CN1895492A - Medicine for treating difficult menstruation and its preparation - Google Patents

Medicine for treating difficult menstruation and its preparation Download PDF

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Publication number
CN1895492A
CN1895492A CN 200610028372 CN200610028372A CN1895492A CN 1895492 A CN1895492 A CN 1895492A CN 200610028372 CN200610028372 CN 200610028372 CN 200610028372 A CN200610028372 A CN 200610028372A CN 1895492 A CN1895492 A CN 1895492A
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China
Prior art keywords
medicine
radix angelicae
angelicae sinensis
rhizoma cyperi
dysmenorrhea
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CN 200610028372
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Chinese (zh)
Inventor
林君
玄振玉
王勇
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SHANGHAI YOUSEEN NEW MEDICINE EXPLOITATION CO Ltd
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SHANGHAI YOUSEEN NEW MEDICINE EXPLOITATION CO Ltd
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Priority to CN 200610028372 priority Critical patent/CN1895492A/en
Publication of CN1895492A publication Critical patent/CN1895492A/en
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Abstract

A Chinese medicine for treating menalgia is prepared from cyperus tuber and Chinese angelica root through extracting by supercritical CO2 and dispensing. Its preparing process is also disclosed.

Description

A kind of medicine for the treatment of dysmenorrhea and preparation method thereof
Technical field
The present invention relates to the extract medicine of Chinese herbal medicine, is with Rhizoma Cyperi with when being classified as raw material, with the supercritical CO of Rhizoma Cyperi and Radix Angelicae Sinensis specifically 2Extract is the medicine of active component preparation, belongs to the field of Chinese medicines.
Background technology
Dysmenorrhea (dysmenorrhea) is the periodicity lower abdominal pain that occurs before and after women's menstrual phase and the menstrual phase, often occurs in before the menstruation and menstrual phase, occurs in once in a while after the menstrual phase in a few days.Lower abdominal pain is Crampy Pain and distending pain, can be radiated to around lumbosacral region, femoribus internus and the anus.Can be with pale complexion, feel sick, vomiting, whole body or hypogastric region fear of cold, frequency of bowel movement, dol urg can be collapsed.The dysmenorrhea degree relies on subjective sensation, no objective criterion, so incidence rate differs.29 provinces and cities' survey results of China (1980), dysmenorrhea incidence rate 33.19%, wherein primary dysmenorrhea 30.06%, and is slight 45.73%, moderate 38.81%, severe 13.55%, Andersch (1982) etc. are in the investigation of not producing the women in 19 years old, and dysmenorrhea accounts for 72.4% (420), and severe pain is through accounting for 15.4% (90), influence orthobiosis and work, and invalid to analgesic.It is rarely found that former sore warp took place in menophania later six months, it is reported that 13% occurred in 1 year in 75% former sore after occurring in menophania 1 year, and 50% in the 3rd year.Secondary dysmenorrhea often occurred in menophania after 2 years, and age, the course of disease of various disease dysmenorrhea differ, and the morning and evening that dysmenorrhea takes place is also different.
Chinese medicine to the TREATMENT OF DYSMENORRHOEA curative effect also by clinical confirmation.The traditional Chinese medical science thinks that primary dysmenorrhea mainly is because the women is subjected to the influence of paathogenic factor between menstrual period, causes appointing towards stasis of blood resistance or cold accumulating in meridian, makes QI-blood circulation not smooth, and the uterus menses are obstructed, consequently " stagnation of QI and blood may bring about pain "; Or dash to appoint, uterus lose in moistening foster, Rong Ze pain.The Chinese traditional treatment general principle of dysmenorrhea is based on the Chong and Ren Meridians regulating QI and blood.The sweet suffering of Radix Angelicae Sinensis and temperature, GUIXIN liver spleen channel, function are enriched blood and are invigorated blood circulation, menstruction regulating and pain relieving." the arteries and veins person house of blood, all blood all belongs to the heart, all persons of promoting blood circulation, must be first reinforcing the heart benefit blood ", and the Radix Angelicae Sinensis invigorating middle warmer has row, in the row benefit is arranged, and is the monarch drug that Chinese medicine is used for treating dysmenorrhea.Because the operation of blood needs the promotion of gas, so based on blood circulation promoting medicine, the qi-activating drug that compatibility is appropriate will be strengthened the performance of blood circulation promoting medicine effect undoubtedly, in numerous qi-activating drugs, Rhizoma Cyperi is gynecological's circulation of qi promoting medicine first-selection.
Present patent is retrieved discovery, and the drug patent of treatment dysmenorrhea is compound preparation mostly, and dosage is bigger, and this is difficult to take for the patient of stomachache with vomiting.Find also that by retrieval the patent No. is that the patent of 200310109012.X has been put down in writing the utilization Radix Angelicae Sinensis volatile oil and Rhizoma Cyperi volatile oil is the feedstock production medicine.But the scope of being put down in writing does not provide best proportioning ratio than broad.
Summary of the invention
The purpose of this invention is to provide a kind of medicine for the treatment of dysmenorrhea and preparation method thereof.
Technical scheme of the present invention is:
A kind of medicine for the treatment of dysmenorrhea provided by the invention is to be made by the raw material of following weight ratio:
Rhizoma Cyperi 1-3 part Radix Angelicae Sinensis 1-3 part.
Preferably, a kind of medicine for the treatment of dysmenorrhea provided by the invention is to be made by the raw material of following weight ratio:
1 part of 1 part of Radix Angelicae Sinensis of Rhizoma Cyperi.
The inventor is through a large number of experiments show that, Rhizoma Cyperi and Radix Angelicae Sinensis compatibility in the scope of 1-3: 3-1 uses, and can obtain beyond thought effect, and is better with one of them effect of drugs than single; And the weight ratio of Rhizoma Cyperi and Radix Angelicae Sinensis is 1: 5 or 5: 1 o'clock, effect and single therapeutic equivalence with Rhizoma Cyperi or Radix Angelicae Sinensis, the effect of the addition that can not be effective.
Another object of the present invention provides the preparation method of treatment dysmenorrhea medicine:
Get Rhizoma Cyperi and Radix Angelicae Sinensis medical material, pulverize, sieve, carry out supercritical CO respectively 2Extraction mixes two kinds of supercritical extract, promptly gets active constituents of medicine.
The supercritical CO of Rhizoma Cyperi and Radix Angelicae Sinensis 2Extraction conditions is: Rhizoma Cyperi extraction conditions: extracting pressure 12-18MPa, extraction temperature 35-45 ℃, separating pressure 8-12MPa, separation temperature 25-35 ℃, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes; Radix Angelicae Sinensis extraction conditions: extracting pressure 20-30MPa, extraction temperature 40-50 ℃, separating pressure 6-10MPa, separation temperature 35-45 ℃, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes.
Preferably, the supercritical CO of Rhizoma Cyperi and Radix Angelicae Sinensis the best 2Extraction conditions is: the Rhizoma Cyperi extraction conditions is: extracting pressure 15MPa, 45 ℃ of extraction temperature, separating pressure 10MPa, 30 ℃ of separation temperatures, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes; The Radix Angelicae Sinensis extraction conditions is: extracting pressure 25MPa, 50 ℃ of extraction temperature, separating pressure 8MPa, 45 ℃ of separation temperatures, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes.
Utilize active constituents of medicine of the present invention can make multiple oral formulations, as soft capsule, drop pill, tablet, capsule etc.
The present invention also provides the preparation method of the soft capsule preparation of this medicine: be the active component of medicine of the present invention and the mixture of oiliness adjuvant in the soft capsule; Soft capsule shell is by water, gelatin, glycerol, and palm fibre is prepared from the adding chocolate.
The advantage of medicine of the present invention: 1. crude drug is medicinal herbs most in use, conveniently is easy to get, and can realize that suitability for industrialized production 2. preparation methoies are simple, and the avirulence organic solvent is beneficial to environmental protection; 3. pharmaceutical effectiveness is good, can satisfy patient demand; 4. refining formula, ingredient is controlled, meets modernization of Chinese medicine requirement.More than meet the practicality of Patent Law, creative requirement.
Simultaneously, soft capsule dosage form of being invented and drops also are highly suitable for this invention medicine.The active component of medicine of the present invention, characteristics are that polarity is lower, show oiliness, make soft capsule and can save technical steps such as absorption, curing, can effectively avoid medicine to ooze out from absorb adjuvant.And soft capsule preparation process herb liquid is not heated, and the medicinal liquid packing is tight, and volatile ingredient is difficult for scattering and disappearing, and preparation process is simple relatively; Softgel shell can be covered the abnormal smells from the patient of oil simultaneously, can improve the compliance that the patient takes medicine; Preparation bioavailability height is taken medicine with easy to carry good looking appearance.Because medicine of the present invention is to be used for treating dysmenorrhea, so drop pill can rapid delivery of pharmaceuticals, and volume is little, and suitable women takes.
The specific embodiment
Embodiment 1
Get Rhizoma Cyperi 1125g, Radix Angelicae Sinensis 3375g, pulverize, cross 40 mesh sieves, carry out supercritical CO respectively 2(the Rhizoma Cyperi extraction conditions is: extracting pressure 12MPa, 35 ℃ of extraction temperature, separating pressure 8MPa, 25 ℃ of separation temperatures, CO in extraction 2Flow is 20~25 kilograms/hour, extracts 90 minutes; The Radix Angelicae Sinensis extraction conditions is: extracting pressure 20MPa, 40 ℃ of extraction temperature, separating pressure 10MPa, 35 ℃ of separation temperatures, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes), get Rhizoma Cyperi extract 20g, Radix Angelicae Sinensis extract 70g after the extract mixing, adds the 130g soybean oil, stirs, and makes 1000 soft capsules.
Embodiment 2
Get Rhizoma Cyperi 1500g, Radix Angelicae Sinensis 3000g, pulverize, cross 60 mesh sieves, carry out supercritical CO respectively 2(the Rhizoma Cyperi extraction conditions is: extracting pressure 18MPa, 40 ℃ of extraction temperature, separating pressure 12MPa, 35 ℃ of separation temperatures, CO in extraction 2Flow is 20~25 kilograms/hour, extracts 90 minutes; The Radix Angelicae Sinensis extraction conditions is: extracting pressure 30MPa, 45 ℃ of extraction temperature, separating pressure 6MPa, 40 ℃ of separation temperatures, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes), get Rhizoma Cyperi extract 30g, Radix Angelicae Sinensis extract 60g after the extract mixing, adds the 130g soybean oil, stirs, and makes 1000 soft capsules.
Embodiment 3
Get Rhizoma Cyperi 2500g, Radix Angelicae Sinensis 2500g, pulverize, cross 50 mesh sieves, carry out supercritical CO respectively 2(the Rhizoma Cyperi extraction conditions is: extracting pressure 15MPa, 45 ℃ of extraction temperature, separating pressure 10MPa, 30 ℃ of separation temperatures, CO in extraction 2Flow is 20~25 kilograms/hour, extracts 90 minutes; The Radix Angelicae Sinensis extraction conditions is: extracting pressure 25MPa, 50 ℃ of extraction temperature, separating pressure 8MPa, 45 ℃ of separation temperatures, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes), get Rhizoma Cyperi extract 45g, Radix Angelicae Sinensis extract 51g after the extract mixing, adds the 124g soybean oil, stirs, and makes 1000 soft capsules.
Embodiment 4
Get Rhizoma Cyperi 3000g, Radix Angelicae Sinensis 1500g, pulverize, cross 40 mesh sieves, carry out supercritical CO respectively 2(the Rhizoma Cyperi extraction conditions is: extracting pressure 12MPa, 35 ℃ of extraction temperature, separating pressure 8MPa, 35 ℃ of separation temperatures, CO in extraction 2Flow is 20~25 kilograms/hour, extracts 90 minutes; The Radix Angelicae Sinensis extraction conditions is: extracting pressure 25MPa, 40 ℃ of extraction temperature, separating pressure 10MPa, 35 ℃ of separation temperatures, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes), get Rhizoma Cyperi extract 55g, Radix Angelicae Sinensis extract 30g after the extract mixing, adds the 135g soybean oil, stirs, and makes 1000 soft capsules.
Embodiment 5
Get Rhizoma Cyperi 3375g, Radix Angelicae Sinensis 1125g, pulverize, cross 60 mesh sieves, carry out supercritical CO respectively 2(the Rhizoma Cyperi extraction conditions is: extracting pressure 15MPa, 40 ℃ of extraction temperature, separating pressure 10MPa, 30 ℃ of separation temperatures, CO in extraction 2Flow is 20~25 kilograms/hour, extracts 90 minutes; The Radix Angelicae Sinensis extraction conditions is: extracting pressure 30MPa, 45 ℃ of extraction temperature, separating pressure 6MPa, 40 ℃ of separation temperatures, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes), get Rhizoma Cyperi extract 54g, Radix Angelicae Sinensis extract 25g after the extract mixing, adds the 141g soybean oil, stirs, and makes 1000 soft capsules.
The pharmacological effect data:
1. title: the Rhizoma Cyperi Radix Angelicae Sinensis drug prepared of different proportionings is brought out the influence of Mouse Uterus spasm and dysmenorrhea model to oxytocin
2. purpose: investigate of the influence of the different proportionings of Rhizoma Cyperi Radix Angelicae Sinensis to experimental result
3. method:
3.1 medicine: Rhizoma Cyperi and Radix Angelicae Sinensis are respectively with 1-5: 5-1 feeds intake, and (extraction conditions is: Rhizoma Cyperi collection: extracting pressure 18MPa, 45 ℃ of extraction temperature to carry out the supercritical CO 2 extraction, separating pressure 12MPa, 25 ℃ of separation temperatures, CO2 flow are 20~25 kilograms/hour, extract 90 minutes; Radix Angelicae Sinensis: extracting pressure 20MPa, 50 ℃ of extraction temperature, separating pressure 8MPa, 45 ℃ of separation temperatures, the CO2 flow is 20~25 kilograms/hour, extracts 90 minutes), two kinds of supercritical extract of gained are mixed, the tween 80 mixing with 1%, and medicine is standby as observing.Used drug dose is 19.2mg/kg.
3.2 grouping: choose 90 of the ripe mices of Healthy female, body weight is 20~22g, and random packet is oxytocin model group, 1% tween 80 matched group, Rhizoma Cyperi and Radix Angelicae Sinensis proportioning group, Rhizoma Cyperi extract group, Radix Angelicae Sinensis extract group etc.
3.3 modeling: every day is in the subcutaneous injection diethylstilbestrol of mice 0.2mg/, for three days on end.The gastric infusion 1 time/day respectively in the 2nd day, the oxytocin model group is irritated stomach normal saline 0.1ml/10g, and 1% tween 80 matched group is irritated stomach 1% tween 80 0.1ml/10g, and other groups press 0.1ml/10g volume filling stomach respective concentration medicine.Only injected oxytocin 0.2u/ in mouse peritoneal in 1 hour behind the medicine, observe after the injected in mice oxytocin and turn round body number of times and each group mouse writhing incidence rate in the 30min.
4. result: 1% tween 80 matched group and oxytocin model group relatively, there was no significant difference.Rhizoma Cyperi and Radix Angelicae Sinensis proportioning group, Rhizoma Cyperi extract group, Radix Angelicae Sinensis extract group all have significant difference with model group.In 5 proportionings of Rhizoma Cyperi and Radix Angelicae Sinensis, Rhizoma Cyperi: Radix Angelicae Sinensis 1: 1 is best, and it is minimum that mice is on average turned round the body number of times, Rhizoma Cyperi: Radix Angelicae Sinensis 1: 5 and Radix Angelicae Sinensis: Rhizoma Cyperi 1: 5 o'clock, mice turn round the body number of times near single with Radix Angelicae Sinensis extract or Rhizoma Cyperi extract.So when Rhizoma Cyperi and Radix Angelicae Sinensis proportioning, that obtains positive effect is Rhizoma Cyperi 1-3: Radix Angelicae Sinensis 1-3.The results are shown in Table 1.
The different proportionings with Radix Angelicae Sinensis of table 1 Rhizoma Cyperi cause the influence of mouse experiment dysmenorrhea model to oxytocin
( x±s,n=10)
Group Dosage (mg/kg) Turn round the body number of times
Oxytocin model group 1% tween 80 matched group Rhizoma Cyperi extract Radix Angelicae Sinensis extract Rhizoma Cyperi and Radix Angelicae Sinensis proportioning group 0.1ml/10g 19.2 19.2 rhizoma cyperis: Radix Angelicae Sinensis (1: 5) rhizoma cyperi: Radix Angelicae Sinensis (1: 3) rhizoma cyperi: Radix Angelicae Sinensis (1: 1) Radix Angelicae Sinensis: rhizoma cyperi (1: 3) Radix Angelicae Sinensis: rhizoma cyperi (1: 5) 37.8±8.3 38.3±7.2 18.5±3.6 ** 19.3±4.8 ** 18.6±2.3 ** 12.6±5.1 ** 10.5±3.6 ** 13.2±1.4 ** 18.4±5.0 **
Annotate: compare * P<0.05, * * P<0.01 with the oxytocin model group.

Claims (8)

1. medicine for the treatment of dysmenorrhea is characterized in that being made by the raw material of following weight ratio:
Rhizoma Cyperi 1-3 part Radix Angelicae Sinensis 1-3 part.
2. a kind of medicine for the treatment of dysmenorrhea as claimed in claim 1 is characterized in that being made by the raw material of following weight ratio:
1 part of 1 part of Radix Angelicae Sinensis of Rhizoma Cyperi.
3. a preparation method for the treatment of the dysmenorrhea medicine is characterized in that the active component of medicine prepares as follows: get Rhizoma Cyperi and Radix Angelicae Sinensis medical material, pulverize, sieve, carry out supercritical CO respectively 2Extraction mixes two kinds of supercritical extract, promptly gets active constituents of medicine.
4. a kind of preparation method for the treatment of the dysmenorrhea medicine as claimed in claim 3 is characterized in that the supercritical CO of Rhizoma Cyperi 2Extraction conditions is: extracting pressure 12-18MPa, extraction temperature 35-45 ℃, separating pressure 8-12MPa, separation temperature 25-35 ℃, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes; The supercritical CO of Radix Angelicae Sinensis 2Extraction conditions is: extracting pressure 20-30MPa, extraction temperature 40-50 ℃, separating pressure 6-10MPa, separation temperature 35-45 ℃, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes.
5. a kind of preparation method for the treatment of the dysmenorrhea medicine as claimed in claim 4 is characterized in that the supercritical CO of Rhizoma Cyperi 2Extraction conditions is: extracting pressure 15MPa, 45 ℃ of extraction temperature, separating pressure 10MPa, 30 ℃ of separation temperatures, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes; The supercritical CO of Radix Angelicae Sinensis 2Extraction conditions is: extracting pressure 25MPa, 50 ℃ of extraction temperature, separating pressure 8MPa, 45 ℃ of separation temperatures, CO 2Flow is 20~25 kilograms/hour, extracts 90 minutes.
6. a kind of according to claim 1 medicine for the treatment of dysmenorrhea is characterized in that making dosage forms such as soft capsule, drop pill, tablet, capsule.
7. as a kind of soft capsule dosage form for the treatment of the dysmenorrhea medicine as described in the claim 6, it is characterized in that in the soft capsule it being the active component of medicine of the present invention and the mixture of oiliness adjuvant.
8. as a kind of soft capsule dosage form for the treatment of the dysmenorrhea medicine as described in the claim 7, it is characterized in that in the soft capsule it being the active component of medicine of the present invention and the mixture of soybean oil.
CN 200610028372 2006-06-29 2006-06-29 Medicine for treating difficult menstruation and its preparation Pending CN1895492A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102205025A (en) * 2011-05-06 2011-10-05 烟台渤海制药集团有限公司 Preparation method of traditional Chinese medicine preparation for treating dysmenorrhea and irregular menstruation

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102205025A (en) * 2011-05-06 2011-10-05 烟台渤海制药集团有限公司 Preparation method of traditional Chinese medicine preparation for treating dysmenorrhea and irregular menstruation
CN102205025B (en) * 2011-05-06 2012-11-07 烟台渤海制药集团有限公司 Preparation method of traditional Chinese medicine preparation for treating dysmenorrhea and irregular menstruation

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