] Cinnamon is pungent, sweet, and very hot. It enters the kidney, spleen, heart, and liver meridians, replenishes fire and helps yang, guides fire back to its source, dispels cold and relieves pain, promotes blood circulation and warms the meridians. The main component is 75-90% cinnamaldehyde. Cinnamon is a warm food that can guide fire downwards and avoid false fire. It is suitable for the symptoms of upper heat and lower cold. It has certain benefits for women to regulate uterine coldness, and it has the effect of warming the stomach and uterus, which can effectively relieve the effect of female uterine coldness.

[0025] Dried ginger belongs to the lung, spleen, and stomach meridians, and can warm the middle and dispel cold, restore yang and dredge the meridians, dry up dampness and eliminate phlegm. Dried ginger is good at warming the middle and restoring yang, and can be used in combination with various blood-warming and blood-stasis-removing medicines.

[0026] Fennel is warm in nature and pungent in taste. It belongs to the liver meridian, spleen meridian, stomach meridian and kidney meridian. It can dispel cold and relieve pain, regulate qi and soothe the stomach. It is a warming medicine and contains a variety of compounds such as volatile oils, sterols, triterpenes, coumarins and amino acids. It has the effects of warming the meridians, dispelling cold, promoting qi and relieving pain for cold uterus. It is used for abdominal cold pain caused by cold uterus, and relieves pain by soothing the liver and regulating qi, warming the kidney and dispelling cold.

[0027] Mugwort is pungent, bitter, warm and slightly toxic. It enters the liver, spleen and kidney meridians, dispels cold and relieves pain, warms the meridians and stops bleeding.

[0028] Toosendan fruit is bitter and cold, and enters the liver, stomach, small intestine, and bladder meridians. It can soothe the liver and regulate qi, kill insects and treat tinea, promote qi circulation and relieve pain. It can be used for lower abdominal distension and pain caused by qi stagnation and dampness, hernia abdominal pain and other symptoms.

[0029] Safflower, guixin, liver meridian, promotes blood circulation and regulates menstruation, removes blood stasis and relieves pain. It is used to treat abdominal pain caused by blood stasis, and is often used with angelica, Chuanxiong, peach kernel, etc. It is often used with safflower and angelica to treat chest pain caused by blood stasis, purple pain caused by blood vessel occlusion, and blood stasis pain caused by trauma. It is often used with guarana, salvia, cassia twig, etc. It is often used to treat chest pain caused by blood stasis, and is often used with red peony root, angelica, etc. It is often used to treat purple swelling and pain caused by blood vessel occlusion. Safflower yellow pigment has a very significant inhibitory effect on platelet aggregation induced by adenosine diphosphate.

[0030] Eucommia ulmoides is warm in nature and sweet in taste. It belongs to the liver and kidney meridians. It nourishes the liver and kidney, strengthens the tendons and bones, and stabilizes pregnancy. It is a yang-tonifying medicine under the category of tonic medicine. Eucommia ulmoides contains eucommia gum, glycosides, alkaloids, organic acids, pectin, vitamin C and various amino acids. It has the effects of sedation, analgesia, diuresis, delaying aging, enhancing physical strength, and resisting fatigue. It can also increase the body's nonspecific immune function.

[0031] Licorice is mild in nature and sweet in taste. It enters the heart meridian, stomach meridian, spleen meridian, and lung meridian. It can nourish the spleen and replenish qi, relieve cough and expectorant, relieve acute and acute pain, and harmonize medicinal properties. It is a qi-tonifying drug classified under tonic drugs, which can make the tonic effect gentle and long-lasting rather than sudden.

[0032] In detail, the warm palace patch includes 8-12 parts of angelica, 8-12 parts of chuanxiong, 3-8 parts of red peony root, 8-12 parts of pollen, 5-8 parts of aconite, 10-15 parts of yanhusuo, 6-8 parts of myrrh, 3-7 parts of cinnamon, 3-7 parts of dried ginger, 7-11 parts of cumin, 10-15 parts of mugwort, 5-8 parts of toosendan, 3-8 parts of safflower, 10-15 parts of eucommia and 5-9 parts of liquorice.

[0033] In detail, the warm palace patch includes 10 parts of angelica, 10 parts of chuanxiong, 5 parts of red peony root, 10 parts of pollen, 7 parts of aconite, 12 parts of yanhusuo, 7 parts of myrrh, 5 parts of cinnamon, 5 parts of dried ginger, 8 parts of fennel, 12 parts of mugwort, 7 parts of toosendan, 5 parts of safflower, 12 parts of eucommia and 7 parts of liquorice in parts by weight.

[0034] Transdermal administration of traditional Chinese medicine is a commonly used method of administration, which allows the active ingredients of traditional Chinese medicine to be absorbed through the skin into the systemic circulation, producing systemic or local therapeutic effects. Transdermal preparations can avoid the first-pass effect of the liver and damage by the gastrointestinal tract, reduce the number of administrations, prolong the administration time, maintain a constant effective blood drug concentration, reduce the toxic and side effects of the drug, and improve the efficacy. However, since the permeation rate of transdermal administration of traditional Chinese medicine is generally low, it is particularly important to improve the transdermal efficiency of the active ingredients of traditional Chinese medicine for the transdermal administration of traditional Chinese medicine. Modern pharmacy can improve the absorption of the active ingredients of traditional Chinese medicine in the skin by preparing them into nano-preparations. In order to enhance the efficacy of the prescription, the following preparation process is provided.

[0035] A production process of a uterus warming patch comprises the following steps:

[0036] The raw materials are crushed by ultrafine nanometer method, filtered by ultrafiltration membrane with pore size of 0.001-0.01 μm, and nano powder and filter residue are obtained; Vaseline is heated into liquid, and the Vaseline liquid and nano powder are stirred and mixed, and the ratio of Vaseline liquid to nano powder is 1:3 mL / g, and the ointment is obtained, and the ointment is added to a blank non-woven fabric patch, and the mass of the ointment is 5-10 g, and then the blank non-woven fabric patch with the ointment added is covered with paper, and stored in a refrigerator at a temperature of 2-10°C.

[0037] By crushing the raw materials into nanopowders, a patch with good absorption performance and high bioavailability is made, which can be used for long-term treatment or adjuvant treatment of chronic and recurrent dysmenorrhea, making up for the shortcomings of Chinese medicine decoctions such as bitter taste, high price, and difficulty in decocting medicines, and giving full play to the advantages of Chinese medicine acupoint patches, so that the drugs can be fully utilized, the efficacy can be maximized, and the effectiveness of treatment can be guaranteed. Solid lipid nanoparticles can form a film on the skin surface because they do not use high-concentration surfactants in their preparation process. Through the hydration of the epidermis after local sealing, they promote drug absorption and increase the contact time and area between the drug and the stratum corneum, which is conducive to the percutaneous absorption of drugs.

[0038] In this embodiment, ethanol is added to the filter residue and refluxed at 60-80°C for extraction for 30-50 minutes, then filtered, centrifuged at 800-1000r / min for 5-10 minutes, concentrated to a thick paste with a water content of 20-30%, and then the thick paste is stirred and mixed with vaseline liquid and nano powder.

[0039] Due to the large particle size of the filter residue, directly making it into an ointment is not conducive to percutaneous absorption. However, extracting the active ingredients in the filter residue and then mixing it with nanopowder can not only enhance the content of active ingredients in the drug, but also enhance drug absorption and improve the bioavailability of the drug, making the patch more effective in treating dysmenorrhea and uterine cold.

[0040] The features and performance of the present application are further described in detail below in conjunction with the embodiments.

[0041] Example 1

[0042] A production process of a uterus warming patch comprises the following steps:

[0043] Ingredients: 10g angelica, 10g chuanxiong, 5g red peony root, 10g pollen, 7g aconite, 12g yanhusuo, 7g myrrh, 5g cinnamon, 5g dried ginger, 8g fennel, 12g mugwort, 7g toosendan, 5g safflower, 12g eucommia and 7g liquorice.

[0044] The raw materials are ultrafinely nano-crushed and filtered through an ultrafiltration membrane with a pore size of 0.005 μm to obtain nano powder and filter residue; Vaseline is heated into liquid, and the Vaseline liquid and the nano powder are stirred and mixed, the ratio of the Vaseline liquid to the nano powder is 1:3 mL / g, and the ointment is obtained, and the ointment is added to a non-woven blank patch, the mass of the ointment is 8 g, and then the non-woven blank patch with the ointment added is covered with paper and stored in a refrigerator at a temperature of 5°C.

[0045] Example 2

[0046] A production process of a uterus warming patch comprises the following steps:

[0047] Ingredients: 8g angelica, 8g chuanxiong, 3g red peony root, 8g pollen, 5g aconite, 10g yanhusuo, 6g myrrh, 3g cinnamon, 3g dried ginger, 7g fennel, 10g mugwort, 5g toosendan, 3g safflower, 10g eucommia and 5g liquorice.

[0048] The raw materials are ultrafinely nano-crushed and filtered through an ultrafiltration membrane with a pore size of 0.001 μm to obtain nano powder and filter residue; Vaseline is heated into liquid, and the Vaseline liquid and the nano powder are stirred and mixed, the ratio of the Vaseline liquid to the nano powder is 1:3 mL / g, and the ointment is obtained, and the ointment is added to a non-woven blank patch, the mass of the ointment is 5 g, and then the non-woven blank patch with the ointment added is covered with paper and stored in a refrigerator at a temperature of 2°C.

[0049] Example 3

[0050] A production process of a uterus warming patch comprises the following steps:

[0051] Ingredients: 12g angelica, 12g chuanxiong, 8g red peony root, 12g pollen, 8g aconite, 15g yanhusuo, 8g myrrh, 7g cinnamon, 7g dried ginger, 11g fennel, 15g mugwort, 8g toosendan, 8g safflower, 15g eucommia and 9g liquorice.

[0052] The raw materials are crushed by ultrafine nanometer method, filtered by ultrafiltration membrane with a pore size of 0.01 μm, and nano powder and filter residue are obtained; Vaseline is heated into liquid, and the Vaseline liquid and nano powder are stirred and mixed, and the ratio of the Vaseline liquid to the nano powder is 1:3 mL / g, and the ointment is obtained after cooling, and the ointment is added to a blank non-woven fabric patch, and the mass of the ointment is 10 g, and then the blank non-woven fabric patch after the ointment is added is covered with paper, and stored in a refrigerator at a temperature of 10°C.

[0053] Example 4

[0054] A production process of a uterus warming patch comprises the following steps:

[0055] Ingredients: 9g angelica, 11g chuanxiong, 7g red peony root, 9g pollen, 7g aconite, 13g yanhusuo, 7g myrrh, 4g cinnamon, 4g dried ginger, 8g fennel, 13g mugwort, 7g toosendan, 6g safflower, 11g eucommia and 8g liquorice.

[0056] The raw materials are ultrafinely nano-crushed, filtered through an ultrafiltration membrane with a pore size of 0.008 μm to obtain nano powder and filter residue, ethanol is added to the filter residue, refluxed and extracted at 70°C for 40 minutes, then filtered, centrifuged at 900 r / min for 8 minutes, and concentrated to a thick paste with a water content of 22% to obtain a thick paste; Vaseline is heated into liquid, the vaseline liquid, the thick paste and the nano powder are stirred and mixed, the ratio of the vaseline liquid to the nano powder is 1:3 mL / g, cooled to obtain an ointment, the ointment is added to a non-woven blank patch, the mass of the ointment is 7 g, and the non-woven blank patch after the ointment is added is covered with paper and stored in a refrigerator at a temperature of 7°C.

[0057] Test results

[0058] 500 female volunteers with dysmenorrhea symptoms, aged 18-40 years old, were randomly divided into 5 groups, 100 people in each group, 1-4 groups used the warming uterus patch of Examples 1-4 respectively, and 5 groups were the control group, using the modified wormwood warming patch (product number: 10046022976732), the method of use was to stick the patch on the navel, each use for 10 hours, and the use time was 6 months. After use, the subjects' feelings and the improvement of dysmenorrhea and cold uterus were recorded, and the results were as follows:

[0059] Table 1 Dysmenorrhea results

[0060] Group No relief of dysmenorrhea / % Dysmenorrhea slightly relieved / % Dysmenorrhea relief / % Dysmenorrhea significantly reduced / % 1 5 4 6 85 2 4 2 12 82 3 5 3 11 81 4 1 3 6 90 5 30 20 10 40

[0061] According to Table 1, compared with the control group, the uterine warming patches of Examples 1-4 can significantly relieve dysmenorrhea, indicating that the uterine warming patches prepared in the examples of the present application have a good therapeutic effect on dysmenorrhea.

[0062] Table 2 Results of uterine cold

[0063]

[0064]

[0065] According to Table 2, compared with the control group, the uterine warming patches of Examples 1-4 can significantly improve the uterine coldness, indicating that the uterine warming patches prepared in the examples of the present application have a good therapeutic effect on uterine coldness.

[0066] Table 3 Results of the test on the effect of use

[0067] Group Dysmenorrhea relief effect / point Improvement effect on uterine coldness / points Comfort level / min 1 8.5 8 8.5 4 9.5 9 8.5 5 4 3 8

[0068] The above scores are the average scores for each group, with 10 being the best and 0 being the worst, and so on.

[0069] According to Table 3, compared with the control group, the uterus warming patch prepared in the embodiment has a better effect on relieving dysmenorrhea and improving uterine coldness, indicating that the present invention has a better uterus warming and analgesic effect.

[0070] In summary, the warm palace patch of the embodiment of the present application has the curative effects of promoting blood circulation, removing blood stasis, warming meridians and relieving pain. The drug is absorbed into the internal organs and meridians through the local transdermal absorption of the skin, avoiding the decomposition of the liver and gastrointestinal tract and fully improving the utilization of the drug. In the square, Angelica sinensis, Chuanxiong, Pollen Typhae and Ophiopogon japonicus are the main drugs, which have the effect of promoting blood circulation, removing blood stasis and relieving pain; Cinnamon bark, dried ginger, fennel and Artemisia argyi are the ministerial drugs, which have the effect of warming the palace and relieving pain; Carthamus tinctorius is the ministerial drug, which can strengthen the merit of promoting blood circulation and removing blood stasis of the main drug; Corydalis yanhusuo and Chuanlianzi are adjuvants, which can promote qi and relieve pain, and strengthen the analgesic properties of the main drug and ministerial drug; Myrrh is an adjuvant, which can promote blood circulation and relieve pain, and strengthen the analgesic effect; Red peony root is an adjuvant, which can promote blood circulation and remove blood stasis, and prevent the various drugs from being too warm; Eucommia ulmoides is an adjuvant, which has the sweet and warm properties of tonifying the kidney, strengthening the waist and relieving pain, and strengthening the property of warming and tonifying; Licorice is a messenger drug, which harmonizes the various drugs, and dense roasting can enhance the merit of tonifying. The prescription is properly matched, the dosage is accurate, and the clinical efficacy is very significant. It is made into a paste acupoint patch to treat some chronic and refractory diseases. It is especially suitable for female patients with frequent dysmenorrhea. In addition, acupoint patch therapy has a long history of development, a wide range of applications, clear clinical efficacy, safety and reliability, stable medicinal properties, no special odor, easy storage, easy to carry and low cost.

[0071] The manufacturing process of the warm palace patch provided in the embodiment of the present application is to crush the raw materials into nano powders to make a patch with good absorption performance and high bioavailability, which can be used for long-term treatment or adjuvant treatment of chronic and recurrent dysmenorrhea, making up for the shortcomings of bitter taste, high price and difficulty in decocting Chinese medicine decoctions, giving full play to the advantages of Chinese medicine acupoint patches, making full use of drugs, maximizing the efficacy and ensuring the effectiveness of treatment. Solid lipid nanoparticles can form a film on the skin surface because they do not use high-concentration surfactants in their preparation process, promote drug absorption through epidermal hydration after local sealing, and increase the contact time and area between the drug and the stratum corneum, which is conducive to percutaneous absorption of drugs.

[0072] The embodiments described above are part of the embodiments of the present application, rather than all of the embodiments. The detailed description of the embodiments of the present application is not intended to limit the scope of the present application for protection, but merely represents the selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present application.

Claims

1. A uterine warming patch, characterized in that: The composition is composed of the following raw materials by weight: 6-15 parts of angelica, 6-15 parts of ligusticum chuanxiong, 3-10 parts of red peony root, 5-15 parts of pollen, 5-10 parts of quinoa, 5-20 parts of yanhusuo, 6-10 parts of myrrh, 3-9 parts of cinnamon, 3-9 parts of dried ginger, 5-15 parts of fennel, 5-20 parts of wormwood, 5-10 parts of toosendan, 3-10 parts of safflower, 5-15 parts of eucommia and 3-9 parts of liquorice; The manufacturing process of the uterus warming patch comprises the following steps: The raw materials are crushed by ultrafine nanometer to obtain nano powder; Vaseline is heated into liquid, the Vaseline liquid and the nano powder are stirred and mixed, cooled to obtain ointment, the ointment is added to the blank non-woven fabric patch, and the blank non-woven fabric patch with the ointment added is covered with paper and stored in a refrigerator.

2. The uterus warming patch according to claim 1, characterized in that: The invention is composed of the following raw materials by weight: 8-12 parts of angelica sinensis, 8-12 parts of chuanxiong, 3-8 parts of red peony root, 8-12 parts of pollen, 5-8 parts of quinoa chinensis, 10-15 parts of yanhusuo, 6-8 parts of myrrh, 3-7 parts of cinnamon bark, 3-7 parts of dried ginger, 7-11 parts of fennel, 10-15 parts of mugwort, 5-8 parts of toosendan fruit, 3-8 parts of safflower, 10-15 parts of eucommia bark and 5-9 parts of liquorice.

3. The uterus warming patch according to claim 2, characterized in that: The invention is composed of the following raw materials by weight: 10 parts of angelica sinensis, 10 parts of chuanxiong rhizome, 5 parts of red peony root, 10 parts of pollen pollen, 7 parts of quinoa chinensis, 12 parts of yanhusuo, 7 parts of myrrh, 5 parts of cinnamon bark, 5 parts of dried ginger, 8 parts of fennel, 12 parts of wormwood leaf, 7 parts of toosendan fruit, 5 parts of safflower, 12 parts of eucommia bark and 7 parts of liquorice.

4. The uterus warming patch according to claim 1, characterized in that: After ultrafine grinding, the mixture is filtered using an ultrafiltration membrane with a pore size of 0.001-0.01 μm to obtain nano powder and filter residue.

5. The uterus warming patch according to claim 4, characterized in that: The method also includes adding ethanol to the filter residue for reflux extraction, filtering, centrifuging, and concentrating to obtain a thick paste, and then stirring and mixing the thick paste with vaseline liquid and nano powder.

6. The uterus warming patch according to claim 5, characterized in that: Reflux extraction at 60-80°C for 30-50min, centrifuge at 800-1000r / min for 5-10min, and concentrate to a thick paste with a water content of 20-30%.

7. The uterus warming patch according to claim 1, characterized in that: The ratio of vaseline liquid to nanopowder was 1:3 mL / g.

8. The uterus warming patch according to claim 1, characterized in that: The mass of the ointment added to the blank non-woven patch is 5-10 g.

9. The uterus warming patch according to claim 1, characterized in that: Refrigerate at 2-10°C.

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