CN102205025B - Preparation method of traditional Chinese medicine preparation for treating dysmenorrhea and irregular menstruation - Google Patents
Preparation method of traditional Chinese medicine preparation for treating dysmenorrhea and irregular menstruation Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title claims abstract description 34
- 239000003814 drug Substances 0.000 title claims abstract description 33
- 206010013935 Dysmenorrhoea Diseases 0.000 title claims abstract description 28
- 208000005171 Dysmenorrhea Diseases 0.000 title claims abstract description 26
- 208000037093 Menstruation Disturbances Diseases 0.000 title abstract 3
- 206010027339 Menstruation irregular Diseases 0.000 title abstract 3
- 238000000034 method Methods 0.000 claims abstract description 24
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- 238000002156 mixing Methods 0.000 claims abstract description 3
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- 238000009472 formulation Methods 0.000 claims description 6
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- 239000002552 dosage form Substances 0.000 claims description 5
- 239000003921 oil Substances 0.000 claims description 5
- 235000019198 oils Nutrition 0.000 claims description 5
- 239000009188 angelicae sinensis extract Substances 0.000 claims description 4
- 150000001875 compounds Chemical class 0.000 claims description 4
- 239000007902 hard capsule Substances 0.000 claims description 4
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- 239000001116 FEMA 4028 Substances 0.000 claims description 2
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- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims description 2
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- 239000003549 soybean oil Substances 0.000 claims description 2
- 239000004615 ingredient Substances 0.000 claims 1
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Abstract
The invention discloses a preparation method of a traditional Chinese medicine preparation for treating dysmenorrhea and irregular menstruation. In a prescription, 5-10 parts of angelica, 1-5 parts of chuanxiong rhizome and 10-15 parts of rhizoma cyperi are taken as raw materials. The preparation method comprises the following steps of: firstly, proportionally weighing powdered angelica and powdered chuanxiong rhizome, and respectively acquiring angelica extract and chuanxiong rhizome extract for later use by adopting a CO2 supercritical extraction method, wherein the extraction conditions are as follows: the pressure is 30MPa, the temperature is 50DEG C, and the extraction time is 120 minutes; proportionally weighing powdered rhizoma cyperi, and acquiring rhizoma cyperi extract for lateruse by adopting the CO2 supercritical extraction method, wherein the extraction conditions are as follows: the pressure is 20MPa, the temperature is 45DEG C, and the extraction time is 120 minutes; then, mixing the angelica extract, the chuanxiong rhizome extract and the rhizoma cyperi extract to obtain an effective part preparation; and finally, forming the traditional Chinese medicine preparation. If the prepared traditional Chinese medicine preparation is used for treating dysmenorrhea and irregular menstruation, the effective rate reaches 76.67%, and the total effective rate reaches 96.67%.
Description
Technical field
The present invention relates to a kind of method for preparing of Chinese medicine preparation, particularly a kind of method for preparing of treating the Chinese medicine preparation of dysmenorrhea and menoxenia.
Background technology
Dysmenorrhea is a kind of common multiple gynecological disease.Show as gynecologic menstrual or the front and back of passing through more, hypogastric region distending pain, cold type of pain, causalgia, twinge, dull pain, bob pain, angor, spasmic pain, tear resistance pain etc. periodically take place.The cause of disease is not clear fully as yet at present.
Menoxenia then often shows as the unusual of menstrual cycle or amount of bleeding, or stomachache and General Symptoms before the menstruation, during menstrual period.The cause of disease possibly be organic disease or malfunction.Pathogenic mechanism is that QI and blood loses in adjusting and causes menoxenia due to dysfunction of CHONG meridian that its cause of disease is many because due to irritability stasis or the asthenia of renal qi.Two kinds of diseases of dysmenorrhea and menoxenia have a lot of identical points in clinical manifestation, the Therapeutic Method of menoxenia and dysmenorrhea treatment method degree of association are also very high.
And the Chinese medicine preparation ubiquity prescription of existing treatment dysmenorrhea and menoxenia is complicated, and technology is loaded down with trivial details, the shortcoming of unsatisfactory curative effect.
Summary of the invention
The present invention aims to provide a kind of method for preparing of treating the Chinese medicine preparation of dysmenorrhea and menoxenia, and in order to overcome the defective of above-mentioned existing Chinese medicine preparation, the medicament for preparing according to this method has therapeutic effect better.
Technical scheme of the present invention is following:
A kind of method for preparing of treating the Chinese medicine preparation of dysmenorrhea and menoxenia is characterized in that: prescription: Radix Angelicae Sinensis: 5-10 part; Rhizoma Chuanxiong: 1-5 part; Rhizoma Cyperi: 10-15 part; Described part refers to weight portion;
(1), in proportion take by weighing powdery Radix Angelicae Sinensis and powdery Rhizoma Chuanxiong, adopt CO
2Supercritical extraction obtains Radix Angelicae Sinensis extract respectively and Rhizoma Chuanxiong extract is subsequent use, extraction conditions: pressure 30MPa, 50 ℃ of temperature, 120 minutes extraction time;
And take by weighing the powdery Rhizoma Cyperi in proportion, adopt CO
2It is subsequent use that supercritical extraction obtains to work as Rhizoma Cyperi extract, extraction conditions: pressure 20MPa, 45 ℃ of temperature, 120 minutes extraction time;
(2), Radix Angelicae Sinensis extract, Rhizoma Chuanxiong extract and Rhizoma Cyperi extract are mixed, obtain effective parts formulation;
(3), medicament molding.Prepared dosage form comprises hard capsule, micropill and soft capsule.
Traditional Chinese medical theory thinks that the reason of dysmenorrhea has: one, feelings will is hindered; Two, drench with rain menstrual period, paddle, or sit the cold wet place that crouches; Three, menstrual period are unclean; Four, the cold thing of surfeit, pungent and drinks; Five, imbalance after being ill; Six, plain body is not enough, or weakness of the spleen and stomach, or deficiency of both the liver and kidney or the like, all can cause gas capable not smooth, blood vessels are unfavorable, stagnation of QI and blood may bring about pain.Because dysmenorrhea pain is corresponding with menstrual cycle at lower abdomen, thus with dash, appoint and the QI and blood of liver freely not relevant, but the difference of deficiency and excess cold and heat is arranged.Wherein, qi and blood stagnation is a dysmenorrhea main diseases therefore, though because of liver is a viscus of storing blood, the happiness bar reaches and main catharsis.In case liver is lost bar and reaches, making of catharsis is not all right, and the QI and blood that not only dashes, appoints is smooth and menstruation is not smooth, and depression of liver-QI, on must not reach by bar, must not descend catharsis, perverse and unreasonable manner is in the breast abdomen, so sore warp.Work as and the blood soothing liver-QI so know the law, the circulation of qi promoting regulating menstruation is advisable.
We are classified as monarch to work as.The hot sweetness and bitterness temperature of Radix Angelicae Sinensis is the key medicine of blood circulation promoting and enriching.Radix Angelicae Sinensis ability warm in nature is loose, and is with sweet ability slow.Through day, the liver desire is loose, and looses it with suffering.Liver is bitter anxious, delays it with sweet.Slow looses it, and liver property is liked, and the benefit of promptly doing so specially go into liver to help the sea of blood, makes blood flow capable.Rhizoma Cyperi " gas is flat and tremble with fear, and is fragrant and can scurry, many hot can the loosing of its flavor, little hardship can be fallen, little sweet ability with, be that liver meridian, hands lack positive three warmers edema caused by disorder of QI principal agent, and doublely lead to 12 through edema caused by disorder of QI.Up chest and diaphragm reaches skin, the ripe Liver and kidney of then walking down outward, outer thorough waist foot ", be the Directorate-General DG of resolving depression of regulating the flow of vital energy.Be the key medicine of menstruction regulating and pain relieving, as ministerial drug, Chinese angelica blood supplementing and blood, promoting blood circulation and stopping pain, Rhizoma Cyperi dispersing the stagnated live-QI to relieve the stagnation of QI, regulating QI to relieve pain; Two medicines share, and Rhizoma Cyperi cures mainly edema caused by disorder of QI, and Radix Angelicae Sinensis cures mainly blood system, and QI and blood is also controlled, and the promoting flow of QI and blood effect strengthens.Rhizoma Chuanxiong is hot, temperature.Return liver, gallbladder, pericardium channel, blood-activating and qi-promoting, wind-expelling pain-stopping effect are arranged, be the article of promoting the circulation of blood regulating menstruation, make the usefulness of messenger drug.The hot Wen Xiang of Rhizoma Chuanxiong scurries promoting flow of QI and blood, the up head, the descending sea of blood, outer thorough fur, wind-expelling pain-stopping.The Radix Angelicae Sinensis dense gas of distinguishing the flavor of is light, and can walk and can keep, be main to nourish blood; Rhizoma Chuanxiong flavor clearing heat in QI system is male, and walk and do not keep, be main with circulation of qi promoting.Two medicines, 5 usefulness, QI and blood is taken into account, and makes its weak point mutually and Zhan Qichang, and the effectiveness multiplication is played nourishing blood for regulating menstruation, promoting flow of QI and blood, the merit of eliminating stasis to stop pain altogether.
Though it is not dysmenorrhea is by caused by energy stagnation and blood stasis, may not blood empty.The menoxenia cause of disease is many because due to irritability stasis or the asthenia of renal qi, and is main with stagnation of liver-QI, and the rule of treatment is main with the depressed liver-energy dispersing and QI regulating blood stasis dispelling; Condition woman is basis with blood, so the accent of ought holding concurrently, in the row benefit is arranged; Then dysmenorrhea is removed and the people does not have wound, so this is classified as monarch's justice, group medicine is harmonious.Soothing liver-QI and do not decrease gas, clots absorbing and non-blood trouble can also the nourishing the liver bodies and help liver usefulness, and blood stasis dispelling blood and tissue regeneration promoting blood, and have to transfer and mend the merit of dashing, appointing are so be radical cure qi depression to blood stasis and cause the good recipe of dysmenorrhea, menoxenia.
The present invention all adopts the CO2 supercritical fluid extraction to Chinese medicine in three, and the active constituent content of extraction is high, and drug effect is clear and definite.
Medicament prepared in accordance with the present invention all improves significantly to symptom, tongue, the arteries and veins such as lower abdomen pain of dysmenorrhoea disease, and for treatment dysmenorrhea and menoxenia, this preparation obvious effective rate reaches 76.67%, and total effective rate reaches 96.67%.
The specific embodiment
Further specify the present invention below in conjunction with embodiment.
It below is the preparation example.
Embodiment one
Prescription: Radix Angelicae Sinensis: 5 parts; Rhizoma Chuanxiong: 1 part; Rhizoma Cyperi: 10 parts; Described part refers to weight portion.
Extract: adopt CO
2Supercritical extraction extracts Radix Angelicae Sinensis, Rhizoma Chuanxiong, Rhizoma Cyperi effective site respectively, processes preparation.Technological parameter: Rhizoma Cyperi extracting pressure 20MPa, 45 ℃ of temperature, separating pressure 15MPa, 45 ℃ of separation temperatures, Radix Angelicae Sinensis, Rhizoma Chuanxiong extracting pressure are 30MPa, 50 ℃ of temperature, separating pressure 12MPa, 50 ℃ ℃ of separation temperatures, the CO of three flavor medical materials
2Flow all is 30 kilograms/hour, and extraction time all is 120 minutes.
Adopt the method for CO2 supercritical extraction (SFE-CO2), obtain its effective part group greater than 60% after making with extra care; Radix Angelicae Sinensis effective site yield is more than 2%, and Rhizoma Cyperi effective site yield is more than 1.9%, and Rhizoma Chuanxiong effective site yield is more than 1.6%.
Molding: dosage forms such as preparation hard capsule and micropill, adopt beta-cyclodextrin inclusion compound method cured effective parts formulation.
With clathrate oil inclusion rate and clathrate recovery rate serves as to investigate index, and utilization saturated aqueous solution envelope carries out enclose.When V (oil) (ml): m (beta-schardinger dextrin-) (g): V (water) is 2: 5: 80 (ml), and when mixing time was 1.5h, the enclose best results can stablize that to keep average oil inclusion rate be 75.86%.
Clathrate can be processed hard capsule, micropill etc.
Embodiment two
Prescription: Radix Angelicae Sinensis: 10 parts; Rhizoma Chuanxiong: 5 parts; Rhizoma Cyperi: 15 parts; Described part refers to weight portion.
Extraction step is with embodiment one.
Molding: with gelatin glycerol is that the capsule material prepares soft capsule.
Oleum Glycines has good flowability and certain viscosity, be good soft capsule oleaginous base, so said preparation is selected the adjuvant of soybean oil as preparation of soft capsule for use.Sprinkler body temperature in the preparation process is investigated, finally confirm to be controlled at 40~50 ℃ more suitable, present embodiment is selected 45 ℃ for use.The soft capsule shell sizing compound formula is a water in the experiment: gelatin: Cera Flava: and Petiolus Trachycarpi oil (1: 1.5: 0.3: 0.44), gained softgel shell plasticity was high, good stability, and disintegrate is easier.
Embodiment three
Wherein prescription is: Radix Angelicae Sinensis: 7 parts; Rhizoma Chuanxiong: 3 parts; Rhizoma Cyperi: 8 parts; Described part refers to weight portion.
Method for preparing is with embodiment one.
It below is the clinical efficacy report.
Though different according to the prepared medicament dosage form of the inventive method, owing to have identical active component, the different dosage form curative effect is roughly the same, below only report embodiment the experimental data of one prepared capsule.
This preparation is mainly used in treatment dysmenorrhes, menoxenia etc., does contrast with TONGJINGBAO KELI, observes case 100 examples altogether, wherein takes TONGJINGBAO KELI 40 examples.The result shows this preparation obvious effective rate 76.67%, total effective rate 96.67%; TONGJINGBAO KELI obvious effective rate 67.5%, total effective rate compares (P<0.05) for 87.5%, two group, and significant difference is arranged.This preparation significantly is superior to TONGJINGBAO KELI on the treatment dysmenorrhea.
Therapeutic Method: treatment group: oral preparation, each 1,2 times on the one; Matched group: with (YUEYUESHU) TONGJINGBAO KELI, one time 1 bag, 2 times on the one.Begin to take in preceding 3 days in menstruation, serve on 7 days, 3 menstrual cycle are 1 course of treatment.
Therapeutic outcome, curative effect relatively has significant difference after treatment group and the treatment of control group.
The clinical experiment result: the medicine that the present invention processes is observed through clinical case, can effectively treat dysmenorrhes.
Table one treatment group and matched group Comparison of therapeutic
Table two dysmenorrhea remission information slip
The treatment group all improves significantly to symptom, tongue, the arteries and veins such as lower abdomen pain of dysmenorrhoea disease, compares with matched group, and difference has extremely significantly meaning, p<0.001.
Claims (6)
1. a method for preparing of treating the Chinese medicine preparation of dysmenorrhea and menoxenia is characterized in that: prescription: Radix Angelicae Sinensis: 5-10 part; Rhizoma Chuanxiong: 1-5 part; Rhizoma Cyperi: 10-15 part; Described part refers to weight portion;
(1), in proportion take by weighing powdery Radix Angelicae Sinensis and powdery Rhizoma Chuanxiong, adopt CO
2Supercritical extraction obtains Radix Angelicae Sinensis extract respectively and Rhizoma Chuanxiong extract is subsequent use, extraction conditions: pressure 30MPa, 50 ℃ of temperature, 120 minutes extraction time;
And take by weighing the powdery Rhizoma Cyperi in proportion, adopt CO
2It is subsequent use that supercritical extraction obtains Rhizoma Cyperi extract, extraction conditions: pressure 20MPa, 45 ℃ of temperature, 120 minutes extraction time;
(2), Radix Angelicae Sinensis extract, Rhizoma Chuanxiong extract and Rhizoma Cyperi extract are mixed, obtain effective parts formulation;
(3), medicament molding.
2. the method for preparing of the Chinese medicine preparation of treatment dysmenorrhea as claimed in claim 1 and menoxenia is characterized in that prescription is: Radix Angelicae Sinensis: 5 parts; Rhizoma Chuanxiong: 1 part; Rhizoma Cyperi: 10 parts.
3. according to claim 1 or claim 2 the method for preparing of Chinese medicine preparation of treatment dysmenorrhea and menoxenia; It is characterized in that: described medicament forming method is: adopt the said effective parts formulation of beta-cyclodextrin inclusion compound method cured, prepared dosage form comprises hard capsule and micropill.
4. the method for preparing of the Chinese medicine preparation of treatment dysmenorrhea as claimed in claim 3 and menoxenia is characterized in that: the usage ratio between effective parts formulation, beta-schardinger dextrin-, the water is 2 ml:5 g:80 ml; Mixing time is 1.5 h.
5. according to claim 1 or claim 2 the method for preparing of Chinese medicine preparation of treatment dysmenorrhea and menoxenia; It is characterized in that: described medicament forming method is: adopt said effective parts formulation to make the preparation major ingredient; Adopt soybean oil as the preparation of soft capsule adjuvant, be prepared into soft capsule under 40~50 ℃ of the sprinkler body temperature.
6. the method for preparing of the Chinese medicine preparation of treatment dysmenorrhea as claimed in claim 5 and menoxenia is characterized in that: the soft capsule shell sizing compound formula is a water: gelatin: Cera Flava: Petiolus Trachycarpi oil=1:1.5:0.3:0.44, this ratio is a weight ratio.
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CN112972574B (en) * | 2019-12-13 | 2024-05-28 | 武汉恒信源药业有限公司 | Pharmaceutical composition for relieving pain caused by primary dysmenorrhea and preparation method thereof |
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CN1481839A (en) * | 2002-09-12 | 2004-03-17 | 广州中医药大学科技产业园有限公司 | Medication for irregular menses and dysmenorrhea and preparation method |
CN1546088A (en) * | 2003-12-02 | 2004-11-17 | 胡惠平 | Dysmenorrhea treating Chinese traditional medicine preparation |
CN1895492A (en) * | 2006-06-29 | 2007-01-17 | 上海玉森新药开发有限公司 | Medicine for treating difficult menstruation and its preparation |
CN101375983A (en) * | 2008-09-28 | 2009-03-04 | 张登科 | Chinese medicinal composition for treating dysmenorrhea and preparation method thereof |
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