CN102793884A - Chinese medical plaster for treating dysmenorrhea and preparation method thereof - Google Patents

Abstract

The invention relates to a traditional Chinese medicine plaster for treating dysmenorrhea and a preparation method thereof. The weight ratio of raw materials is as follows: 10-30 parts of Chuanxiong, 10-30 parts of Angelica, 9-25 parts of Rhizoma Cyperi, and 9-25 parts of Wuyao , 9-25 parts of litchi core, 8-22 parts of cumin, 3-15 parts of clove, 3-18 parts of cinnamon, 3-18 parts of galangal, 6-20 parts of corydalis. Refluxing ethanol extraction of Corydalis Corydalis and concentrating it into a thick paste, extracting volatile oil from Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, Litchi Kernel, Cumin, clove, cinnamon, and Galangal with steam distillation, and decocting the dregs after extracting the volatile oil with water. The medicinal liquid is combined and concentrated, and the concentrated liquid is concentrated by alcohol precipitation to form a thick paste. Uniform, spread, add protective layer. The compatibility of various medicines in the whole prescription can play the effect of promoting blood circulation and removing blood stasis, warming meridian and relieving pain. The characteristics of this prescription are to seek the cause and cure the root cause, and to treat both the symptoms and the root causes. It is a good prescription for the treatment of primary dysmenorrhea.

Description

A traditional Chinese medicine plaster for treating dysmenorrhea and preparation method thereof

technical field

The invention relates to a traditional Chinese medicine, in particular to a traditional Chinese medicine for treating primary dysmenorrhea and a preparation method thereof.

Background technique

Dysmenorrhea refers to pain and swelling in the lower abdomen and waist before and after menstruation or during menstruation. In severe cases, it is accompanied by symptoms such as nausea, vomiting, and cold extremities. Dysmenorrhea can be divided into two categories: primary and secondary. Primary dysmenorrhea refers to dysmenorrhea without pelvic organic lesions. Because of its high incidence, it often affects women's daily life, study and work to a certain extent. According to the sample survey conducted by the Chinese Women's Menstrual Physiological Constant Cooperative Group in 1980, the incidence of dysmenorrhea in my country was 33.19%, of which primary dysmenorrhea accounted for 36.06%, seriously affecting 13.55% of workers. Traditional Chinese medicine physicians of all dynasties, guided by holistic concept and syndrome differentiation and treatment, seek the cause and treat the root cause, and adopt traditional Chinese medicine treatment, which increasingly shows unique advantages and can achieve the goal of radical cure.

Traditional Chinese medicine believes that the cause of dysmenorrhea is stagnation of qi and blood stasis, cold coagulation of blood stasis, and damp heat stasis leading to poor circulation of qi and blood in the uterus. . Primary dysmenorrhea belongs to the category of "abdominal pain during menstruation" and "dysmenorrhea" in traditional Chinese medicine.

The record of dysmenorrhea in traditional Chinese medicine was first found in "Synopsis of the Golden Chamber·Women's Miscellaneous Diseases and Syndrome and Treatment", which said: "Drainage of menstrual flow is unfavorable, and the abdomen is full of pain...." It belongs to the category of "abdominal pain during menstruation" in traditional Chinese medicine. In "On the Causes and Symptoms of Various Diseases", "Moonwater comes to abdominal pain" is the first to be established. "Shengji Zonglu Women's Blood Qi Gate" said: "Virgins who suffer from abdominal pain due to menstrual water, it is due to the sudden arrival of the heavenly gui, the Rong Wei has not been reconciled, the mind is restless, and the cold air is the guest, and the blood and Qi are not fluent. It can cause menstrual fluid to stagnate between the umbilicus and abdomen, causing stinging pain. The treatment method should follow the blood and qi, and if there is no stagnation, the pain will heal itself." Chen Ziming in the Song Dynasty believed that dysmenorrhea is caused by cold, Those with Qi depression and those with blood knots. The Ming Dynasty's "Jingyue Quanshu Women's Regulations" has a saying: "Abdominal pain during menstruation is evidenced by deficiency and excess. The excess may be due to stagnation of cold, stagnation of blood, stagnation of qi, or stagnation of heat; stagnation of yin and blood may be the cause of deficiency. , due to deficiency of qi. However, those with real pain often have pain before the operation, and the pain will be relieved by passing the meridian; for those with weak pain, after the operation, the blood will go away and the pain will not stop, or the blood will go away and the pain will be more beneficial. In general, it can be Those who can be kneaded are false, and those who refuse to be kneaded are real."

The "Tenth Five-Year Plan" national planning textbook for general higher education "Gynecology of Traditional Chinese Medicine" classifies dysmenorrhea into qi stagnation and blood stasis type, cold coagulation blood stasis type, damp heat stasis type, qi and blood deficiency type, and kidney qi deficiency type. There are two main reasons for primary dysmenorrhea: "Pain if there is no flow" or "Pain if there is no glory". Treatment must depend on the basics, and the causes of diseases are intricate, and gynecological diseases are mainly caused by dysfunction of the liver, spleen, and kidneys. There is a saying in "Nvke Jinglun": "Nourishing menstruation is like nourishing blood, and nourishing blood is like nourishing water and fire". The treatment of dysmenorrhea should be based on the principle of "treating the symptoms urgently, and treating the root cause if it is slow", and it is advisable to relieve the pain quickly. Commonly used medicines mainly regulate qi and blood. According to the different types of dysmenorrhea, they are combined with medicines for regulating qi, warming interior medicine, clearing away heat, and nourishing qi and blood. Treatment principles.

Contents of the invention

The object of the present invention is to provide a traditional Chinese medicine plaster for treating dysmenorrhea and a preparation method thereof. The traditional Chinese medicine can promote blood circulation and remove blood stasis, warm menstrual flow and relieve pain. The traditional Chinese medicine of the invention has convenient application and definite drug effect.

The technical scheme that the present invention takes is:

A traditional Chinese medicine plaster for treating dysmenorrhea, the weight ratio of raw materials consists of: 10-30 parts of Rhizoma Chuanxiong, 10-30 parts of Angelica sinensis, 9-25 parts of Rhizoma Rhizoma Cyperi, 9-25 parts of Wuyao, and 9-25 parts of Lychee Kernel , cumin 8-22 parts, cloves 3-15 parts, cinnamon 3-18 parts, galangal 3-18 parts, Corydalis 6-20 parts.

The above-mentioned traditional Chinese medicine plaster for treating dysmenorrhea, the preferred weight ratio of its raw materials consists of: 15-25 parts of Rhizoma Chuanxiong, 15-25 parts of Angelica, 10-20 parts of Cyperus Cyperi, 10-20 parts of Wuyao, and 10-20 parts of Lychee Kernel , cumin 10-20 parts, cloves 5-12 parts, cinnamon 5-15 parts, galangal 5-15 parts, Corydalis 8-18 parts.

The above-mentioned traditional Chinese medicine plaster for treating dysmenorrhea, its raw materials are further preferably composed of 18-22 parts by weight of Rhizoma Chuanxiong, 18-22 parts of Angelica sinensis, 12-18 parts of Cyperus cyperi, 12-18 parts of black medicine, 12-18 parts of litchi core 12-18 parts of cumin, 6-10 parts of cloves, 8-12 parts of cinnamon, 5-15 parts of galangal, and 9-15 parts of Corydalis.

The preparation method of the above-mentioned traditional Chinese medicine plaster for treating dysmenorrhea comprises the steps:

(1) Corydalis is crushed through No. 1 sieve, extracted with ethanol under reflux, filtered, recovered ethanol, and concentrated into a thick paste with a relative density of 1.25-1.35 (60-75°C) for later use;

(2) Extract volatile oil from Rhizoma Chuanxiong, Angelica, Rhizoma Cyperi, Cinnamon, Litchi Kernel, Cumin, Clove, Cinnamon, and Galangal with steam.

(3) After extracting the volatile oil, decoct the medicinal residues of Ligusticum chuanxiong, angelica, Cyperus cyperi, Wuyao, litchi core, fennel, clove, cinnamon, and galangal, and combine with the medicinal solution in step (2), and concentrate to a relative density Concentrate of 1.05-1.15 (65-80°C);

(4) Stir the concentrated solution with ethanol, let it stand, precipitate, filter, recover the ethanol from the filtrate and concentrate it into a thick paste of 1.25-1.35 (60-80°C) for later use;

(5) Combine the thickening paste of corydalone in step (1) and the concentrated thickening paste of decoction and alcohol precipitation in step (4), and mix evenly, and prepare the mixed thickening paste for later use;

(6) Mix the pressure-sensitive adhesive with the mixed thick paste, the volatile oil extracted in step (2), and the transdermal absorption accelerator, apply it, and add a protective layer.

The preparation method of above-mentioned plaster for treating dysmenorrhea preferably follows the steps:

(1) Reflux and extract Corydalis powder plus ethanol for 2-4 times, add 60%-85% (V/V) ethanol 5-12 times the mass of Corydalis each time, reflux for 0.5-2 hours each time, filter and combine Filtrate, recover ethanol under reduced pressure and condense into Corydalis ethanol extraction thick paste, relative density is 1.25-1.35 (60-75°C);

(2) Add Rhizoma Chuanxiong, Angelica, Rhizoma Cyperi, Cinnamon, Litchi Kernel, Fennel, Clove, Cinnamon, Galangal with 3-5 times the total mass of water, steam distillation to extract volatile oil, and the time for extracting volatile oil is 5-5. After 9 hours, the volatile oil is set aside. After the volatile oil is extracted, the chuanxiong, angelica, Cyperus cyperi, black medicine, lychee kernel, fennel, clove, cinnamon, and galangal are stored separately, and the medicinal liquid is combined into the subsequent water decoction;

(3) Combine Rhizoma Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, Lychee Kernel, Cumin, Clove, Cinnamon, and Galangal after extracting the volatile oil, add water to decoct 2-4 times, and add 6-10 times the total weight of the drug each time water, decoct for 1-2 hours each time, filter, and combine the filtrates to form a decoction, which is extracted from Rhizoma Chuanxiong, Angelica Cyperi, Cyperus Cyperi, Aegya, Lychee Kernel, Cumin, Clove, Cinnamon, and Galangal The medicinal liquid after the volatile oil is combined and concentrated to a decoction concentrate with a relative density of 1.05-1.15 (65-80°C);

(4) Add the decoction concentrate to 95% (V/V) ethanol with a mass of 1.5-2 times (m/m) of the decoction concentrate, stir, let it settle and filter it, and recover the ethanol from the filtrate under reduced pressure and concentrate it to Water-decoction and alcohol-precipitated concentrated extract with a relative density of 1.25-1.35 (60-80°C);

(5) Merge and mix the fumarol thickening paste and the decoction and alcohol precipitation concentrated extract, and use it as a mixed thick paste for later use;

(6) Mix the pressure-sensitive adhesive with the thick paste in step (5), the volatile oil extracted in step (2), and the transdermal absorption enhancer, apply it, and add a protective layer.

The transdermal absorption accelerator in the above step (6) is preferably azone, and the pressure-sensitive adhesive is preferably a hot-melt pressure-sensitive adhesive.

The dosage of the pressure-sensitive adhesive is 3-5 times (m/m) of the mass of the mixed thick ointment, and the dosage of the transdermal absorption accelerator is 1-5% (m/m) of the total mass of the pressure-sensitive adhesive and the mixed thick ointment.

The plaster contains 1.2g-2.0g of mixed thick ointment per 100 square centimeters.

The traditional Chinese medicine plaster of the invention has the functions of promoting blood circulation and removing blood stasis, warming menstrual flow and relieving pain.

Ligusticum chuanxiong is the dried rhizome of Rhizoma chuanxiong of Umbelliferae. Pungent, warm, returns liver, gallbladder, pericardium meridian. Promoting blood circulation and promoting qi, expelling wind and relieving pain. It can be used for irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain and other diseases. "Shen Nong's Materia Medica": "Spicy, warm. Mainly for strokes into the brain headache, cold arthralgia spasms and emergency, gold wounds, women with blood closed and childless." , middle evil, death acute swelling and pain, hypochondriac wind pain, warming the middle and internal cold." "Compendium of Materia Medica": "There is no rhizome, and the blood is also a medicine. The liver is bitter and anxious, so it is suitable for those with blood deficiency; To disperse it, so it is suitable for people with stagnation of qi." "Materia Medica Huiyan": "Xiong xiong, ascending leader, regulating menstrual water, opening stagnation in the middle, medicine for qi in the blood. It is made by angelica, and it is not the first to treat blood. And the treatment of qi is also very effective." "Materia Medica Congxin": "Chuanxiong, which is a medicine of qi in the blood, promotes clear yang and opens all depressions, moistens liver dryness and nourishes liver deficiency, ascends to the head, descends to the sea of blood, searches for wind and dispels stasis , relieve pain and regulate menstruation."

Angelica is the dry root of Angelica sinensis. Sweet, pungent, warm. Return liver, heart, spleen channel. Enriching and promoting blood circulation, regulating menstruation and relieving pain. For irregular menstruation, amenorrhea dysmenorrhea, cold abdominal pain and so on. "Shen Nong's Materia Medica": "The housewife leaks, the child is lost, all the evil sores are sore, boil and drink it." New blood and main symptom addiction." "Secrets of Indications" says: "Blood is stagnant and does not flow, and pain is caused. Angelica body is pungent and warm to disperse it, so that the qi and blood will return to their own." "Materia Medica Mengguan": "" It is said that angelica is the blood medicine, how to treat the qi in the chest? They don’t know that the angelica is not only the blood, and the taste is pungent, but it is the blood qi medicine. When the cough is against the upper qi, it does not stop one end. There are also those who have yin deficiency and yang without attachment to cause it. Now use blood medicine to nourish yin, harmonize with yang, etc., then the blood will harmonize and the qi will fall." "Compendium of Materia Medica": "Cure headache, all kinds of pain in the trusted subordinates, moisten the intestines, stomach, muscles, bones and skin , cure carbuncle and gangrene. Evacuate pus and relieve pain. Harmonize blood and nourish blood.” Angelica and Chuanxiong are used together to promote blood circulation and remove blood stasis.

Cyperus Cyperus is the dry rhizome of Cyperaceae Cyperus cyperus. Pungent, slightly bitter, slightly sweet, flat. It has the effects of soothing the liver and relieving depression, regulating the flow of vital energy and widening the middle, regulating menstruation and relieving pain. For stagnation of qi due to depression of the liver, distending pain in the chest and hypochondriac, irregular menstruation, amenorrhea and dysmenorrhea. "Tangye Materia Medica": "Fructus cyperus, the qi medicine in the blood. The prescription is used to treat metrorrhagia, which is to replenish qi and stop bleeding. It can also dissolve blood coagulation, which is also to push Chen." Wang Haogu: "Xiang Attachment, the yin in the yang, the qi medicine in the blood. It must be used when the qi is stagnant and the blood qi is stagnant. Stir-fried black can stop bleeding and treat metrorrhagia, and this is the fairy medicine for women.”

Galangal is the dried rhizome of the ginger plant Galangal. Pungent, hot, return spleen and stomach meridian. Warming the spleen and dispelling cold, promoting qi circulation and relieving pain. "Ben Jing Feng Yuan" believes that galangal can cure "postpartum patients with deficiency and cold in the lower Jiao, blood stasis, and pain in the lower abdomen". Zhen Quan said in "On the Nature of Medicine" that "Galangal can cure chronic cold in the abdomen, cure wind, broken qi, abdominal cold, gas pain, remove wind-cold numbness, weakness, treat lower qi, cold and reverse the heart, Abdominal pain, vomiting and diarrhea." "Materia Medica Huiyan": "Galangal, dampness..." "Properties of Medicine": "...to remove wind-cold numbness and weakness" "Materia Medica Seeking the Original": "Treating headache, wind-cold arthralgia". Rhizoma Rhizoma Cyperi and Galangal are compatible, and it is very effective in promoting qi and dispelling cold.

Wuyao is the dry root tuber of Lauraceae plant Wuyao. Xin, Wen. Return lung, spleen, kidney, urinary bladder channel. Promoting qi and relieving pain, warming kidney and expelling cold. For stagnation of qi due to cold condensation, distending pain in the chest and abdomen, abdominal pain due to menstrual cold, etc. "Materia Medica Tongxuan": "Regulate the stagnation of the seven emotions, stop qi and blood, cholera vomiting and diarrhea, and phlegm and food retention." Middle evil,...open the chest and diaphragm, remove all cold air, relieve cold pain in trusted subordinates,...also stop frequent urination, stranguria, and turbidity." "Medicine Huayi": "Quickly ventilate, evacuate and stagnate, better than incense Attachment. Externally relieve the exterior and regulate the muscles, and internally widen the middle and smooth the Qi. Use it to dispel cold air, and the cold and pain will be cured; , can be reduced suddenly; dredging meridian qi, apoplexy, paralysis of limbs, stagnation of blood qi in the first child, and gradually being able to pass, all rely on the power of its qi force."

Litchi seed is the dry mature seed of Sapindaceae plant Litchi. Sweet in the mouth, slightly bitter, warm. Return liver, kidney channel. Promoting qi and dispelling stagnation, dispelling cold and relieving pain. For cold hernia abdominal pain. "Compendium of Materia Medica": "Treatment of tingling pain in women's blood." Kou Zongshi: "Soothing stagnation of the liver, and a medicine for stagnant qi."

Cumin is the dry ripe fruit of the umbelliferous plant fennel. Xin, Wen. Return liver, kidney, spleen, stomach warp. Dispelling cold and relieving pain, regulating qi and harmonizing stomach. For cold colic abdominal pain, dysmenorrhea, cold pain in the lower abdomen, wrist abdominal distension and pain. "Materia Medica Huiyan": "Fennel enters the Taiyin and Shaoyin meridians of the hands and feet. It is also a medicine for warming the middle and quickening the qi....It warms the middle and dispels the cold, and it is the key product of the lower abdomen to the yin." " "Medicine and Medicine": "Spicy fragrance can disperse evil spirits, warm nature can remove cold, thick qi can sink, and it is specially used to treat the lower part of the kidney and bladder."

Cloves are the dried flower buds of cloves, a plant in the Myrtaceae family. Function cures mainly, warms middle-JIAO and subdues adverse events, invigorates the kidney and supports yang. For spleen and stomach deficiency cold, confidant cold pain, impotence due to deficiency of the kidney. "Compendium of Materia Medica": "Stop qi, and reverse qi." "Materia Medica Congxin": "Warming and pure yang, venting the lungs and warming the stomach, can heal the kidneys, strengthen yang, and warm the vulva." It can be published, and cloves can warm the stomach."

Cinnamon is the dry bark of Cinnamon lauraceae. Pungent, sweet, very hot. Return kidney, spleen, heart, liver channel. Replenishing fire and supporting yang, drawing fire back to the original source, dispelling cold and relieving pain, warming the meridians. For confidant cold pain, cold colic abdominal pain, dysmenorrhea amenorrhea. "Bielu of Famous Doctors": "Strengthen the joints, unblock the blood vessels, relieve the insufficiency of the principles, and promote hundreds of medicines, without fear." ""Materia Medica": "Osmanthus, used together with Angelica and Chuanxiong, is the most effective for women's postpartum blood stasis and pillow pain." Guidance of hundreds of medicines." "Medical Materia Medica": "Break blood, Tongli month closed, afterbirth."

Corydalis Corydalis is the dried tuber of Corydalis Corydalis. Pungent, bitter, warm, return liver, spleen meridian. Promoting blood circulation, promoting qi circulation, relieving pain. It is used for pain in the chest and hypochondria, epigastrium and abdomen, chest obstruction and heartache, amenorrhea dysmenorrhea, postpartum stasis, tumbling and swelling. "Compendium": "Crysanthemum Corydalis can promote stagnation of qi in blood and stagnation of blood in qi, so it is specially used to treat all kinds of pain in the whole body. It is wonderful to use it." Smooth, harmonious and smooth, the qi moves; pungent can moisten and disperse, and disperse can activate blood. Blood activates qi, so it can control blood loss and postpartum diseases caused by blood."

The compatibility of various medicines in the whole prescription can play the effect of promoting blood circulation and removing blood stasis, warming meridian and relieving pain. The characteristics of this prescription are to seek the cause and cure the root cause, and to treat both the symptoms and the root causes. It is a good prescription for the treatment of primary dysmenorrhea.

Detailed ways

Example 1

A traditional Chinese medicine plaster for treating dysmenorrhea, the weight ratio of raw materials consists of: 20 parts of Rhizoma Chuanxiong, 20 parts of Angelica sinensis, 15 parts of Cyperus cyperi, 15 parts of black medicine, 15 parts of litchi core, 15 parts of cumin, 8 parts of cloves, 10 parts of cinnamon, 10 parts of galangal, 12 parts of Corydalis.

Preparation:

(1) Corydalis crushed through No. 1 sieve, added ethanol and refluxed for extraction 3 times, each time adding 70% (V/V) ethanol 8 times the mass of Corydalis, refluxed for 1 hour each time, filtered, combined filtrates, and recovered under reduced pressure Ethanol and concentrated into Yanhusuo ethanol extraction thick paste, the relative density is 1.30 (65 ℃);

(2) Add chuanxiong, angelica, Cyperus cyperi, wuyao, lychee core, cumin, clove, cinnamon, and galangal with 4 times the total mass of water, and steam distillation to extract volatile oil. The time for extracting volatile oil is 6 hours. For later use, the chuanxiong, angelica, Cyperus cyperi, black medicine, lychee core, fennel, clove, cinnamon, and galangal dregs after extracting the volatile oil are stored separately, and the medicinal liquid is combined into the water decoction;

(3) After extracting the volatile oil, decoct the medicinal residues of Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, litchi core, cumin, clove, cinnamon, and galangal with water for 3 times, adding water 10 times the total mass of the medicine each time, Decoct for 1.5 hours each time, filter, and combine the filtrates to form a decoction. The decoction is mixed with Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, litchi core, cumin, cloves, cinnamon, and galangal to extract volatile oils. Combine and concentrate to decoct concentrate with a relative density of 1.10 (70°C);

(4) Add 95% (V/V) ethanol to 1.5 times the mass (m/m) of the decoction concentrated solution and stir, let it settle and filter it, and recover the ethanol from the filtrate under reduced pressure and concentrate it to a relative density of 1.35 ( 75°C) decocted and alcohol-precipitated concentrated extract;

(5) Combine and mix the thickening paste of corydalone with decoction and alcohol precipitation, and use it as a mixed thick paste for later use;

(6) Add the hot-melt pressure-sensitive adhesive 3 times the mass of the mixed thick paste, the volatile oil extracted in step (2), and azone and mix evenly. The amount of azone is 3% of the mass of the hot-melt pressure-sensitive adhesive and the mixed thick paste ( m/m), coating, plus protective layer. Each sticker is 4cm×6cm.

Example 2

A traditional Chinese medicine plaster for treating dysmenorrhea, the weight ratio of raw materials consists of: 18 parts of Rhizoma Chuanxiong, 18 parts of Angelica sinensis, 12 parts of Cyperus cyperi, 12 parts of black medicine, 12 parts of litchi core, 12 parts of fennel, 6 parts of cloves, 8 parts of cinnamon, 5 parts of galangal, 9 parts of Corydalis.

Preparation:

(1) Corydalis crushed through No. 1 sieve, add ethanol to reflux and extract twice, each time add 65% (V/V) ethanol 5 times the mass of Corydalis, reflux for 0.5 hours each time, filter, combine filtrates, and recover under reduced pressure Ethanol and concentrated into Yanhusuo ethanol extraction thick paste, the relative density is 1.25 (60 ℃);

(2) Add chuanxiong, angelica, Cyperus cyperi, wuyao, lychee core, cumin, clove, cinnamon, and galangal with water three times the total mass, and steam distill to extract the volatile oil. The time for extracting the volatile oil is 5 hours. For later use, the chuanxiong, angelica, Cyperus cyperi, black medicine, lychee core, fennel, clove, cinnamon, and galangal dregs after extracting the volatile oil are stored separately, and the medicinal liquid is combined into the water decoction;

(3) After extracting the volatile oil, decoct the medicinal residues of Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, litchi core, fennel, clove, cinnamon, and galangal with water, adding water 6 times the total weight of the drug each time, Boil for 1 hour each time, filter, and combine the filtrates to form a decoction. The decoction is mixed with Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, litchi core, cumin, cloves, cinnamon, and galangal to extract volatile oils. Combine and concentrate to decoct concentrate with a relative density of 1.05 (80°C);

(4) Add 95% (V/V) ethanol to 1.5 times its mass (m/m) of decoction concentrate, stir, let it settle and filter, and recover ethanol from the filtrate under reduced pressure and concentrate to a relative density of 1.25 ( 80°C) decocted and alcohol-precipitated concentrated extract;

(5) Combine and mix the thickening paste of corydalone with decoction and alcohol precipitation, and use it as a mixed thick paste for later use;

(6) Add the hot-melt pressure-sensitive adhesive 5 times the mass of the mixed thick paste, the volatile oil extracted in step (2), and azone and mix evenly. The amount of azone is 5% of the mass of the hot-melt pressure-sensitive adhesive and the mixed thick paste ( m/m), coating, plus protective layer. Each sticker is 4cm×6cm.

Example 3

A traditional Chinese medicine plaster for treating dysmenorrhea, the weight ratio of raw materials consists of: 22 parts of Rhizoma Chuanxiong, 22 parts of Angelica sinensis, 18 parts of Cyperus cyperi, 18 parts of black medicine, 18 parts of litchi core, 18 parts of fennel, 10 parts of cloves, 12 parts of cinnamon, 15 parts of galangal, 15 parts of Corydalis.

Preparation:

(1) Corydalis crushed through No. 1 sieve, add ethanol to reflux and extract 4 times, each time add 85% (V/V) ethanol 12 times the mass of Corydalis, reflux for 2 hours each time, filter, combine filtrates, and recover under reduced pressure Ethanol and concentrated into Yanhusuo ethanol extraction thick paste, the relative density is 1.35 (75 ℃);

(2) Add chuanxiong, angelica, Cyperus cyperi, wuyao, lychee core, cumin, clove, cinnamon, galangal to 5 times the total mass of water, steam distillation to extract volatile oil, the time for extracting volatile oil is 9 hours, volatile oil For later use, the chuanxiong, angelica, Cyperus cyperi, black medicine, lychee core, fennel, clove, cinnamon, and galangal dregs after extracting the volatile oil are stored separately, and the medicinal liquid is combined into the water decoction;

(3) After extracting the volatile oil, decoct the medicinal residues of Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, litchi core, cumin, clove, cinnamon, and galangal with water for 4 times, adding water 10 times the total mass of the medicine each time, Decoct for 2 hours each time, filter, and combine the filtrates to form a decoction. The decoction is mixed with Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, litchi core, cumin, cloves, cinnamon, and galangal to extract volatile oils. Combine and concentrate to decoction concentrate with a relative density of 1.15 (65°C);

(4) Add 95% (V/V) ethanol twice the mass (m/m) to the decoction concentrate, stir, let it settle and filter, and recover the ethanol from the filtrate under reduced pressure and concentrate it to a relative density of 1.35 ( 60 ℃) decocted and alcohol-precipitated concentrated extract;

(5) Combine and mix the thickening paste of corydalone with decoction and alcohol precipitation, and use it as a mixed thick paste for later use;

(6) Add the hot-melt pressure-sensitive adhesive 4 times the mass of the mixed thick paste, the volatile oil extracted in step (2), and azone and mix evenly. The amount of azone is 1% of the mass of the hot-melt pressure-sensitive adhesive and the mixed thick paste ( m/m), coating, plus protective layer. Each sticker is 4cm×6cm.

Example 4

A traditional Chinese medicine plaster for treating dysmenorrhea, the weight ratio of raw materials consists of: 15 parts of chuanxiong, 15 parts of angelica, 10 parts of Cyperus cyperi, 10 parts of black medicine, 10 parts of litchi core, 10 parts of fennel, 5 parts of cloves, 5 parts of cinnamon, 5 parts of galangal, 8 parts of Corydalis.

Preparation:

(1) Corydalis crushed through No. 1 sieve, add ethanol to reflux and extract twice, each time add 80% (V/V) ethanol 10 times the mass of Corydalis, reflux for 1.5 hours each time, filter, combine filtrates, and recover under reduced pressure Ethanol and concentrated into Yanhusuo ethanol extraction thick paste, the relative density is 1.32 (70 ℃);

(2) Add chuanxiong, angelica, Cyperus cyperi, wuyao, lychee core, fennel, clove, cinnamon, and galangal with water three times the total mass, and steam distill to extract the volatile oil. The time for extracting the volatile oil is 8 hours. For later use, the chuanxiong, angelica, Cyperus cyperi, black medicine, lychee core, fennel, clove, cinnamon, and galangal dregs after extracting the volatile oil are stored separately, and the medicinal liquid is combined into the water decoction;

(3) After extracting the volatile oil, decoct the medicinal residues of Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, litchi core, fennel, clove, cinnamon, and galangal with water, adding water 7 times the total mass of the drug each time, Decoct for 2 hours each time, filter, and combine the filtrates to form a decoction. The decoction is mixed with Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, litchi core, cumin, cloves, cinnamon, and galangal to extract volatile oils. Combine and concentrate to decoction concentrate with a relative density of 1.12 (75°C);

(4) Add 95% (V/V) ethanol to 1.5 times the mass (m/m) of the decoction concentrated solution and stir, let it settle and filter it, and recover the ethanol from the filtrate under reduced pressure and concentrate it to a relative density of 1.35 ( 65°C) decocted and alcohol-precipitated concentrated extract;

(5) Combine and mix the thickening paste of corydalone with decoction and alcohol precipitation, and use it as a mixed thick paste for later use;

(6) Add the hot-melt pressure-sensitive adhesive 3.5 times the mass of the mixed thick paste, the volatile oil extracted in step (2), and azone and mix evenly. The amount of azone is 2% of the mass of the hot-melt pressure-sensitive adhesive and the mixed thick paste ( m/m), coating, plus protective layer. Each sticker is 4cm×6cm.

Example 5

A traditional Chinese medicine plaster for treating dysmenorrhea, the weight ratio of raw materials consists of: 25 parts of chuanxiong, 25 parts of angelica, 20 parts of Cyperus cyperi, 20 parts of black medicine, 20 parts of litchi core, 20 parts of cumin, 12 parts of cloves, 15 parts of cinnamon, 15 parts of galangal, 18 parts of Corydalis.

Preparation:

(1) Corydalis crushed through No. 1 sieve, added ethanol and refluxed for extraction 3 times, each time adding 75% (V/V) ethanol 6 times the mass of Corydalis, refluxed for 1 hour each time, filtered, combined filtrates, and recovered under reduced pressure Ethanol and concentrated into Yanhusuo ethanol extraction thick paste, the relative density is 1.35 (70 ℃);

(2) Add chuanxiong, angelica, Cyperus cyperi, wuyao, lychee core, cumin, clove, cinnamon, and galangal with 4 times the total mass of water, and steam distillation to extract volatile oil. The time for extracting volatile oil is 6 hours. For later use, the chuanxiong, angelica, Cyperus cyperi, black medicine, lychee core, fennel, clove, cinnamon, and galangal dregs after extracting the volatile oil are stored separately, and the medicinal liquid is combined into the water decoction;

(3) Add water to decoct chuanxiong, angelica, Cyperus cyperi, Wuyao, lychee core, fennel, clove, cinnamon, and galangal dregs after extracting the volatile oil, and add water 6 times the total weight of the drug each time, Boil for 1 hour each time, filter, and combine the filtrates to form a decoction. The decoction is mixed with Chuanxiong, Angelica, Rhizoma Cyperi, Wuyao, litchi core, cumin, cloves, cinnamon, and galangal to extract volatile oils. Combined and concentrated to a decoction concentrate with a relative density of 1.10 (60°C);

(4) Add 95% (V/V) ethanol twice the mass (m/m) to the decoction concentrated solution and stir, let it settle and filter it, and recover the ethanol from the filtrate under reduced pressure and concentrate it to a relative density of 1.32 ( 65°C) decocted and alcohol-precipitated concentrated extract;

(5) Combine and mix the thickening paste of corydalone with decoction and alcohol precipitation, and use it as a mixed thick paste for later use;

(6) Add the mixed thick paste to the hot-melt pressure-sensitive adhesive 4.5 times its mass, the volatile oil extracted in step (2), and azone and mix evenly. The amount of azone is 4% of the mass of the hot-melt pressure-sensitive adhesive and the mixed thick paste ( m/m), coating, plus protective layer. Each sticker is 4cm×6cm.

Example 6

A traditional Chinese medicine plaster for treating dysmenorrhea, the weight ratio of raw materials consists of: 30 parts of chuanxiong, 30 parts of angelica, 25 parts of Cyperus cyperi, 25 parts of black medicine, 25 parts of litchi core, 22 parts of cumin, 15 parts of cloves, 18 parts of cinnamon, 18 parts of galangal, 20 parts of Corydalis.

Preparation method: with embodiment 3.

Example 7

A traditional Chinese medicine plaster for treating dysmenorrhea, the weight ratio of raw materials consists of: 10 parts of Rhizoma Chuanxiong, 10 parts of Angelica sinensis, 9 parts of Cyperus cyperi, 9 parts of black medicine, 9 parts of litchi core, 8 parts of fennel, 3 parts of cloves, 3 parts of cinnamon, 3 parts of galangal, 6 parts of Corydalis.

Preparation method: with embodiment 2.

Example 8

A traditional Chinese medicine plaster for treating dysmenorrhea, the weight ratio of raw materials consists of: 10 parts of Rhizoma Chuanxiong, 30 parts of Angelica, 9 parts of Cyperus Cyperi, 25 parts of Wuyao, 9 parts of Litchi Kernel, 8 parts of Fennel, 3 parts of Clove, 3 parts of cinnamon, 18 parts of galangal, 20 parts of Corydalis.

Preparation method: with embodiment 4.

Example 9

A traditional Chinese medicine plaster for treating dysmenorrhea, the weight ratio of raw materials consists of: 30 parts of Rhizoma Chuanxiong, 10 parts of Angelica, 25 parts of Rhizoma Cyperi, 9 parts of Wuyao, 25 parts of Litchi Kernel, 22 parts of Fennel, 15 parts of Clove, 18 parts of cinnamon, 3 parts of galangal, 6 parts of Corydalis.

Preparation method: with embodiment 5.

animal testing

1. Effects on the rat dysmenorrhea model induced by oxytocin:

Take 50 female rats weighing 180-220g, divide them into 5 groups randomly, and inject diethylstilbestrol subcutaneously for 10 days continuously (1st day: 0.8mg/rat, 2nd-9th day: 0.4mg/rat, 10th day: 0.8mg/rat), on the 6th day of subcutaneous injection of diethylstilbestrol, the administration was as follows: ①The rats in the normal control group were given blank ointment, and 2.16cm ² ointment was given per kilogram of body weight, and applied once a day for a total of 5 days. ② In group 1 of the drug example of the present invention, the rats were respectively given the drug of the example 1 of the present invention, and 2.16 ^cm ointment was given per kilogram of body weight, and applied once a day for 5 days in total. ③ In group 6 of the drug example of the present invention, the rats were respectively given the drug of the example 6 of the present invention, and 2.16 ^cm ointment was given per kilogram of body weight, and applied once a day for a total of 5 days. ④ In the 7th group of the drug example of the present invention, the rats were respectively given the drug of the 7th example of the present invention, and 2.16 ^cm ointment was given per kilogram of body weight, and applied once a day for a total of 5 days. ⑤ In the positive control drug group (Wenjingzhitong ointment group), the rats were given 2.16cm ² Wenjingzhitong ointment per kilogram of body weight, applied once a day, and administered continuously for 5 days. 24 hours after the last administration of diethylstilbestrol, and 45 minutes after applying the ointment, intraperitoneal injection of oxytocin 2μ/rat, then record the latency period and number of writhing reactions of the rats within 30 minutes after the injection of oxytocin, and calculate the inhibition rate. The results were statistically processed between groups, as shown in Table 1.

Table 1. Effect of the medicine of the present invention on the rat dysmenorrhea model caused by oxytocin

Note: Compared with normal control group, *P<0.05, **P<0.01, ***P<0.001

Table 1 result shows: after intraperitoneal injection of oxytocin can cause the writhing reaction of rats, the high, middle and low doses of the medicine of the present invention can obviously prolong the latency period of oxytocin-induced rats' writhing reaction, and reduce the number of times of writhing in 30 minutes All have extremely significant difference compared with normal control group, illustrate that medicine of the present invention has better analgesic effect to rat dysmenorrhea model.

2. The effect on the pain-inducing effect of the hot plate method in mice:

Several healthy female mice weighing 18-20 g were taken, and 50 mice whose pain threshold was between 5 and 30 seconds were screened out on a hot plate before the test, and were randomly divided into 5 groups. Administer according to the following methods: ① normal control mice were given blank ointment, and ^3.12cm ointment was given per kilogram of body weight, and applied once a day for a total of 3 days. ② In group 1 of the drug example of the present invention, the mice were respectively given the drug of the example 1 of the present invention, and ^a 3.12 cm ointment was given per kilogram of body weight, and applied once a day for a total of 3 days. ③ In group 6 of the drug embodiment of the present invention, the mice were given the drug of the embodiment 6 of the present invention respectively, and were given 3.12 ^cm ointment per kilogram of body weight, and applied once a day for a total of 3 days. ④ In the 7th group of the drug example of the present invention, the mice were respectively given the drug of the 7th example of the present invention, and the ointment was given to ^3.12 cm per kilogram of body weight, and applied once a day for a total of 3 days. ⑤ In the positive control drug group (Wenjingzhitong ointment group), the mice were given ^3.12cm2 of Wenjingzhitong ointment per kilogram of body weight, applied once a day, and administered continuously for 3 days. The pain thresholds of 30 minutes, 60 minutes, 90 minutes, and 120 minutes after the last medicine were measured by hot plate apparatus, and the results were statistically processed between groups. The results are shown in Table 2 and Attached Table 2.

Table 2. The analgesic effect of medicine of the present invention to hot plate method mouse

Note: Compared with normal control group, *P<0.05, **P<0.01, ***P<0.001

Attached table 2. The analgesic effect of medicine of the present invention on hot plate method mouse

Note: Compared with normal control group, *P<0.05, **P<0.01, ***P<0.001

By table 2 and continuation table 2 result as seen, the pain threshold value of different time after medicine of the present invention is all improved in various degrees with pre-drug comparison, compares with normal control group, the pain threshold value of each time period has difference in various degrees, shows that this invention The invented drug has a good analgesic effect on hot plate mice.

Experimental results show that the medicine of the present invention has a better therapeutic effect on animal models of dysmenorrhea, can increase the pain threshold, and effectively improve pain symptoms.

Clinical Trials

Clinical observation and summary of 45 cases of primary dysmenorrhea were carried out by applying the traditional Chinese medicine of the present invention, and better clinical curative effect was obtained. General clinical information: 45 cases are outpatients, the youngest is 17 years old, the oldest is 22 years old, and the average age is 19 years old.

one. Diagnostic criteria:

Women who have periodic lower abdominal pain during menstruation, accompanied by other discomforts, so as to affect work and life; gynecological examination without obvious organic lesions; occur in adolescent girls or young women who have not given birth 2 to 3 years after menarche.

Criteria for inclusion of cases: Those who meet the diagnostic criteria of traditional Chinese medicine with cold coagulation and blood stasis syndrome can be included in the experimental cases.

Criteria for excluded cases: those who did not meet the diagnostic criteria of traditional Chinese medicine; those who were found to have organic lesions of the genital organs by gynecological examination; those who were allergic or allergic to multiple drugs; Those who affect the judgment of efficacy or safety.

two. Observation indicators:

Safety observation: general physical examination items; blood, urine, and stool routine tests; heart, liver, and kidney function tests.

Curative effect observation: related symptoms and signs; changes in tongue and pulse conditions.

Efficacy Judgment Criteria:

Recovery: Abdominal pain and other symptoms disappeared after treatment, and there was no recurrence in 3 menstrual cycles after drug withdrawal.

Markedly effective: Abdominal pain was significantly relieved, and other symptoms disappeared or alleviated.

Effective: Pain relief, other symptoms improved.

Ineffective: Abdominal pain and other symptoms did not change.

3. Treatment method: Each paste is 4cm×6cm, and it is pasted on Shenque acupoint 2-3 days before menstruation, 1 paste per day. Continuous use for 3 menstrual cycles.

4. Treatment effect:

Among the 45 cases, 20 cases were cured, accounting for 44.4%; 18 cases were markedly effective, accounting for 40.0%; 5 cases were effective, accounting for 11.1%; 2 cases were ineffective, accounting for 4.4%, the total effective rate was 95.5%.

Detection of safety indicators: In the clinical observation, blood routine, urine routine, liver and kidney function tests were performed on 20 patients before and after treatment, and the results showed that there were no abnormalities in the indicators before and after treatment in the 20 patients.

Adverse reactions: no obvious toxic side effects and adverse reactions.

Claims (8)

1. Chinese medicine plaster of treating dysmenorrhea; It is characterized in that its raw material medicines in portions by weight ratio consists of: Rhizoma Chuanxiong 10-30 part, Radix Angelicae Sinensis 10-30 part, Rhizoma Cyperi 9-25 part, Radix Linderae 9-25 part, Semen Litchi 9-25 part, Fructus Foeniculi 8-22 part, Flos Caryophylli 3-15 part, Cortex Cinnamomi 3-18 part, Rhizoma Alpiniae Officinarum 3-18 part, Rhizoma Corydalis 6-20 part.

2. the Chinese medicine plaster of treatment dysmenorrhea according to claim 1; It is characterized in that its raw material medicines in portions by weight ratio consists of: Rhizoma Chuanxiong 15-25 part, Radix Angelicae Sinensis 15-25 part, Rhizoma Cyperi 10-20 part, Radix Linderae 10-20 part, Semen Litchi 10-20 part, Fructus Foeniculi 10-20 part, Flos Caryophylli 5-12 part, Cortex Cinnamomi 5-15 part, Rhizoma Alpiniae Officinarum 5-15 part, Rhizoma Corydalis 8-18 part.

3. the Chinese medicine plaster of treatment dysmenorrhea according to claim 2; It is characterized in that its raw material medicines in portions by weight ratio consists of: Rhizoma Chuanxiong 18-22 part, Radix Angelicae Sinensis 18-22 part, Rhizoma Cyperi 12-18 part, Radix Linderae 12-18 part, Semen Litchi 12-18 part, Fructus Foeniculi 12-18 part, Flos Caryophylli 6-10 part, Cortex Cinnamomi 8-12 part, Rhizoma Alpiniae Officinarum 5-15 part, Rhizoma Corydalis 9-15 part.

4. the method for preparing of the Chinese medicine plaster of any described treatment dysmenorrhea of claim 1-3 is characterized in that, comprises the steps:

(1) Rhizoma Corydalis was pulverized sieve No. one, added alcohol reflux, filtered, and reclaimed ethanol, and be condensed into relative density when being 60-75 ℃ the thick paste of 1.25-1.35 subsequent use;

(2) Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Linderae, Semen Litchi, Fructus Foeniculi, Flos Caryophylli, Cortex Cinnamomi, Rhizoma Alpiniae Officinarum are used water vapour distillation volatile oil, volatile oil is subsequent use, and medicinal residues are deposited in addition, and combining medicine is in postorder decocting liquid;

(3) will extract Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Linderae, Semen Litchi, Fructus Foeniculi, Flos Caryophylli, Cortex Cinnamomi, Rhizoma Alpiniae Officinarum medicinal residues behind the volatile oil, decocte with water and with step (2) combining medicine, be condensed into the concentrated solution of relative density 1.05-1.15 when being 65-80 ℃;

(4) concentrated solution is added ethanol and stir, leave standstill, deposition filters, filtrate recycling ethanol and when being condensed into 60-80 ℃ the thick paste of 1.25-1.35 subsequent use;

(5) the Rhizoma Corydalis alcohol extraction thick paste of step (1) and the water decoction-alcohol sedimentation of step (4) are concentrated thick paste merging mixing, subsequent use for mixing thick paste;

(6) with pressure sensitive adhesive and the volatile oil, the Percutaneous absorption enhancer mixing that mix thick paste, step (2) extraction, coating adds protective layer.

5. the method for preparing of the Chinese medicine plaster of treatment dysmenorrhea according to claim 4 is characterized in that, comprises the steps:

(1) the Rhizoma Corydalis powder is added alcohol reflux 2-4 time; Each ethanol that adds Rhizoma Corydalis quality 5-12 volumetric concentration 60%-85% doubly; Each backflow 0.5-2 hour, filter merging filtrate; Decompression recycling ethanol also is condensed into Rhizoma Corydalis ethanol extraction thick paste, 1.25-1.35 when relative density is 60-75 ℃;

(2) Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Linderae, Semen Litchi, Fructus Foeniculi, Flos Caryophylli, Cortex Cinnamomi, Rhizoma Alpiniae Officinarum are added its gross mass 3-5 water doubly; Vapor distillation extracts volatile oil; The time of extracting volatile oil is 5-9 hour; Volatile oil is subsequent use, and Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Linderae, Semen Litchi, Fructus Foeniculi, Flos Caryophylli, Cortex Cinnamomi, Rhizoma Alpiniae Officinarum medicinal residues behind the extraction volatile oil are deposited in addition, and combining medicine is in postorder decocting liquid;

Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Linderae, Semen Litchi, Fructus Foeniculi, Flos Caryophylli, Cortex Cinnamomi, the Rhizoma Alpiniae Officinarum that (3) will extract behind the volatile oil merge; Decocte with water 2-4 time; Each medicine gross mass 6-10 water doubly that adds decocted 1-2 hour at every turn, filtered; Merging filtrate; Be decocting liquid, decocting liquid and Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Cyperi, the Radix Linderae, Semen Litchi, Fructus Foeniculi, Flos Caryophylli, Cortex Cinnamomi, Rhizoma Alpiniae Officinarum extract the combining medicine behind the volatile oil, the water drug-decocting concentrating liquid of 1.05-1.15 when being concentrated into relative density and being 65-80 ℃;

(4) ethanol that water drug-decocting concentrating liquid is added water drug-decocting concentrating liquid quality 1.5-2 volumetric concentration 95% doubly stirs, and staticly settles and filters, the water decoction-alcohol sedimentation concentrated extract of 1.25-1.35 with decompression filtrate recycling ethanol and when being concentrated into relative density and being 60-80 ℃;

(5) Rhizoma Corydalis alcohol extraction thick paste and water decoction-alcohol sedimentation concentrated extract are merged mixing, subsequent use for mixing thick paste;

(6) pressure sensitive adhesive is mixed volatile oil, the Percutaneous absorption enhancer mixing that thick paste, step (2) extract with step (5), coating adds protective layer.

6. according to the method for preparing of the Chinese medicine plaster of claim 4 or 5 described treatment dysmenorrheas, it is characterized in that step (6) Percutaneous absorption enhancer is an azone, pressure sensitive adhesive is a hot-fusible pressure-sensitive adhesive.

7. according to the method for preparing of the Chinese medicine plaster of claim 4 or 5 described treatment dysmenorrheas, it is characterized in that, the consumption of pressure sensitive adhesive for the 3-5 that mixes the thick paste quality doubly, the Percutaneous absorption enhancer consumption is pressure sensitive adhesive and the 1-5% that mixes the thick paste gross mass.

8. according to the method for preparing of the Chinese medicine plaster of claim 4 or 5 described treatment dysmenorrheas, it is characterized in that the per 100 square centimeters of include mixed thick paste amounts of plaster are 1.2g-2.0g.