CN106421630A - Radix Curcumae Aromaticae extract product, and preparation method and application thereof - Google Patents
Radix Curcumae Aromaticae extract product, and preparation method and application thereof Download PDFInfo
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- radix curcumae
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
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- Biotechnology (AREA)
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- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
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Abstract
The invention discloses a Radix Curcumae Aromaticae extract product, and a preparation method and an application thereof. The preparation method of the Radix Curcumae Aromaticae extract product comprises the following steps: 1, carrying out CO2 supercritical extraction on Radix Curcumae Aromaticae extract to obtain Radix Curcumae Aromaticae extract and Radix Curcumae Aromaticae raffinate, and carrying out clathration on the extract with beta-cyclodextrin to obtain a clathrate; 2, carrying out alcohol extraction on the Radix Curcumae Aromaticae raffinate obtained in step 1, filtering the obtained alcohol extract to obtain alcohol extraction medicine residues and a filtrate, and concentrating the filtrate to obtain alcohol extract; and mixing the alcohol extract with the clathrate to obtain the Radix Curcumae Aromaticae extract product. The method extracts effective positions or effective components and auxiliary components as possible, and the Radix Curcumae Aromaticae extract product has the efficacy of coursing the liver and rectifying qi, reducing phlegm and resolving masses, rectifying qi and relaxing veins, and regulating the thoroughfare and controlling vessels, has an internal secretion conditioning effect, and realizes treatment or assisted treatment of mammary gland hyperplasia.
Description
Technical field
The present invention relates to technical field of Chinese medicines, in particular to being a kind of Radix Curcumae extract and its preparation method and application.
Background technology
The pathogenesis of cyclomastopathy：Traditional Chinese medicine thinks that generation cyclomastopathy and liver,spleen,kidney, punching times are relevant, many
There is mechanism of qi obstructed, blood stasis, expectorant coagulate, caused by making the strongly fragrant resistance of meridian qi and blood be agglomerated into core.Ancients think " disease of married woman arises from strongly fragrant more ",
Because women easily suffers from stagnation of liver-QI for the psychological characteristics of feelings will change.Meanwhile, motherland's medical science thinks that gas and blood are closely bound up, gas
Handsome, gas row then blood, the stagnation of QI then blood stasis for blood, then mammary gland changes hematogenous blockage therewith, thus easily forming liver energy stagnation type breast
Gland hypertrophy disease.
The important pathogenesis of cyclomastopathy are stagnation of QI due to depression of the liver liver controlling conveyance and dispersion, and irritability is preferably happy and bar reaches, liver being bold and firm viscera, and body is cloudy to be used
Sun preferably rise send out and evacuate.Irritability had both disliked depression, also avoided high.Because feelings will is unsuccessful, melancholy puzzled, strongly fragrant impairing the liver long, or it is subject to essence
God stimulates, irritable angry, all may result in depression of liver-QI, the mechanism of qi stasis of blood is stagnant, pents up in breast stomach network, newborn network meridian and vessels obstruction is obstructed, no
General rule causes mastalgia bitterly.
The treatment of cyclomastopathy can adopt blood circulation promoting and blood stasis dispelling and dissipating phlegm and resolving masses method, and activating blood and removing stasis Method is the conventional side for the treatment of nodules of the breast
Method.The traditional Chinese medical science has saying of " pathogen usually intruding into collateral in protracted disease ", and nodules of the breast onset is slow, and the course of disease is long, touching do not heal, therefore lump in breast is to tie in breast for accumulation of phlegm in the hypochondrium
Caused by network.Qi depression to blood stasis, newborn network blocks, and is the basic pathogenesis of cyclomastopathy." addiction " " knot " " bitterly " is the total clinic of breast disease
Feature, the no matter breast disease of which kind of pattern of syndrome, on the basis of differentiation of symptoms and signs for classification of syndrome treats, the method all needing R. concomitans blood circulation promoting and blood stasis dispelling is to dredge gas
Blood, makes addiction blood agglomeration blockization dissipate, newborn network is unobstructed and swell and ache from disappearing.Modern medicine study result also confirms that promoting blood circulationization addiction method can change
It is apt to or corrects blood circulation and microcirculation disturbance, drug for invigorating blood circulation and eliminating stasis has reduction blood viscosity, accelerates the effect such as blood flow,
Thus promoting the lump of hypertrophy and fiber to absorb.
Cyclomastopathy belongs to the card of deficiency in origin and excess in superficiality, and the rule for the treatment of with dispersing the stagnated live-QI to relieve the stagnation of QI, dissipating phlegm and resolving masses, regulating qi and dredging collateral, Chong and Ren Meridians regulating is
Preferably.The present invention explores a kind of Radix Curcumae extract so as to application has significant effect in treatment cyclomastopathy.
Content of the invention
Present invention aim to providing a kind of Radix Curcumae extract of effectively treatment cyclomastopathy.
It is a further object of the present invention to provide the preparation method of this treatment Radix Curcumae extract.
The purpose of the present invention is achieved in the following ways：
A kind of Radix Curcumae extract treating cyclomastopathy, is prepared by the following method and obtains：
(1) by Radix Curcumae through CO2Supercritical extraction obtains Radix Curcumae extract and Radix Curcumae raffinate, by extract β-ring paste
Spermatophore closes, and obtains clathrate；
(2) the Radix Curcumae raffinate alcohol extraction obtaining step (1), filters, and obtains alcohol extraction medicinal residues and filtrate, and filtrate concentrates, and obtains
To alcohol-extracted extract；
(3) alcohol-extracted extract and clathrate mixing are obtained final product.
Described CO2Supercritical extraction condition is：Extracting pressure is 25-35MPa, extraction temperature 25-35 DEG C, CO2Flow
11-15L/h, extraction time 1-2h, obtain Radix Curcumae extract and raffinate.
Radix Curcumae extract with the condition that beta-schardinger dextrin-carries out inclusion is：Ratio between extract and beta-schardinger dextrin-is 1ml:
3-5g, the times amount that adds water is 4-8 times, and the inclusion time is 20-60 minute.
Preferably described CO2Supercritical extraction condition is：Extracting pressure is 35MPa, 30 DEG C of extraction temperature, CO2Flow 13L/
H, extraction time 1.5h, separating still I pressure 10～11MPa, 48 DEG C of temperature；Separating still II pressure 7～8MPa, 36 DEG C of temperature.?
To Radix Curcumae extract and raffinate；
Radix Curcumae extract beta-schardinger dextrin-carries out inclusion and obtains clathrate, and preferably inclusion condition is extract and beta-schardinger dextrin-
Weight is than for 1ml:5g, plus 8 times amount water of beta-schardinger dextrin-weight, inclusion 60min.
Described step (2) may comprise steps of：Radix Curcumae raffinate is taken to add 6-10 times of weight 70%- of Radix Curcumae medical material
90% alcohol reflux 1-3 time, each 1-2 hour, backflow stands more than 12 hours, Aspirate supernatant, 300 mesh filtrations,
Filtrate is evaporated to the alcohol-extracted extract of relative density 1.15～1.25 under the conditions of 60 DEG C.
Described step (2) specifically includes following steps：Take Radix Curcumae raffinate to add 8 times of weight 80% ethanol of Radix Curcumae medical material to return
Stream extracts twice, 2 hours every time, and backflow stands more than 12 hours, Aspirate supernatant, filtration, and filtrate reduced in volume is to 60 DEG C
Under the conditions of relative density 1.15～1.25 clear paste.
Described step (3) specifically includes following steps：By clathrate, alcohol-extracted extract mix homogeneously, it is dried under vacuum to do
Cream, is ground into fine powder.
Dosage form made by above-mentioned Radix Curcumae extract and pharmaceutically acceptable adjuvant, and preferred dosage form is tablet, capsule, granule
Agent, pill.
The preparation method of above-mentioned Radix Curcumae extract, the method comprises the following steps：
Take Radix Curcumae 54 weight portion, Herba Agrimoniae 54 weight portion, Oletum Trogopterori 45 weight portion, Alumen 54 weight portion, Sal Nitri 54 weight
Part, Resina Toxicodendri 18 weight portion, stir-baked Fructus Aurantii in bran 90 weight portion, Semen Strychni Pulveratum 36 weight portion；
Above-mentioned raw materials are prepared in such a way：
(1) by Radix Curcumae through CO2Supercritical extraction obtains Radix Curcumae extract and Radix Curcumae raffinate, by extract β-ring paste
Spermatophore closes, and obtains clathrate；
(2) the Radix Curcumae raffinate alcohol extraction obtaining step (1), filters, and obtains alcohol extraction medicinal residues and filtrate, and filtrate concentrates, and obtains
To alcohol-extracted extract；
(3) alcohol-extracted extract and clathrate mixing are obtained final product.
The Radix Curcumae extract for the treatment of cyclomastopathy of the present invention increases in preparation treatment or prevention or auxiliary treatment mammary gland
Application in raw medicine.
Radix Curcumae is zingiberaceous plant RADIX CURCUMAE (Cur cuma weny uj in Y.H.Chenet C.Ling), Rhizoma Curcumae Longae
(Curclma longa L.), Guangxi zedoary (Curcumakw angsiensis S.G.Lee et C.F.Liang) or fluffy cowherb
The dried root of art (Curcuma haeocaulis Val.).The above two practise respectively title " RADIX CURCUMAE " and " Radix Curcuma ", remaining
Claim osmanthus Radix Curcumae or green filament Radix Curcumae by different habit of character.Radix Curcumae mainly originates in the ground such as Sichuan, Fujian, Zhejiang, Guangxi.Main in Radix Curcumae
Containing compositions such as volatile oil, curcumin, polysaccharide, a small amount of trace element, wherein volatile oil is Radix Curcumae antineoplastic effective composition, Rhizoma Curcumae Longae
Element is Rhizoma Curcumae blood fat reducing, antioxidation, the principle active component of antiinflammatory.Modern pharmacology research shows, it is thin that Radix Curcumae has protection liver
Born of the same parents, promotion liver cell regeneration, anticancer, antibacterial, antioxidative effect.Volatile oil and curcumin are the principle active component of Radix Curcumae.
Radix Curcumae volatile oil not only has the effect of sterilization, antiviral, antiinflammatory and blood circulation promoting and blood stasis dispelling, removing the necrotic tissue and promoting granulation, and may also suppress tumor
The growth of cell, has positive role to prevention cervical cancer.Curcumin has multiple pharmacology such as antitumor, antiinflammatory, antibacterial, antioxidation
Effect, and toxicity is low, has good clinical practice potentiality, is widely paid close attention to by both at home and abroad.
Radix Curcumae extract of the present invention can increase the stability of medicine, and can improve bioavailability, and the present invention is strongly fragrant
Golden extract has the effects such as blood circulation promoting and blood stasis dispelling, pain relieving eliminating stagnation, heat-clearing and toxic substances removing, strengthening vital QI to eliminate pathogenic factors, qi-restoratives dredging collateral, for each phase hypertrophy
Tuberosity all has good dissipation role.Fundamentally disintegrate the Primary factors of cyclomastopathy using Radix Curcumae extract of the present invention, plus
To estrogen antagonist, block it makes the effect of gland tissue hyperplasia and edema to upper TAM, releases the discomfort such as pain and distension, with
Reach effect for the treatment of both the principal and secondary aspects of a disease.Additionally, also there is good eliminating stagnation effect to cyclomastopathy tuberosity.
In this technique, (1) adopts CO2Volatile oil in Radix Curcumae is preferentially proposed by supercritical technology, and is wrapped with beta-schardinger dextrin-
Close, obtain clathrate；(2) Radix Curcumae medicinal residues adopt alcohol extraction, obtain alcohol-extracted extract；(3) clathrate, alcohol-extracted extract, mix.The present invention
There is advantages below：Volatile oil in Radix Curcumae is preferentially extracted, and is carried out inclusion with beta cyclodextrin, be sufficiently reserved Radix Curcumae
Volatile oil, makes active constituent content greatly improve.The Radix Curcumae extract that the present invention treats cyclomastopathy can make various dosage forms
(including hard capsule for oral administration, soft capsule, tablet, granule, drop pill).
The know-why of the present invention and technical study：
It is directed to different material in this technique and adopts different preparation technologies, so that the effective site of each raw material is obtained fully
Application, and decrease side effect, it is embodied in the following aspects：
First, Radix Curcumae CO2The research of supercritical extraction volatile oil technique
1st, orthogonal test impact CO2The principal element of supercritical extraction volatile oil yield have extracting pressure, extraction kettle temperature,
CO2Flow velocity and extraction time, therefore select orthogonal table L9(34) design orthogonal test, weigh 100g Radix Curcumae and be ground into coarse powder, to extract
Rate (%) is taken to be evaluation index, test arrangement and the results are shown in Table 1.(extraction yield %=(gained oil mass/inventory) × 100%)
Table 1 Radix Curcumae CO2The orthogonal experiment factor level table of supercritical extraction
Table 2 Radix Curcumae CO2Supercritical extraction Orthogonal experiment results table
(F0.05(2,2)=19.00) by range analysiss result be A>B>C>D understands, optimal group between each factor and level
It is combined into A3B2C2D2, with D item as error term, carry out variance analyses further, the results are shown in Table 3.
Table 3 Radix Curcumae CO2Supercritical extraction analysis of variance table
(F0.05 (2,2)=19.00) from the results of analysis of variance, each factor on extraction yield there are no significant impact.Excellent
The optimised process of choosing is combined as A3B2C2D2.
2. supercritical confirmatory experiment
In order to verify the above results, weigh 100g Radix Curcumae coarse powder, from A3B2C2D2Condition carries out CO2Supercritical checking is real
Test, the results are shown in Table 4.
Table 4 CO2Supercritical confirmatory experiment result table
Conclusion：3 times experimental result confirms：A3B2C2D2Super critical condition is consistent substantially with Orthogonal experiment results, optimal extraction
The parameter is taken to be：Optimal extraction parameters are：Extracting pressure 35MPa, 30 DEG C of extraction temperature, CO2Flow 13L/h, extraction time is
1.5h.Separating still I pressure 10～11MPa, 48 DEG C of temperature；Separating still II pressure 7～8MPa, 36 DEG C of temperature.
2nd, the determination of Radix Curcumae volatile oil inclusion parameter
1st, the determination of inclusion method
Colloid milling, saturated water solution method, ultrasonic method are the most frequently used inclusion method.Under identical material ratio, plus
Enter beta-schardinger dextrin -20g, with oil：Beta-schardinger dextrin-(ml：G)=1：4th, plus 5 times of the water of beta-schardinger dextrin-weight, inclusion time 40min, plus alcohol
Amount 50% carries out inclusion, colloid milling, saturated water solution method, ultrasonic method is compared with clathrate yield for index.
Finally record colloid milling, saturated water solution method, ultrasonic method inclusion rate be respectively 76.18%, 68.11%,
59.31%, determine the best approach that colloid milling is inclusion.
2nd, take off the determination of bag method parameter
The determination of 2.1 de- bag solvents
Take the clathrate being obtained through colloid mill method of equivalent, respectively with the methanol of equivalent, dichloromethane, petroleum ether dissolution, surpass
Sound 40min, with oily utilization rate and oil content as index, show that most preferably de- bag solvent is methanol.
The determination of 2.2 de- bag methods
Take the clathrate being obtained through colloid mill method of equivalent, with the methanol dissolving of equivalent, be respectively adopted circumfluence method and ultrasonic method
Carry out de- bag 40min, with oily utilization rate and oil content as index, show that most preferably de- bag method is ultrasonic method.
The determination of 2.3 de- bag times
Take the clathrate being obtained through colloid mill method of equivalent, with the dissolving of the methanol of equivalent, with ultrasonic method take off respectively bag 20min,
40min, 60min, with oily utilization rate and oil content as index, show that the most preferably de- bag time is 40min.
3rd, the determination of inclusion method parameter
3.1 orthogonal experiment
Take the volatile oil of appropriate extraction, orthogonal experiment water-glass is designed according to amount of water, material ratio and inclusion time and is shown in Table
5.
Table 5 Radix Curcumae volatile oil clathrate orthogonal experiment factor level table
With clathrate yield, oily utilization rate and oil content obtain Orthogonal experiment results table for inspection target, such as table 6
Clathrate oil content=clathrate oil content/clathrate amount × 100%
Oily utilization rate=clathrate oil content/throwing oil mass × 100%
Table 6 orthogonal experiment calendar and analysis of results table
9 experimental programs are provided in table.If No. 6 experiment is A2B3C1D2, i.e. material ratio 1：6,5 times of amount of water, inclusion
Time 20min, is pushed away with this.
With clathrate yield as index, range analysiss result A>B>C.Best of breed between each factor and level is
A3B3C3, with C item as error term, carry out variance analyses further, the results are shown in Table 7
Table 7 is with clathrate yield for index scoring variance table
(F0.05(2,2)=19.00) with clathrate yield as index, each empirical factor is to experimental result there are no significant shadow
Ring, preferred optimised process is A3B3C3.
With oily utilization rate as index, range analysiss result A>B>C.Best of breed between each factor and level is A3B3C3,
With C item as error term, carry out variance analyses further, the results are shown in Table 8.
Table 8 is with oily utilization rate for index scoring variance table
(F0.05(2,2)=19.00) with oily utilization rate as index, each level on experimental result there are no significant impact, preferably
Optimised process be A3B3C3.
With oil content as index, range analysiss result A>C>B.Best of breed between each factor and level is A2B2C3, with
B item is error term, carries out variance analyses further, the results are shown in Table 9.
Table 9 is with oil content for index scoring variance table
(F0.05(2,2)=19.00) with oil content as index, oil and β-CD ratio have the impact of work property to experimental result, preferably
Optimised process be A2B2C3.
Can be seen that from three index range analysiss：Oil is more than other factors with the impact of β-CD ratio；Sought with comprehensive grading
Look for optimised process, in three indexs of clathrate process research, choose 100 points best of conduct of result, three's weight system respectively
Number is respectively inclusion yield 0.2, oily utilization rate 0.4, oil content 0.4.By computing formula：Comprehensive grading Y=weight × (100- is
High level+yi).Analyzed by directly perceived, with comprehensive grading as index, show that each factor is A on extracting result impact order>B>C, respectively
Best of breed between factor and level is A3B3C3, with C item as error term, carry out variance analyses the results of analysis of variance further
It is shown in Table 10.
Table 10 comprehensive grading variance table
(F0.05(2,2)=19.00) with comprehensive grading as index, each factor on experimental result there are no significant impact, preferably
Optimised process be A3B3C3.
The confirmatory experiment of 5 inclusion parameters
In order to verify the above results, weigh 100g Radix Curcumae coarse powder, from A3B3C3Condition carries out verifying that inclusion essential oil is real
Test, the results are shown in Table 11.
Table 11 inclusion essential oil experimental result table
| Experiment | Inclusion rate | Oily utilization rate | Oil content |
| 1 | 81.78% | 77.35% | 15.95% |
| 2 | 82.19% | 78.92% | 16.46% |
| 3 | 82.67% | 80.07% | 16.28% |
It is consistent with Orthogonal Parameter result through 3 experiment results, that is, the optimal parameter condition of Radix Curcumae volatile oil inclusion is
Oil：Beta-schardinger dextrin-is 1:5, plus 8 times amount water, inclusion 60min.
3rd, alcohol extraction process research
1st, the principal element of orthogonal test impact alcohol extraction process has concentration of alcohol, solvent times amount, return time and extracts secondary
Number.Above-mentioned 4 factors respectively take 3 levels to carry out L9(34) orthogonal test, take the Radix Curcumae CO of recipe quantity2The medicinal residues of supercritical extraction
The factor level table of according to the form below is extracted, and screens optimum extraction process, and experimental factor level is shown in Table 12.
The quadrature factor water-glass of table 12 alcohol extraction condition
It is inspection target that the present invention selects dry spun (%), general flavone content (%), carries out data to orthogonal experiment and divides
Analysis.Orthogonal calendar and the results are shown in Table 13.
Table 13 dry spun (%) and general flavone content (%) are orthogonal arrangement and the result table of inspection target
(in table, provide 9 experimental programs.If No. 6 experiment is A2B3C1D2, i.e. 80% ethanol, 10 times amount reflux, extract,
2 times, each 1h, the rest may be inferred)
With general flavone content as index, it is A by range analysiss result>C>D>B, the best of breed between each factor and level
For A3B2C3D2, with B item as error term, carry out variance analyses further, the results are shown in Table 14.
The analysis of variance table with general flavone content as index for the table 14
(F0.05(2,2)=19.00), with general flavone content as index, there are no significant to experimental result for each factor level
Impact, extraction process best of breed is A3B2C3D2.
With dry spun as index, range analysiss result is A>D>C>B, the best of breed between each factor and level is
A2B3C2D3, with B item as error term, carry out variance analyses further, the results are shown in Table 15.
The analysis of variance table with dry spun as index for the table 15
(F0.05(2,2)=19.00), with dry spun as index, each factor on experimental result there are no significant impact, carry
Taking technique best of breed is A2B3C2D3.
For the orthogonal result of more rational evaluation, find optimum extraction process, comprehensive grading is carried out to two evaluation indexes, to two
Individual index weights coefficient is respectively for 0.6 and 0.4.With comprehensive grading as index, show that each factor is suitable on extracting result impact
Sequence is A>C>D>B, the best of breed between each factor and level is A3B2C3D2, with B item as error term, carry out variance further
Analysis, the results are shown in Table 16.
The analysis of variance table with comprehensive grading as index for the table 16
(F0.05(2,2)=19.00) with comprehensive grading index as index, each factor is not statistically significant to experimental result,
Extraction process best of breed is A3B2C3D2.
2nd, alcohol extraction confirmatory experiment
In order to verify the above results, take the Radix Curcumae of recipe quantity, from A3B2C3D2Condition carries out confirmatory experiment, obtains result such as
Table 17；
Table 17 alcohol extraction confirmatory experiment result table
| Experiment number | General flavone content (%) | Dry spun (%) |
| 1 | 30.69 | 24.68 |
| 2 | 29.78 | 26.76 |
| 3 | 30.30 | 25.45 |
The result of confirmatory experiment is consistent substantially with Orthogonal Parameter, so the optimum process condition of alcohol extraction experiment is concentration of alcohol
For 90%, ethanol consumption is 8 times amount, extracts twice, each 2h.
The present invention is further described below by way of the test of pesticide effectiveness (in tests below Radix Curcumae extract of the present invention according to
Embodiment 1 method prepares)：
1st, laboratory animal：SD female non-pregnant rat 220g about 80
2nd, reagent：
Estradiol benzoate injection specification 2g.L-1/, Shanghai General Pharmaceutical Co., ltd.'s lot number 150501
Estradiol (E2), progesterone (P) test kit all has Beijing English biotechnology research institute of China product batch number 151012
Slide gauge Shenzhen Xin Baolai detecting instrument company limited
Refrigerated centrifuger Beijing epoch Bei Li centrifuge company limited
R-911 Full automatic exempts from industry head office of calculating instrument Chinese University of Science and Technology
3rd, method
3.1 take 60 SD rats to be randomly divided into 6 groups, model group (normal saline 15ml/), blank control group (etc.
Amount normal saline 15ml/), the high, medium and low dosage group of Radix Curcumae extract of the present invention (2.4,1.2,0.6g/).Blank control group
Rat muscle injecting normal saline (0.05ml/ is only), once a day, each model group rats intramuscular injection estradiol benzoate 0.5
/, extremely experiment terminates once a day.Modeling started gastric infusion after 1 week, and one time a day, is administered 4 weeks, takes after last dose 2h
Material.
The forward and backward slide gauge of mensure modeling of 3.2 cyclomastopathy accurately measures rat the 2nd to left and right 2 breast diameter
And height of nipples, and observe its outward appearance.
Fasting 12h before 3.3 hormone determination experiments, after last dose 2h, abdominal aortic blood 5mL, 3 000r min- 1High
Fast frozen centrifugation 15min, takes serum to add the cold petroleum ether of 4mL, recentrifuge after mixing.Phase is abandoned in suction, lower dried up with nitrogen after
Sealing is dried, to be measured.
Exempt from calculating instrument and radioimmunoassay kitss using r-911 Full automatic, by product description, serum is carried out female
Glycol (E2), progesterone (P) detection.
4 results
4.1 on papilla diameter, height of nipples impact
Compared with normal group, model group rats papilla diameter and highly significant increase, and nipple holds up hyperemia.In injection female two
Alcohol reaches swelling peak on the 2nd week, and swelling maintains an equal level within the 3rd week, begins to decline at the 4th week.Radix Curcumae extract is high, middle dose group nipple is straight
Footpath, highly compare with model group and be substantially reduced.Result shows, the cyclomastopathy that Radix Curcumae extract induces to estradiol has significantly
Inhibitory action.
Table 18 Radix Curcumae extract affects on papilla diameter
Compare with blank control groupbP<0.001；Compare with model control groupcP<0.01；dP<0.001；
Table 19 Radix Curcumae extract affects on height of nipples
Compare with blank control groupbP<0.01；Compare with model control groupcP<0.01；dP<0.05；
4.2 couples of serum estradiol (E2), the impact of progesterone (P) content
Testing result shows, positive controls and Radix Curcumae extract high dose group have dropped compared with model group estrogen level
Low, progesterone level raises, and result see table
Table 20 Radix Curcumae extract is to serum estradiol (E2), the impact of progesterone (P) content
Compare with blank control groupbP<0.001；Compare with model control groupeP<0.05；dP<0.001；
5. discuss
Illustrated by above results of animal, Radix Curcumae extract of the present invention has obvious treatment cyclomastopathy
Effect, improves the quality of life of patient, and any toxic and side effects and untoward reaction in experimentation.This
The bright described technique preparing Radix Curcumae extract has medical material utilization rate height, and prepared tablet does not have any side reaction, and surely
Qualitative height.
6. the side's of tearing open efficacy study
We split to raw material components of the present invention and carry out curing mammary gland hyperplasia experiment, effect of more each prescription further,
Five prescriptions are respectively：
Prescription 1：Radix Curcumae volatile oil clathrate；
Prescription 2：Radix Curcumae Chinese crude drug；
Prescription 3：Radix Curcumae alcohol extraction；
Prescription 4：Embodiment of the present invention Radix Curcumae extract；
Experimental procedure is with 3.1 curing mammary gland hyperplasias experiment under Efficacy experiments item, after modeling, blank control group and model comparison
Group gives same volume solvent, and prescription 1-4 gives the given the test agent of 1.2g/kg, the results are shown in Table 28.
Table 21 affects on papilla diameter
Compare with blank control groupbP<0.001；Compare with model control groupcP<0.01；dP<0.05；Compare with prescription 4eP
<0.05
Table 22 affects on height of nipples
Compare with blank control groupbP<0.01；Compare with model control groupcP<0.001；dP<0.05；Compare with prescription 4eP<0.05
Table 23 is to serum estradiol (E2), the impact of progesterone (P) content
Compare with blank control groupbP<0.001；Compare with model control groupcP<0.001；dP<0.01；eP<0.05；With group
Side 4 comparesfP<0.05；
The therapeutic effect of prescription 4 is significantly better than other prescriptions as can be seen from the above table, and Radix Curcumae extract of the present invention can be described
Treatment to cyclomastopathy is of great advantage.
In sum, compared with prior art, the beneficial effect that the present invention possesses：
The raw material prescription of Radix Curcumae extract of the present invention comes the clinical practice under free guidance of traditional Chinese medicine theory, prescription
Flavour of a drug refine, with strong points.Described raw material prescription Chinese medicine depressed liver-energy dispersing and QI regulating, dissipating phlegm and resolving masses, regulating qi and dredging collateral, Chong and Ren Meridians regulating, medicine has
Effect composition is easy to absorb, and is conducive to playing drug effect；In described raw material prescription, each medical material is integration of edible and medicinal herbs medical material, nontoxic secondary work
With.
The extraction process advantage of Radix Curcumae extract of the present invention is：Using supercritical extraction technique Radix Curcumae volatile oil
Advantage distillation out, and is used beta cyclodextrin inclusion, is sufficiently reserved Radix Curcumae volatile oil, and make monarch drug in Radix Curcumae extract has
Effective component content greatly improves.In addition the inventive method also can mitigate Radix Curcumae volatile oil to gastrointestinal stimulation, makes effectively
Position or effective ingredient and auxiliary element is as much as possible extracts, and the invalid components such as heavy metal and suck tissue are as far as possible
Do not extract, reduce the injury to human body.
Therefore, Radix Curcumae extract of the present invention has significantly during treatment or prevention or auxiliary treatment cyclomastopathy
Effect.
Specific embodiment
Below in conjunction with specific embodiment, the present invention is described in further detail.
Embodiment 1：Radix Curcumae extract tablet
(1) extraction of Radix Curcumae volatile oil and inclusion：Weigh Radix Curcumae 54g, using CO2Supercritical extraction is extracted, extraction
Pressure power is 35MPa, 30 DEG C of extraction temperature, CO2Flow 15L/h, extraction time 2h, are extracted thing Radix Curcumae volatile oil, and
Raffinate, the extract being obtained by extraction carries out inclusion with beta-schardinger dextrin-, and the ratio between extract and beta-schardinger dextrin-is 1ml:4g,
The times amount that adds water is 6 times, and the inclusion time is 60 minutes, obtains clathrate A.
(2) alcohol extraction：Take Radix Curcumae raffinate to add Radix Curcumae medical material 10 times amount 90% alcohol reflux 2 times, 2 hours every time, return
Flow back to flow liquid and stand more than 12 hours, Aspirate supernatant, 300 mesh filtrations, filtrate is evaporated to relatively close under the conditions of 60 DEG C
The alcohol-extracted extract of degree 1.15～1.25, standby；
(3) mixing, dry, pulverizing：By Radix Curcumae volatile oil clathrate A, alcohol-extracted extract mix homogeneously, it is dried under vacuum to do
Cream, is ground into fine powder standby.
(4) tabletting：Take the fine powder in (3), add suitable auxiliary materials and mixing, diameter 10mm punch die, tabletting, piece weight 0.3g/
Piece；
(5) coating：OPADRY film coating obtains final product.
Application in treatment cyclomastopathy for the Tablets, containing taking once 3,3 times a day.
Embodiment 2：Radix Curcumae extract capsule
(1) extraction of Radix Curcumae volatile oil and inclusion：Weigh Radix Curcumae 54g, using CO2Supercritical extraction is extracted, extraction
Pressure power is 35MPa, 30 DEG C of extraction temperature, CO2Flow 13L/h, extraction time 2h, are extracted thing Radix Curcumae volatile oil, and
Raffinate, the extract being obtained by extraction carries out inclusion with beta-schardinger dextrin-, and the ratio between extract and beta-schardinger dextrin-is 1ml:5g,
The times amount that adds water is 8 times, and the inclusion time is 60 minutes, obtains clathrate A.
(2) alcohol extraction：Take Radix Curcumae raffinate to add Radix Curcumae medical material 8 times amount 80% alcohol reflux 3 times, 1.5 hours every time, return
Flow back to flow liquid and stand more than 12 hours, Aspirate supernatant, 300 mesh filtrations, filtrate is evaporated to relatively close under the conditions of 60 DEG C
The alcohol-extracted extract of degree 1.15～1.25, standby；
(3) mixing, dry, pulverizing：By Radix Curcumae volatile oil clathrate A, alcohol-extracted extract mix homogeneously, it is dried under vacuum to do
Cream, is ground into fine powder standby.
(4) capsule filling：Take the fine powder in (3), add suitable auxiliary materials and mixing, take No. 0 capsule, loading amount is 0.45g/
Grain, carries out fill.
Radix Curcumae extract capsule of the present invention treatment cyclomastopathy in application, be administered orally one time 3,3 times a day.
Embodiment 3：Radix Curcumae extract granule
(1) extraction of Radix Curcumae volatile oil and inclusion：Weigh the Radix Curcumae 54g of recipe quantity, using CO2Supercritical extraction is carried out
Extract, extracting pressure is 30MPa, 35 DEG C of extraction temperature, CO2Flow 13L/h, extraction time 1.5h, are extracted thing Radix Curcumae and wave
Hair oil, and raffinate, the extract being obtained by extraction carries out inclusion with beta-schardinger dextrin-, the ratio between extract and beta-schardinger dextrin-
For 1ml:6g, the times amount that adds water is 6 times, and the inclusion time is 40 minutes, obtains clathrate A.
(2) alcohol extraction：Radix Curcumae raffinate is taken to add 8 times amount, 80 alcohol reflux 2 times, 1.5 hours every time, backflow backflow was quiet
Put more than 12 hours, Aspirate supernatant, 300 mesh filtrations, filtrate be evaporated under the conditions of 60 DEG C relative density 1.15～
1.25 alcohol-extracted extract, standby；
(3) mixing, dry, pulverizing：By Radix Curcumae volatile oil clathrate A, alcohol-extracted extract mix homogeneously, it is dried under vacuum to do
Cream, is ground into fine powder standby.
(4) pelletize：Take the fine powder in (3), add suitable auxiliary materials and mixing, cross 10 mesh sieves, make wet granular.
(5) dry, granulate：Put≤60 DEG C of dryings, with 12 mesh sieve granulate.
(6) subpackage：Use polyethylene composite film subpackage, loading amount obtains final product for 10g/ bag.
Application in treatment cyclomastopathy for the granule of the present invention, takes after mixing it with water three times a day, one bag every time.
Embodiment 4：Radix Curcumae extract capsule
(1) extraction of Radix Curcumae volatile oil and inclusion：Weigh the Radix Curcumae 54g of recipe quantity, using CO2Supercritical extraction is carried out
Extract, extracting pressure is 30MPa, 35 DEG C of extraction temperature, CO2Flow 15L/h, extraction time 2h, are extracted the volatilization of thing Radix Curcumae
Oil, and raffinate, the extract being obtained by extraction carries out inclusion with beta-schardinger dextrin-, and the ratio between extract and beta-schardinger dextrin-is
1ml:5g, the times amount that adds water is 6 times, and the inclusion time is 60 minutes, obtains clathrate A.
(2) alcohol extraction：Radix Curcumae raffinate is taken to add 10 times amount, 80 alcohol reflux 2 times, 1.5 hours every time, flowed back backflow
Standing more than 12 hours, Aspirate supernatant, 300 mesh filtrations, filtrate be evaporated under the conditions of 60 DEG C relative density 1.15～
1.25 alcohol-extracted extract, standby；
(3) mixing, dry, pulverizing：By Radix Curcumae volatile oil clathrate A, alcohol-extracted extract mix homogeneously, it is dried under vacuum to do
Cream, is ground into fine powder standby.
(4) pelletize：Take the fine powder in (3), add suitable auxiliary materials and mixing, cross 10 mesh sieves, make wet granular.
(5) dry, granulate：Put≤60 DEG C of dryings, with 16 mesh sieve granulate.
(6) subpackage：Gained capsule is carried out fill with No. 1 capsule, gained capsule is encapsulated with aluminum-plastic-aluminum, mounted box, obtain final product.
Application in treatment cyclomastopathy for the capsule of the present invention, is administered orally three times a day, two every time.
Embodiment 5：Radix Curcumae extract soft capsule
(1) extraction of Radix Curcumae volatile oil and inclusion：Weigh the Radix Curcumae 54g of recipe quantity, using CO2Supercritical extraction is carried out
Extract, extracting pressure is 30MPa, 35 DEG C of extraction temperature, CO2Flow 15L/h, extraction time 2h, are extracted the volatilization of thing Radix Curcumae
Oil, and raffinate, the extract being obtained by extraction carries out inclusion with beta-schardinger dextrin-, and the ratio between extract and beta-schardinger dextrin-is
1ml:3g, the times amount that adds water is 6 times, and the inclusion time is 20 minutes, obtains clathrate A.
(2) alcohol extraction：Radix Curcumae raffinate is taken to add 8 times amount, 90% alcohol reflux 2 times, 2 hours every time, backflow backflow was quiet
Put more than 12 hours, Aspirate supernatant, 300 mesh filtrations, filtrate be evaporated under the conditions of 60 DEG C relative density 1.15～
1.25 alcohol-extracted extract, standby；
(3) mixing, dry, pulverizing：By Radix Curcumae volatile oil clathrate A and alcohol-extracted extract mix homogeneously, it is dried under vacuum to do
Cream, is ground into fine powder standby.
(4) pelletize：Take the fine powder in (3), add suitable auxiliary materials and mixing, make semisolid.
(5) soft capsule processed：Semisolid is sealed in suitable soft capsule material, makes soft capsule
Embodiment 6：Radix Curcumae extract drop pill
(1) extraction of Radix Curcumae volatile oil and inclusion：Weigh Radix Curcumae 54g, using CO2Supercritical extraction is extracted, extraction
Pressure power is 35MPa, 35 DEG C of extraction temperature, CO2Flow 13L/h, extraction time 2h, are extracted thing Radix Curcumae volatile oil, and
Raffinate, the extract being obtained by extraction carries out inclusion with beta-schardinger dextrin-, and the ratio between extract and beta-schardinger dextrin-is 1ml:5g,
The times amount that adds water is 8 times, and the inclusion time is 60 minutes, obtains clathrate A.
(2) alcohol extraction：Radix Curcumae raffinate is taken to add 10 times amount, 80% alcohol reflux 2 times, 1.5 hours every time, backflow backflow
Liquid stands more than 12 hours, Aspirate supernatant, 300 mesh filtrations, and filtrate is evaporated to relative density 1.15 under the conditions of 60 DEG C
～1.25 alcohol-extracted extract, standby；
(3) mixing, dry, pulverizing：By Radix Curcumae volatile oil clathrate A, alcohol-extracted extract mix homogeneously, it is dried under vacuum to do
Cream, is ground into fine powder standby.
(4) drop pill processed：Take the fine powder in (3), add suitable matrix body to mix, make drop pill.
Claims (9)
1. a kind of Radix Curcumae extract is it is characterised in that this Radix Curcumae extract is prepared by the following method and obtains：
(1) by Radix Curcumae through CO2Supercritical extraction obtains Radix Curcumae extract and Radix Curcumae raffinate, by extract beta-schardinger dextrin-bag
Close, obtain clathrate；
(2) the Radix Curcumae raffinate alcohol extraction obtaining step (1), filters, and obtains alcohol extraction medicinal residues and filtrate, and filtrate concentrates, and obtains alcohol
Extracted extract；
(3) alcohol-extracted extract and clathrate mixing are obtained final product.
2. Radix Curcumae extract according to claim 1 is it is characterised in that CO described in step (1)2Supercritical extraction condition
For：Extracting pressure is 25-35MPa, extraction temperature 25-35 DEG C, CO2Flow 11-15L/h, extraction time 1-2h, obtain Radix Curcumae extraction
Take thing and raffinate；Radix Curcumae extract with the condition that beta-schardinger dextrin-carries out inclusion is：Ratio between extract and beta-schardinger dextrin-
Example is 1ml:3-5g, the times amount that adds water is 4-8 times, and the inclusion time is 20-60 minute.
3. Radix Curcumae extract according to claim 2 is it is characterised in that CO described in step (1)2Supercritical extraction condition
For：Extracting pressure is 35MPa, 30 DEG C of extraction temperature, CO2Flow 13L/h, extraction time 1.5h, obtain Radix Curcumae extract and extraction
Excess；Radix Curcumae extract with the condition that beta-schardinger dextrin-carries out inclusion is：Inclusion condition for extract with beta-schardinger dextrin-weight ratio is
1ml:5g, plus 8 times amount water, inclusion 60min.
4. Radix Curcumae extract according to claim 1 is it is characterised in that described step (2) specifically includes following steps：
Radix Curcumae raffinate is taken to add 6-10 times of weight 70%-90% alcohol reflux of Radix Curcumae medical material 1-3 time, each 1-2 hour, backflow
Standing more than 12 hours, Aspirate supernatant, 300 mesh filtrations, obtain medicinal residues and filtrate；Filtrate is evaporated under the conditions of 60 DEG C
The alcohol-extracted extract of relative density 1.15～1.25.
5. Radix Curcumae extract according to claim 1 is it is characterised in that described step (2) specifically includes following steps：
Radix Curcumae raffinate is taken to add 8 times of weight 80% alcohol reflux of Radix Curcumae medical material twice, 2 hours every time, backflow stood 12 hours
More than, Aspirate supernatant, filtration, the clear paste of filtrate reduced in volume relative density 1.15～1.25 under the conditions of 60 DEG C.
6. Radix Curcumae extract according to claim 1 is it is characterised in that described step (3) specifically includes following steps general
Clathrate, alcohol-extracted extract mix homogeneously, are dried under vacuum to dry cream, are ground into fine powder.
7. Radix Curcumae extract according to claim 1 it is characterised in that described Radix Curcumae extract with pharmaceutically acceptable
Adjuvant make dosage form, preferred dosage form be tablet, capsule, granule, pill.
8. a kind of preparation method of the Radix Curcumae extract described in claim 1 is it is characterised in that the method comprises the following steps：
(1) by Radix Curcumae through CO2Supercritical extraction obtains Radix Curcumae extract and Radix Curcumae raffinate, by extract beta-schardinger dextrin-bag
Close, obtain clathrate；
(2) the Radix Curcumae raffinate alcohol extraction obtaining step (1), filters, and obtains alcohol extraction medicinal residues and filtrate, and filtrate concentrates, and obtains alcohol
Extracted extract；
(3) alcohol-extracted extract and clathrate mixing are obtained final product.
9. the answering in the medicine of preparation treatment or prevention or auxiliary treatment cyclomastopathy of the Radix Curcumae extract described in claim 1
With.
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