CN101219192B - Chinese medicine composition, preparation for treating mammary gland hyperplasia and method for preparing the same - Google Patents
Chinese medicine composition, preparation for treating mammary gland hyperplasia and method for preparing the same Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composite, a preparation and a preparation method thereof for treating cyclomastopathy. The medicine composite is prepared by 3-13 portions of north fruit of hawthorn, 6-20 portions of roasted malt, 6-22 portions of leatherleaf milletia and 1-10 portions of rice-paper plant pith according to the weight proportion. The preparation comprises tablet, powder, capsule, oral solution, various extracts or granule solid beverage. The preparation method combines traditional decocting method with modern equipment and technology to reliably ensure an extracting of effective ingredients from each raw material medicine. The prescription of the invention has less raw material medicines, thus avoiding the problems of similar efficacies and biological activities and repeat use of lots of medicinal materials in a big prescription, and realizing scientific and rational medication; in addition, the problem that a great amount of ineffective ingredients are absorbed in a big prescription can be prevented, therefore, side-effect caused by too many raw material medicines is further reduced. The invention is also good for the study of pharmacological action of traditional Chinese medicines for treating cyclomastopathy and the control of medicine quality.
Description
Technical field
The present invention relates to Chinese medicine composition, particularly the Chinese medicine composition of treatment cyclomastopathy.
Background technology
Cyclomastopathy accounts for 70%～80% of mastopathy, is the modal mastopathy of the women of child-bearing age, and its sickness rate is about 40%, with tangible mastalgia, often forms breast tuberosity or lump, and part patient has the danger of the breast carcinoma of developing into.Therefore, cyclomastopathy is effectively treated for the health of safeguarding numerous women, improve the quality of living, Breast Cancer Prevention is extremely important.External for a long time many with hormones, vitamin medicaments or operative treatment cyclomastopathy.Since the eighties, adopted tamoxifen treatment cyclomastopathy, the patient of report to estrogen receptor positive arranged, effective percentage can reach 86%, but take for a long time vaginal hemorrhage, thrombocytopenia can take place, feel sick, side effect such as vomiting, edema and blood calcium increase.
Seeing that the morbidity of cyclomastopathy is unbalance relevant with neuroendocrine, need the characteristics of long-term prescription in the treatment, traditional Chinese medicine compares to chemical drugs and has more advantage.Domestic employing Chinese medicine cyclomastopathy has obtained certain progress, and Chinese Pharmacopoeia version in 2005 has been recorded three prescriptions of treating cyclomastopathy: RUKUAIXIAO PIAN, newborn disease spirit granule and BUPIXIAO PIAN.Yet because the prescription of this type of prescription is complicated, flavour of a drug are mostly about 10 flavors, and are even more.This treats the herbal pharmacology mechanism of action of cyclomastopathy for discussion and the quality control of medicine has increased certain degree of difficulty.
Summary of the invention
First purpose of the present invention is, to the deficiency of prior art, provides that a kind of prescription is few, the Chinese medicine composition of the treatment cyclomastopathy that helps inquiring into the herbal pharmacology mechanism of action and help quality control.
Second purpose of the present invention is that a kind of preparation of treating the Chinese medicine composition of cyclomastopathy is provided.
The 3rd purpose of the present invention is that a kind of method for preparing of treating the Chinese medicinal composition preparation of cyclomastopathy is provided.
For realizing first goal of the invention, a kind of like this Chinese medicine composition of treating cyclomastopathy is provided.This Chinese medicine composition is formulated according to weight ratio by four flavor crude drug, and they are respectively: Fructus Crataegi 3～13, Fructus Hordei Germinatus (parched) 6～20, Caulis Spatholobi 6～22, Medulla Tetrapanacis 1～10.
For realizing second goal of the invention, a kind of like this Chinese medicinal composition preparation of treating cyclomastopathy is provided.The preparation of this Chinese medicine composition is tablet, powder, capsule, oral administration solution, various extractum or dissolved granule.
For realizing the 3rd goal of the invention, a kind of like this method for preparing of treating the Chinese medicinal composition preparation of cyclomastopathy is provided.This method for preparing comprises the steps:
1. batching, weighing:, and take by weighing corresponding crude drug respectively according to volume of production according to the weight ratio of Fructus Crataegi, Fructus Hordei Germinatus (parched), Caulis Spatholobi and Medulla Tetrapanacis;
2. feed intake:, drop in the thermal cycle multi-function extractor the crude drug branch that the takes by weighing bag of boiling medicine of packing into;
3. washing: in the thermal cycle multi-function extractor, add the room temperature purified water to the submergence crude drug, stir and emit liquid after 1 minute, with flush away dirt ash;
4. extract: in extraction pot, add purified water to submergence crude drug, decoct after 30 minutes at dipping under 30 ℃ of environment and extract, decoct altogether and extract 2 times; Behind dipping, replenish 10 times of volumes of purified water to crude drug for the first time, decocted 1 hour; Add for the second time 8 times of volumes of purified water to crude drug, decocted 45 minutes; The decoction filtration that finishes, merge extractive liquid; Then, be 10 when spending from 90 ℃ of concentrating under reduced pressure, the Baume degrees that under 70 ℃, records, move in the settling tank, left standstill 12 hours;
5. concentrate and receive cream: from settling tank, emit sedimentary crude drug extract, filter with high speed centrifuge, filtrating merges with supernatant; Concentrating under reduced pressure again is before accessing preparation tablet, powder, capsule, oral administration solution, various extractum or dissolved granule till the needed thick paste;
6. prepare preparation:, accomplish the preparation of corresponding preparations according to the preparation characteristic of tablet, powder, capsule, oral administration solution, various extractum or dissolved granule.
From the scheme that realizes first goal of the invention, can find out, only use in the present invention that four flavor raw material of Chinese medicine medicines---compare with the Chinese patent medicine of existing treatment cyclomastopathy, its prescription is less.In addition because the crude drug in the prescription of the present invention is few, so avoided the drug effect and the biological activity of many medical materials in the present big prescription close, reusable problem has been accomplished medication scientifically and rationally; Avoided simultaneously in the present big prescription the absorbed problem of many invalid elements being arranged again, and then greatly reduced the toxic and side effects of bringing because of the reason of too much crude drug.Obviously, great convenience also is provided, has increased accuracy and reliability for the herbal pharmacology mechanism of action of inquiring into the treatment cyclomastopathy; Simultaneously can also guarantee quality control to medicine.
Can find out that from the scheme that realizes second goal of the invention the present invention has multiple dosage form.So, and even the patient just can select according to its different medication custom economic condition.
Can find out that from the scheme that realizes the 3rd goal of the invention the present invention has combined traditional method of boiling medicine and modern comfort and technology, thereby guarantee extraction reliably each crude drug effective ingredient.
Obviously, 5. concentrate to receive among the result of cream in step, to the denseness (Baume degrees) of resultant thick paste, should according to finally actually needs prepare which kind of preparation and confirm.
Come the present invention is described further below in conjunction with the specific embodiment.
The specific embodiment
A kind of Chinese medicine composition of treating cyclomastopathy.This Chinese medicine composition is formulated according to weight ratio by four flavor crude drug, and according to the formulation principle of Chinese medicine " monarch ", they are respectively: Fructus Crataegi 3～13, Fructus Hordei Germinatus (parched) 6～20, Caulis Spatholobi 6～22, Medulla Tetrapanacis 1～10.Specifically can be:
Fructus Crataegi 3, Fructus Hordei Germinatus (parched) 6, Caulis Spatholobi 6, Medulla Tetrapanacis 1;
Fructus Crataegi 13, Fructus Hordei Germinatus (parched) 20, Caulis Spatholobi 22, Medulla Tetrapanacis 10;
Fructus Crataegi 12, Fructus Hordei Germinatus (parched) 19, Caulis Spatholobi 22, Medulla Tetrapanacis 2;
Fructus Crataegi 3, Fructus Hordei Germinatus (parched) 20, Caulis Spatholobi 22, Medulla Tetrapanacis 9;
Fructus Crataegi 12, Fructus Hordei Germinatus (parched) 20, Caulis Spatholobi 20, Medulla Tetrapanacis 9.
The weight ratio of preferred four flavor crude drug is: Fructus Crataegi 5～11, Fructus Hordei Germinatus (parched) 8～18, Caulis Spatholobi 8～20, Medulla Tetrapanacis 3～8.Specifically can be:
Fructus Crataegi 5, Fructus Hordei Germinatus (parched) 8, Caulis Spatholobi 8, Medulla Tetrapanacis 3;
Fructus Crataegi 11, Fructus Hordei Germinatus (parched) 18, Caulis Spatholobi 20, Medulla Tetrapanacis 8;
Fructus Crataegi 6, Fructus Hordei Germinatus (parched) 18, Caulis Spatholobi 20, Medulla Tetrapanacis 5;
Fructus Crataegi 10, Fructus Hordei Germinatus (parched) 18, Caulis Spatholobi 18, Medulla Tetrapanacis 6;
Fructus Crataegi 6, Fructus Hordei Germinatus (parched) 18, Caulis Spatholobi 20, Medulla Tetrapanacis 5;
Fructus Crataegi 5, Fructus Hordei Germinatus (parched) 18, Caulis Spatholobi 18, Medulla Tetrapanacis 8;
Fructus Crataegi 6, Fructus Hordei Germinatus (parched) 12, Caulis Spatholobi 12, Medulla Tetrapanacis 7;
Fructus Crataegi 7, Fructus Hordei Germinatus (parched) 15, Caulis Spatholobi 16, Medulla Tetrapanacis 3;
Fructus Crataegi 6, Fructus Hordei Germinatus (parched) 14, Caulis Spatholobi 14, Medulla Tetrapanacis 5.
Most preferably the weight ratio of four flavor crude drug is: Fructus Crataegi 8, Fructus Hordei Germinatus (parched) 12, Caulis Spatholobi 14, Medulla Tetrapanacis 4.
The preparation of above-mentioned Chinese medicine composition can be tablet, powder, capsule, oral administration solution, various extractum or dissolved granule.Wherein, dissolved granule preferably.
The method for preparing of above-mentioned Chinese medicinal composition preparation comprises the steps:
1. batching, weighing:, and take by weighing corresponding crude drug respectively according to volume of production according to the weight ratio of Fructus Crataegi, Fructus Hordei Germinatus (parched), Caulis Spatholobi and Medulla Tetrapanacis;
2. feed intake:, drop in the thermal cycle multi-function extractor the crude drug branch that the takes by weighing bag of boiling medicine of packing into;
3. washing: in the thermal cycle multi-function extractor, add the room temperature purified water to the submergence crude drug, stir and emit liquid after 1 minute, with flush away dirt ash;
4. extract: in extraction pot, add purified water to submergence crude drug, decoct after 30 minutes at dipping under 30 ℃ of environment and extract, decoct altogether and extract 2 times; Behind dipping, replenish 10 times of volumes of purified water to crude drug for the first time, decocted 1 hour; Add for the second time 8 times of volumes of purified water to crude drug, decocted 45 minutes; The decoction filtration that finishes, merge extractive liquid; Then, be 10 when spending from 90 ℃ of concentrating under reduced pressure, the Baume degrees that under 70 ℃, records, move in the settling tank, left standstill 12 hours;
5. concentrate and receive cream: from settling tank, emit sedimentary crude drug extract, filter with high speed centrifuge, filtrating merges with supernatant; Concentrating under reduced pressure again is before accessing preparation tablet, powder, capsule, oral administration solution, various extractum or dissolved granule till the needed thick paste;
6. prepare preparation:, accomplish the preparation of corresponding preparations according to the preparation characteristic of tablet, powder, capsule, oral administration solution, various extractum or dissolved granule.
For preferred dissolved granule, the again concentrating under reduced pressure process of its step in 5. is: till from 90 ℃ of concentrating under reduced pressure, up to the Baume degrees that records under 70 ℃ being the thick paste of 15 degree; When 6. its step prepared dissolved granule: using weight ratio was 2: 11 part in cane sugar powder and dextrin, with 1.5～1.55 parts of said thick pastes, in airpillow-dry granulator, prepares dissolved granule with spray art; The boiling indoor temperature is controlled at 70 ℃.
For example:
Step 1. in, take by weighing according to optimum weight percent: Fructus Crataegi 8kg, Fructus Hordei Germinatus (parched) 12kg, Caulis Spatholobi 14kg, Medulla Tetrapanacis 4kg;
After 5. step concentrated receipts cream, according to the deviation of actual measurement Baume degrees, preparing weight for follow-up granulation step was this thick paste of 15Kg or 15.5Kg;
Step 6. in, take by weighing cane sugar powder 6.67Kg, dextrin 3.33Kg according to the mixing ratio of thick paste and cane sugar powder, dextrin.
At last, inspect packing again by ready samples, packing inspection warehouse-in: granulate accomplish after, sampling censorship from sampler after the assay was approved, is deposited granule in addition and to be treated branch or to use the automatic packaging machine packing.For example: this dissolved granule of per 10 grams is adorned a parcel.The censorship warehousing after passing.Can dress up one bag by per 20 parcels before the warehouse-in.
According to custom, can claim that this dissolved granule is four flavor dissolved granulies or four flavor electuaries.Other dosage forms also can be in front titled with " four flavors ".For example: four flavor dry extracts, four flavor extractum, four flavor capsules, four flavor oral liquids etc.
Pharmacodynamic study of the present invention and checking:
Get 60 rats that are copied into the cyclomastopathy disease model, be divided into six groups at random according to 10 every group:
First group of medication proportioning is Fructus Crataegi 3, Fructus Hordei Germinatus (parched) 6, Caulis Spatholobi 6, Medulla Tetrapanacis 1;
Second group of medication proportioning is Fructus Crataegi 3, Fructus Hordei Germinatus (parched) 20, Caulis Spatholobi 22, Medulla Tetrapanacis 9;
The 3rd group of medication proportioning is Fructus Crataegi 12, Fructus Hordei Germinatus (parched) 20, Caulis Spatholobi 20, Medulla Tetrapanacis 9;
The 4th group of medication proportioning is Fructus Crataegi 5, Fructus Hordei Germinatus (parched) 18, Caulis Spatholobi 18, Medulla Tetrapanacis 8;
The 5th group of medication proportioning is Fructus Crataegi 8, Fructus Hordei Germinatus (parched) 12, Caulis Spatholobi 14, Medulla Tetrapanacis 4;
The 6th group is the blank group with the distilled water of Isodose.
Wherein, medication group dosage is 15g crude drug/kg, and be administered once every day; Successive administration 35 days was got blood from the rat eye socket in 1 hour after the last administration, put the method for exempting from and measured lutropin (LH), follicle stimulating hormone (FSH), prolactin antagonist (PRL), progesterone (PROG), testosterone (TESTO), estradiol (E2); Put to death animal then, every rat is selected 2 of second pair of mammary gland tissues, draws materials through basad maximum tangent plane of nipple; Weigh, measure volume with drainage.Mammary gland tissue is placed 10% neutral formalin, after fully fixing, draw materials, paraffin wax flaking, HE dyeing, gummy sealing by routine.With OLYMPUSBX51 microscope biology and pathological tissue image analysis system observation analysis and pickup image.Get uterus, ovary, claim its weight and calculate its organ coefficient.With above experiment triplicate, the calculating of averaging.
Discover that the blank group of feeding with the distilled water of Isodose and ovary weight, mammary gland weight, mammary gland coefficient, the mammary gland volume of model group are higher than treatment group (P＜0.01), respectively take medicine and do not have significant difference between the group.Hormonal readiness and blank group comparison through the hyperplasia of mammary gland model group of treatment significantly is lower than matched group, shows the treatment group and rat mammary gland hypertrophy that each administration group causes modeling has and significantly alleviates and regressive effect.
Pathological research to treatment group and matched group shows that each administration group cyclomastopathy and model group relatively have significant difference (P＜0.01), shows that the cyclomastopathy that each administration group causes modeling has tangible reverse elimination and minimizing effect.
Clinical verification:
At The First Affiliated Hospital of Third Military Medical University of PLA mammary gland center,, carried out therapeutic trial with four flavor dissolved granulies of the present invention earlier to 45 patients that suffer from cyclomastopathy; After progressively expand 875 patients altogether again to, carried out therapeutic trial with four flavor dissolved granulies, four flavor dry extracts, four flavor extractum (precipitate with ethanol), four flavor extractum dosage forms such as (not precipitate with ethanol) respectively.Dosage is: every day three times, contained clean crude drug amount is 29.3 grams in each medication.Clinical observation finds, the releasing mastalgia that has, softening enclosed mass, stops effect such as galactorrhea, and average effective percentage in the recent period reaches 99.3%; Wherein, medication proportioning is that Fructus Crataegi 8, Fructus Hordei Germinatus (parched) 12, Caulis Spatholobi 14, recent effective percentage Medulla Tetrapanacis 4, several kinds of dosage forms are all more than 99.6%.
Claims (7)
1. a Chinese medicine composition of treating cyclomastopathy is characterized in that, this Chinese medicine composition is formulated according to weight ratio by four flavor crude drug, and they are respectively: Fructus Crataegi 5～11, Fructus Hordei Germinatus (parched) 8～18, Caulis Spatholobi 8～20, Medulla Tetrapanacis 3～8.
2. according to the Chinese medicine composition of the said treatment cyclomastopathy of claim 1, it is characterized in that the weight ratio of said four flavor crude drug is: Fructus Crataegi 8, Fructus Hordei Germinatus (parched) 12, Caulis Spatholobi 14, Medulla Tetrapanacis 4.
3. according to the Chinese medicine composition of claim 1 or 2 said treatment cyclomastopathy, it is characterized in that the preparation of this Chinese medicine composition is tablet, powder, capsule, oral administration solution, various extractum or dissolved granule.
4. according to the Chinese medicine composition of the said treatment cyclomastopathy of claim 3, it is characterized in that the preparation of this Chinese medicine composition is a dissolved granule.
5. according to the method for preparing of the Chinese medicinal composition preparation of the said treatment cyclomastopathy of claim 3, it is characterized in that this method for preparing comprises the steps:
1. batching, weighing:, and take by weighing corresponding crude drug respectively according to volume of production according to the weight ratio of Fructus Crataegi, Fructus Hordei Germinatus (parched), Caulis Spatholobi and Medulla Tetrapanacis;
2. feed intake:, drop in the thermal cycle multi-function extractor the crude drug branch that the takes by weighing bag of boiling medicine of packing into;
3. washing: in the thermal cycle multi-function extractor, add the room temperature purified water to the submergence crude drug, stir and emit liquid after 1 minute, with flush away dirt ash;
4. extract: in extraction pot, add purified water to submergence crude drug, decoct after 30 minutes at dipping under 30 ℃ of environment and extract, decoct altogether and extract 2 times; Behind dipping, replenish 10 times of volumes of purified water to crude drug for the first time, decocted 1 hour; Add for the second time 8 times of volumes of purified water to crude drug, decocted 45 minutes; The decoction filtration that finishes, merge extractive liquid; Then, be 10 when spending from 90 ℃ of concentrating under reduced pressure, the Baume degrees that under 70 ℃, records, move in the settling tank, left standstill 12 hours;
5. concentrate and receive cream: from settling tank, emit sedimentary crude drug extract, filter with high speed centrifuge, filtrating merges with supernatant; Concentrating under reduced pressure again is before accessing preparation tablet, powder, capsule, oral administration solution, various extractum or dissolved granule till the needed thick paste;
6. prepare preparation:, accomplish the preparation of corresponding preparations according to the preparation characteristic of tablet, powder, capsule, oral administration solution, various extractum or dissolved granule.
6. according to the method for preparing of the Chinese medicinal composition preparation of the said treatment cyclomastopathy of claim 4, it is characterized in that the method for preparing of said dissolved granule has the following steps:
1. batching, weighing:, and take by weighing corresponding crude drug respectively according to volume of production according to the weight ratio of Fructus Crataegi, Fructus Hordei Germinatus (parched), Caulis Spatholobi and Medulla Tetrapanacis;
2. feed intake:, drop in the thermal cycle multi-function extractor the crude drug branch that the takes by weighing bag of boiling medicine of packing into;
3. washing: in the thermal cycle multi-function extractor, add the room temperature purified water to the submergence crude drug, stir and emit liquid after 1 minute, with flush away dirt ash;
4. extract: in extraction pot, add purified water to submergence crude drug, decoct after 30 minutes at dipping under 30 ℃ of environment and extract, decoct altogether and extract 2 times; Behind dipping, replenish 10 times of volumes of purified water to crude drug for the first time, decocted 1 hour; Add for the second time 8 times of volumes of purified water to crude drug, decocted 45 minutes; The decoction filtration that finishes, merge extractive liquid; Then, be 10 when spending from 90 ℃ of concentrating under reduced pressure, the Baume degrees that under 70 ℃, records, move in the settling tank, left standstill 12 hours;
5. concentrate to receive cream: from settling tank, emit sedimentary crude drug extract, filter with high speed centrifuge, filtrating merges with supernatant, again from 90 ℃ of concentrating under reduced pressure, up to the Baume degrees that records under 70 ℃ be the thick paste of 15 degree till;
6. prepare dissolved granule: using weight ratio is 2: 11 part in cane sugar powder and dextrin, with 1.5～1.55 parts of said thick pastes, in airpillow-dry granulator, prepares dissolved granule with spray art; The boiling indoor temperature is controlled at 70 ℃.
7. according to the method for preparing of the Chinese medicinal composition preparation of the said treatment cyclomastopathy of claim 5; It is characterized in that; In the process of the said dissolved granule of preparation, the again concentrating under reduced pressure of its step in 5. is: till from 90 ℃ of concentrating under reduced pressure, up to the Baume degrees that records under 70 ℃ being the thick paste of 15 degree; When 6. its step prepared dissolved granule: using weight ratio was 2: 11 part in cane sugar powder and dextrin, with 1.5～1.55 parts of said thick pastes, in airpillow-dry granulator, prepares dissolved granule with spray art; The boiling indoor temperature is controlled at 70 ℃.
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| CN101954021B (en) * | 2010-09-26 | 2012-03-21 | 中国人民解放军第三军医大学第一附属医院 | Method for detecting quality of Chinese medicinal composition for treating proliferation of mammary gland |
| CN105288350A (en) * | 2014-07-25 | 2016-02-03 | 冯亚平 | Rutong oral liquid |
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Non-Patent Citations (2)
| Title |
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| 刘松青等.四味颗粒质量标准的研究.2004年中国西部药学论坛论文汇编（上册）.2004,227-233. * |
| 蒲永东等.四味冲剂治疗乳腺增生症近期疗效观察.中国中西医结合杂志.1989,(5),301. * |
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