CN101024028A - Medicine composition for treating mammary gland hyperplasia and its extracting preparing method - Google Patents
Medicine composition for treating mammary gland hyperplasia and its extracting preparing method Download PDFInfo
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Abstract
The present invention discloses a Chinese medicine for effectively curing hyperplasia of mammary glands with obvious therapeutic effect. It is made up by using 13 Chinese medicinal materials of bupleurum root, Chinese angelica root, ligusticum root, red peony root, cyperus root and others through a certain preparation process. Said invention also provides the concrete steps of its preparation process.
Description
Technical field
The present invention relates to medicinal preparation and extract preparation method, specifically a kind of pharmaceutical composition and extraction preparation method that is specially adapted to treat cyclomastopathy.
Background technology
Cyclomastopathy is women's commonly encountered diseases and frequently-occurring disease, and it is the normally disorder of mammary gland that a kind of physiology hypertrophy and subinvolution cause in essence.Cyclomastopathy mainly shows as the hyperplasia of prostate of matter between mammary gland, and hypertrophy can betide around the glandular tube and with the cyst that differs in size and form; Also can occur in the glandular tube and show as nipple sample hypertrophy, the latex dust cystic dilatation of epithelium.The clinical symptoms of this disease is mainly lump in breast and mastalgia.It is reported that the normal high 2-4 of women of the danger that this disease is cancerated has doubly caused people's great attention so actively prevent and treat cyclomastopathy.The cause of disease of cyclomastopathy is still not fully aware of at present, but the general medicine expert thinks that itself and psychentonia, endocrine disturbance cause body lutein secretion minimizing, estrogen to increase relevant relatively.Traditional Chinese Medicine experts thinks that stagnation of QI due to depression of the liver, feelings will internal injury are the main causes of bringing out this disease.When depressed emotion, the stagnation of QI are not usually relaxed, QI and blood week loss degree pents up in breast stomach network, and newborn network meridian and vessels obstruction is obstructed, stagnation of QI and blood may bring about pain and cause mastalgia; Liver-QI transversely invading the stomach, dysfunction of the spleen in transportation is given birth in expectorant is turbid, and it is nuclear that qi depression to blood stasis is held the expectorant knot under the arm poly-, follows through staying poly-Ruzhong, so the Ruzhong caking.At present, if the clinical drug main Chinese patent medicine that is used for the treatment of cyclomastopathy, as RUKANG PIAN, RUPIXIAO, asparagine sheet, XIAOJIN DAN, ease pill or the like.These Chinese patent medicines generally are based on depressed liver-energy dispersing and QI regulating, activating blood circulation to dissipate blood stasis, its prescription or cold partially or partial heat, and clinical application effect is still not very good.
Summary of the invention
The object of the present invention is to provide a kind of new pharmaceutical composition that is used for the treatment of cyclomastopathy, a kind of extraction preparation method of this pharmaceutical composition is provided simultaneously, in the hope of providing more medication to select for clinical.
The object of the present invention is achieved like this:
The principles of formulating prescriptions of the present invention are based on activating blood circulation to dissipate blood stasis, depressed liver-energy dispersing and QI regulating, and heavily the kidney invigorating and warming YANG is gentle in the hope of the pharmaceutical properties that is made up is suitable for transferring reaching the usefulness of unclogging and readjusting simultaneously, do not have the biased and consumption of cold and heat simultaneously again and take by force and love stagnant evil;
Pharmaceutical composition of the present invention is to be made by the crude drug of following weight parts ratio:
20～50 parts of Radix Bupleuri, 20～50 parts of Radix Angelicae Sinensis, 20～50 parts of Rhizoma Cyperis, 20～50 parts of 20～50 parts of Radix Paeoniae Rubra of Rhizoma Chuanxiong, 26～50 parts of Semen Cuscutae, 26～50 parts of Herba Cynomoriis, 26～50 parts of Caulis Polygoni Multiflori, 20～50 parts of Spina Gleditsiaes, Eupolyphaga Seu Steleophaga 13-26 part, 20～50 parts of Herba Epimedii, 20～50 parts of Herba Leonuris, 26～50 parts of Herba Artemisiae Anomalaes.
The preferable amount proportioning of each crude drug is:
20～30 parts of Radix Bupleuri, 20～30 parts of Radix Angelicae Sinensis, 20～30 parts of Rhizoma Cyperis, 20～30 parts of 20～30 parts of Radix Paeoniae Rubra of Rhizoma Chuanxiong, 26～36 parts of Semen Cuscutae, 26～36 parts of Herba Cynomoriis, 26～36 parts of Caulis Polygoni Multiflori, 20～30 parts of Spina Gleditsiaes, Eupolyphaga Seu Steleophaga 13-26 part, 20～30 parts of Herba Epimedii, 20～30 parts of Herba Leonuris, 26～36 parts of Herba Artemisiae Anomalaes.
The more preferred consumption proportion of each crude drug is:
20 parts of Radix Bupleuri, 20 parts of Radix Angelicae Sinensis, 20 parts of Rhizoma Cyperis, 20 parts of 20 parts of Radix Paeoniae Rubra of Rhizoma Chuanxiong, 26.6 parts of Semen Cuscutae, 26.6 parts of Herba Cynomoriis, 26.6 parts of Caulis Polygoni Multiflori, 20 parts of Spina Gleditsiaes, 13.3 parts of Eupolyphaga Seu Steleophagas, 20 parts of Herba Epimedii, 20 parts of Herba Leonuris, 26 parts of Herba Artemisiae Anomalaes.
The present invention is monarch with the Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI, Chinese Angelica blood replonishing easing the affected liver, the Rhizoma Cyperi resolving depression of regulating the flow of vital energy, the Rhizoma Chuanxiong promoting flow of QI and blood, the three is a ministerial drug also, the supporing yang the liver benefiting of Herba Cynomorii, Herba Epimedii the kidney invigorating dehumidifying, the nourishing the liver of Semen Cuscutae kidney tonifying, Radix Paeoniae Rubra cooling blood and dissolving stasis, Eupolyphaga Seu Steleophaga removing blood stasis eliminating stagnation, Spina Gleditsiae dissipating blood stasis for subsidence of swelling, Herba Leonuri invigorate blood circulation dispel turbid, the relieving distension of Herba Artemisiae Anomalae removing blood stasis, the Caulis Polygoni Multiflori tranquilizing by nourishing the heart is altogether for assisting a ruler in governing a country the double messenger drug that fills of Radix Bupleuri.
The extract of pharmaceutical composition of the present invention can add acceptable accessories, and formulation method is prepared into dosage forms such as capsule, tablet, powder, pill, granule, powder, oral liquid routinely.Can be made into granule, capsule etc. as adding beta-schardinger dextrin-, sucrose, protein sugar.
The extraction preparation method of this pharmaceutical composition provided by the invention is:
A, take by weighing each drug component by following weight proportion:
20～50 parts of Radix Bupleuri, 20～50 parts of Radix Angelicae Sinensis, 20～50 parts of Rhizoma Cyperis, 20～50 parts of 20～50 parts of Radix Paeoniae Rubra of Rhizoma Chuanxiong, 26～50 parts of Semen Cuscutae, 26～50 parts of Herba Cynomoriis, 26～50 parts of Caulis Polygoni Multiflori, 20～50 parts of Spina Gleditsiaes, Eupolyphaga Seu Steleophaga 13-26 part, 20～50 parts of Herba Epimedii, 20～50 parts of Herba Leonuris, 26～50 parts of Herba Artemisiae Anomalaes; With all drug components, pulverize separately becomes coarse powder, and is standby.
B, get Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Cyperi three flavor medicines, after soaking, extract, collect volatile oil, medicinal residues and aqueous solution device are in addition retained, and be standby;
C, under 40～45 ℃ of constant temperatures, with beta-schardinger dextrin-volatile oil is carried out enclose, stirred 1～1.5 hour, under 2～4 ℃ of conditions, cold preservation 10～12 hours, sucking filtration, clathrate with a spot of water and petroleum ether after, be lower than under 40 ℃ of temperature conditions, dry 6～8 hours, porphyrize is crossed 60～80 mesh sieves, and is standby;
D, the medicinal residues in the b step are added the water of 8～10 times of amounts, decocted 1～1.5 hour, filter, the aqueous solution in filtrate and the b step merges, and the amalgamation liquid retention is standby;
E, with Radix Bupleuri, Herba Artemisiae Anomalae, Herba Cynomorii three flavor medicines, add 70～75% alcohol reflux 2 times of 8～10 times of amounts, each 1～1.5 hour, filter, merging filtrate, decompression filtrate recycling ethanol is concentrated into relative density and is 1.18～1.22 clear paste, and is standby;
F, with medicinal residues in the e step and Radix Paeoniae Rubra, Herba Epimedii, Spina Gleditsiae, Herba Leonuri, Semen Cuscutae, Caulis Polygoni Multiflori, Eupolyphaga Seu Steleophaga seven flavor medicine mixing, the water that adds 10～12 times of amounts, decoct 2 times, each 1～1.5 hour, filter, filtrate is with after amalgamation liquid in the d step mixes, the relative density that is evaporated to is 1.02～1.05 o'clock, after adding 1% positive sky one-tenth II type natural clarifying agent B component 2ml～4ml in every 100ml filtrate, add concentration again and be 1% became II type natural clarifying agent A component 4ml～6ml in positive day, stir evenly, 60～70 ℃ of water bath heat preservations 1～1.5 hour, under 2～4 ℃ of conditions, leave standstill 20～24 hours after, filter, it is 1.22～1.28 clear paste that filtrate decompression is concentrated into relative density;
G, with the clear paste in clear paste in the e step and the f step merge, mixing, add the clathrate in the c step again, be former medicament extract behind the mixing.
The inventive method has adopted different extracting method respectively at the characteristic of crude drug in the prescription of the present invention.This method both can effectively keep the peculiar activity of crude drug, produced good synergism after can impelling simultaneously each drug component compatibility again.
The invention pharmaceutical composition can be used for treating mammary glands in women cyclomastopathy, lump in breast and distending pain of the breast.
The usage and dosage of medicinal granule of the present invention is: the adult takes 1 bag (6.0g), every day 3 times at every turn.15～30 days courses of treatment.The clinicist also can determine the usage and dosage of medicine according to patient's concrete condition.
Pharmaceutical composition of the present invention has the endocrine function of adjusting hypophysis-gonad axis, can effectively regulate the concentration of body serum estradiol and lutropin, simultaneously can obviously suppress mammoplasia, suppressing granuloma induced by implantation of cotton pellets forms, reduce capillary permeability, improve the mice microcirculation, and have significant analgesic activity.Thereby medicine of the present invention can be controlled cyclomastopathy by many target spots, cyclomastopathy is had the effect for the treatment of both the principal and secondary aspects of a disease.
The granule of pharmaceutical composition of the present invention is called " mastalgia is peaceful " temporarily in clinical practice.
The beneficial effect of pharmaceutical composition of the present invention has obtained checking by following test:
The experiment medicine
The granule of pharmaceutical composition of the present invention (peaceful) hereinafter to be referred as mastalgia, the 6.0g/ bag.Positive control drug: RUKANG PIAN, specification: the 0.359g/ sheet, product batch number: 20020416, authentication code: the accurate word ZF20000197 of ZZ4337 traditional Chinese medicines number, produce by Ankang Chia Tai Pharmaceutical Co., Ltd..Estradiol benzoate injection, 1mg/ml, product batch number 01010216 is produced by Shanghai General Pharmaceutical Co., ltd..Progesterone injection, 20mg/1ml, product batch number: 020701, produce by Shanghai General Pharmaceutical Co., ltd..
Laboratory animal
The Wistar rat, Xinjiang medical experiment animal supply center provides, and produces the moving word of certificate Xinjiang doctor (1996) No. 16001.
Kunming mouse, Xinjiang medical experiment animal supply center provides, and produces the moving word of certificate Xinjiang doctor (1996) No. 16001.
Reagent and instrument: 722 grating spectrophotometers, Shanghai the 3rd analytical tool factory.Optical microscope (Olympus), Japan produces.
Laboratory condition
120 square metres of Animal House entire area, 23 ± 2 ℃ of room temperatures, humidity 40～60% has air cleaner.
Drug effect embodiment 1: medicine of the present invention is to the influence of rat mammary gland hypertrophy and serum hormone:
Get 60 of Wistar female rats, body weight 153.4 ± 16.8g.According to the body weight equilibrium, be divided into blank group, model group, positive controls and mastalgia at random and rather organize (mastalgia is rather organized according to dosage 1.0g/kg, and 2.0g/kg, 4.0g/kg are divided into peaceful 1 group of mastalgia again successively, peaceful 2 groups of mastalgia, peaceful 3 groups of mastalgia).Every group 10.Except that the blank group, all the other respectively organize the equal intramuscular injection estradiol benzoate of rat (E
2) 0.5mg/kg, every day 1 time, continuous 25 days.Then use intramuscular injection Progesterone 5mg/kg instead, every day 1 time, continuous 5 days.Blank group intramuscular injection normal saline (NS) 0.2ml/, continuous 30 days.Intramuscular injection E
2After 10 days, begin administration according to prescribed dose, blank group and model group such as only give at capacity NS.Irritate stomach, once a day, continuous 30 days.2h after the last administration, the height of the 2nd, 3 pair of nipple (or breast) is measured in the ether light anaesthesia, and carotid artery is got blood, measures serum E
2And LH (lutropin).And downcut the 2nd pair of breast (complete), and 10% formalin fixed, specimens paraffin embedding slices, HE dyeing is analyzed with light microscopic malingering reason.Blank group, the peaceful group of each mastalgia compare with model group, mean t check between the work group.
The result of histopathologic examination of test shows:
Acinus is intensive in a large amount of hypertrophy of the acinus of model group mammary gland and conduit, lobule, differs in size, and alveolar lumen enlarges, and enlarges in the ductal ectasia, conduit lumen of gland, occurs a large amount of secretions in the lumen of gland.The modeling success is described thus.
The rat mammary gland hypertrophy of the especially heavy dose of group of the peaceful group of mastalgia obviously alleviates and dwindles, and acinus and glandular lobule obviously reduce, and become the sparse distribution that is dispersed in.Its pathological section is similar to the breast structure of blank group.
See for details and see accompanying drawing 1,2,3,4,5,6.
Description of drawings
Fig. 1: blank group pathological section picture.
Fig. 2: model group pathological section picture.
Fig. 3: positive controls pathological section picture.
Fig. 4: the peaceful 1 group of pathological section picture of mastalgia.
Fig. 5: the peaceful 2 groups of pathological section pictures of mastalgia.
Fig. 6: the peaceful 3 groups of pathological section pictures of mastalgia.
The breast pain rather sees table 1 for details to the impact of rat mammary gland hyperplasia.
The peaceful impact to the rat mammary gland hyperplasia of table 1. breast pain (n=10,
)
| Group | n | Dosage (g/kg) | Second pair of breast height (mm) | The 3rd pair of breast height (mm) |
| The blank group | 10 | 2.0ml | 0.17±0.03 | 0.18±0.02 |
| Model group | 10 | 2.0ml | 0.27±0.04 ++ | 0.28±0.04 +++ |
| Positive controls | 10 | 0.33 | 0.19±0.01 *** | 0.19±0.03 *** |
| Peaceful 1 group of breast pain | 10 | 1.0 | 0.20±0.04 *** | 0.21±0.04 ** |
| Peaceful 2 groups of breast pain | 10 | 2.0 | 0.20±0.03 *** | 0.20±0.03 *** |
| Peaceful 3 groups of breast pain | 10 | 4.0 | 0.15±0.03 *** | 0.15±0.03 *** |
++ P＜0.05, ++ compare with the blank group+P＜0.01, * * P＜0.05, compare with model group * * * P＜0.01.
As can be seen from Table 1, model group is compared with the blank group has significant difference, and the modeling success is described; Breast pain rather organize to compare with model group has significant difference, illustrates that newborn bitterly peaceful three dosage groups all can obviously reduce by two Height to breast; The peaceful group of breast pain does not have significant difference with positive controls, illustrates that both are reducing the breast height The effect of aspect is basic identical.
The breast pain rather sees table 2 for details to the impact of estradiol, lutropin in the proliferation of mammary gland rat blood serum.
The peaceful impact to estradiol, the level of luteinizing hormone in the proliferation of mammary gland rat blood serum of table 2. breast pain (n=10,
)
| Group | n | Dosage (g/kg) | E 2 | LH |
| The blank group | 10 | 2.0ml | 24.98±16.52 | 3.0±0.0 |
| Model group | 10 | 2.0ml | 722.06±355.10 +++ | 16.5±3.12 +++ |
| Positive controls | 10 | 0.33 | 298.50±465.10 * | ＜3.0±0.0 |
| Peaceful 1 group of breast pain | 10 | 1.0 | 578.46±401.24 * | ＜3.0±0.0 |
| Peaceful 2 groups of breast pain | 10 | 2.0 | 27.98±24.24 *** | ＜3.0±0.0 *** |
| Peaceful 3 groups of breast pain | 10 | 4.0 | 55.04±31.13 *** | ＜3.0±0.0 *** |
++ compare with the blank group+P＜0.01; * P＞0.05, * * * P＜0.01 and model group comparison.
As can be seen from Table 2, model group is compared with the blank group has significant difference, and the modeling success is described; Breast pain rather organize to compare with model group has significant difference, illustrates that newborn bitterly peaceful three dosage groups all can reduce female Two pure and mild lutropin concentration, particularly middle and high its effect of dosage group is particularly evident; The breast pain is rather middle and high Dosage group and positive controls have significant difference, illustrate that the breast pain is rather aspect the endocrine of adjusting pituitary-gonadal axis Effect be better than positive controls.
Drug effect embodiment 2: medicine of the present invention is to the impact (mouse writhing method) of the analgesic activity of mouse:
Get 50 of Kunming mouses, the male and female dual-purpose, body weight 20.7 ± 1.5g is divided into blank group, the positive Control group, the peaceful group of breast pain. The breast pain is rather organized according to dosage 1.5g/kg, and 3.0g/kg, 6.0g/kg divide again successively Be peaceful 1 group of breast pain, peaceful 2 groups of breast pain, peaceful 3 groups of breast pain. Gavage, every day 1 time, for three days on end. Last 1.5h after the administration, each only organizes mouse lumbar injection 0.6% acetic acid 0.2ml/, and mouse in the immediate record 15min The writhing number of times is organized a mean t check.
Result of the test sees table 3 for details
The peaceful particle Dichlorodiphenyl Acetate of table 3. breast pain cause the mouse writhing reaction impact (n=10,
)
| Group | n | Dosage (g/kg) | The writhing number of times (inferior/15min) |
| The blank group | 10 | 20.0ml | 39.4±13.3 |
| The positive control drug group | 10 | 0.47 | 18.1±7.0 *** |
| Peaceful 1 group of breast pain | 10 | 1.50 | 34.3±9.9 |
| Peaceful 2 groups of breast pain | 10 | 3.00 | 22.2±10.7 *** |
| Peaceful 3 groups of breast pain | 10 | 6.00 | 19.7±8.7 *** |
Compare with the blank group * * P＜0.01
Test shows: lumbar injection 0.6% sour causing in the mouse writhing reaction, make the mouse writhing number of times obvious Reduce (P＜0.01). Prompting breast pain rather has certain analgesic activity.
Drug effect embodiment 3: medicine of the present invention is to the swollen impact that generates of rat granuloma
Get 50 of Wistar rats, the male and female dual-purpose, body weight 120-150g divides at random according to body weight and sex equilibrium For blank group, positive controls and the peaceful group of breast pain (the breast pain is rather organized according to dosage 1.0g/kg, 2.0g/kg, 4.0g/kg be divided into successively again peaceful 1 group of breast pain, peaceful 2 groups of breast pain, peaceful 3 groups of breast pain). Other gets cotton balls 20 ± 1mg/ Individual, autoclave sterilization, each cotton balls injects ampicillin 0.1ml, 60 ℃ of oven dry. Each organizes the rat etherization Lower, all in left and right sides forelimb armpit skin sterilization otch 1cm, fill in one of cotton balls, sew up. Gastric infusion, Once a day, continuous 7 days. 2h after the last administration takes out cotton balls (connective tissue around connecting), does for 70 ℃ Dry, weigh, deduct former cotton balls and heavily be granuloma heavily, calculate the inhibiting rate that medicine generates granuloma.
Result of the test sees table 4 for details:
The impact that the peaceful granules in rats granuloma induced by implantation of cotton pellets of table 4 breast pain generates (n=10,)
| Group | n | Dosage (g/kg) | Granuloma dry weight (mg) | Inhibiting rate (%) |
| The blank group | 10 | 20.0ml | 166.01±32.42 | |
| Positive controls | 10 | 0.33 | 82.28±20.88 | 22.38 |
| Peaceful 1 group of breast pain | 10 | 1.00 | 82.68±21.72 | 22.01 |
| Peaceful 2 groups of breast pain | 10 | 2.00 | 57.74±15.17 *** | 45.53 |
| Peaceful 3 groups of breast pain | 10 | 4.00 | 54.64±19.1 *** | 48.46 |
Compare with the blank group * * P＜0.01.
The swollen test of rat granuloma is chronic inflammation model, detects granulation and proliferation of fibrous tissue.
Result of the test shows, and the peaceful middle and high dosage group of breast pain (2.0,4.0g/kg) can obviously suppress granuloma shape Become (P＜0.01), inhibiting rate is 45.53 and 48.46%. Test shows that simultaneously the peaceful middle and high dosage group of breast pain exists The effect that suppresses granulation and proliferation of fibrous tissue aspect is better than positive controls.
Drug effect embodiment 4: medicine of the present invention is to the impact of mouse peritoneal capillary permeability
Get 50 of Kunming mouses, the male and female dual-purpose, body weight 20.3 ± 0.9g, according to body weight, sex equilibrium with Machine is divided into the blank group, the peaceful group of breast pain (rather organize according to dosage 1.5g/kg, 3.0g/kg, 6.0g/kg by the breast pain Be divided into successively again peaceful 1 group of breast pain, peaceful 2 groups of breast pain, peaceful 3 groups of breast pain). Gastric infusion, connects every day 1 time Continuous 7 days. 1.5h after the last administration, the equal tail vein of each mouse inject 0.5% Evans blue NS solution 0.1ml/10g, And lumbar injection 0.6% acetic acid 0.2ml/ only puts to death mouse behind the 20min immediately, cuts off belly, uses 6ml NS Gradation washing abdominal cavity, the sucking-off flushing liquor is diluted to 10.0ml with NS after merging, the centrifugal 15min of 3000rpm, Get supernatant and survey trap in 590nm, respectively organize the difference of peritoneal fluid, organize a t check.
Result of the test sees table 5 for details.
The impact of the peaceful Granules on Mouse abdominal cavity of table 5. breast pain capillary permeability (n=10,)
| Group | n | Dosage (g/kg) | Trap (A) |
| The blank group | 10 | 20.0ml | 0.38±0.14 |
| Positive controls | 10 | 0.47 | 0.21±0.08 ** |
| Peaceful 1 group of breast pain | 10 | 1.50 | 0.20±0.07 ** |
| Peaceful 1 group of breast pain | 10 | 3.00 | 0.21±0.06 ** |
| Peaceful 1 group of breast pain | 10 | 6.00 | 0.20±0.04 ** |
Compare with the blank group * P＜0.05.
Result of the test shows that the peaceful group of breast pain all can make the mouse peritoneal capillary permeability reduce.
Drug effect embodiment 5: medicine of the present invention is to the microcirculatory impact of Mice Auricle
Get 50 of Kunming mouses, about body weight 24.1 ± 1.5g, the male and female dual-purpose, is divided into by 10 every group The blank group, the positive control drug group, the peaceful group of breast pain (the breast pain is rather organized according to dosage 1.5g/kg, 3.0g/kg, 6.0g/kg be divided into successively again peaceful 1 group of breast pain, peaceful 2 groups of breast pain, peaceful 3 groups of breast pain). Gastric infusion, every day 1 Inferior, for three days on end. 30min after the last administration, 60min, 90min, 100 times of om observation mouse ears exterior features The external caliber of arteriole (A), thin vein (V), the open quantity of capillary are (with the friendship of 1mm horizontal line The fork number). Mouse is earlier with 20% urethane 0.07ml/10g (1.4g/kg), and im anaesthetizes, and with Medical adhesive plaster The light subsides draws auricle hair, mouse web portion to be fixed on the mouse observation platform downwards, and one picks up the ears, and underlay 0.5cm is thick has Machine glass (ear holder) drips a little cedar oil at Er Tuo and auricle surface, and observation platform is placed microscope carrier On, use cold light source. Relatively (compare) A, V bore and capillary opening amount after the medication with the blank group Variation. Result of the test sees table 6, table 7 for details.
The peaceful microcirculatory impact in Granules on Mouse ear corridor of table 6 breast pain (n=10, X ± SD)
| Group | n | Dosage (g/kg) | Different time external caliber (μ m) | |||||
| 30min | 60min | 90min | ||||||
| A | V | A | V | A | V | |||
| The blank group | 10 | 20ml | 0.34±0.06 | 0.70±0.06 | 0.30±0.06 | 1.04±0.02 | 0.50±0.03 | 0.68±0.68 |
| Positive controls | 10 | 0.47 | 0.52±0.04 *** | 0.84±0.05 *** | 0.61±0.04 *** | 1.03±0.04 | 0.52±0.05 | 0.94±0.03 *** |
| Peaceful 1 group of breast pain | 10 | 1.50 | 0.51±0.11 *** | 0.69±0.12 | 0.65±0.15 *** | 0.91±0.06 *** | 0.58±0.16 | 0.86±0.12 *** |
| Peaceful 2 groups of breast pain | 10 | 3.00 | 0.48±0.05 *** | 0.94±0.14 *** | 0.58±0.10 *** | 1.28±0.25 ** | 0.61±0.10 ** | 0.86±0.15 ** |
| Peaceful 3 groups of breast pain | 10 | 6.00 | 0.67±0.09 *** | 1.27±0.13 *** | 0 64±0.16 *** | 1.38±0.18 *** | 0.61±0.18 | 1.25±0.25 *** |
* P＜0.05, compare with the NS group * * * P＜0.01.
The impact of the peaceful Granules on Mouse ear corridor of table 7 breast pain capillary opening amount (n=10,
)
| Group | n | Dosage (g/kg) | Different time capillary opening amount (individual/mm) | ||
| 30min | 60min | 90min | |||
| The blank group | 10 | 20ml | 1.0±0.00 | 1.0±0.00 | 1.0±0.00 |
| Positive controls | 10 | 0.47 | 1.0±0.00 | 1.0±0.52 | 1.2±0.42 |
| Peaceful 1 group of breast pain | 10 | 1.5 | 1.5±0.53 ** | 1.7±0.48 *** | 1.6±0.52 ** |
| Peaceful 1 group of breast pain | 10 | 3.0 | 1.0±0.00 | 2.2±0.79 *** | 2.4±0.52 *** |
| Peaceful 1 group of breast pain | 10 | 6.0 | 1.0±0.00 | 1.5±0.52 ** | 1.4±0.42 |
* P＜0.05, compare with the NS group * * * P＜0.01.
Result of the test shows that the peaceful group of breast pain can effectively promote the expansion of mouse ear corridor microcirculation artery and vein, increases The opening amount of capillary.
Toxicologic study
1. during the oral determination of acute toxicity trial test of mice, with Cmax (80%), the maximum gastric capacity (0.4ml/10g) of irritating can not surveyed concrete LD
50So measure its maximum tolerated dose (MTD): the peaceful suspension oral gavage 0.4ml/10g of 80% mastalgia, continuous 2 times, 4h observed 7 days at interval.The result does not have death, does not also have any poisoning manifestations.So mice oral MTD is 64.0g/kg, 213 times of per kilogram consumption every day that is equivalent to be grown up.Point out this preparation not have overt toxicity.
2. 4 months long term toxicities of rat: 120 of Wistar rats, male and female half and half.Be divided into matched group, 4.0,8.0, three dosed administration groups of 12.0g/kg (adding 13.3,26.6,40.0 times that are equivalent to per day for adults per kilogram of body weight consumption respectively).Gastric infusion, every day 1 time, continuous 4 months.Behind the medicine 60 days, carried out item inspection after 120 days and the drug withdrawal in 14 days: inflow, food-intake, body-mass index, organ coefficient, urine biochemistry, peripheral blood picture, blood biochemistry and pathology histological examination.As a result, administration group and control rats compare, and every index Non Apparent Abnormality is not seen the pathological change relevant with drug effect.Think that the peaceful granule of mastalgia in dosage, does not have overt toxicity to rat.
In sum, mastalgia rather has the outgrowth effect of antagonism rat mammary gland, can reduce rat breast height and serum estradiol, lutropin concentration, and analgesia is arranged, suppress saturating property of blood vessel and granuloma induced by implantation of cotton pellets and improve the microcirculatory effect of mice.It is compared with positive control drug, has more significant drug effect.Above-mentioned experiment provides the pharmacology foundation for the cyclomastopathy of the peaceful clinical treatment of mastalgia.
The specific embodiment
Example of formulations 1
The preparation of the former medicament extract of the present invention:
A, take by weighing each drug component: Radix Bupleuri 200g, Radix Angelicae Sinensis 200g, Rhizoma Cyperi 200g, Rhizoma Chuanxiong 200g Radix Paeoniae Rubra 200g by following weight proportion, Semen Cuscutae 266g, Herba Cynomorii 266g, Caulis Polygoni Multiflori 266g, Spina Gleditsiae 200g, Eupolyphaga Seu Steleophaga 133g, Herba Epimedii 200g, Herba Leonuri 200g, Herba Artemisiae Anomalae 266g.With above 13 flavors, pulverize separately becomes coarse powder (10 order), and is standby.
B, get Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Cyperi three flavors, add 12 times of water gagings, extracted volatile oil 8 hours, collect volatile oil, medicinal residues and aqueous solution device are in addition retained, and be standby;
C, the every 1ml of volatile oil carry out enclose (45 ℃ constant temperature stir 1 hour) with the 8g beta-schardinger dextrin-, and 4 ℃ of cold preservations are spent the night, and sucking filtration, clathrate be with a spot of water and petroleum ether, and below 40 ℃ dry 6 hours, porphyrize, mistake 80 mesh sieves are standby;
D, the medicinal residues in the b step are added 10 times of water gagings decocted 1 hour, filter, the aqueous solution in filtrate and the b step merges, and the amalgamation liquid retention is standby.
E, Radix Bupleuri, Herba Artemisiae Anomalae, Herba Cynomorii three flavors add 10 times of amount 70% alcohol reflux 2 times, each 1.0 hours, filter, merging filtrate, medicinal residues are retained standby, decompression filtrate recycling ethanol, being concentrated into relative density is the clear paste of 1.18～1.22 (60 ℃), device is preserved standby in addition;
F, medicinal residues in the e step and Radix Paeoniae Rubra, Herba Epimedii, Spina Gleditsiae, Herba Leonuri, Semen Cuscutae, Caulis Polygoni Multiflori, Eupolyphaga Seu Steleophaga seven flavor medicine material mixing, add 12 times of water gagings, decoct 2 times, each 1.5 hours, filter, amalgamation liquid in filtrate and the d step merge mix after, when being evaporated to relative density and being 1.02～1.05 (60 ℃), add in every 100ml filtrate became II type natural clarifying agent B component 2ml in 1% positive day after, add concentration again and be 1% became II type natural clarifying agent A component 4ml in positive day, stir evenly, 60～70 ℃ of water bath heat preservations 1 hour, 4 ℃ leave standstill 24 hours after, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.22～1.28 (60 ℃).
G, with the clear paste in clear paste in the e step and the f step merge, mixing, add the Benexate Hydrochloride in the c step again, be former medicament extract behind the mixing.
It is that positive sky, Tianjin becomes one of " ZTC 1+1 natural clarifying agent series " product of clarification technique company limited production that positive day one-tenth II type natural clarifying agent A component, positive sky wherein becomes II type natural clarifying agent B component, and it all can be buied on market.
The granule of example of formulations 2 pharmaceutical compositions of the present invention
With former medicament extract prepared among the embodiment 1, add cane sugar powder (80 order) 552g, protein sugar 15g, adopt the fluidized-bed spray granulation machine to make granule 1000g.
The tablet of example of formulations 3 pharmaceutical compositions of the present invention
With former medicament extract prepared among the embodiment 1 is active component, by known method for preparing tablet thereof, adds starch, and dextrin, magnesium stearate etc. are mixed and made into granule, and the machine punching press is in blocks.
Embodiment 4～6
Can select known preparation method for use, make oral formulations such as oral liquid, capsule and soft capsule, the proportioning weight of each component is as follows:
Above example of formulations, just the proportioning and the dosage form of drug component are different, but all have effect of the present invention.
Claims (3)
1, a kind of pharmaceutical composition for the treatment of cyclomastopathy is characterized in that its crude drug by the following weight parts ratio forms:
20～50 parts of Radix Bupleuri, 20～50 parts of Radix Angelicae Sinensis, 20～50 parts of Rhizoma Cyperis, 20～50 parts of Rhizoma Chuanxiongs, 20～50 parts of Radix Paeoniae Rubra, 26～50 parts of Semen Cuscutae, 26～50 parts of Herba Cynomoriis, 26～50 parts of Caulis Polygoni Multiflori, 20～50 parts of Spina Gleditsiaes, 13～26 parts of Eupolyphaga Seu Steleophagas, 20～50 parts of Herba Epimedii, 20～50 parts of Herba Leonuris, 26～50 parts of Herba Artemisiae Anomalaes.
2, pharmaceutical composition according to claim 1 is characterized in that the consumption proportion of each crude drug is:
20～30 parts of Radix Bupleuri, 20～30 parts of Radix Angelicae Sinensis, 20～30 parts of Rhizoma Cyperis, 20～30 parts of 20～30 parts of Radix Paeoniae Rubra of Rhizoma Chuanxiong, 26～36 parts of Semen Cuscutae, 26～36 parts of Herba Cynomoriis, 26～36 parts of Caulis Polygoni Multiflori, 20～30 parts of Spina Gleditsiaes, 13～26 parts of Eupolyphaga Seu Steleophagas, 20～30 parts of Herba Epimedii, 20～30 parts of Herba Leonuris, 26～36 parts of Herba Artemisiae Anomalaes.
3, a kind of extraction preparation method for the treatment of the pharmaceutical composition of cyclomastopathy is characterized in that it may further comprise the steps:
A, take by weighing each drug component by following weight proportion:
20～50 parts of Radix Bupleuri, 20～50 parts of Radix Angelicae Sinensis, 20～50 parts of Rhizoma Cyperis, 20～50 parts of 20～50 parts of Radix Paeoniae Rubra of Rhizoma Chuanxiong, 26～50 parts of Semen Cuscutae, 26～50 parts of Herba Cynomoriis, 26～50 parts of Caulis Polygoni Multiflori, 20～50 parts of Spina Gleditsiaes, 13～26 parts of Eupolyphaga Seu Steleophagas, 20～50 parts of Herba Epimedii, 20～50 parts of Herba Leonuris, 26～50 parts of Herba Artemisiae Anomalaes; All drug component pulverize separately are become coarse powder, standby;
B, get Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Cyperi three flavor medicines, after soaking, extract, collect volatile oil, medicinal residues and aqueous solution device are in addition retained, and be standby;
C, under 40～45 ℃ of constant temperatures, with beta-schardinger dextrin-volatile oil is carried out enclose, stirred 1～1.5 hour, under 2～4 ℃ of conditions, cold preservation 10～12 hours, sucking filtration, clathrate with a spot of water and petroleum ether after, be lower than under 40 ℃ of temperature conditions, dry 6～8 hours, porphyrize is crossed 60～80 mesh sieves, and is standby;
D, the medicinal residues in the b step are added the water of 8～10 times of amounts, decocted 1～1.5 hour, filter, the aqueous solution in filtrate and the b step merges, and the amalgamation liquid retention is standby;
E, with Radix Bupleuri, Herba Artemisiae Anomalae, Herba Cynomorii three flavor medicines, add 70～75% alcohol reflux 2 times of 8～10 times of amounts, each 1～1.5 hour, filter, merging filtrate, decompression filtrate recycling ethanol is concentrated into relative density and is 1.18～1.22 clear paste, and is standby;
F, with medicinal residues in the e step and Radix Paeoniae Rubra, Herba Epimedii, Spina Gleditsiae, Herba Leonuri, Semen Cuscutae, Caulis Polygoni Multiflori, Eupolyphaga Seu Steleophaga seven flavor medicine mixing, the water that adds 10～12 times of amounts, decoct 2 times, each 1～1.5 hour, filter, filtrate is with after amalgamation liquid in the d step mixes, the relative density that is evaporated to is 1.02～1.05 o'clock, after adding 1% positive sky one-tenth II type natural clarifying agent B component 2ml～4ml in every 100ml filtrate, add concentration again and be 1% became II type natural clarifying agent A component 4ml～6ml in positive day, stir evenly, 60～70 ℃ of water bath heat preservations 1～1.5 hour, under 2～4 ℃ of conditions, leave standstill 20～24 hours after, filter, it is 1.22～1.28 clear paste that filtrate decompression is concentrated into relative density;
G, with the clear paste in clear paste in the e step and the f step merge, mixing, add the clathrate in the c step again, be former medicament extract behind the mixing.
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| CNB2007100616390A CN100558384C (en) | 2007-03-29 | 2007-03-29 | A kind of pharmaceutical composition and extraction preparation method thereof that is used for the treatment of cyclomastopathy |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101401884B (en) * | 2008-11-10 | 2012-05-09 | 贾辉 | Traditional Chinese medicine decoction for treating gland hyperplasia |
| CN103656530A (en) * | 2013-12-23 | 2014-03-26 | 刘永秋 | Traditional Chinese medicine composition for treating breast hyperplasia |
| CN108245644A (en) * | 2018-01-31 | 2018-07-06 | 广西维格曼科技有限公司 | A kind of Chinese medicine liquid for mammary gland maintenance |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107669997A (en) * | 2017-09-21 | 2018-02-09 | 吉林吉春制药股份有限公司 | It is a kind of to be used to treat irregular menstruation, pharmaceutical composition of swollen breasts and preparation method thereof |
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2007
- 2007-03-29 CN CNB2007100616390A patent/CN100558384C/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101401884B (en) * | 2008-11-10 | 2012-05-09 | 贾辉 | Traditional Chinese medicine decoction for treating gland hyperplasia |
| CN103656530A (en) * | 2013-12-23 | 2014-03-26 | 刘永秋 | Traditional Chinese medicine composition for treating breast hyperplasia |
| CN103656530B (en) * | 2013-12-23 | 2015-08-19 | 刘永秋 | A kind of Chinese medicine composition for the treatment of cyclomastopathy |
| CN108245644A (en) * | 2018-01-31 | 2018-07-06 | 广西维格曼科技有限公司 | A kind of Chinese medicine liquid for mammary gland maintenance |
| CN108245644B (en) * | 2018-01-31 | 2021-03-02 | 广西维格曼科技有限公司 | Traditional Chinese medicine liquid for breast maintenance |
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| CN100558384C (en) | 2009-11-11 |
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