CN1857678A - Mastoproliferation treating medicine and its preparing method - Google Patents

Abstract

The invention provides a medicament for treating mammary gland hyperplasia and a preparation method thereof. The medicament is prepared from the following raw materials in proportions by weight: Radix Paeoniae Rubra 12-24, Bupleurum 12-24, Angelica 12-24 , Rhizoma Cyperus 6~15, Curcuma 6~15, Qingpi 6~15, Prunella vulgaris 12~24, Cat's Claw 12~24, Sagittarius 6~15, Saponaria thorn 6~15, Bombyx mori 6~15, Scorpio 6-15, Scrophulariaceae 6-15, Fritillaria 12-24. The method is to use supercritical CO ₂ fluid to extract the active ingredients of Bupleurum, Rhizoma Cyperi, Angelica, Curcuma and Qingpi; The active ingredients of subtilis, cat's claw, scrophulariaceae, soil Fritillaria, sagittaria and saponins; the final product is obtained by adding cyclodextrin for inclusion.

Description

A kind of medicine for treating mammary gland hyperplasia and preparation method thereof

technical field

The invention relates to a medicine for treating mammary gland hyperplasia, specifically the medicine prepared from Chinese herbal medicine, and also relates to a preparation method of the medicine.

Background technique

Mass is one of the common clinical manifestations of surgical diseases, which can be divided into two categories: benign and malignant. It is a common and frequently-occurring disease that endangers human health. For the treatment of mass diseases, due to the lack of effective drug treatment, surgical resection is generally the main method, which increases the suffering of patients. In Chinese medicine, mass diseases not only belong to surgery, but also are scattered in internal medicine, gynecology, ENT and other categories. Regarding treatment, general treatment principles were proposed as early as in the "Nei Jing". Modern Chinese medicine proceeds from the whole, and treats according to syndrome differentiation, and has achieved good results in some categories. And relate to the medicine that adopts Chinese medicine preparation to treat mammary gland hyperplasia, there is no report so far.

Contents of the invention

One of the objects of the present invention is to provide a medicament for treating mammary gland hyperplasia with remarkable curative effect and no side effects. The second purpose is to provide a preparation method of the medicine which achieves the first purpose and has a simple process and is easy to operate.

One of purpose of the present invention can be realized by following technical measures:

The medicament of the present invention is a medicament made from the following raw materials in parts by weight

Paeoniae Rubra 12～24 Bupleurum 12～24 Angelica 12～24

Cyperus 6～15 Turmeric 6～15 Green skin 6～15

Prunella vulgaris 12～24 Cat’s claw 12～24 Arrowhead 6～15

Saponaria thorn 6～15 Dead silkworm 6～15 Full scorpion 6～15

Scrophulariaceae 6～15 and Fritillaria 12～24.

The optimum weight portion proportioning of preparation medicine of the present invention is

Radix Paeoniae 18 Bupleurum 18 Angelica 18

Cyperus 9 turmeric 9 green skin 9

Prunella 18 Cat's Claw 18 Arrowhead 10

Saponaria thorn 9 Bombyx silkworm 9 Full scorpion 9

Scrophulariaceae 15 Soil Fritillaria 18.

Said dosage form of the present invention is any said dosage form in pharmacy; Said pharmaceutical dosage form can be powder, powder, tablet, pill, granule or capsule, wherein is preferred with granule or capsule.

Two of the object of the present invention can be realized by following technical measures:

The production method that above-mentioned each component is made into medicine of the present invention is:

a. Take Bupleurum powder and put it into the extraction kettle, and extract with supercritical _CO2 fluid to obtain saikosaponin or bupleurum volatile oil;

b. The same process as a, but the difference is that the Bupleurum powder is replaced by the mixed powder of Cyperus cyperi, angelica, turmeric, and green skin to obtain volatile oil;

c. Take silkworms and scorpions and extract them under reflux with dilute ethanol solution, filter off the residue, combine the ethanol extract, recover ethanol under reduced pressure and concentrate it into an alcohol extract;

d, the same process as c, the difference is that red peony root is used instead of silkworm and scorpion to obtain alcohol extraction cream;

e. First take Prunella vulgaris, Cat’s Claw, Scrophulariae Scrophulariae, Soil Fritillary, Arrowhead, Saponaria, and decoct it by decocting. The decoction is concentrated and cooled to room temperature naturally, and then slowly add dilute ethanol under stirring. The solution is precipitated and filtered, and the ethanol is recovered under reduced pressure and concentrated into a concentrated paste of decoction and alcohol precipitation;

f. Mix the alcohol extraction paste prepared by steps c and d with the concentrated paste prepared by decoction and alcohol precipitation prepared by step e, add 200 to 800 parts by weight of dextrin and 5 to 30 parts by weight of stevioside, mix well, and then Spray drying at 40-90°C and pulverize to obtain dry cream powder;

g. Take 1 to 12 parts by weight of β-cyclodextrin, add 15 to 35 times the weight of distilled water, and ultrasonically mix to form a β-cyclodextrin solution; in addition, take saikosaponin or bupleurum volatile oil prepared in step a, Dilute with 3 to 8 times the weight of absolute ethanol, slowly add it to the β-cyclodextrin solution during the ultrasonic process at 20 to 60 ° C, refrigerate, filter with suction, and wash the filter layer with distilled water and absolute ethanol respectively , dried at 30-70°C to obtain saikosaponin β-cyclodextrin inclusion compound powder;

h, the same procedure as g, except that the volatile oil prepared by b procedure is used to replace the saikosaponin or bupleurum volatile oil prepared by a procedure to obtain volatile oil β-cyclodextrin inclusion compound powder;

m. Mix the dry paste powder with volatile oil β-cyclodextrin inclusion compound and saikosaponin β-cyclodextrin inclusion compound to form a powder. Make the powder into powder, tablet or pill, and add appropriate amount of Pharmaceutical starch is used to make granules, and the granules are packed into capsules to make capsules.

Two of the object of the present invention can also be realized by following technical measures:

The supercritical CO ₂ fluid extraction described in the steps a and b is to heat or cool the extraction kettle and the desorption kettle to 30-60°C respectively, and then add CO ₂ gas into the system. When the pressure is 20-50MPa, the constant temperature 1. Extraction under constant pressure for 1.0 to 3.0 hours;

The reflux extraction of dilute ethanol solution described in c and d operations is to add 50-80% ethanol solution of 6-15 times by weight of silkworm and scorpion, soak for 0.5-1 hour, and reflux at 50-100°C for 2 ～3 times, 1～3 hours each time; the relative density of the alcohol extraction paste is 1.10～1.50;

The decocting method described in the e process is to add Prunella vulgaris, Cat’s Claw, Scrophulariaceae Scrophulariae, Soil Fritillaria, Arthia chinensis and Saponaria japonica 6 to 15 times the weight of water, soak and decoct 2 to 3 times , 1 to 3 hours each time, combine the decoction and concentrate to a decoction concentrate with a relative density of 1.03 to 1.50; then cool to room temperature, and slowly add 60 to 95 parts by weight of the concentrate under stirring. % ethanol, continue to stir for 10-40 minutes, set aside to settle at 0-8°C for 24-72 hours, filter, and decoct in water and alcohol to precipitate the concentrated paste with a relative density of 1.10-1.50;

The refrigerating time described in the g process is 10 to 30 hours.

Cystic hyperplasia of the breast is called breast addiction in traditional Chinese medicine. It is believed that the onset is related to emotions, diet, fatigue, and internal injuries. Most doctors start from the whole and combine syndrome differentiation with disease differentiation to achieve endocrine regulation and enhance body immunity. At present, the dialectical treatment of cystic hyperplasia of the breast is mainly divided into liver depression and qi stagnation, phlegm and blood stasis and Chong Ren disorder according to different stages and syndromes. , warming the kidney and helping the yang, adjusting the camera, Chong and Ren and other treatment methods. Based on the treatment of the disease for many years, the present invention concludes that the main method is to soothe the liver and activate blood circulation, with the aid of resolving phlegm and dissipating stagnation, and adjusting photography and function, that is, on the basis of dialectical syndrome and disease differentiation, combined with modern medical understanding and modern pharmacological research of traditional Chinese medicine. Prescription medicine. The present invention complies with "Yi Zong Jin Jian" Haizao Yuhu Decoction, "Miscellaneous Diseases Origin and Flow Rhinoceros Candle" Pojian Powder and "Medical Heart Wu" Xiaoyu Pills, combined with clinical practice, the function is softening and resolving hard masses, promoting blood circulation and dredging collaterals , swelling and pain relief. It is used to treat various breast lump diseases, such as tumors and chronic inflammation, and can be effectively treated. This prescription reuses Radix Paeoniae Rubra and Prunella vulgaris, which are the monarch drugs together, to soften and resolve stagnation, soften the liver and nourish yin. Qing Dynasty Chen Shiduo pointed out in "Stone Chamber Secret Record Soft Treatment Method": "If the disease is strong and refuses to disperse easily, it should be treated with soft treatment... After a long time, it will become firm and soft, and softness can cure rigidity." Compatibility Arrowhead mushroom, Fritillaria chinensis, cat's claw, Qingpi reduce phlegm and dampness, detoxify and dissipate stagnation, among which Qingpi has the function of invigorating the spleen and stomach, and can cure the source of phlegm. Swell and relieve pain to dissipate stagnation to strengthen the power of monarch medicine to dissipate stagnation. Arrowhead mushroom, cat's claw grass, and green bark have the power to dissipate stagnation, and can also guide all kinds of medicines directly to the disease, so as to achieve the purpose of dissipating tumors. They are all adjuvant medicines. make medicine. Looking at the whole prescription, there are a total of fourteen herbs that complement each other, the formula is compact, and the attack is the main, and the attack has the effect of nourishing.

The medicine of the present invention takes granules as an example, which are filled in the preparation chamber, with 3-10 grams per pack. Oral administration, 6-40 grams each time, 2-3 times a day, 10-30 days as a course of treatment, generally 2-6 courses of treatment.

The medicine of the invention has the effects of promoting blood circulation and removing blood stasis, soothing the liver, resolving phlegm and resolving stagnation, reducing swelling and alleviating pain. It is used for treating mammary gland hyperplasia, and has the positive effects of high efficiency, long-acting, quick-acting, low toxicity and few side effects. Taking decoction as an example, the medicine of the present invention has been clinically used, and it has been proved that it has the effects of softening and resolving hard masses, promoting qi and resolving phlegm, promoting blood circulation and dredging collaterals, reducing swelling and relieving pain, and is used for treating various breast lump diseases, such as tumors, chronic inflammation, etc. Blocks, etc., have achieved remarkable results. The invention adopts supercritical _CO2 fluid extraction technology and cyclodextrin inclusion technology, such as preparation into granules, so that the quality is more stable and controllable, easy to take and improve curative effect.

Pharmacodynamics test of medicine of the present invention:

1. Anti-inflammatory effect:

In the xylene-induced inflammation method of mice, the high, medium and low dose groups of the medicine of the present invention can obviously reduce the inflammatory reaction, and there is a significant difference compared with the control group, and there is a dose-effect relationship. In the rat foot formaldehyde-induced inflammation method, the medicine of the present invention can obviously inhibit the inflammatory response. The medicine of the present invention has the best effect at 0.3-4.0 hours, and there is no dose-effect relationship. The medicament of the present invention can reduce the permeability of the capillaries in the peritoneal cavity of mice.

2. Antibacterial effect

The medicine of the present invention has different degrees of antibacterial effects on Staphylococcus aureus, pathogenic Escherichia coli, Salmonella typhi, and Streptococcus pneumoniae. No effect on Pseudomonas aeruginosa.

3. Analgesic effect

The medicament of the invention can significantly reduce the times of writhing in mice, which is significantly different from that of the control, and has a dose-effect relationship.

4. Immune function test

The high, medium and low dose groups of the medicine of the present invention have significant enhancing effect on humoral immunity as indexed by serum agglutinin. No dose-effect relationship.

5, the influence of medicine of the present invention on rabbit coagulation time

The medicine of the present invention has the effect of obviously prolonging the coagulation time (P<0.05).

The toxicology test of medicine of the present invention:

The medicine of the present invention is administered to mice (20～60) g/kg/d [human dosage (0.1～1.0) g/kg/d] within one day, observes continuously for seven days, none dies, is equivalent to 120 of the clinical dosage. times, it shows that the medicine is non-toxic and safe. The clinically recommended daily dose for adults is 6-40g, and 10-30 days is a course of treatment. The LD50 of the drug was not detected in the acute toxicity test, and its maximum tolerated dose is more than 100 times the clinical dose. ) dosage of 60 times is a high dose, and 30 times is a low dose to give medicine to rats respectively. According to the principle that the long-term poisoning time is 2-4 times of the clinical course of treatment, the continuous administration time of long-term poisoning is determined to be 45 days. Obvious toxicity, and there are no drugs such as eighteen anti-nineteen fears in the prescription, so long-term toxicity experiments on dogs are avoided. In a word, the drug of the present invention is safe and non-toxic in clinically planned dosage and cycle.

The clinical data of medicine of the present invention:

Before and after the drug treatment of the present invention, the improvement of the patient's breast distending pain symptoms and the change of the nodular lump in the breast are combined with computer infrared light inspection and color Doppler ultrasound examination to observe the therapeutic effect of the drug of the present invention on mammary gland hyperplasia, adverse reactions and the drug of the present invention. It has anti-inflammatory and analgesic effects on experimental animals. In order to fully understand the therapeutic effect of the drug on cystic hyperplasia of the breast. In order to complete this research content well, the present invention presses (" Chinese medicine disease diagnosis curative effect standard " ZY/T001.2-94 issued by the State Administration of Traditional Chinese Medicine) and diagnostic reference standard (2002 Chinese Medical Association of Surgical Association breast disease specialty Adopted at the 8th meeting of the committee) as the research diagnostic standard of this subject, formulate the selection method of medical records, all the selected patients meet the above standard, and combined with computer infrared breast examination instrument, color Doppler ultrasound or pathological auxiliary diagnosis to exclude breast cancer, mammary fibroid or other breast diseases. Observe in detail, record the changes of symptoms and signs before and after the patient's treatment to determine the curative effect, so as to further observe the clinical definite curative effect of the medicine of the present invention. The whole process is carefully arranged, carefully organized, coordinated with each other, and strictly standardized. 79 cases of clinical observations, including 45 cases of the treatment group, take the medicine of the present invention three times a day, 10g each time, 10 days is a course of treatment, generally 2 to 3 A course of treatment can be obviously effective, and 5-6 courses of treatment can be cured. Among them, 29 cases were cured, accounting for 64.4%; 12 cases were effective, accounting for 26.6%; the total effective rate was 91.1%; 34 cases in the control group were treated with Rukang Tablets, three times a day, 2 capsules each time, and the course of treatment was the same as that of the treatment group. 17 cases were fully cured, accounting for 50%, and 12 cases were effective, accounting for 35%. Group. Comparison of curative effects of symptoms and signs between the two groups after treatment: the treatment group was significantly better than the control group. After treatment, hemorheology indicators in the treatment group: whole blood viscosity, hematocrit, and fibrinogen all decreased significantly compared with those before treatment.

Detailed ways

Example 1:

Weigh raw materials (kg) according to the following proportioning ratio:

Radix Paeoniae 16 Bupleurum 20 Angelica 18

Cyperus 8 Turmeric 8 Green Peel 10

Prunella 18 Cat's Claw 16 Arrowhead 10

Saponaria thorn 8 zombie silkworm 10 full scorpion 12

Scrophulariaceae 12 Soil Fritillaria 18.

The production method is as follows:

Supercritical CO ₂ fluid extraction: use supercritical CO ₂ fluid (SFE-CO ₂ ) to extract the main active components saikosaponin and bupleurum volatile oil in Bupleuri. Put the Bupleurum dry powder into the extraction kettle, and heat or cool the extraction kettle, desorption kettle I, desorption kettle II, and storage tank respectively. When the selected temperature is 30°C, open the _CO2 gas cylinder to pressurize the system, and when the selected pressure is 50MPa, close the gas cylinder to circulate the extraction and keep constant temperature and pressure. When the selected extraction time is up to 1.0h, the material is discharged from the outlets of the analysis kettle I and the analysis kettle II to obtain saikosaponin or bupleurum volatile oil.

With 60% ethanol as entrainer, CO ₂ supercritically extracts the volatile oils from Cyperus cyperi, Angelica sinensis, Curcuma turmeric, and Qingpi medicinal materials. A certain amount of mixed dry powder of Cyperus cyperi, angelica, turmeric, and green skin is put into the extraction kettle, and the extraction kettle, desorption kettle I, desorption kettle II, and storage tank are heated or cooled respectively. When the selected temperature is 30°C, open the _CO2 gas cylinder to pressurize the system, and when the selected pressure is 50MPa, close the gas cylinder to circulate the extraction and keep constant temperature and pressure. When the selected extraction time is reached 1.0h, the material is discharged from the outlets of the analysis kettle I and the analysis kettle II to obtain volatile oil. According to "Chinese Pharmacopoeia" 2000 edition one appendix 41 page first method, measure its relative density to be 1.0.

Extraction of alcohol extraction drugs: Weigh the prescribed amount of silkworm and scorpion, add 7 times the weight of 80% ethanol, soak for about 0.5h, heat and reflux at 50°C for 3 times, each time for 1.h, filter off the residue , combine the ethanol extracts, recover the ethanol under reduced pressure and concentrate it into an ethanol extract with a relative density of 1.5.

Extraction of Radix Paeoniae Rubra: Weigh the amount of Radix Radix Radix Radix Paeoniae Rubra, add 7 times the weight of 80% ethanol, soak for about 0.5h, heat and reflux extraction at 50°C for 3 times, each time for 1h, filter off the residue, and combine the ethanol extract , ethanol is recovered under reduced pressure and concentrated into an alcohol extract with a relative density of 1.5.

Extraction of decocted and alcohol-precipitated medicines: Weigh the prescribed amount of Prunella vulgaris, Cat’s Claw, Scrophulariaceae, Solanum Fritillaria, Arthia sativa, Saponaria thorn, add 7 times the weight of water, soak and decoct Boil 3 times, each time for 1 hour, combine the decoction, concentrate into a decoction concentrate with a relative density of 1.1, naturally cool the decoction concentrate to room temperature, slowly add 1 times the weight of the decoction concentrate under stirring 90% ethanol, continue to stir for 10 minutes, set aside to settle at 1°C for 70 hours, filter, decoct in water to precipitate the concentrated ointment, cool the decoction to room temperature naturally after concentration, and then slowly add 50% of The dilute ethanol solution is precipitated and filtered, and the ethanol is recovered under reduced pressure and concentrated into a decoction and alcohol precipitation concentrated paste with a relative density of 1.10.

Mixing of alcohol extraction cream and preparation of dry cream powder: Mix the above-mentioned alcohol extraction cream and decoction and alcohol precipitation concentrated cream, add 800 parts by weight of dextrin and 5 parts by weight of stevioside, mix well, and spray at 85°C Dried and crushed to obtain dry cream powder.

Preparation of β-cyclodextrin inclusion complex of volatile oil: Weigh 1 part by weight of β-cyclodextrin, add 15 parts by weight of distilled water, and ultrasonically mix to form a β-cyclodextrin solution; Saponin or bupleurum volatile oil, diluted with 3 parts by weight of absolute ethanol, was added dropwise into the β-cyclodextrin solution during ultrasonication at 60°C, taken out, refrigerated at 2°C for 30 hours, suction filtered, and filtered The layers were washed with distilled water and absolute ethanol respectively, the filter layer was taken out, and dried at 30°C to obtain β-cyclodextrin inclusion compound powder of volatile oil;

Preparation of saikosaponin β-cyclodextrin inclusion complex: Weigh 1 part by weight of β-cyclodextrin, add 15 parts by weight of distilled water, and mix uniformly by ultrasonication. Separately take the saikosaponin or bupleurum volatile oil prepared in step a, dilute it with 4 parts by weight of absolute ethanol, drop it into the β-cyclodextrin solution in the ultrasonic process at 60°C, take it out, Refrigerate for 10 hours, filter with suction, wash the filter layer with distilled water and absolute ethanol respectively, take out the filter layer, and dry at 30°C to obtain a white loose inclusion compound powder, namely saikosaponin β-cyclodextrin inclusion compound powder.

Mixing of medicinal powder and preparation of granules: mix the above-mentioned dry cream powder with volatile oil β-cyclodextrin inclusion complex powder and saikosaponin β-cyclodextrin inclusion complex powder to form a powder, and make the powder into a powder according to the routine Or tablets or pills, or add appropriate amount of pharmaceutical starch to make granules, and put the granules into capsules to make capsules.

Example 2:

Weigh raw materials (kg) according to the following proportioning ratio:

Radix Paeoniae 20 Bupleurum 18 Angelica 18

Cyperus 12 Turmeric 8 Green Peel 12

Prunella 20 Cat's Claw 18 Arrowhead 10

Saponaria thorn 10 Bombyx silkworm 12 Full scorpion 10

Scrophulariaceae 10 Soil Fritillaria 20.

The production method is as follows:

Supercritical CO ₂ fluid extraction: use supercritical CO ₂ fluid (SFE-CO ₂ ) to extract the main active components saikosaponin and bupleurum volatile oil in Bupleuri. Put Bupleurum dry powder into the extraction kettle, heat or cool the extraction kettle, desorption kettle I, desorption kettle II, and storage tank respectively, and when the selected temperature reaches 60°C, open the _CO2 cylinder to pressurize the system, When the selected pressure of 20MPa is reached, close the cylinder, circulate the extraction, and keep constant temperature and pressure. When the selected extraction time is reached 3.0h, the material is discharged from the outlets of the analysis kettle I and the analysis kettle II to obtain saikosaponin or bupleurum volatile oil.

With 50% ethanol as entrainer, CO ₂ supercritically extracts the volatile oils from Cyperus cyperi, Angelica sinensis, Curcuma turmeric, and Qingpi medicinal materials. Put a certain amount of mixed dry powder of Rhizoma Cyperi, Angelica, Curcuma, and Qingpi into the extraction kettle, and heat or cool the extraction kettle, desorption kettle I, desorption kettle II, and storage tank respectively. When the selected temperature is reached, 55°C, Open the CO ₂ gas cylinder to pressurize the system, and when the selected pressure reaches 20MPa, close the gas cylinder, circulate the extraction, and keep constant temperature and pressure. After reaching the selected extraction time 3.0h, discharge the material from the discharge port of the analysis kettle I and the analysis kettle II to obtain volatile oil, according to the first method on page 41 of an appendix of "Chinese Pharmacopoeia" 2000 edition, record its relative density as 0.70.

Extraction of alcohol extraction drugs: Weigh the prescribed amount of silkworm and scorpion, add 14 times the amount of 50% ethanol, soak for about 1 hour, heat and reflux at 100°C for 2 times, each time for 3 hours, filter off the residue, and combine the ethanol extract , ethanol was recovered under reduced pressure and concentrated into an alcohol extract with a relative density of 1.15.

Extraction of Radix Paeoniae Rubra: Weigh the amount of Radix Radix Radix Radix Paeoniae Rubra of the recipe, add 14 times the amount of 50% ethanol, soak for about 1 hour, heat and reflux at 100°C for 2 extractions, 3 hours each time, filter off the residue, combine the ethanol extracts, reduce The ethanol is recovered under pressure and concentrated into an alcohol extract with a relative density of 1.10.

Extraction of decocted and alcohol-precipitated medicines: Weigh the prescribed amount of Prunella vulgaris, Cat’s Claw, Scrophulariaceae, Solanum Fritillaria, Arthia sativa, Saponaria thorn, add 7 times the weight of water, soak and decoct Boil twice, 3 hours each time, combine the decoction, concentrate into a decoction concentrate with a relative density of 1.5, cool the decoction concentrate to room temperature naturally, slowly add 3 times the weight of the decoction concentrate under stirring 60% ethanol, continue to stir for 40 minutes, set aside to settle at 8°C for 24 hours, filter, decoct in water to precipitate the concentrated ointment, cool the decoction to room temperature naturally after concentration, and then slowly add 80% of The dilute ethanol solution is precipitated and filtered, and the ethanol is recovered under reduced pressure and concentrated into a water decoction and alcohol precipitation concentrated paste with a relative density of 1.50.

Mixing of alcohol extraction cream and preparation of dry cream powder: Mix the above-mentioned alcohol extraction cream and decoction and alcohol precipitation concentrated cream, add 250 parts by weight of dextrin and 25 parts by weight of stevioside, mix well, and spray at 45°C Dried and crushed to obtain dry cream powder.

Preparation of β-cyclodextrin inclusion complex of volatile oil: Weigh 11 parts by weight of β-cyclodextrin, add 30 parts by weight of distilled water, and ultrasonically mix to form a β-cyclodextrin solution; Saponin or bupleurum volatile oil is diluted with 8 times the weight of absolute ethanol, and is added dropwise into the solution of β-cyclodextrin during the ultrasonic process at a specified temperature. Drop into the β-cyclodextrin solution, take it out, refrigerate at 12°C for 12 hours, filter with suction, wash the filter layer with distilled water and absolute ethanol respectively, take out the filter layer, and dry at 65°C to obtain a white loose clathrate powder. That is, volatile oil β-cyclodextrin inclusion complex powder.

Preparation of saikosaponin β-cyclodextrin inclusion complex: Weigh 10 parts by weight of β-cyclodextrin, add 35 parts by weight of distilled water, and mix uniformly by ultrasonication. Separately take the saikosaponin or bupleurum volatile oil prepared in step a, dilute it with 7 times the amount of absolute ethanol, put it dropwise into the solution of β-cyclodextrin during the ultrasonic process at 25°C, take it out, and heat it at 3°C Refrigerate for 28 hours, filter with suction, wash the filter layer with distilled water and absolute ethanol respectively, take out the filter layer, and dry at 60°C to obtain a white loose inclusion compound powder, namely saikosaponin β-cyclodextrin inclusion compound powder.

Mixing of medicinal powder and preparation of granules: mix the above-mentioned dry cream powder with volatile oil β-cyclodextrin inclusion complex powder and saikosaponin β-cyclodextrin inclusion complex powder to form a powder, and make the powder into a powder according to the routine Or tablets or pills, or add appropriate amount of pharmaceutical starch to make granules, and put the granules into capsules to make capsules.

Claims (6)

1, a kind of medicine for the treatment of cyclomastopathy is characterized in that it is the medicament of being made by the following weight parts proportion raw material

Radix Paeoniae Rubra 12～24 Radix Bupleuri 12～24 Radix Angelicae Sinensis 12～24

Rhizoma Cyperi 6～15 Radix Curcumaes 6～15 Pericarpium Citri Reticulatae Virides 6～15

Spica Prunellae 12～24 Radix Ranunculi Ternatis 12～24 Pseudobulbus cremastrae seu pleiones 6～15

Spina Gleditsiae 6～15 Bombyx Batryticatus 6～15 Scorpios 6～15

Radix Scrophulariae 6～15 Rhizoma Bolbostematiss 12～24.

2, the medicine of treatment cyclomastopathy according to claim 1, wherein the weight portion proportioning of each raw material is

Radix Paeoniae Rubra 18 Radix Bupleuri 18 Radix Angelicae Sinensis 18

Rhizoma Cyperi 9 Radix Curcumaes 9 Pericarpium Citri Reticulatae Virides 9

Spica Prunellae 18 Radix Ranunculi Ternatis 18 Pseudobulbus cremastrae seu pleiones 9

Spina Gleditsiae 9 Bombyx Batryticatus 9 Scorpios 9

Radix Scrophulariae 15 Rhizoma Bolbostematiss 18.

3, the medicine of treatment cyclomastopathy according to claim 1 and 2 is characterized in that said medicament is a said dosage form on any pharmaceutics.

4, the medicine of treatment cyclomastopathy according to claim 3 is characterized in that said medicament is powder, tablet, pill, granule or capsule.

5, the preparation method of the medicine of the described treatment cyclomastopathy of claim 1 is characterized in that

A, get the Radix Bupleuri powder and add in the extraction kettle supercritical CO ₂Fluid extraction gets saikoside or Radix Bupleuri volatile oil;

B, with a operation, different is replaces the Radix Bupleuri powder with Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Curcumae, Pericarpium Citri Reticulatae Viride mixed powder, volatile oil component;

C, get Bombyx Batryticatus, Scorpio with Diluted Alcohol solution reflux, extract,, the elimination residue merges ethanol extract, and decompression recycling ethanol also is condensed into alcohol extraction cream;

D, with the c operation, different is to replace Bombyx Batryticatus, Scorpio with Radix Paeoniae Rubra, alcohol extraction cream;

E, get Spica Prunellae, Radix Ranunculi Ternati, Radix Scrophulariae, Rhizoma Bolbostematis, Pseudobulbus cremastrae seu pleiones, Spina Gleditsiae earlier, decoct with decocting method, decocting liquid naturally cools to room temperature after concentrating, and slowly adds Diluted Alcohol solution down in stirring then, through precipitation, filtration, decompression recycling ethanol also is condensed into the water decoction-alcohol sedimentation condensed cream;

F, the alcohol extraction cream of c, d operation preparation and the water decoction-alcohol sedimentation condensed cream of e operation preparation are mixed, add the dextrin of 200～800 weight portions and the stevioside of 5～30 weight portions, mixing again in 40～90 ℃ of spray dryinges, is pulverized the powder that gets dry extract;

G, get the beta-schardinger dextrin-of 1～12 weight portion, add the distilled water of 15～35 times of weight portions, the ultrasonic beta-schardinger dextrin-solution that is mixed into; Other gets the saikoside or the Radix Bupleuri volatile oil of the preparation of a operation, dehydrated alcohol dilution with 3～8 times of weight portions, under 20～60 ℃, in ultrasonic procedure, slowly add in the beta-schardinger dextrin-solution, through cold preservation, sucking filtration, filtering layer is used distilled water and absolute ethanol washing respectively, 30～70 ℃ of dry down saikoside Benexate Hydrochloride powder that get;

H, with the g operation, different is replaces the saikoside or the Radix Bupleuri volatile oil of the preparation of a operation with the volatile oil of b operation preparation, the volatile oil beta cyclodextrin inclusion complex powder;

M, with dried cream powder and volatile oil beta cyclodextrin inclusion complex, saikoside Benexate Hydrochloride mixing.

6, according to the preparation method of the medicine of the described treatment cyclomastopathy of claim 5, it is characterized in that

Supercritical CO described in a, the b operation ₂Fluid extraction is that extraction kettle, extraction-container are heated respectively or be cooled to 30～60 ℃, adds CO then in system ₂Gas when pressure is 20～50MPa, extracted under constant temperature, the constant voltage 1.0～3.0 hours;

Diluted Alcohol solution reflux, extract, described in c, the d operation is 50～80% the ethanol liquid that adds 6～15 times of weight portions of Bombyx Batryticatus, Scorpio, soaks 0.5～1 hour, 50～100 ℃ of backflows 2～3 times down, each 1～3 hour; The relative density of described alcohol extraction cream is 1.10～1.50;

It is the water that adds Spica Prunellae, Radix Ranunculi Ternati, Radix Scrophulariae, Rhizoma Bolbostematis, Pseudobulbus cremastrae seu pleiones and 6～15 times of weight portions of Spina Gleditsiae that decocting method described in the e operation decocts, soaking the back decocts 2～3 times, each 1～3 hour, merging decocting liquid and being concentrated into relative density was 1.03～1.50 water drug-decocting concentrating liquid; Be cooled to room temperature then, under agitation slowly add 60～95% ethanol of 1～3 times of weight portion of water drug-decocting concentrating liquid, continue to stir 10～40 minutes, staticly settled 24～72 hours under 0～8 ℃, filter, water decoction-alcohol sedimentation condensed cream relative density is 1.10～1.50;

Cold preservation time described in the g operation is 10～30 hours.