CN101053646A - Traditional Chinese medicinal composition for treating endometriosis and its preparation method - Google Patents
Traditional Chinese medicinal composition for treating endometriosis and its preparation method Download PDFInfo
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Abstract
Disclosed is a Chinese medicinal composition for treating endometriosis, which pertains to the field of Chinese medicine. The composition adopts red sage root, motherwort, zedoary, coix seed and corydalis tuber as raw materials, and is extracted and refined by a variety of processes according to a certain combination requirement to a variety of medicinal forms, preferably into a tablet form. The invention also discloses a method for preparing the Chinese medicinal composition.
Description
Technical field
The present invention relates to the preparation method of a kind of pharmaceutical composition and said composition, particularly a kind of Chinese medicine composition that is used for the treatment of endometriosis and preparation method thereof belongs to the field of Chinese medicines.
Background technology
Under the normal condition, endometrium is covered in the cavity of uterine body face, as because of certain factor, makes endometrium in other position growths of health, can become endometriosis.This ectopic inner membrance not only has the body of gland of inner membrance on the histology, and intermembranous matter centers in having; On function, significant change is arranged, promptly change, but the part hormonal effects of becoming pregnant is only arranged, can produce " menstruation " on a small quantity and cause all clinical pictures with menstrual cycle with estrogen level.The patient is as becoming pregnant, and Ectopic Endometrium can have the decidua sample to change.Though this Ectopic Endometrium is grown, be different from the infiltration of malignant tumor in its hetero-organization or organ.The peak that primary disease takes place was at 30～40 years old.Endometriotic actual incidence rate is many far beyond clinical findings.As because of other disease row laparotomy explorations of gynecological the time and to the uterus adnexa specimen of excision, carefully doing the pathology inspection, can find that about 20～25% patients have ectopic endometrium.Clinical common method of treatment:
1, the hormone therapy side effect is moisture retention and weight increase.Suffering from hypertension, heart disease or renal insufficiency person should not use.Main by liver metabolism, and may produce certain infringement to hepatocyte, so suffer from women's forbidding of liver illness.
2, the operative treatment operative treatment is the main method of endometriosis, and postoperative easily recurs, and sequela is many.Age, especially the state of an illness was heavy, and the recidivist was arranged, and should carry out full uterus and bilateral adnexectomy near menopause.Avoid ovarian endometrial cyst to break during operation as far as possible.The endometriosis person takes place in stomach wall, perineal incision place, should thoroughly excise, otherwise can recur, so do not advocate to use.
Though 3, radiotherapy radiotherapy is used for the existing history for many years of endometriosis, but use multiple medicine and operation and reach very high curative effect, generally do not destroy ovarian function, and the effect of radiotherapy endometriosis, be to destroy ovary tissue, thereby eliminate the influence of ovarian hormone, make ectopic inner membrance atrophy, reach the purpose of treatment.Lonizing radiation are to ectopic inner membrance destruction and not obvious.
If Drug therapy can reach a good effect, a lot of side effect with avoiding in the clinical practice alleviate patient's pain, are fit to clinical practice.
Summary of the invention
One object of the present invention is to provide a kind of Chinese medicine composition for the treatment of endometriosis;
Another object of the present invention is to provide the preparation method of above-mentioned Chinese medicine composition.
The object of the present invention is achieved like this, according to the Chinese medicine and pharmacy theory, utilizes the property of medicine of medical herbs uniqueness, adopts Herba Leonuri, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Semen Coicis, Rhizoma Corydalis according to certain compatibility requirement, processes through special process.
The crude drug of preparation pharmaceutical composition of the present invention forms and proportioning can have various ways, and these several forms can both be brought into play therapeutical effect, and they are respectively:
(1) Radix Salviae Miltiorrhizae 3～8 weight portions, Rhizoma Curcumae 1～5 weight portion, Semen Coicis 5～15 weight portions
(2) Herba Leonuri 3～8 weight portions, Rhizoma Curcumae 1～5 weight portion, Semen Coicis 5～15 weight portions
(3) Radix Salviae Miltiorrhizae 3～8 weight portions, Rhizoma Curcumae 1～5 weight portion, Semen Coicis 5～15 weight portions, Rhizoma Corydalis 1～5 weight portion
(4) Herba Leonuri 3～8 weight portions, Rhizoma Curcumae 1～5 weight portion, Semen Coicis 5～15 weight portions, Rhizoma Corydalis 1～5 weight portion
Ratio behind the above proportion optimization is:
(1) Radix Salviae Miltiorrhizae 5 weight portions, Rhizoma Curcumae 3 weight portions, Semen Coicis 10 weight portions
(2) Herba Leonuri 5 weight portions, Rhizoma Curcumae 3 weight portions, Semen Coicis 10 weight portions
(3) Radix Salviae Miltiorrhizae 5 weight portions, Rhizoma Curcumae 3 weight portions, Semen Coicis 10 weight portions, Rhizoma Corydalis 3 weight portions
(4) Herba Leonuri 5 weight portions, Rhizoma Curcumae 3 weight portions, Semen Coicis 10 weight portions, Rhizoma Corydalis 3 weight portions
This pharmaceutical composition can adopt traditional method to be decocted in water for oral dose, and also can adopt modern crafts to extract and refiningly be processed into various clinical and can use dosage form, comprises pill, tablet, granule, capsule, emplastrum, mixture, drop pill, suppository etc.
Though the dosage form difference of above preparation, flavour of a drug are also different, all adopt identical preparation process, the crude drug of soon respectively distinguishing the flavor of extracts processing respectively, makes extract, extract is mixed add suitable pharmaceutic adjuvant then, and process route is made required dosage form routinely.Specific to the preparation method of extract of each flavor medicine, division is as follows:
A, get red rooted salvia, decoct with water 2～3 times, filter, merging filtrate concentrates, and relative density is 1.05～1.10 during to 60 ℃, add ethanol and make that to contain alcohol amount be 70%～75%, filter decompression recycling ethanol, relative density is 1.05～1.15 during to 60 ℃, adding hydrochloric acid adjusting pH is 1～2, filters, and precipitation adds 2～4 times of ethyl acetate and stirs evenly, filter, acetic acid ethyl fluid is standby; Acid liquid ethyl acetate extraction 2～4 times, combined ethyl acetate liquid merges with above-mentioned standby acetic acid ethyl fluid, reclaims ethyl acetate, and drying under reduced pressure gets Radix Salviae Miltiorrhizae extract;
As with total salvianolic acid content in high performance liquid chromatography or the tlc scanning determination gained Radix Salviae Miltiorrhizae extract, in salvianolic acid B greater than 50%.
B, get Herba Leonuri, decoct with water 2～3 times, merge decocting liquid, concentrate, relative density is 1.05～1.10 during to 60 ℃, adds ethanol and makes that to contain the alcohol amount be 70%～75%, filter, decompression recycling ethanol, relative density is 1.05～1.10 during to 60 ℃, by the strong cationic resin of having handled well, it is colourless that elder generation's water is eluted to effluent, the ammonia eluting of reuse 3%～5% or with 3%～5% hydrochloric acid solution eluting is collected eluent, adds suitable hydrochloric acid solution or sodium hydroxide solution and is neutralized to neutrality, concentrate, evaporate to dryness is ground into fine powder, is extracted into the inanimate object alkali reaction with the dehydrated alcohol percolation; Reclaim ethanol, drying under reduced pressure gets Herba Leonuri extract;
As total alkaloid content with high performance liquid chromatography or thin layer chromatography scanning or spectrophotometry gained Herba Leonuri extract, in stachydrine hydrochloride greater than 50%.
C, get the Rhizoma Curcumae medical material, vapor distillation extracts volatile oil, Rhizoma Curcumae volatile oil;
D, get the Semen Coicis medical material, use supercritical carbon dioxide extraction, obtain Semen Coicis oil; This wherein the supercritical carbon dioxide extraction parameter be: 40～60 ℃ of extraction kettle temperature, pressure 23～25Mpa; 50～55 ℃ of detached dowel temperature, pressure 12～15Mpa; 30～35 ℃ of extraction-container temperature, pressure 7～8Mpa, flow 1200～1500L/h, 2 hours extraction time.
E, get the Rhizoma Corydalis medical material,, merge ethanol with 50%～80% ethanol extraction 2～4 times, reclaim ethanol and do not have the alcohol flavor, add the hydrochloric acid of 1～2 times of amount 1%～10%, stir evenly, filter, it is 10～11 that filtrate hydro-oxidation sodium solution is regulated pH, chloroform extraction 2～4 times merges, and reclaims chloroform, drying under reduced pressure gets the Rhizoma Corydalis extract;
As with total alkaloid contents in high performance liquid chromatography or the tlc scanning determination gained Rhizoma Corydalis extract, in tetrahydropalmatine greater than 50%.
Above-described appropriate drug adjuvant comprises various diluent clear and definite in the commonly used or textbook of pharmaceutics, binding agent, disintegrating agent, fluidizer, opacifier, coating materials etc.; The common process route be meant that those of ordinary skills can both understand or from textbook, the preparation process of the various preparations that may learn of equipment operating manual.
At the characteristics of medicinal property and indication, it is optimum dosage form that the inventor selects tablet, and preferred its preparation method is as follows:
A, get red rooted salvia, decoct with water 3 times, filter, merging filtrate concentrates, and relative density is 1.05～1.10 during to 60 ℃, add ethanol and make that to contain alcohol amount be 75%, filter decompression recycling ethanol, relative density is 1.05～1.15 during to 60 ℃, adding hydrochloric acid adjusting pH is 1～2, filters, and precipitation adds 3 times of ethyl acetate and stirs evenly, filter, acetic acid ethyl fluid is standby; Acid liquid is with ethyl acetate extraction 3 times, and combined ethyl acetate liquid merges with above-mentioned standby acetic acid ethyl fluid, reclaims ethyl acetate, drying under reduced pressure, Radix Salviae Miltiorrhizae extract, total salvianolic acid content in salvianolic acid B greater than 50%.
B, get the Rhizoma Curcumae medical material, thinly slice, vapor distillation extracts volatile oil, Rhizoma Curcumae volatile oil.
C, get exsiccant Semen Coicis medical material, use supercritical carbon dioxide extraction: the extraction kettle temperature is 40～60 ℃, pressure 23～25Mpa, 50～55 ℃ of detached dowel temperature, pressure 12～15Mpa, 30～35 ℃ of extraction-container temperature, pressure 7～8Mpa, flow 1200～1500L/h, obtains Semen Coicis oil at 2 hours extraction time.
D, get the Rhizoma Corydalis medical material, be ground into coarse powder, with 50%～80% ethanol extraction 2～4 times, merge ethanol, reclaim ethanol and do not have the alcohol flavor, add 2 times of amounts of hydrochloric acid of 2%, stir evenly, filter, it is 10～11 that filtrate hydro-oxidation sodium solution is regulated pH, chloroform extraction 2～4 times, merge, reclaim chloroform, drying under reduced pressure, the Rhizoma Corydalis extract, total alkaloids in tetrahydropalmatine greater than 50%.
E, with a, b, the extract obtained mixing of c, d, add microcrystalline Cellulose, carboxymethylstach sodium is an amount of, tabletting, promptly.
The inventor of medicine of the present invention is aspect the selection and compatibility thereof of crude drug, carried out series of experiment research, by the side's of tearing open experimental study, determined the crude drug composition of preparation medicine of the present invention, make it compared with prior art have significantly outstanding curative effect advantage, realized the potentiation purpose of important compatible combination.
Following experimental example further specifies the medical application of medicine of the present invention by observing the endometriotic curative effect of tablet in treatment of the present invention.
Clinical data: the patient is all from outpatient service
Test group 1: writing out a prescription is Radix Salviae Miltiorrhizae, Semen Coicis, Rhizoma Curcumae
Test group 2: writing out a prescription is Radix Salviae Miltiorrhizae, Semen Coicis, Rhizoma Curcumae, Rhizoma Corydalis
Test group 3: writing out a prescription is Herba Leonuri, Semen Coicis, Rhizoma Curcumae
Test group 4: writing out a prescription is Herba Leonuri, Semen Coicis, Rhizoma Curcumae, Rhizoma Corydalis
Matched group: GUIZHI FULING JIAONANG (Kang Yuan pharmaceutcal corporation, Ltd in Jiangsu produces, lot number: 030915, and the 0.31g/ grain), each 3, every day 3 times.
Diagnostic criteria meets " new Chinese medicine clinical research guideline " and is foundation, drafts with reference to " obstetrics and gynecology " relevant gynecopathy diagnostic criteria.
Case choice criteria all genus gynecopathies recurrence after operation or through laparoscopic diagnosis or add B ultrasonic diagnosis through gynecologial examination and be and include object in.
The Chinese medical discrimination standard is through preceding inferior belly gas pain, and through going severe pain, pain is drawn the waist sacrum, and pain is very fainted, abdominal pain with tenderness, and blockage of menstruation, the folder clot, alleviation of pain under the piece, rectal tenesmus, uncomfortable in chest easypro through the fore udder distending pain, dyspareunia, purplish tongue is dark, and the limit point has ecchymosis, white and thin fur, stringy pulse.
Be divided into treatment at random and organize 120 examples, matched group 40 examples.24～47 years old treatment group age, average (34.5 ± 5.42) year; The course of disease 3 months～12 years, average (4.23 ± 3.52) year; Dysmenorrhea 54 examples, rectal tenesmus 36 examples, sexual anhedonia 17 examples, menoxenia 15 examples, basal body temperature two-phase 15 examples that are not true to type, infertile 15 examples, pelvic cavity tuberosity 41 examples, chocolate cyst of ovary 21 examples.23～48 years old matched group age, average (35.2 ± 5.21) year; The course of disease 7 months～11 years, average (4.65 ± 3.43) year; Dysmenorrhea 37 examples, rectal tenesmus 25 examples, sexual anhedonia 13 examples, menoxenia 11 examples, basal body temperature two-phase 11 examples that are not true to type, infertile 12 examples, pelvic cavity tuberosity 29 examples, chocolate cyst of ovary 16 examples.Learn by statistics and handle, two groups of data there was no significant differences have comparability (P＞0.05).
Therapeutic Method recipe quantity every day is made preparation by selection process.Divide and take for 3 times.All stopping using during two groups of patient treatments, other treats the medicine of gynecopathy.With 3 months be 1 course of treatment, write down situations such as clinical symptoms, gynecologial examination, ultrasound diagnosis, basal body temperature, gestation after 2 courses of treatment.Followed up a case by regular visits to after the drug withdrawal 3 months, infertile patient was followed up a case by regular visits to 1 year.
Curative effect determinate standard and result
The position of observation index and method abdominal pain during menstruation, character, degree, persistent period; The phase of menstruation, amount, color, matter and follow disease, tongue arteries and veins card; Gynecologial examination: position, mobility, jarjavay's ligaments, uterus rear wall and the douglas cul-de-sac etc. that mainly comprise the uterus locate to have or not tuberosity and nodular size, quality (unmarried woman does the anus inspection).
Criterion of therapeutical effect is drafted following criterion with reference to the clinical guidance principle of " new Chinese medicine clinical research guideline " relevant treatment by Chinese herbs endometriosis.Clinical recovery: symptom all disappears, and local sign such as pelvic lump disappears substantially, infertile patient gestation or fertility; Produce effects: symptom disappears substantially, and pelvic lump dwindles more than 1/2, though local sign exists, infertile patient is become pregnant; Effectively: sx, pelvic lump dwindle more than 1/3; Invalid: cardinal symptom changes or worsens, and local patholoic change has the trend of increasing the weight of.
Therapeutic outcome
Two groups of treatment total effectses compare (table 1)
| Grouping | n | Recovery from illness | Produce effects | Effectively | Invalid | The P value |
| Treatment is organized 1 treatment and is organized 2 treatments and organize 3 treatments and organize 4 matched groups | 30 30 30 30 40 | 2 3 2 3 2 | 12 16 11 15 22 | 10 14 12 15 12 | 1 1 2 1 4 | ＜0.05 |
As seen from Table 1, the treatment group is evident in efficacy, and total effective rate is 95.8%, and wherein the clinical recovery rate is 8.3%, and obvious effective rate is 45%, accounts for 53.3% of total effective rate, the significant difference of having compared with the matched group total effective rate (＜0.05).And the analgesic effect of treatment group 2 and 4 is better.
Below further set forth technical scheme of the present invention with the specific embodiment, but the claimed content of the present patent application and not only in these dosage forms.The consumption of crude drug can be a unit with ton, kilogram, gram etc. also not only in the embodiment consumption in the actual production, but the consumption proportion of each crude drug is still according to technical scheme of the present invention.
The specific embodiment
Embodiment 1:
Prescription: Radix Salviae Miltiorrhizae 3000g Rhizoma Curcumae 1000g Semen Coicis 5000g
Method for making: a, get red rooted salvia, decoct with water 3 times, filter, merging filtrate concentrates, and relative density is 1.05～1.10 during to 60 ℃, add ethanol and make that to contain alcohol amount be 70%, filter decompression recycling ethanol, relative density is 1.05～1.15 during to 60 ℃, adding hydrochloric acid adjusting pH is 1～2, filters, and precipitation adds 3 times of ethyl acetate and stirs evenly, filter, acetic acid ethyl fluid is standby; Acid liquid ethyl acetate extraction 2 times, combined ethyl acetate liquid merges with above-mentioned standby acetic acid ethyl fluid, reclaims ethyl acetate, and drying under reduced pressure gets Radix Salviae Miltiorrhizae extract.
B, get the Rhizoma Curcumae medical material, thinly slice, vapor distillation extracts volatile oil, Rhizoma Curcumae volatile oil, and with the betacyclodextrin inclusion.
C, get exsiccant Semen Coicis medical material, use supercritical carbon dioxide extraction: the extraction kettle temperature is 40～60 ℃, pressure 23～25Mpa, 50～55 ℃ of detached dowel temperature, pressure 12～15Mpa, 30～35 ℃ of extraction-container temperature, pressure 7～8Mpa, flow 1200～1500L/h, 2 hours extraction time.Obtain Semen Coicis oil with the betacyclodextrin inclusion.
D, add Rhizoma Curcumae volatile oil inclusion complex and Semen Coicis volatile oil inclusion complex in Radix Salviae Miltiorrhizae extract, mixing adds 10% microcrystalline Cellulose and 3% carboxymethylstach sodium again, and mixing is made 1000, the bag film-coat, promptly.
Embodiment 2:
Prescription: Radix Salviae Miltiorrhizae 800g Rhizoma Curcumae 500g Semen Coicis 1500g
Method for making: a, get red rooted salvia, decoct with water 2 times, filter, merging filtrate concentrates, and relative density is 1.05～1.10 during to 60 ℃, add ethanol and make that to contain alcohol amount be 75%, filter decompression recycling ethanol, relative density is 1.05～1.15 during to 60 ℃, adding hydrochloric acid adjusting pH is 1～2, filters, and precipitation adds 3 times of ethyl acetate and stirs evenly, filter, acetic acid ethyl fluid is standby; Acid liquid ethyl acetate extraction 3 times, combined ethyl acetate liquid merges with above-mentioned standby acetic acid ethyl fluid, reclaims ethyl acetate, and drying under reduced pressure gets Radix Salviae Miltiorrhizae extract.
B, get the Rhizoma Curcumae medical material, thinly slice, vapor distillation extracts volatile oil, Rhizoma Curcumae volatile oil.
C, get exsiccant Semen Coicis medical material, use supercritical carbon dioxide extraction: the extraction kettle temperature is 40～60 ℃, pressure 23～25Mpa, 50～55 ℃ of detached dowel temperature, pressure 12～15Mpa, 30～35 ℃ of extraction-container temperature, pressure 7～8Mpa, flow 1200～1500L/h, 2 hours extraction time.Obtain Semen Coicis oil.
D, in Radix Salviae Miltiorrhizae extracts, add appropriate amount of starch, and spray into Rhizoma Curcumae volatile oil and Semen Coicis volatile oil, encapsulated after the cold drying, make 1000, promptly.
Embodiment 3:
Prescription: Radix Salviae Miltiorrhizae 800g Rhizoma Curcumae 100g Semen Coicis 1500g
Method for making a, get red rooted salvia, decoct with water 3 times, filter, merging filtrate concentrates, and relative density is 1.05～1.10 during to 60 ℃, add ethanol and make that to contain alcohol amount be 75%, filter decompression recycling ethanol, relative density is 1.05～1.15 during to 60 ℃, adding hydrochloric acid adjusting pH is 1～2, filters, and precipitation adds 3 times of ethyl acetate and stirs evenly, filter, acetic acid ethyl fluid is standby; Acid liquid ethyl acetate extraction 3 times, combined ethyl acetate liquid merges with above-mentioned standby acetic acid ethyl fluid, reclaims ethyl acetate, and drying under reduced pressure gets Radix Salviae Miltiorrhizae extract.
B, get the Rhizoma Curcumae medical material, thinly slice, vapor distillation extracts volatile oil, Rhizoma Curcumae volatile oil.
C, get exsiccant Semen Coicis medical material, use supercritical carbon dioxide extraction: the extraction kettle temperature is 40～60 ℃, pressure 23～25Mpa, 50～55 ℃ of detached dowel temperature, pressure 12～15Mpa, 30～35 ℃ of extraction-container temperature, pressure 7～8Mpa, flow 1200～1500L/h, 2 hours extraction time.Obtain Semen Coicis oil.
D, taking polyethylene glycol 6000 in addition, polyethylene glycol 1500 is heated to 65 ℃ and makes fusing, stirs evenly, as substrate; Get Radix Salviae Miltiorrhizae extract, it is an amount of to add water, grinds to form thick paste, joins in the substrate under stirring, and adds Rhizoma Curcumae volatile oil and Semen Coicis volatile oil again, and 65 ℃ of insulations stir evenly, and moulding is made 1000 pieces of suppositorys, promptly.
Embodiment 4:
Prescription: Radix Salviae Miltiorrhizae 500g, Rhizoma Curcumae 300g, Semen Coicis 1000g
Method for making: a, get red rooted salvia, decoct with water 2 times, filter, merging filtrate concentrates, and relative density is 1.05～1.10 during to 60 ℃, add ethanol and make that to contain alcohol amount be 70%, filter decompression recycling ethanol, relative density is 1.05～1.15 during to 60 ℃, adding hydrochloric acid adjusting pH is 1～2, filters, and precipitation adds 4 times of ethyl acetate and stirs evenly, filter, acetic acid ethyl fluid is standby; Acid liquid ethyl acetate extraction 4 times, combined ethyl acetate liquid merges with above-mentioned standby acetic acid ethyl fluid, reclaims ethyl acetate, and drying under reduced pressure gets Radix Salviae Miltiorrhizae extract;
B, get the Rhizoma Curcumae medical material, vapor distillation extracts volatile oil, Rhizoma Curcumae volatile oil, and with the betacyclodextrin inclusion;
C, get the Semen Coicis medical material, use supercritical carbon dioxide extraction, obtain Semen Coicis oil, and with the betacyclodextrin inclusion;
D, get the inclusion complex of Radix Salviae Miltiorrhizae extract and volatile oil, add 45% starch again, mixing, the system soft material is made pill.
Embodiment 5:
Prescription: Herba Leonuri 300g, Rhizoma Curcumae 100g, Semen Coicis 1500g, Rhizoma Corydalis 500g
Method for making: a, get Herba Leonuri, decoct with water 3 times, merge decocting liquid, concentrate, relative density is 1.05～1.10 during to 60 ℃, adds ethanol and makes that to contain the alcohol amount be 70%, filter, decompression recycling ethanol, relative density is 1.05～1.10 during to 60 ℃, by the strong cationic resin of having handled well, it is colourless that elder generation's water is eluted to effluent, the ammonia eluting of reuse 5% or with 3% hydrochloric acid solution eluting is collected eluent, adds suitable hydrochloric acid solution or sodium hydroxide solution and is neutralized to neutrality, concentrate, evaporate to dryness is ground into fine powder, is extracted into the inanimate object alkali reaction with the dehydrated alcohol percolation; Reclaim ethanol, drying under reduced pressure gets Herba Leonuri extract;
B, get the Rhizoma Curcumae medical material, vapor distillation extracts volatile oil, Rhizoma Curcumae volatile oil, and with the small amount of ethanol diluted for use;
C, get the Semen Coicis medical material, use supercritical carbon dioxide extraction, obtain Semen Coicis oil, and with the small amount of ethanol diluted for use;
D, get the Rhizoma Corydalis medical material,, merge ethanol, reclaim ethanol and do not have the alcohol flavor, add the hydrochloric acid of 2 times of amounts 5% with 70% ethanol extraction 3 times, stir evenly, filter, it is 10～11 that filtrate hydro-oxidation sodium solution is regulated pH, chloroform extraction 2 times, merge, reclaim chloroform, drying under reduced pressure gets the Rhizoma Corydalis extract;
E, Herba Leonuri extract, Rhizoma Corydalis extract are mixed, add dextrin 240g, starch 20g, mixing, with 85% alcohol granulation, granulate sprays into the alcoholic solution of above-mentioned volatile oil, and hot blast drying is distributed into granule.
Embodiment 6: other mix proportion schemes, preparation method is with reference to above each embodiment
| Scheme number | Inventory (kg) | ||||
| Radix Salviae Miltiorrhizae | Herba Leonuri | Rhizoma Curcumae | Semen Coicis | Rhizoma Corydalis | |
| 1 | 3 | 1 | 5 | ||
| 2 | 8 | 5 | 15 | ||
| 3 | 3 | 1 | 15 | ||
| 4 | 8 | 5 | 5 | ||
| 5 | 3 | 3 | 8 | ||
| 6 | 8 | 3 | 12 | ||
| 7 | 3 | 4 | 14 | ||
| 8 | 8 | 4 | 10 | ||
| 9 | 3 | 1 | 5 | 1 | |
| 10 | 3 | 1 | 15 | 5 | |
| 11 | 8 | 5 | 5 | 5 | |
| 12 | 8 | 5 | 15 | 1 | |
| 13 | 4 | 5 | 6 | 5 | |
| 14 | 5 | 4 | 10 | 4 | |
| 15 | 6 | 3 | 12 | 3 | |
| 16 | 7 | 2 | 14 | 2 | |
Claims (14)
1. Chinese medicine composition for the treatment of endometriosis is characterized in that this pharmaceutical composition mainly made by following raw material medicaments: Radix Salviae Miltiorrhizae 3～8 weight portions, Rhizoma Curcumae 1～5 weight portion, Semen Coicis 5～15 weight portions.
2, Chinese medicine composition as claimed in claim 1 is characterized in that the preferred proportion of each crude drug is: Radix Salviae Miltiorrhizae 5 weight portions, Rhizoma Curcumae 3 weight portions, Semen Coicis 10 weight portions.
3, Chinese medicine composition as claimed in claim 1 or 2 is characterized in that the Herba Leonuri that Radix Salviae Miltiorrhizae in the crude drug also can be commensurability replaces.
4, the endometriotic Chinese medicine composition of a kind of treatment, its thing are that this Chinese medicine composition made by following crude drug: Radix Salviae Miltiorrhizae 3～8 weight portions, Rhizoma Curcumae 1～5 weight portion, Semen Coicis 5～15 weight portions, Rhizoma Corydalis 1～5 weight portion.
5, Chinese medicine composition as claimed in claim 4 is characterized in that the optimum ratio of each crude drug is: Radix Salviae Miltiorrhizae 5 weight portions, Rhizoma Curcumae 3 weight portions, Semen Coicis 10 weight portions, Rhizoma Corydalis 3 weight portions.
6,, it is characterized in that the Herba Leonuri that Radix Salviae Miltiorrhizae in the crude drug also can be commensurability replaces as claim 4 or 5 described Chinese medicine compositions.
7, as claim 3 or 6 described Chinese medicine compositions, it is characterized in that being made into pill, tablet, granule, capsule, obedient unguentum, mixture, drop pill, suppository etc. clinical applicable any.
8, preparation is as the method for arbitrary described Chinese medicine composition in the claim 1～7, it is characterized in that this method is selected crude drug to be extracted respectively be processed into extract, then corresponding extract is added suitable pharmaceutic adjuvant, process route is made required dosage form routinely.
9, preparation method as claimed in claim 8 is characterized in that the preparation process of each crude drug extract is respectively:
A, get red rooted salvia, decoct with water 2～3 times, filter, merging filtrate concentrates, and relative density is 1.05～1.10 during to 60 ℃, add ethanol and make that to contain alcohol amount be 70%～75%, filter decompression recycling ethanol, relative density is 1.05～1.15 during to 60 ℃, adding hydrochloric acid adjusting pH is 1～2, filters, and precipitation adds 2～4 times of ethyl acetate and stirs evenly, filter, acetic acid ethyl fluid is standby; Acid liquid ethyl acetate extraction 2～4 times, combined ethyl acetate liquid merges with above-mentioned standby acetic acid ethyl fluid, reclaims ethyl acetate, and drying under reduced pressure gets Radix Salviae Miltiorrhizae extract;
B, get Herba Leonuri, decoct with water 2～3 times, merge decocting liquid, concentrate, relative density is 1.05～1.10 during to 60 ℃, adds ethanol and makes that to contain the alcohol amount be 70%～75%, filter, decompression recycling ethanol, relative density is 1.05～1.10 during to 60 ℃, by the strong cationic resin of having handled well, it is colourless that elder generation's water is eluted to effluent, the ammonia eluting of reuse 3%～5% or with 3%～5% hydrochloric acid solution eluting is collected eluent, adds suitable hydrochloric acid solution or sodium hydroxide solution and is neutralized to neutrality, concentrate, evaporate to dryness is ground into fine powder, is extracted into the inanimate object alkali reaction with the dehydrated alcohol percolation; Reclaim ethanol, drying under reduced pressure gets Herba Leonuri extract;
C, get the Rhizoma Curcumae medical material, vapor distillation extracts volatile oil, Rhizoma Curcumae volatile oil;
D, get the Semen Coicis medical material, use supercritical carbon dioxide extraction, obtain Semen Coicis oil;
E, get the Rhizoma Corydalis medical material,, merge ethanol with 50%～80% ethanol extraction 2～4 times, reclaim ethanol and do not have the alcohol flavor, add the hydrochloric acid of 1～2 times of amount 1%～10%, stir evenly, filter, it is 10～11 that filtrate hydro-oxidation sodium solution is regulated pH, chloroform extraction 2～4 times merges, and reclaims chloroform, drying under reduced pressure gets the Rhizoma Corydalis extract.
10, as the preparation method of Chinese medicine composition as described in the claim 9, it is characterized in that with total salvianolic acid content in the gained Radix Salviae Miltiorrhizae extract among spectrophotography or high performance liquid chromatography or the tlc scanning determination a, in salvianolic acid B greater than 50%;
11, as the preparation method of Chinese medicine composition as described in the claim 9, it is characterized in that total alkaloid content with gained Herba Leonuri extract among high performance liquid chromatography or thin layer chromatography scanning or the spectrophotometry b, in stachydrine hydrochloride greater than 50%.
12, as the preparation method of Chinese medicine composition as described in the claim 9, it is characterized in that the supercritical carbon dioxide extraction parameter is among the d: 40～60 ℃ of extraction kettle temperature, pressure 23～25Mpa; 50～55 ℃ of detached dowel temperature, pressure 12～15Mpa; 30～35 ℃ of extraction-container temperature, pressure 7～8Mpa, flow 1200～1500L/h, 2 hours extraction time.
13, as the preparation method of Chinese medicine composition as described in the claim 9, it is characterized in that with total alkaloid contents in high performance liquid chromatography or the tlc scanning determination d gained Rhizoma Corydalis extract, in tetrahydropalmatine greater than 50%.
14, use in preparation is used for the treatment of the medicine of endometriosis as arbitrary described Chinese medicine composition in the claim 1～6.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103239681A (en) * | 2013-05-22 | 2013-08-14 | 江西博莱大药厂 | Compound tasmanian bluegum leaf Chinese herbal composition and preparation method thereof |
| CN105833209A (en) * | 2016-06-15 | 2016-08-10 | 山东中医药大学附属医院 | Traditional Chinese medicine composition for treating endometriosis uterina |
| CN106860835A (en) * | 2017-02-24 | 2017-06-20 | 河南中医药大学 | A kind of Chinese medicine of prevention endometriosis of pelvis postoperative recurrence |
-
2006
- 2006-04-13 CN CN 200610076968 patent/CN101053646A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103239681A (en) * | 2013-05-22 | 2013-08-14 | 江西博莱大药厂 | Compound tasmanian bluegum leaf Chinese herbal composition and preparation method thereof |
| CN105833209A (en) * | 2016-06-15 | 2016-08-10 | 山东中医药大学附属医院 | Traditional Chinese medicine composition for treating endometriosis uterina |
| CN105833209B (en) * | 2016-06-15 | 2021-06-22 | 山东中医药大学附属医院 | Traditional Chinese medicine composition for treating endometriosis |
| CN106860835A (en) * | 2017-02-24 | 2017-06-20 | 河南中医药大学 | A kind of Chinese medicine of prevention endometriosis of pelvis postoperative recurrence |
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