CN110538255A - Traditional Chinese medicine composition for treating hyperplasia of mammary glands and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating hyperplasia of mammary glands and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating hyperplasia of mammary glands, which is prepared from the following components in parts by weight: 1-60 parts of snakegourd fruit, 1-60 parts of orange leaf, 1-15 parts of vinegar green tangerine peel, 1-15 parts of dried orange peel, 1-60 parts of barbed skullcap herb, 1-60 parts of wild chrysanthemum flower, 1-60 parts of processed rhizoma arisaematis, 1-60 parts of vinegar rhizoma cyperi, 0-15 parts of perilla leaf and 0-60 parts of pseudo-ginseng; and a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition has the advantages of definite curative effect, quick response, no toxic or side effect and the like.
Description
Technical Field
The invention relates to the field of traditional Chinese medicines. More specifically, the invention relates to a traditional Chinese medicine composition for treating hyperplasia of mammary glands and a preparation method and application thereof.
Background
The hyperplasia of mammary glands is a common disease of gynecology, is better than middle-aged women at the age of 25-39 years, is characterized in that different parts of breasts grow singly or frequently to form a lump, the texture is soft, the boundary is unclear, the breasts are movable and often accompanied by pains of different degrees, especially before menstruation, after fatigue or emotional fluctuation such as qi generation (Chinese medicine called qi depression), the lump is enlarged and the pain is aggravated, and after the menstruation, the lump is obviously reduced and the pain is relieved, the pain is generally distending pain and rarely stabbing pain.
In recent years, the incidence of mammary gland hyperplasia tends to increase year by year, and the age of the mammary gland is getting lower. About 70% to 80% of women are investigated to have different degrees of hyperplasia of mammary glands. The actual cause of the disease is not clear and may be related to imbalances in the hormone levels in the body or greater sensitivity of the mammary tissue to sex hormones.
The existing traditional Chinese medicine for treating hyperplasia of mammary glands has the disadvantages of unobvious treatment effect, slow effect, long-term pain of a large number of patients, no relief for years and poor life quality.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating hyperplasia of mammary glands and a preparation method and application thereof, and the traditional Chinese medicine composition has the advantages of simple preparation method, convenient taking, exact curative effect and no toxic or side effect.
In order to achieve the objects and other advantages according to the present invention, there is provided a Chinese medicinal composition for treating mammary gland hyperplasia, comprising the following components in parts by weight: 1-60 parts of snakegourd fruit, 1-60 parts of orange leaf, 1-15 parts of vinegar green tangerine peel, 1-15 parts of dried orange peel, 1-60 parts of barbed skullcap herb, 1-60 parts of wild chrysanthemum flower, 1-60 parts of processed rhizoma arisaematis, 1-60 parts of vinegar rhizoma cyperi, 0-15 parts of perilla leaf and 0-60 parts of pseudo-ginseng.
Wherein, trichosanthes: sweet, slightly bitter and cold, entering lung, stomach and large intestine meridians. Clear heat and remove phlegm, relieve chest stuffiness and dissipate nodulation, moisten dryness and smooth intestines. Can be used for treating cough due to lung heat, turbid phlegm, thoracic obstruction, cardialgia, distention and fullness in chest, acute mastitis, pulmonary abscess, intestinal abscess swelling and pain, and constipation.
Orange leaves: bitter; and (6) cooling. Soothing liver, moving qi, resolving phlegm, and removing toxic swelling. It is indicated for hypochondriac pain, acute mastitis, pulmonary abscess, cough, fullness and distention in chest and diaphragm, and hernia.
green tangerine peel: bitter and pungent in flavor and warm in nature. It enters liver, gallbladder and stomach meridians. Has the effects of soothing liver, breaking qi, removing food retention and resolving stagnation. Can be used for treating distending pain in chest and hypochondrium, hernia pain, nodules of breast, mammary abscess, food stagnation, qi stagnation, and abdominal pain.
Dried orange peel: bitter and pungent in flavor and warm in nature. It enters lung and spleen meridians. Regulate qi to invigorate spleen, dry dampness and resolve phlegm. Can be used for treating abdominal distention, anorexia, vomiting, diarrhea, cough, and excessive phlegm.
Barbed skullcap herb: pungent and even. Has the effects of clearing away heat and toxic materials, promoting blood circulation, dispelling blood stasis, relieving swelling and pain, and preventing cancer; treating appendicitis, hepatitis, stomach ache, early hepatocarcinoma, lung cancer, cervical cancer, mastitis, etc.; it can be used for treating pain, furuncle, traumatic injury, and swelling and pain.
Wild chrysanthemum flower: bitter, pungent and cool in taste, has the effects of clearing away heat and toxic materials, dispelling pathogenic wind and heat, removing blood stasis, improving eyesight, and lowering blood pressure. It can be used for preventing and treating epidemic cerebrospinal meningitis, influenza, hypertension, hepatitis, dysentery, carbuncle, furuncle, and sore.
Rhizoma arisaematis: bitter, pungent and warm. Is toxic. It enters lung, liver and spleen meridians. Dry dampness and resolve phlegm, and can be used for treating cold phlegm, damp phlegm, cough, chest distress, etc. Dispel wind and relieve spasm, and can be used for wind-phlegm syndrome such as vertigo, apoplexy, phlegm stagnation, epilepsy and tetanus. Externally used, it can dissipate nodulation and relieve swelling, and is indicated for abscess, deep rooted carbuncle, phlegm nodule, arthralgia and other symptoms. Can be used for treating cancer, hyperlipidemia, heel pain, herpes zoster, and hordeolum.
Rhizoma cyperi: pungent, slightly bitter, slightly sweet and neutral. It enters liver, spleen and triple energizer meridians. To soothe the liver, relieve depression, regulate qi, relieve epigastric distention, regulate menstruation and alleviate pain. Can be used for treating stagnation of qi due to depression of the liver, distending pain in chest and hypochondrium, hernia pain, breast pain, stagnation of qi in spleen and stomach, abdominal distention, fullness and pain, menoxenia, amenorrhea, and dysmenorrhea.
And (3) perilla leaves: pungent flavor and entering the lung meridian of Taiyin. Descending and rushing reversely to expel turbidity, and eliminating stagnation to dissipate nodulation. Can be used for treating exterior wind-cold, relieving asthma and cough, eliminating carbuncle and swelling, relieving injury, stopping bleeding, and removing crab toxin.
Pseudo-ginseng: sweet, slightly bitter and warm. It enters liver and stomach meridians. Disperse blood stasis, stop bleeding, resolve swelling and alleviate pain. Can be used for treating hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic hemorrhage, thoracico-abdominal pain, and traumatic swelling and pain.
Preferably, the traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following components in parts by weight: 1-20 parts of snakegourd fruit, 1-20 parts of orange leaf, 1-5 parts of vinegar green tangerine peel, 1-5 parts of dried orange peel, 1-20 parts of barbed skullcap herb, 1-20 parts of wild chrysanthemum flower, 1-20 parts of processed rhizoma arisaematis and 1-20 parts of vinegar rhizoma cyperi.
Preferably, the traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following components in parts by weight: 8 parts of snakegourd fruit, 8 parts of tangerine leaf, 2 parts of vinegar green tangerine peel, 2 parts of tangerine peel, 8 parts of barbed skullcap herb, 8 parts of wild chrysanthemum flower, 8 parts of processed rhizoma arisaematis and 8 parts of vinegar rhizoma cyperi.
The invention also provides a preparation method of the traditional Chinese medicine composition for treating hyperplasia of mammary glands, which comprises the following steps:
A. weighing the components according to the formula amount, adding water which is 10 times of the total weight of the components, decocting for 2 times, each time for 1-2h, filtering, combining filtrates of the two times, and sieving the filtrate with a 80-mesh sieve to obtain a primary extract;
B. ultrafiltering the primary extract with ultrafiltration column with cut-off molecular weight of 5000-.
Preferably, the preparation method of the traditional Chinese medicine composition for treating hyperplasia of mammary glands further comprises the following steps of pretreating the components before adding water in the step A, wherein the steps are as follows: weighing the components according to the formula amount, placing the components into a stainless steel container, adding a sodium bicarbonate solution which is 3 times of the weight of each component into the stainless steel container, uniformly mixing, soaking at room temperature for 12 hours, then placing the stainless steel container at-18 ℃ for freezing for 12 hours, taking out the stainless steel container, placing the stainless steel container into an oven at 80 ℃ for drying for 4 hours, taking out, after the stainless steel container is cooled, adding the sodium bicarbonate solution which is 3 times of the weight of each component into the stainless steel container again, and repeating the soaking, freezing and drying processes once, wherein the mass concentration of the sodium bicarbonate solution is 9%, and the thickness of each component in the stainless steel container is 5 cm.
Preferably, the preparation method of the traditional Chinese medicine composition for treating hyperplasia of mammary glands further comprises the step of adding pharmaceutically acceptable auxiliary materials into the traditional Chinese medicine composition to prepare traditional Chinese medicine oral liquid, mixture, granules, tablets, capsules, soft capsules or pellets.
The preparation method of the oral liquid comprises the following steps: and D, adding a proper amount of purified water into the traditional Chinese medicine composition prepared in the step B for dilution, fixing the volume, sterilizing and filling to obtain the traditional Chinese medicine composition. The preparation method of the mixture comprises the following steps: and C, aseptically packaging the traditional Chinese medicine composition prepared in the step B to obtain the traditional Chinese medicine composition. The preparation method of the granules comprises the following steps: and C, concentrating and drying the traditional Chinese medicine composition prepared in the step B, adding proper auxiliary materials and 85% ethanol, granulating, drying and finishing granules to obtain the traditional Chinese medicine composition. The preparation method of the tablet comprises the following steps: and C, concentrating and drying the traditional Chinese medicine composition prepared in the step B, crushing, adding a proper amount of auxiliary materials, metering according to 0.2-0.3 g/tablet, and preparing into a round or other tablet dosage form according to a tablet processing and preparing method. The preparation method of the capsule comprises the following steps: and C, concentrating and drying the traditional Chinese medicine composition prepared in the step B, crushing, adding a proper amount of auxiliary materials, metering according to 0.2-0.3 g/granule, and preparing into a capsule preparation according to a capsule processing and preparing method. The preparation method of the soft capsule comprises the following steps: and C, concentrating the traditional Chinese medicine composition prepared in the step B to prepare a liquid medicine, mixing the liquid medicine with a soft capsule material mainly comprising gelatin, respectively flowing out at different speeds from the outer layer and the inner layer of the double-layer dropper, enabling a quantitative liquid medicine to be wrapped by a quantitative liquid medicine, dripping the liquid medicine into a cooling liquid immiscible with the liquid medicine, forming a spherical shape under the action of surface tension, gradually cooling and solidifying to form a soft capsule. The preparation method of the pellet comprises the following steps: and C, concentrating and drying the traditional Chinese medicine composition prepared in the step B, crushing, adding auxiliary material powder, uniformly mixing, adding an adhesive to prepare a soft material, sieving and granulating, rolling in a coating pot to prepare small balls, and coating to obtain the required pellets.
the invention also provides application of the traditional Chinese medicine composition for treating hyperplasia of mammary glands in preparing a medicine for treating hyperplasia of mammary glands, postoperative recurrence of breast cancer and postoperative scar pain.
the invention at least comprises the following beneficial effects:
Firstly, the traditional Chinese medicine composition has reasonable formula, and all the components have synergistic effect and supplement each other. The snakegourd fruit clears heat and removes phlegm, relieves chest stuffiness and stagnation, and moistens dryness and smoothes intestines; orange leaf is bitter in property, is flat, soothes liver, promotes qi circulation, reduces phlegm, eliminates swelling and toxin, treats hypochondriac pain, acute mastitis, pulmonary abscess, cough, fullness in chest and diaphragm, hernia and the like, and is a monarch drug together; pericarpium Citri Reticulatae viride and pericarpium Citri Reticulatae can sooth liver, regulate qi, resolve phlegm and relieve depression; folium Perillae, descending the adverse flow of qi to expel turbidity, eliminating stagnation and dispersing accumulation, is used as ministerial drug; sculellaria barbata and wild chrysanthemum are pungent and bitter in flavor, enter lung and liver channels, clear heat and remove toxicity, dispel wind and calm liver; rhizoma arisaematis has effects of eliminating dampness and phlegm, dispelling pathogenic wind and relieving spasm, resolving hard mass and subsiding swelling; the nutgrass galingale rhizome regulates qi, relieves stagnation, relieves pain and regulates menstruation, and is used for treating liver-stomach disharmony, qi depression, distending pain of chest, abdomen and hypochondrium, phlegm and fluid retention and fullness; notoginseng radix, radix Notoginseng, used as adjuvant drug, has the effects of removing blood stasis, stopping bleeding, relieving swelling and alleviating pain. The whole formula has the effects of clearing away heat and toxic materials, regulating qi and relieving swelling. Pharmacological experiments prove that the formula of the traditional Chinese medicine composition accords with the traditional Chinese medicine principle and the pathological characteristics of patients suffering from hyperplasia of mammary glands or postoperative recurrence of breast cancer and postoperative scar pain, has the effects of regulating qi, resolving masses, detoxifying and relieving pain, and can be used for preparing medicines for treating hyperplasia of mammary glands, postoperative recurrence of breast cancer, postoperative scar pain and the like.
Secondly, the components of the traditional Chinese medicine composition are traditional Chinese medicinal materials, so that the traditional Chinese medicine composition is easy to obtain medicine sources, low in cost, capable of relieving the burden of patients and free of toxic and side effects; the raw materials of the traditional Chinese medicine composition can be prepared into preparations such as mixture, oral liquid, granules, tablets, capsules, soft capsules, pellets and the like through extraction and concentration, and are convenient to take.
Thirdly, when the traditional Chinese medicine composition is prepared, all the components are soaked in the sodium bicarbonate solution and then are frozen, thawed and dried, on one hand, the components can be fully swelled and degraded moderately by the alkalescent sodium bicarbonate solution, so that the porosity of all the components is increased, on the other hand, the sodium bicarbonate is heated and decomposed in the drying process to generate carbon dioxide gas, so that the inside of cells of all the components is locally sprayed and exploded, and the freezing and thawing processes are matched, so that the wall breaking rate of all the components is greatly improved, the synergistic effect of the components is achieved, and the content of effective components and the treatment effect of the traditional Chinese medicine composition are improved.
Additional advantages, objects, and features of the invention will be set forth in part in the description which follows and in part will become apparent to those having ordinary skill in the art upon examination of the following or may be learned from practice of the invention.
Detailed Description
the present invention is further described in detail below with reference to examples so that those skilled in the art can practice the invention with reference to the description.
It is to be noted that the experimental procedures described in the following examples are conventional ones unless otherwise specified, and the reagents and materials described therein are commercially available without otherwise specified.
Example 1:
The traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following components: 100g of snakegourd fruit, 100g of tangerine leaf, 100g of green tangerine peel with vinegar, 100g of tangerine peel, 100g of barbed skullcap herb, 100g of wild chrysanthemum flower, 100g of rhizoma arisaematis preparata and 100g of nutgrass galingale rhizome with vinegar.
The preparation method of the traditional Chinese medicine composition for treating hyperplasia of mammary glands comprises the following steps:
A. Weighing the components according to the formula amount, adding 8000g of water, decocting for 2 times, each time for 1-2h, filtering, combining the filtrates, and sieving the filtrate with a 80-mesh sieve to obtain a primary extract;
B. ultrafiltering the primary extract with ultrafiltration column with cut-off molecular weight of 5000-.
Example 2:
The traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following components: 60g of snakegourd fruit, 60g of tangerine leaf, 15g of green tangerine peel with vinegar, 15g of tangerine peel, 60g of barbed skullcap herb, 60g of wild chrysanthemum flower, 60g of prepared arisaema tuber, 60g of nutgrass galingale rhizome with vinegar, 15g of perilla leaf and 60g of pseudo-ginseng.
The preparation method of the traditional Chinese medicine composition for treating hyperplasia of mammary glands comprises the following steps:
A. Weighing the components according to the formula amount, adding 4650g of water, decocting for 2 times, each time for 1-2h, filtering, combining the two filtrates, and sieving the filtrate with a 80-mesh sieve to obtain a primary extract;
B. Ultrafiltering the primary extract with ultrafiltration column with cut-off molecular weight of 5000-.
Example 3:
The traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following components in parts by weight: 100g of snakegourd fruit, 100g of tangerine leaf, 25g of green tangerine peel with vinegar, 25g of tangerine peel, 100g of barbed skullcap herb, 100g of wild chrysanthemum flower, 100g of rhizoma arisaematis preparata and 100g of nutgrass galingale rhizome with vinegar.
The preparation method of the traditional Chinese medicine composition for treating hyperplasia of mammary glands comprises the following steps:
A. weighing the components according to the formula amount, adding 6500g of water, decocting for 2 times, each time for 1-2h, filtering, combining the filtrates, and sieving the filtrate with a 80-mesh sieve to obtain a primary extract;
B. Ultrafiltering the primary extract with ultrafiltration column with cut-off molecular weight of 5000-.
Example 4:
The traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following components in parts by weight: 80g of snakegourd fruit, 80g of tangerine leaf, 20g of green tangerine peel with vinegar, 20g of tangerine peel, 80g of barbed skullcap herb, 80g of wild chrysanthemum flower, 80g of prepared arisaema tuber and 80g of nutgrass galingale rhizome with vinegar.
The preparation method of the traditional Chinese medicine composition for treating hyperplasia of mammary glands comprises the following steps:
A. Weighing the components according to the formula amount, adding 5200g of water, decocting for 2 times, each time for 1-2h, filtering, mixing filtrates, and sieving the filtrate with 80 mesh sieve to obtain primary extractive solution;
B. Ultrafiltering the primary extract with ultrafiltration column with cut-off molecular weight of 5000-.
Adding appropriate amount of purified water into the obtained Chinese medicinal composition, diluting to a constant volume of 2000ml, mixing, sterilizing, and bottling to obtain 10ml oral liquid.
example 5:
The traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following components in parts by weight: 80g of snakegourd fruit, 80g of tangerine leaf, 20g of green tangerine peel with vinegar, 20g of tangerine peel, 80g of barbed skullcap herb, 80g of wild chrysanthemum flower, 80g of prepared arisaema tuber, 80g of nutgrass galingale rhizome with vinegar and 10g of perilla leaf.
The preparation method of the traditional Chinese medicine composition for treating hyperplasia of mammary glands comprises the following steps:
A. Weighing the components according to the formula amount, adding 5300g of water, decocting for 2 times, each time for 1-2 hours, filtering, combining filtrates, and sieving the filtrate with a 80-mesh sieve to obtain a primary extract;
B. Ultrafiltering the primary extract with ultrafiltration column with cut-off molecular weight of 5000-.
Adding appropriate amount of purified water into the obtained Chinese medicinal composition, diluting to a constant volume of 2000ml, mixing, sterilizing, and bottling to obtain 10ml oral liquid.
example 6:
The traditional Chinese medicine composition for treating hyperplasia of mammary glands is prepared from the following components in parts by weight: 80g of snakegourd fruit, 80g of tangerine leaf, 20g of green tangerine peel with vinegar, 20g of tangerine peel, 80g of barbed skullcap herb, 80g of wild chrysanthemum flower, 80g of prepared arisaema tuber and 80g of nutgrass galingale rhizome with vinegar.
The preparation method of the traditional Chinese medicine composition for treating hyperplasia of mammary glands comprises the following steps:
A. Weighing the components according to the formula weight, placing the components into a stainless steel container, adding 1560g of sodium bicarbonate solution into the stainless steel container, uniformly mixing, soaking at room temperature for 12h, then placing the stainless steel container at-18 ℃ for freezing for 12h, taking out the stainless steel container, placing the stainless steel container in an oven at 80 ℃ for drying for 4h, taking out, after the stainless steel container is cooled, adding 1560g of the sodium bicarbonate solution into the stainless steel container again, and repeating the soaking, freezing and drying processes once, wherein the mass concentration of the sodium bicarbonate solution is 9%, and the thickness of each component in the stainless steel container is 5 cm;
B. Adding 5200g of water into the stainless steel container, decocting for 2 times, each time for 1.5h, filtering, mixing filtrates, and sieving with 80 mesh sieve to obtain primary extractive solution;
C. Ultrafiltering the primary extract with ultrafiltration column with cut-off molecular weight of 5000-.
Adding appropriate amount of purified water into the obtained Chinese medicinal composition, diluting to a constant volume of 2000ml, mixing, sterilizing, and bottling to obtain 10ml oral liquid.
Drug toxicity test
1. Laboratory animal
Kunming mice with the weight of 18-22g are selected, half of the mice are female and half of the mice are male, the mice are fed freely, and the mice are raised in a conventional mode.
2. acute toxicity test
LD50 (modified kouyama method) was measured in the oral acute toxicity test of the oral liquid prepared in example 6 of the present invention to mice. 40 mice were randomly divided into 4 groups of 10 mice each, and the mice were raised in cages with half each of the males and females. The preparation is administered by oral gavage at clinical dosage of 5, 10, 25, and 50 times daily dosage. Mice were observed and recorded for ingestion, drinking, respiration, activity and death after dosing for 15 days. The dead mice and mice sacrificed at the end of observation were subjected to a necropsy, and abnormal tissues or organs were examined for pathology.
3. Long term toxicity test
80 mice were selected, half female and half male. Each group had 20 animals, and was randomly divided into 4 groups of high dose, medium dose, low dose and blank control, which were raised in cages. Mice were gavaged with 10, 20, and 50 times daily dose of clinical adults, and the test group was gavaged with the oral liquid concentrate prepared in example 6 of the present invention, and the blank control group was given distilled water of the same volume for 2 times/d for 15 consecutive weeks. Daily observations record general conditions of mice such as feeding, behavioral activity, feces, etc. The body mass was weighed 1 time per week. After the last administration for 24 hours, 5 mice in each group were selected, anesthetized by intraperitoneal injection of 10% chloral hydrate, and the animals were sacrificed to dissect and observe the change of organs. The results were statistically processed and compared for significance of differences between groups by t-test.
4. Results
Acute toxicity test: the condition of mice in each dose group has not been changed obviously: there were no abnormalities in physical appearance, behavioral activity, diet, respiration, and feces, and none died.
Long-term toxicity test: the condition of mice in each dose group has not been changed obviously: no abnormalities in physical signs, behavioral activities, diet, respiration and feces were observed, and none of the animals died. After continuous administration for 15 weeks, the body mass of the mice in the high, medium and low dose groups is normally increased, and compared with a blank control group, the body mass change is not obviously different.
clinical trial
The control group was strictly established according to the design scheme of parallel, random, control experiment, and the clinical efficacy of the oral liquid prepared in examples 4, 5, and 6 was observed.
selection of pathology
1 diagnostic criteria
Diagnosis standard of hyperplasia of mammary glands: the Western diagnosis standard refers to the Chinese preventive medicine society, women's health care division, mammary gland health care and mammary gland disease prevention and treatment group (consensus of mammary gland hyperplasia diagnosis and treatment experts, China's journal of Utility surgery 2016, 7, 36, 7). Pathological examination is the gold standard for diagnosing benign and malignant diseases of the breast. The traditional Chinese medicine diagnosis standard is as follows: liver qi stagnation, qi stagnation and blood stasis (1997, national standard of the people's republic of China-the term "clinical diagnosis and treatment of Chinese medicine" in 1997).
2. Test pathological criteria
inclusion cases: the diagnosis of Western medicine accords with the diagnosis standard of hyperplasia of mammary glands, postoperative recurrence of breast cancer and postoperative scar pain and belongs to the remission stage, the diagnosis of Chinese medicine syndrome differentiation accords with liver qi depression, qi stagnation and blood stasis of adults between the ages of 18 and 75 years, and patients with informed consent can be brought into test cases.
Excluding cases: (1) patients in acute exacerbation; (2) the syndrome differentiation of the traditional Chinese medicine does not belong to the patients with liver qi stagnation, qi stagnation and blood stasis; (3) people with age below 18 years and over 75 years, pregnant women or lactating women, who are allergic to the medicine; (4) patients with severe heart failure and heart function of grade IV should not be taken into the test cases; (5) if the patient does not meet the inclusion criteria, is not taking the medicine according to the regulations, cannot judge the curative effect or the data is not complete, the judgment of the curative effect is affected.
The statistical method comprises the following steps: the data is tested by chi-square method, the quantitative index conforms to the t test for normal distribution, and the quantitative index does not conform to the sum of rank test for normal distribution.
Second, test method
1. The grouping method comprises the following steps: random and control experiments are adopted for observation, a random control grouping method is adopted for the cases brought into the test, a treatment group 1, a treatment group 2, a treatment group 3 and a control group are found out on a random table, and the four groups of cases are ensured to be close to each other in terms of sex, age, course of disease and the like.
2. the total number of cases was not less than 120, with treatment group 1: 30 cases, treatment group 2: 30 cases, treatment group 3: 30 cases, control group: 30 cases.
3. Method of treatment
(1) Treatment groups: the basic treatment is the same as a control group, and the oral liquid prepared in the embodiment 4-6 of the invention is taken at the same time for oral treatment, the usage is 20ml each time, three times a day, three months of treatment course and 1 year follow-up visit, wherein the oral liquid prepared in the embodiment 4 is taken in the treatment group 1, the oral liquid prepared in the embodiment 5 is taken in the treatment group 2, and the oral liquid prepared in the embodiment 6 is taken in the treatment group 3.
(2) Control group: the Xiaojin pill is taken 20-50 times a day 2 times by using the method. The treatment course is three months, and the follow-up visit is 1 year.
4. Criteria for efficacy assessment
(1) The effect is displayed; the physical fitness is enhanced, the physical strength is recovered, and symptoms such as chest distress, chest pain, dyspnea and the like are obviously relieved;
(2) The method has the following advantages: the symptoms of physical fitness enhancement, chest distress, chest pain, dyspnea and the like are relieved;
(3) And (4) invalidation: no change in symptoms.
5. the results of the treatment are shown in Table 1
TABLE 1
| Treatment group 1 | Treatment group 2 | treatment group 3 | control group | |
| number of examples | 30 | 30 | 30 | 30 |
| Age (age) | 34-68 | 31-61 | 33-66 | 33-72 |
| Show effect | 25 | 23 | 27 | 16 |
| Is effective | 4 | 5 | 2 | 5 |
| Invalidation | 1 | 2 | 1 | 9 |
| Total effective rate | 96.66％ | 93.33％ | 96.66％ | 70.0％ |
Therefore, the oral liquid prepared by the invention has definite curative effect, and the total effective rate is more than 96%. Clinical observation shows that: the oral liquid prepared by the invention has obvious curative effect on treating hyperplasia of mammary glands, or postoperative recurrence of breast cancer and postoperative scar pain, takes effect quickly, and can obviously reduce or disappear symptoms such as breast distending pain, stabbing pain, lumps and the like.
if acute exacerbation occurs, the patient is treated conventionally in the acute attack stage.
Drug ingredient detection test
The dry basis contents of hesperidin, scutellarin, linarin, chlorogenic acid and alpha-cyperone in the oral liquids prepared in examples 4, 5 and 6 were determined by high performance liquid chromatography, and the results are shown in table 2. Wherein, the chromatographic column is: thermo C18, 250 mm. times.4.6 mm, 5 μm; the column temperature is 30 ℃; the mobile phase for detecting hesperidin is methanol-acetic acid-water (28:4:68), the flow rate is 1 mL/min-1, and the detection wavelength is 283 nm; detecting scutellarin with methanol-0.02% formic acid (28:72) as mobile phase, isocratic eluting at flow rate of 1.0 mL/min-1 and detection wavelength of 335 nm; the mobile phase for detecting the linarin and the chlorogenic acid is acetonitrile-0.1% phosphoric acid solution, gradient elution is carried out, the flow rate is 1.0 ml.min < -1 >, and the detection wavelength is 326 nm; the mobile phase for detecting alpha-cyperone is methanol-water (75: 25), the flow rate is 1.0 mL/min < -1 >, and the detection wavelength is 254 nm.
TABLE 2
| group of | Hesperidin | Scutellarin | Linarin | Chlorogenic acid | Alpha-cyperone |
| Example 4 | 1.32mg/g | 0.20mg/g | 0.28mg/g | 0.25mg/g | 0.25mg/g |
| example 5 | 1.16mg/g | 0.18mg/g | 0.19mg/g | 0.21mg/g | 0.21mg/g |
| Example 6 | 1.39mg/g | 0.23mg/g | 0.30mg/g | 0.20mg/g | 0.28mg/g |
As can be seen from table 2, the preparation method of example 6 can significantly increase the content of hesperidin, scutellarin, linarin, and α -cyperone in the oral liquid, and the method of example 6 requires the least amount of medicinal materials and has the most significant clinical application effect.
Typical cases
case 1. king XX, female, 57 years old, retired worker. The symptom is that bilateral breast pain is 4 months, mammary gland hyperplasia is diagnosed by a mammary gland diagnostic apparatus and B ultrasonic examination, and the hyperplasia is increased along with the menstrual cycle. The physical examination showed that many nodules were accessible in the right breast, with a flexible texture and high mobility. The oral liquid prepared in the embodiment 4 of the invention is taken 20ml each time, three times a day, and 7 days are a course of treatment. After 3 treatment courses, the mass is reduced and the pain is relieved. The lump disappeared after 3 months of administration. The disease condition is not repeated after 1 year of follow-up visit.
Case 2. plum X, female, age 34, farmer. The unilateral breast pain is 6 months, the B-ultrasonic examination diagnoses that the mammary gland is hyperplasia, a plurality of nodules can be touched in the left breast, and the nodules with the size of 3cm X2 cm can be touched in the lower outer quadrant, so that the breast pain is not adhered to the surrounding skin, and the surface is smooth. The oral liquid prepared in the embodiment 5 of the invention is taken 20ml each time, three times a day, and 7 days are a course of treatment. After 4 treatment courses, the mass is reduced and the pain is relieved. The lump disappeared after 4 months of administration. The disease condition is not repeated after 1 year of follow-up visit.
Case 3, king X, female, age 41, teacher. Unilateral breast pain for 3 months, with diagnosis of hyperplasia of mammary glands and breast nodules by B-ultrasound. The oral liquid prepared in the embodiment 6 of the invention is taken 20ml each time, three times a day, and 7 days are a course of treatment. After 2 treatment courses, the mass is reduced and the pain is relieved. The lump disappears after 2 months of administration. The disease condition is not repeated after 1 year of follow-up visit.
While embodiments of the invention have been disclosed above, it is not limited to the applications listed in the description and the embodiments, which are fully applicable in all kinds of fields of application of the invention, and further modifications may readily be effected by those skilled in the art, so that the invention is not limited to the specific details without departing from the general concept defined by the claims and the scope of equivalents.
Claims (7)
1. The traditional Chinese medicine composition for treating hyperplasia of mammary glands is characterized by being prepared from the following components in parts by weight: 1-60 parts of snakegourd fruit, 1-60 parts of orange leaf, 1-15 parts of vinegar green tangerine peel, 1-15 parts of dried orange peel, 1-60 parts of barbed skullcap herb, 1-60 parts of wild chrysanthemum flower, 1-60 parts of processed rhizoma arisaematis, 1-60 parts of vinegar rhizoma cyperi, 0-15 parts of perilla leaf and 0-60 parts of pseudo-ginseng.
2. The traditional Chinese medicine composition for treating hyperplasia of mammary glands according to claim 1, which is prepared from the following components in parts by weight: 1-20 parts of snakegourd fruit, 1-20 parts of orange leaf, 1-5 parts of vinegar green tangerine peel, 1-5 parts of dried orange peel, 1-20 parts of barbed skullcap herb, 1-20 parts of wild chrysanthemum flower, 1-20 parts of processed rhizoma arisaematis and 1-20 parts of vinegar rhizoma cyperi.
3. The traditional Chinese medicine composition for treating hyperplasia of mammary glands according to claim 2, which is prepared from the following components in parts by weight: 8 parts of snakegourd fruit, 8 parts of tangerine leaf, 2 parts of vinegar green tangerine peel, 2 parts of tangerine peel, 8 parts of barbed skullcap herb, 8 parts of wild chrysanthemum flower, 8 parts of processed rhizoma arisaematis and 8 parts of vinegar rhizoma cyperi.
4. The preparation method of the traditional Chinese medicine composition for treating hyperplasia of mammary glands according to any one of claims 1 to 3, comprising the following steps:
A. Weighing the components according to the formula amount, adding water which is 10 times of the total weight of the components, decocting for 2 times, each time for 1-2h, filtering, combining filtrates of the two times, and sieving the filtrate with a 80-mesh sieve to obtain a primary extract;
B. Ultrafiltering the primary extract with ultrafiltration column with cut-off molecular weight of 5000-.
5. The method for preparing a Chinese medicinal composition for treating mammary gland hyperplasia according to claim 4, further comprising, in the step A, pretreating the components before adding water, specifically: weighing the components according to the formula amount, placing the components into a stainless steel container, adding a sodium bicarbonate solution which is 3 times of the weight of each component into the stainless steel container, uniformly mixing, soaking at room temperature for 12 hours, then placing the stainless steel container at-18 ℃ for freezing for 12 hours, taking out the stainless steel container, placing the stainless steel container into an oven at 80 ℃ for drying for 4 hours, taking out, after the stainless steel container is cooled, adding the sodium bicarbonate solution which is 3 times of the weight of each component into the stainless steel container again, and repeating the soaking, freezing and drying processes once, wherein the mass concentration of the sodium bicarbonate solution is 9%, and the thickness of each component in the stainless steel container is 5 cm.
6. The method for preparing a Chinese medicinal composition for treating mammary gland hyperplasia according to claim 4, further comprising adding pharmaceutically acceptable adjuvants into the Chinese medicinal composition, and making into Chinese medicinal oral liquid, mixture, granule, tablet, capsule, soft capsule or pellet.
7. The use of the Chinese medicinal composition for treating mammary gland hyperplasia according to any one of claims 1 to 3 in the preparation of a medicament for treating mammary gland hyperplasia, postoperative recurrence of breast cancer, and postoperative scar pain.
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