CN100502885C - Medicinal composition for treating dysmenorrhea and preparation process thereof - Google Patents
Medicinal composition for treating dysmenorrhea and preparation process thereof Download PDFInfo
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- CN100502885C CN100502885C CNB2006100789709A CN200610078970A CN100502885C CN 100502885 C CN100502885 C CN 100502885C CN B2006100789709 A CNB2006100789709 A CN B2006100789709A CN 200610078970 A CN200610078970 A CN 200610078970A CN 100502885 C CN100502885 C CN 100502885C
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Abstract
The invention discloses a medicinal compound to cure menalgia and preparing craft, which is characterized by the following: producing with chiretta polysaccharide, angelica benzine and ambigua total alkalinity; mixing the effective active element; producing to corresponding agent type. This invention also relates to the usage of the medicinal compound to prepare menalgia medicine.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation technology thereof, particularly a kind of pharmaceutical composition and preparation technology thereof who treats dysmenorrhea.
Background technology
Dysmenorrhea is meant that the women in menstrual period and front and back thereof, lower abdomen or flank pain occur, even pain and waist sacrum, whenever sends out with menstrual cycle, and severe patient can bring adverse effect for work and life with many syndromes.Present clinical two kinds of constitutional and the Secondary cases that often it are divided into, primary dysmenorrhea refers to that the genitals does not have obvious pathological changes person more, is more common in adolescent girls, the unmarried and married person of not educating.Secondary dysmenorrhea is then many to be had due to the organic disease because of the genitals.
Simple doctor trained in Western medicine is to the treatment of primary disease, at present steroid hormone class medicines that adopt suppress ovulation more, and the prostaglandin antagonist, spasmolysis and analgesia class medicine is though these methods can obtain curative effect, but hormone medicine easily disturbs normal menstrual cycle, cause menoxenia, and latter's half-life is short, curative effect can not be lasting, still do not reach the purpose of radical cure, and be easy to generate side effect.
Chinese medicine angelica is the dry root of Umbelliferae archangel Radix Angelicae Sinensis (Angelica sinensis Colive), has effects such as promoting blood circulation and hemostasis, adjusting meridian and stopping leukorrhea.Radix Angelicae Sinensis polysaccharide and Radix Angelicae Sinensis volatile oil are respectively total polysaccharides and the volatile oil (also being quintessence oil) that extracts from natural medicinal raw material Radix Angelicae Sinensis.Radix Angelicae Sinensis polysaccharide and Radix Angelicae Sinensis volatile oil are one of main components in the Radix Angelicae Sinensis, and domestic and international in recent years composition Study and the pharmaceutical research to Radix Angelicae Sinensis polysaccharide and Radix Angelicae Sinensis volatile oil had new progress.Radix Angelicae Sinensis polysaccharide is to the obvious effect of body immune system, hemopoietic system, and the good efficacy to antitumor, radioresistance damage has tangible analgesia, anticoagulation and anastalsis.Radix Angelicae Sinensis volatile oil at the isolated uterine smooth muscle, relieving asthma, maincenter suppresses, analgesia and there is pharmacologically active widely aspects such as Immune Effects.Rhizoma Corydalis total alkaloids is the total alkaloids that extracts in the natural medicinal raw material Rhizoma Corydalis.Rhizoma Corydalis is the dry tuber of papaveraceae plant corydalis Corydalis yanhusuo W.T.Wang.Rhizoma Corydalis total alkaloids has analgesic activity, can resist the contractile response that oxytocin causes the isolated rat uterus, and pharmacologically active is widely arranged.But the research of, potentiation collaborative to Radix Angelicae Sinensis polysaccharide, Radix Angelicae Sinensis volatile oil and Rhizoma Corydalis total alkaloids and the improvement aspect of making clinical dosage form are still waiting further raising.
Summary of the invention
The object of the invention is to disclose a kind of pharmaceutical composition and preparation technology thereof.
The present invention seeks to be achieved through the following technical solutions:
The crude drug of pharmaceutical composition of the present invention consists of:
Radix Angelicae Sinensis polysaccharide 1-9 weight portion Radix Angelicae Sinensis volatile oil 1-9 weight portion Rhizoma Corydalis total alkaloids 1-9 weight portion.Above-mentioned three flavor crude drug preferred weight proportionings are as follows:
Radix Angelicae Sinensis polysaccharide 2 weight portion Radix Angelicae Sinensis volatile oils 8 weight portion Rhizoma Corydalis total alkaloidss 4 weight portions;
Radix Angelicae Sinensis polysaccharide 5 weight portion Radix Angelicae Sinensis volatile oil 5 weight portion Rhizoma Corydalis total alkaloidss, 5 weight portions or
Radix Angelicae Sinensis polysaccharide 8 weight portion Radix Angelicae Sinensis volatile oils 2 weight portion Rhizoma Corydalis total alkaloidss 4 weight portions.
Radix Angelicae Sinensis polysaccharide of the present invention adopts the phenolsulfuric acid method to measure, content with glucose meter greater than 50%; Radix Angelicae Sinensis volatile oil adopts gas chromatography determination, content in ligustilide greater than 20%; Rhizoma Corydalis total alkaloids adopts determined by ultraviolet spectrophotometry, content in tetrahydropalmatine greater than 50%.
In the pharmaceutical composition crude drug of the present invention Radix Angelicae Sinensis polysaccharide can but be not limited to following method and make:
Radix Angelicae Sinensis is with the distilled water reflux, extract, of 6-10 times of weight portion 2-4 time, and each 3-5h is after 2-4 the extracting solution merging, distilling under reduced pressure concentrates, and after the concentrated solution pre-cooling, adds the ethanol of 2-4 times of parts by volume, stir, after leaving standstill, slightly carried polysaccharide, slightly carried the polysaccharide dissolved in distilled water with the High speed refrigerated centrifuge collecting precipitation, under the 3-5 ℃ of condition to distill water dialysis 2-4 days, centrifugal removal precipitation, the supernatant lyophilization, promptly.
The method for optimizing of Radix Angelicae Sinensis polysaccharide is as follows in the pharmaceutical composition crude drug of the present invention:
Radix Angelicae Sinensis is with the distilled water reflux, extract, of 8 times of weight portions 3 times, and each 4h is after 3 times extracting solution merges, distilling under reduced pressure concentrates, and after the concentrated solution pre-cooling, adds the ethanol of 3 times of parts by volume, stir, after leaving standstill, slightly carried polysaccharide, slightly carried the polysaccharide dissolved in distilled water with the High speed refrigerated centrifuge collecting precipitation, under 4 ℃ of conditions to distill water dialysis 3 days, centrifugal removal precipitation, the supernatant lyophilization, promptly.
In the pharmaceutical composition crude drug of the present invention Radix Angelicae Sinensis volatile oil can but be not limited to following method and make:
Get the angelica root powder, put in the extractor, add 4-8 times of parts by volume hexane soaked overnight, extracted 14-18 hour in the water bath with thermostatic control, reclaim solvent, promptly.
The method for optimizing of Radix Angelicae Sinensis volatile oil is as follows in the pharmaceutical composition crude drug of the present invention:
Get the angelica root powder, put in the extractor, add 6 times of parts by volume hexane soaked overnight, extracted 16 hours in the water bath with thermostatic control, reclaim solvent, promptly.
In the pharmaceutical composition crude drug of the present invention Rhizoma Corydalis total alkaloids can but be not limited to following method and make:
Get the Rhizoma Corydalis powder and put in the extractor, moistening with strong aqua ammonia, 5-7 times of parts by volume chloroform extraction 2-4 hour filters, the filtrate water bath method, promptly.
The method for optimizing of Rhizoma Corydalis total alkaloids is as follows in the pharmaceutical composition crude drug of the present invention:
Get the Rhizoma Corydalis powder and put in the extractor, moistening with strong aqua ammonia, 6 times of parts by volume chloroform extraction 3 hours filter, the filtrate water bath method, promptly.
The pass of wherein wt part and parts by volume is the relation of gram and milliliter.
The preparation of Radix Angelicae Sinensis polysaccharide, Radix Angelicae Sinensis volatile oil, Rhizoma Corydalis total alkaloids crude drug can be but be not limited to above method.Radix Angelicae Sinensis polysaccharide can be a water extract-alcohol precipitation, and process is removed oils and fats and protein gained polysaccharide, or adopts water extract-alcohol precipitation gained polysaccharide, through the Radix Angelicae Sinensis polysaccharide of ultrafilter membrane gained certain molecular weight scope; Radix Angelicae Sinensis volatile oil can be the Radix Angelicae Sinensis volatile oil that steam distillation, supercritical extraction, organic solvent soaking extraction method etc. obtain; Rhizoma Corydalis total alkaloids can be the Rhizoma Corydalis total alkaloids that solvent cold-maceration, ethanol extraction method, ether or chloroform extraction method etc. obtain.
Get the above-mentioned composition crude drug, add conventional adjuvant,, make clinical oral liquid, capsule, pill, granule, tablet, intramuscular dose or the intravenous injection accepted according to common process.
The preparation technology of drug composition oral preparation of the present invention is as follows:
Get the crude drug Radix Angelicae Sinensis volatile oil and carry out enclose with the beta-schardinger dextrin-of 20-70 weight portion, the gained clathrate mixes with Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids, adds conventional adjuvant, makes oral formulations according to conventional method.Preferred 45,60 weight portions of beta-schardinger dextrin-wherein
The preferred for preparation technology of drug composition oral preparation of the present invention is as follows:
The preparation of capsule: get the crude drug Radix Angelicae Sinensis volatile oil and carry out enclose, behind gained clathrate and Radix Angelicae Sinensis polysaccharide, the Rhizoma Corydalis total alkaloids mix homogeneously, add conventional adjuvant, use 70% alcohol granulation in the usual way with 30 weight portion beta-schardinger dextrin-s, drying, encapsulated, promptly.
The preparation of tablet: get the crude drug Radix Angelicae Sinensis volatile oil and carry out enclose, behind gained clathrate and Radix Angelicae Sinensis polysaccharide, the Rhizoma Corydalis total alkaloids mix homogeneously, add conventional adjuvant with 45 weight portion beta-schardinger dextrin-s, use 70% alcohol granulation in the usual way, add 0.125 weight portion magnesium stearate mixing, tabletting, promptly.
The preparation of granule: get the crude drug Radix Angelicae Sinensis volatile oil and carry out enclose, behind gained clathrate and Radix Angelicae Sinensis polysaccharide, the Rhizoma Corydalis total alkaloids mix homogeneously, add conventional adjuvant, use 70% alcohol granulation in the usual way with 60 weight portion beta-schardinger dextrin-s, drying, promptly.
The preparation of oral liquid formulations: get the crude drug Radix Angelicae Sinensis volatile oil and carry out enclose with 50 weight portion HP-, gained clathrate and Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids, dissolve with pure water, add sodium benzoate 5 weight portions and ethylparaben 1.25 weight portions and make dissolving, add water to 2500 parts by volume, stir evenly, filter, fill, promptly.
The concrete preparation technology of medicine composition injection preparation of the present invention is as follows:
Radix Angelicae Sinensis volatile oil carries out enclose with 20-30 weight portion HP-, gained clathrate and Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids dissolve with 100-200 parts by volume water for injection, adding the 0.05-0.2% active carbon stirred 3-7 minute, filter, water for injection adds to the 700-1000 parts by volume, regulates pH value to 4.0-6.0, filter, fill, sterilization, promptly.
The preferred for preparation technology of medicine composition injection preparation of the present invention is as follows:
Radix Angelicae Sinensis volatile oil carries out enclose with 24 weight portion HP-, gained clathrate and Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids dissolve with 160 weight portion waters for injection, adding 0.1% active carbon stirred 5 minutes, filter, water for injection adds to 800 parts by volume, regulates pH value to 5.0, filter, fill, sterilization, promptly.
Compositions of the present invention has therapeutical effect to dysmenorrhea, obviously is better than single component wherein aspect dysmenorrhea treatment, has obvious synergistic, potentiation.Pharmacodynamic experiment shows: pharmaceutical composition of the present invention has good analgesic activity and to the contraction inhibitory action in uterus.Simultaneously, pharmaceutical composition of the present invention is except that having more available variety range and leeway to dysmenorrhea treatment the time, also simple because of its composition, effective ingredient is concentrated, thereby the use amount of medicine is reduced relatively, and after being made into the medicine of several formulations form, can also realize that the scope of occupation mode and/or patient's object is more extensive, the purpose that helps promoting the use of on a large scale.
Following experimental example and embodiment are used to further specify but are not limited to the present invention.
Experimental example 1 analgesic experiment
1. diethylstilbestrol and oxytocin are brought out the influence of Mouse Uterus spasm
80 of female mice hysterospasm ♀ mices are brought out in diethylstilbestrol and oxytocin, are divided into 8 groups.Radix Angelicae Sinensis volatile oil: Radix Angelicae Sinensis polysaccharide: Rhizoma Corydalis total alkaloids is the present composition of 2:1:1 (sample 1), 1:1:1 (sample 2), 1:1:2 (sample 3), 1:2:1 (sample 4) different proportion form, press 120mg (effective ingredient total amount)/kg and irritate stomach, matched group is the Radix Angelicae Sinensis volatile oil and the Rhizoma Corydalis total alkaloids of equivalent, carried out the contrast experiment respectively, compared between organizing with the F check.Experimental result is as shown in table 1.1h gives Rhizoma Corydalis total alkaloids, Radix Angelicae Sinensis volatile oil, medicine of the present invention through irritating stomach before the experiment, and model control group waits the capacity normal saline.Observe in mouse writhing response latency and the 30min and turn round the body number of times.
The influence of Mouse Uterus spasm is brought out in table 1 pair diethylstilbestrol and oxytocin
Compare with model group: *: P＜0.05, * *: P＜0.01
The experimental result of table 1 shows that the laboratory sample group of the present invention of three kinds of active component different proportion forms all can make the mouse writhing response latency obviously prolong, and turns round the body number of times and obviously reduces (the P value all＜0.01).The result of table 1 also demonstrates, the effect that the laboratory sample of four groups of different proportion forms brings out the Mouse Uterus spasm to diethylstilbestrol and oxytocin is basic identical, and the influence that the Mouse Uterus spasm is brought out in diethylstilbestrol and oxytocin of sample 1, sample 2, sample 3, sample 4 all is better than Radix Angelicae Sinensis polysaccharide group, Radix Angelicae Sinensis volatile oil group and the Rhizoma Corydalis total alkaloids group of single component, illustrates that pharmaceutical composition of the present invention has obvious synergistic function.
2. the influence of female mice writhing response due to the Dichlorodiphenyl Acetate
Laboratory sample is respectively Radix Angelicae Sinensis volatile oil: Radix Angelicae Sinensis polysaccharide: Rhizoma Corydalis total alkaloids is the present composition of 2:1:1 (sample 1), 1:1:1 (sample 2), 1:1:2 (sample 3), 1:2:1 (sample 4) different proportion form, press 120mg (effective ingredient total amount)/kg and irritate stomach, matched group be equivalent Radix Angelicae Sinensis volatile oil, Rhizoma Corydalis total alkaloids and etc. the capacity normal saline.1h ip 1% acetic acid 0.2mL/ only observes in administration mouse writhing response latency and the 30min and turns round the body number of times after the administration, and calculates the protection percentage rate.
The influence of female mice writhing response due to table 2 Dichlorodiphenyl Acetate
Compare with model group: *: P＜0.05, * *: P＜0.01, * * *: P＜0.001
The experimental result of table 2 shows that the laboratory sample group of the present invention of three kinds of active component different proportion forms all can make the mouse writhing response latency obviously prolong, and turns round the body number of times and obviously reduces, and turns round the body protective rate and obviously improves (the P value all＜0.01).The result of table 2 also demonstrates, the effect of female mice writhing response is basic identical due to the laboratory sample Dichlorodiphenyl Acetate of four groups of different proportion forms, and the influence of female mice writhing response all is better than Radix Angelicae Sinensis polysaccharide group, Radix Angelicae Sinensis volatile oil group and the Rhizoma Corydalis total alkaloids group of single component due to the Dichlorodiphenyl Acetate of sample 1, sample 2, sample 3, sample 4, illustrates that pharmaceutical composition of the present invention has obvious synergistic function.
3. to the influence of hot plate method analgesic activity
Laboratory sample is respectively Radix Angelicae Sinensis volatile oil: Radix Angelicae Sinensis polysaccharide: Rhizoma Corydalis total alkaloids is the present composition of 2:1:1 (sample 1), 1:1:1 (sample 2), 1:1:2 (sample 3), 1:2:1 (sample 4) different proportion form, press 120mg (effective ingredient total amount)/kg and irritate stomach, matched group be equivalent Radix Angelicae Sinensis volatile oil, Rhizoma Corydalis total alkaloids and etc. the capacity normal saline.Experimentize behind the 1h after the administration, the variation of the threshold of pain respectively organized in record, calculates the threshold of pain and improve percentage rate.If sufficient reaction do not occur licking in the 60S, 60S is counted in the threshold of pain.
The influence of table 3 pair hot plate method analgesic activity
Compare with model group: *: P＜0.05, * *: P＜0.01, * * *: P＜0.001
The experimental result of table 3 shows, the laboratory sample group of the present invention of three kinds of active component different proportion forms all can significantly postpone mice and (P＜0.05) occur licking the sufficient response time, and the threshold of pain is improved percentage rate and obviously improved.The result of table 3 also demonstrates, the laboratory sample of four groups of different proportion forms is basic identical to the effect of hot plate method analgesic activity, and the influence to the hot plate method analgesic activity of sample 1, sample 2, sample 3, sample 4 all is better than Radix Angelicae Sinensis polysaccharide group, Radix Angelicae Sinensis volatile oil group and the Rhizoma Corydalis total alkaloids group of single component, illustrates that pharmaceutical composition of the present invention has obvious synergistic function.
The influence of 2 pairs of ♀ mices of experimental example isolated uterine spontaneous activity
Laboratory sample is respectively Radix Angelicae Sinensis volatile oil: Radix Angelicae Sinensis polysaccharide: Rhizoma Corydalis total alkaloids is the present composition of 2:1:1 (sample 1), 1:1:1 (sample 2), 1:1:2 (sample 3), 1:2:1 (sample 4) different proportion form.Healthy ♀ unpregnancy mice, body weight 20-24g presses 2mg/kg SC diethylstilbestrol injection before the experiment, and continuous 2d is to improve the sensitivity of uterus to medicine.During experiment mice is taken off neck and put to death, cut open rapidly and get the uterus, place immediately to fill through gaseous mixture (95%O
2+ 5%CO
2) in the saturated Rockwell liquid of %, careful periuterine connective tissue and the fatty tissue removed, make the uterus specimen that is about 1cm, specimen one end is fixed on the little hook of specimen plate, place in the bath that fills 20ml Rockwell liquid, the other end links to each other with tonotransducer, and water-bath keeps in the bath temperature (37 ± 0.5) ℃, feeds 60-80 bubble/min of gaseous mixture, specimen load 1g, chart speed 4mm/min, range 20mv, balance 1h, write down one section normal contraction curve, adding final concentration is above-mentioned each drug solution of 1.0mg/ml, and the shrinkage amplitude and the contraction frequency of the interior uterine smooth muscle of 10min are recorded in it on desk-top balance recorder after the observed and recorded administration.
The influence of table 4 pair Mouse Uterus spontaneous activity
Annotate: compare with matched group before the administration:: *: P＜0.05, * *: P＜0.01, * * *: P＜0.001
The experimental result of table 4 shows that the laboratory sample group of the present invention of three kinds of active component different proportion forms all can significantly suppress the uterine contraction amplitude.The result of table 3 also demonstrates, the laboratory sample of four groups of different proportion forms all can obviously suppress uterotonic amplitude, and sample 1, sample 2, sample 3, sample 4 uterotonic inhibitory action all is better than Radix Angelicae Sinensis polysaccharide group, Radix Angelicae Sinensis volatile oil group and the Rhizoma Corydalis total alkaloids group of single component, illustrate that pharmaceutical composition of the present invention has obvious synergistic function.
Following embodiment all can realize the described effect of above-mentioned experimental example.
The specific embodiment:
Embodiment 1: the preparation of capsule
Get Radix Angelicae Sinensis volatile oil 15kg Radix Angelicae Sinensis polysaccharide 15kg Rhizoma Corydalis total alkaloids 15kg, Radix Angelicae Sinensis volatile oil carries out enclose with the 90kg beta-schardinger dextrin-, behind gained clathrate and Radix Angelicae Sinensis polysaccharide, the Rhizoma Corydalis total alkaloids mix homogeneously, add conventional adjuvant, use 70% alcohol granulation in the usual way, drying, encapsulated, promptly.
The wherein preparation of Radix Angelicae Sinensis polysaccharide: Radix Angelicae Sinensis is with the distilled water reflux, extract, of 8 times of weight portions 3 times, and each 4h is after 3 times extracting solution merges, distilling under reduced pressure concentrates, and after the concentrated solution pre-cooling, adds the ethanol of 3 times of parts by volume, stir, after leaving standstill, slightly carried polysaccharide, slightly carried the polysaccharide dissolved in distilled water with the High speed refrigerated centrifuge collecting precipitation, under 4 ℃ of conditions to distill water dialysis 3 days, centrifugal removal precipitation, the supernatant lyophilization, promptly.Radix Angelicae Sinensis polysaccharide adopts the phenolsulfuric acid method to measure, and content is 55% with glucose meter;
The preparation of Radix Angelicae Sinensis volatile oil: get the angelica root powder, put in the extractor, add 6 times of weight portion hexane soaked overnight, extracted 16 hours in the water bath with thermostatic control, reclaim solvent, promptly.Radix Angelicae Sinensis volatile oil adopts gas chromatography determination, and content counts 25% with ligustilide;
The preparation of Rhizoma Corydalis total alkaloids: get the Rhizoma Corydalis powder and put in the extractor, moistening with strong aqua ammonia, 6 times of weight portion chloroform extraction 3 hours filter, the filtrate water bath method, promptly.Rhizoma Corydalis total alkaloids adopts determined by ultraviolet spectrophotometry, and content counts 55% with tetrahydropalmatine.
Embodiment 2: the preparation of tablet
Radix Angelicae Sinensis volatile oil 30kg Radix Angelicae Sinensis polysaccharide 7.5kg Rhizoma Corydalis total alkaloids 15kg, Radix Angelicae Sinensis volatile oil carries out enclose with the 180kg beta-schardinger dextrin-, gained clathrate and Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids mix homogeneously, add conventional adjuvant, use 70% alcohol granulation in the usual way, add 0.5kg magnesium stearate mixing, tabletting, promptly.
Embodiment 3: the preparation of granule
Radix Angelicae Sinensis volatile oil 3kg Radix Angelicae Sinensis polysaccharide 12kg Rhizoma Corydalis total alkaloids 6kg, Radix Angelicae Sinensis volatile oil carries out enclose with the 90kg beta-schardinger dextrin-, gained clathrate and Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids mix homogeneously, add conventional adjuvant, use 70% alcohol granulation in the usual way, drying, promptly.
Embodiment 4: the preparation of oral liquid formulations
Get Radix Angelicae Sinensis volatile oil 2kg Radix Angelicae Sinensis polysaccharide 2kg Rhizoma Corydalis total alkaloids 2kg, Radix Angelicae Sinensis volatile oil carries out enclose with the 20kg HP-, gained clathrate and Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids, with the pure water dissolving, add sodium benzoate 2kg and ethylparaben 0.5kg and make dissolving, add water to 1000L, stir evenly, filter, fill, promptly.
The wherein preparation of Radix Angelicae Sinensis polysaccharide: Radix Angelicae Sinensis is with the distilled water reflux, extract, of 8 times of weight portions 3 times, and each 4h is after 3 times extracting solution merges, distilling under reduced pressure concentrates, and after the concentrated solution pre-cooling, adds the ethanol of 3 times of parts by volume, stir, after leaving standstill, slightly carried polysaccharide, slightly carried the polysaccharide dissolved in distilled water with the High speed refrigerated centrifuge collecting precipitation, under 4 ℃ of conditions to distill water dialysis 3 days, centrifugal removal precipitation, the supernatant lyophilization, promptly.
The preparation of Radix Angelicae Sinensis volatile oil: get the angelica root powder, put in the extractor, add 6 times of parts by volume hexane soaked overnight, extracted 16 hours in the water bath with thermostatic control, reclaim solvent, promptly.
The preparation of Rhizoma Corydalis total alkaloids: get the Rhizoma Corydalis powder and put in the extractor, moistening with strong aqua ammonia, 6 times of parts by volume chloroform extraction 3 hours filter, the filtrate water bath method, promptly.
Embodiment 5: the preparation of injection
Radix Angelicae Sinensis volatile oil 2.5g Radix Angelicae Sinensis polysaccharide 10g Rhizoma Corydalis total alkaloids 5g, Radix Angelicae Sinensis volatile oil carries out enclose with the 30g HP-, gained clathrate and Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids add 0.1% active carbon and stirred 5 minutes with the dissolving of 200ml water for injection, filter, water for injection adds to 1000ml, regulate pH value to 5.0, filter fill, sterilization, promptly.Above-mentioned Radix Angelicae Sinensis polysaccharide adopts the phenolsulfuric acid method to measure, and content is 50% with glucose meter; Radix Angelicae Sinensis volatile oil adopts gas chromatography determination, and content counts 30% with ligustilide; Rhizoma Corydalis total alkaloids adopts determined by ultraviolet spectrophotometry, and content counts 55% with tetrahydropalmatine.
Claims (15)
1, a kind of pharmaceutical composition for the treatment of dysmenorrhea is characterized in that the crude drug of this pharmaceutical composition consists of: Radix Angelicae Sinensis polysaccharide 1-9 weight portion Radix Angelicae Sinensis volatile oil 1-9 weight portion Rhizoma Corydalis total alkaloids 1-9 weight portion; Wherein Radix Angelicae Sinensis polysaccharide adopts the phenolsulfuric acid method to measure, content with glucose meter greater than 50%; Radix Angelicae Sinensis volatile oil adopts gas chromatography determination, content in ligustilide greater than 20%; Rhizoma Corydalis total alkaloids adopts determined by ultraviolet spectrophotometry, content in tetrahydropalmatine greater than 50%.
2, pharmaceutical composition as claimed in claim 1 is characterized in that the crude drug of this pharmaceutical composition consists of: Radix Angelicae Sinensis polysaccharide 2 weight portion Radix Angelicae Sinensis volatile oils 8 weight portion Rhizoma Corydalis total alkaloidss 4 weight portions.
3, pharmaceutical composition as claimed in claim 1 is characterized in that the crude drug of this pharmaceutical composition consists of: Radix Angelicae Sinensis polysaccharide 5 weight portion Radix Angelicae Sinensis volatile oils 5 weight portion Rhizoma Corydalis total alkaloidss 5 weight portions.
4, pharmaceutical composition as claimed in claim 1 is characterized in that the crude drug of this pharmaceutical composition consists of: Radix Angelicae Sinensis polysaccharide 8 weight portion Radix Angelicae Sinensis volatile oils 2 weight portion Rhizoma Corydalis total alkaloidss 4 weight portions.
5, as claim 1,2,3 or 4 described pharmaceutical compositions, it is characterized in that Radix Angelicae Sinensis polysaccharide is made by following method in the crude drug of this pharmaceutical composition: Radix Angelicae Sinensis is with the distilled water reflux, extract, of 6-10 times of weight portion 2-4 time, each 3-5h, after 2-4 time extracting solution merges, distilling under reduced pressure concentrates, after the concentrated solution pre-cooling, the ethanol that adds 2-4 times of parts by volume stirs, after leaving standstill, slightly carried polysaccharide with the High speed refrigerated centrifuge collecting precipitation, slightly carry the polysaccharide dissolved in distilled water, to distill water dialysis 2-4 days, centrifugal removal precipitated under the 3-5 ℃ of condition, the supernatant lyophilization, promptly; Radix Angelicae Sinensis volatile oil is made by following method in the crude drug: get the angelica root powder, put in the extractor, add 4-8 times of parts by volume hexane soaked overnight, extracted 14-18 hour in the water bath with thermostatic control, reclaim solvent, promptly; Rhizoma Corydalis total alkaloids is made by following method in the crude drug: get the Rhizoma Corydalis powder and put in the extractor, moistening with strong aqua ammonia, 5-7 times of parts by volume chloroform extraction 2-4 hour filters, the filtrate water bath method, promptly.
6, pharmaceutical composition as claimed in claim 5, it is characterized in that Radix Angelicae Sinensis polysaccharide is made by following method in the crude drug of this pharmaceutical composition: Radix Angelicae Sinensis is with the distilled water reflux, extract, of 8 times of weight portions 3 times, each 4h, after 3 times extracting solution merges, distilling under reduced pressure concentrates, after the concentrated solution pre-cooling, the ethanol that adds 3 times of parts by volume stirs, after leaving standstill, slightly carried polysaccharide with the High speed refrigerated centrifuge collecting precipitation, slightly carry the polysaccharide dissolved in distilled water, under 4 ℃ of conditions to distill water dialysis 3 days, centrifugal removal precipitation, the supernatant lyophilization, promptly; Radix Angelicae Sinensis volatile oil is made by following method in the crude drug: get the angelica root powder, put in the extractor, add 6 times of weight portion hexane soaked overnight, extracted 16 hours in the water bath with thermostatic control, reclaim solvent, promptly; Rhizoma Corydalis total alkaloids is made by following method in the crude drug: get the Rhizoma Corydalis powder and put in the extractor, moistening with strong aqua ammonia, 6 times of parts by volume chloroform extraction 3 hours filter, the filtrate water bath method, promptly.
7, as claim 1,2,3,4 or 6 described pharmaceutical compositions, it is characterized in that getting pharmaceutical composition crude drug of the present invention, add conventional adjuvant, according to common process, make oral liquid formulations, syrup, mixture, capsule, pill, granule, tablet, intramuscular dose or intravenous injection.
8, preparation of drug combination method as claimed in claim 7, it is characterized in that this preparation method is: get the crude drug Radix Angelicae Sinensis volatile oil and carry out enclose with 20-70 weight portion beta-schardinger dextrin-, behind gained clathrate and Radix Angelicae Sinensis polysaccharide, the Rhizoma Corydalis total alkaloids mix homogeneously, add conventional adjuvant, make oral formulations according to conventional method.
9, preparation of drug combination method as claimed in claim 8 is characterized in that beta-schardinger dextrin-is 45 weight portions in this preparation method.
10, preparation of drug combination method as claimed in claim 8 is characterized in that beta-schardinger dextrin-is 60 weight portions in this preparation method.
11, preparation of drug combination method as claimed in claim 8, the preparation method that it is characterized in that oral liquid formulations is: get the crude drug Radix Angelicae Sinensis volatile oil and carry out enclose with 50 weight portion HP-, gained clathrate and Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids, with the pure water dissolving, add sodium benzoate 5 weight portions and ethylparaben 1.25 weight portions and make dissolving, add water to 2500 parts by volume, stir evenly, filter, fill, promptly.
12, preparation of drug combination method as claimed in claim 7, the preparation method that it is characterized in that injection formulation is: get the crude drug Radix Angelicae Sinensis volatile oil and carry out enclose with 20-30 weight portion HP-, gained clathrate and Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids add the 0.05-0.2% active carbon and stirred 3-7 minute with the dissolving of 100-200 parts by volume water for injection, filter, water for injection adds to the 700-1000 parts by volume, regulate pH value to 4.0-6.0, filter fill, sterilization, promptly.
13, preparation of drug combination method as claimed in claim 12, the preparation method that it is characterized in that injection formulation is: get the crude drug Radix Angelicae Sinensis volatile oil and carry out enclose with 24 weight portion HP-, gained clathrate and Radix Angelicae Sinensis polysaccharide, Rhizoma Corydalis total alkaloids dissolve with 160 parts by volume waters for injection, add 0.1% active carbon and stir 5 minutes, filter, water for injection adds to 800 parts by volume, regulate pH value to 5.0, filter fill, sterilization, promptly.
14, as the application of pharmaceutical composition as described in the claim 1,2,3 or 4 in preparation treatment dysmenorrhea medicine.
15, pharmaceutical composition as claimed in claim 5, it is characterized in that getting pharmaceutical composition crude drug of the present invention, add conventional adjuvant,, make oral liquid formulations, syrup, mixture, capsule, pill, granule, tablet, intramuscular dose or intravenous injection according to common process.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2006100789709A CN100502885C (en) | 2006-04-28 | 2006-04-28 | Medicinal composition for treating dysmenorrhea and preparation process thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2006100789709A CN100502885C (en) | 2006-04-28 | 2006-04-28 | Medicinal composition for treating dysmenorrhea and preparation process thereof |
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| CN101062108A CN101062108A (en) | 2007-10-31 |
| CN100502885C true CN100502885C (en) | 2009-06-24 |
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| CN106176865A (en) * | 2016-08-29 | 2016-12-07 | 吉林紫鑫药业股份有限公司 | A kind of pharmaceutical composition for menoxenia menalgia |
| CN108420855B (en) * | 2018-06-06 | 2020-11-17 | 四川省中医药科学院 | Pharmaceutical composition for preventing and treating dysmenorrhea |
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Assignee: Sichuan Xinyuan Pharmaceutical Co., Ltd. Assignor: Sichuan Kelun Pharmaceutical Co., Ltd. Contract fulfillment period: 2009.8.1 to 2019.7.31 contract change Contract record no.: 2009510000136 Denomination of invention: Medicinal composition for treating dysmenorrhoea and its preparation method and application Granted publication date: 20090624 License type: Exclusive license Record date: 20091030 |
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Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2009.8.1 TO 2019.7.31; CHANGE OF CONTRACT Name of requester: SICHUAN XINYUAN PHARMACY CO., LTD. Effective date: 20091030 |