CN102125607A - Medicinal composition and preparation method thereof - Google Patents

Medicinal composition and preparation method thereof Download PDF

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CN102125607A
CN102125607A CN 201010034358 CN201010034358A CN102125607A CN 102125607 A CN102125607 A CN 102125607A CN 201010034358 CN201010034358 CN 201010034358 CN 201010034358 A CN201010034358 A CN 201010034358A CN 102125607 A CN102125607 A CN 102125607A
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preparation
drug regimen
extraction
radix paeoniae
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刘安
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Institute of Materia Medica of CAMS
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Abstract

The invention relates to a medicinal composition which consists of pseudo-ginseng and white paeony root (or red paeony root). The medicinal composition is prepared into a pharmaceutically allowable preparation such as an oral preparation, an injection preparation or the like. The medicinal composition has effects of activating blood circulation to dissipate blood stasis, benefiting vital energy and relieving pain, and is mainly used for treating cardiovascular and cerebrovascular diseases such as coronary heart disease, angina pectoris, cerebral ischemia and the like.

Description

A kind of drug regimen and preparation method thereof
Technical field
The invention belongs to the Chinese medicine research field, relate to a kind of Chinese medicine preparation for the treatment of cardio-cerebralvascular diseases and preparation method thereof that can be used for.
Technical background
Cardiovascular and cerebrovascular disease is the particularly commonly encountered diseases and the frequently-occurring disease of middle-aged and elderly people health of harm humans health, has become first and second cause of death of world's most countries.In China, the cardio-cerebralvascular diseases M ﹠ M is the trend that rises year by year in recent years.It is reported that there is nearly 3,000,000 people every year in China because of cardiovascular and cerebrovascular disease death.The traditional Chinese medical science thinks that cardiovascular and cerebrovascular disease is many because of " imbalance of YIN and YANG, mechanism of qi be contrary disorderly cause the painstaking effort stasis of blood stagnates, blockage of the cardiac vessels ", thereby many employing " blood circulation promoting and blood stasis dispelling " rule of treatment carry out the treatment of cardio-cerebralvascular diseases, has obtained gratifying effect.
The Chinese medicine of treatment cardio-cerebralvascular diseases is more, for example FUFANG DANSHEN DIWAN, FUFANG DANSHEN PIAN, Yufengningxin capsule etc., in clinical practice, show certain advantage, but existed drawbacks such as bioavailability is low, onset is slow, prescription is complicated, dose is big mostly.Though SHUXUENING injection, XUESHUANTONG ZHUSHEYE, Flos Carthami injection etc. have rapid-action characteristics, yet because the quality control aspect, its safety has been subjected to query.So develop especially treating coronary heart disease and angina pectoris of prevention and treatment cardiovascular and cerebrovascular disease, still be a meaningful and suitable difficult task.
Summary of the invention
Drug regimen of the present invention adopts drug for invigorating blood circulation and eliminating stasis Radix Notoginseng and the Radix Paeoniae Alba (or Radix Paeoniae Rubra) compatibility, has the effect of blood circulation promoting and blood stasis dispelling, QI invigorating pain relieving.Radix Notoginseng is used for blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain as monarch drug.Compendium of Material Medica cloud: " Radix Notoginseng hemostasis, the blood that looses, analgesic therapy." " book on Chinese herbal medicine is looked for the truth " record: " Radix Notoginseng, common people only know the function hemostasis and pain-relieving.Hardly realize bitterly and ache work that blood ends because of applying the blood that looses because of blood stasis.The bitter temperature of Radix Notoginseng abnormal smells from the patient can be in its blood stasis of blood systemization "." jade is seized medicine and separated " record: Radix Notoginseng can " with battalion hemostasis, the clots absorbing of promoting blood circulation, clots absorbing blood and see fresh blood.All puerperal, menstrual period, traumatic injury, carbuncle, all blood stasis are all broken; All nosebleed, metrorrhagia, knife injury, arrow wounds of telling, all fresh blood all end ".Modern pharmacological research shows, Radix Notoginseng has hemostasis, antithrombotic, promotion hemopoietic, resists myocardial ischemia, blood vessel dilating and antiinflammatory action, has significant analgesic activity simultaneously.The Radix Paeoniae Alba has nourishing blood to suppress the hyperactive liver, slow middle pain relieving, and yin fluid astringing is received the effect of antiperspirant." herbal classic " record: the Radix Paeoniae Alba can " main pathogen stomachache is removed arthralgia due to stagnation of blood, and be broken hard long-pending, controls cold and heat hernia abdominal mass, pain relieving, diuresis, QI invigorating." " not Lu " record: the Radix Paeoniae Alba can " clear and coherent blood vessels, slow in, dispelling malignant blood, expelling extravasated blood, the gas that anhydrates, sharp bladder, intestine and small intestine, subduing inflammation, row cold and heat when (controlling), attacked by pestiferous factors stomachache, lumbago." modern pharmacological research shows that the Radix Paeoniae Alba has: 1, analgesic activity, can suppress mouse writhing, shout, the hot plate reaction, morphine is suppressed writhing response synergism, and can resist and faint from fear due to the pentylenetetrazole; 2, motion has inhibitory action to spasmolysis to the intestinal tube stomach function regulating, significantly resists the uterine contraction that oxytocin causes; 3, to the effect coronary artery dilator of cardiovascular system, (d-cachou extract and progallin A have antithrombotic and antiplatelet aggregative activity) brings high blood pressure down.The Radix Paeoniae Alba and Radix Paeoniae Rubra effect are more or less the same, but the Radix Paeoniae Alba is longer than reducing swelling and alleviating pain, and Radix Paeoniae Rubra then is longer than blood circulation promoting and blood stasis dispelling.According to the disease symptoms difference, can select to use the Radix Paeoniae Alba or Radix Paeoniae Rubra.The present invention combines Radix Notoginseng " blood circulation promoting and blood stasis dispelling " with the Radix Paeoniae Alba " promoting the circulation of QI to relieve pain ", make gas capable, beniol, thus reach the effect for the treatment of both the principal and secondary aspects of a disease.
Preparation of the present invention is to constitute like this: calculate according to components by weight percent, it is made for 99~1 parts by 1~99 part of the Radix Notoginseng and the Radix Paeoniae Alba (or Radix Paeoniae Rubra).
This drug regimen can adopt the method for independent extraction or united extraction, specifically: (1) gets the Radix Notoginseng and the Radix Paeoniae Alba separately, add 4~20 times of water gagings or alcohol respectively, extract 1~5 time, extraction time is 0.5~3.0 hour, as adopt the mode of diafiltration or warm macerating, extraction time can proper extension to 72 hour; (2) get the Radix Notoginseng and the Radix Paeoniae Alba, add 4~20 times of water gagings or alcohol, extract 1~5 time, extraction time is 0.5~3.0 hour, and as adopting the mode of diafiltration or warm macerating, extraction time can proper extension to 72 hour.
The exquisite method of this drug regimen mainly contains: water precipitating, precipitate with ethanol, flocculent precipitation, macroporous adsorbent resin separation, polyamide separation etc. other can be in industrial attainable exquisite method.It is worthy of note that exquisite is not necessary for this drug regimen, according to the difference of selected dosage form with prepare the different of purpose, can optionally adopt different exquisite methods.
The applicant has carried out following experiment, proves the effectiveness of medicine of the present invention.
(1) to the influence of intraluminal middle cerebral artery occlusion in rats focal cerebral ischemia
Get 40 of the healthy male SD rats of body weight 130~150g, be divided into 4 groups at random, be i.e. blank group, of the present invention group, Radix Notoginseng group and Radix Paeoniae Alba group, 10 every group by body weight.Extract the back gastric infusion, administration every day 3 times, successive administration 7 days.The blank group is given the equal-volume normal saline.Each organizes rat behind the 6th day administration 1h, lumbar injection 10% chloral hydrate (350mg/kg) anesthesia.Fix by method right arm reclining such as Tamura, do a curved incision at the eye corner of the eyes and external auditory meatus midline, be about 1.5cm, pinch off temporalis and excision, bite away zygomatic arch with rongeur, expose the squamosal bone major part, about 2mm holes with dental burr at the place below uniting before zygomatic arch and squamosal bone then, open an about 2mm diameter microcephalia window, expose middle cerebral artery.There are 50% liquor ferri trichloridi (with the preparation of 1mol/L hydrochloric acid), 10 μ l to drop on the small pieces filter paper suction, apply at this section of rat middle cerebral artery place, remove filter paper behind the placement 30min, use the normal saline flushing local organization, layer-by-layer suture steams again behind the conventional skin degerming and raises.The operation process room temperature is controlled at 23~25 ℃.Postoperative (23h after the modeling) on the secondth continues administration 1 time.Get administration according to the method described above and modeling and respectively organize rat, carry out the behavior scoring of nervous symptoms in postoperative 6h and 24h.Method is as follows: 1. carry the Mus tail and observe forelimb flexing situation, stretch to ground, count 0 fen as two forelimb symmetries, as the offside forelimb of operation occur that wrist is bent, elbow flexing, shoulder inward turning or existing wrist elbow flexing have shoulder inward turning person again, counts 1,2,3,4 fen respectively.2. animal is placed on the level land, push away both shoulders respectively, check resistance to side shifting, as bilateral resistance equity and strong, count 0 fen, resistance descender when promoting as offside to operation, according to decline degree difference be divided into gently, in, weigh three degree, count 1,2,3 fen respectively.3. the two forelimbs of animal are put on the wire netting, observed two muscle of anterior limb tension force.Two muscle of anterior limb tension force equities and strong person count 0 fen, count 1,2,3 fen according to operation offside limb tension force decline degree difference equally.4. animal has and does not stop counting 1 fen to a side person of turn-taking, and according to standards of grading, full marks are 11 minutes, and mark is high more, and the animal behavior obstacle is serious more.
The result shows (seeing Table 1), and according to behavioristics's standards of grading, each organizes rat 6h, 24h appearance neurosigns in various degree after modeling.With the blank group relatively, each administration group all can reduce the behavior scoring that the middle cerebral artery thromboembolism causes rats with cerebral ischemia to some extent, but of the present invention group of effect organize far above the Radix Notoginseng group and the Radix Paeoniae Alba, difference has significance.
Table 1 medicine to the influence of middle cerebral artery thromboembolism rat neurosigns (x ± s, n=10)
Annotate: compare with model group: *P<0.05, *P<0.01, compare with the Radix Notoginseng group: #p<0.05, compare with Radix Paeoniae Alba group: a p<0.05, aa p<0.01 ##p<0.01.
(2) to the influence of cerebral infarction scope
Get administration as stated above, modeling and carry out 4 groups of rats of postoperative 24h behavior scoring, every group 10, the difference sacrificed by decapitation, take out full brain rapidly, remove olfactory bulb, cerebellum and low brain stem, left and right brain separates, and crown 3 cuttves of cutting divide 4 under 0-4 ℃ respectively, rapidly the brain sheet is placed TTC dyeing (the contained 4%TTC 1.5ml of every 5ml dye liquor, 1mol/L K 2HPO 40.1ml), 37 ℃ of lucifuge temperature are incubated 30min, take out to be placed on the 24h that keeps in Dark Place in 10% formalin.The non-ischemic region in dyed back is a rose, and infarct is a white.The white infarct kitchen range carefully dug down weigh, the percentage ratio that accounts for total brain weight with infarction tissue's weight calculates the cerebral infarction scope of every animal respectively, the comparable group differences as the cerebral infarction scope.The left side brain is a blank.
The result shows (seeing Table 2), with the blank group relatively, each organize medicine all can minimizing intraluminal middle cerebral artery occlusion in rats thromboembolism in various degree due to the percentage by weight of infarction size, but of the present invention group of effect is better than Radix Notoginseng and Radix Paeoniae Alba group, significant difference;
Table 2 medicine to the influence of middle cerebral artery thromboembolism rat cerebral infarction scope (x ± s, n=10)
Figure G2010100343588D00032
Annotate: T check between group, compare with model group: *P<0.05, *P<0.01, compare with the Radix Notoginseng group: #p<0.05, compare with Radix Paeoniae Alba group: a p<0.05, aa p<0.01 ##p<0.01.
Shown after the two herbal medicine use in conjunction, aspect the treatment cardiac-cerebral ischemia obvious synergistic effect is being arranged by above-mentioned drug efficacy study, its pharmacological action all is better than the Radix Notoginseng and the Radix Paeoniae Alba, significant difference, and then explanation the present invention has tangible cardiovascular and cerebrovascular diseases effect.
The specific embodiment
Embodiment 1
Get Radix Notoginseng 1500g, Radix Paeoniae Alba 1500g, add 8 times of water gagings, merge decoction 3 times, each 2 hours, merging filtrate concentrated, vacuum drying, and adding starch is an amount of, granulates, and incapsulates (1000), promptly gets product.
Embodiment 2
Get Radix Notoginseng 1000g, Radix Paeoniae Rubra 2000g, add 8 times of amount 70% ethanol respectively, decoct 3 times, each 2 hours, merge extractive liquid, concentrated, drying, and adding starch and dextrin are an amount of, granulate, and tabletting (1000) promptly gets product.
Embodiment 3
Get Radix Notoginseng 2000g, add 8 times of water gagings earlier and decocted 1 hour, filter, add Radix Paeoniae Alba 1000g again, add water 6000ml again, decoct 2 times, each 2 hours, merging filtrate concentrated, and filters, and adds flavoring agent etc., and fill (1000) promptly gets product.
Embodiment 4
Get Radix Notoginseng 2500g, Radix Paeoniae Alba 500g, add 8 times of water gagings and decoct 2 times, each 1.5h, merge extractive liquid,, last AB-8 macroporous adsorbent resin, 2 column volumes of first water eluting, 3 column volumes of reuse 95% ethanol elution, merge ethanol elution, concentrate drying, it is an amount of to add starch, granulate, incapsulate (500), promptly get product.
Case study on implementation 5
Adopt patent products obtained therefrom of the present invention (prepared tablet in the embodiment 1), once clinical treatment and observe case history 200 examples (wherein male 121 examples, women 79 examples, 55.8 years old mean age, course of disease 2-18).Diagnostic criteria: by angina pectoris diagnostic criteria and national coronary heart disease traditional Chinese medical science typing standard of working out in 1980 of whole nation revision in 1979.Observation index: the Total Test patient is coronarography, recording blood pressure, the rhythm of the heart before treatment, checks blood, routine urinalysis, blood fat, liver, renal function and platelet count, makees conventional leads electrocardiogram and rabat, measures surface activity of blood platelet and aggregation.Treatment finishes all above-mentioned projects of check of back.Therapeutic Method: oral 3 times of invention group (tablet) every day, each 2; Matched group is according to the explanation administration of taking medicine of corresponding medicine.Per 21 days is a course of treatment, takes medicine altogether two courses of treatment.Efficacy assessment standard: by the angina pectoris and the ECG curative effect evaluation criterion of whole nation revision in 1979.
Table 3 invention group and 3 matched group coronary heart disease curative effects are relatively
Figure G2010100343588D00041
Figure G2010100343588D00051

Claims (6)

1. drug regimen and preparation method thereof is characterized in that: calculate according to components by weight percent, it is to be made for 99~1 parts with the Radix Paeoniae Alba (or Radix Paeoniae Rubra) by 1~99 part of Radix Notoginseng.
2. a kind of drug regimen as claimed in claim 1 and preparation method thereof is characterized in that: calculate according to components by weight percent, it is to be made for 90~10 parts with the Radix Paeoniae Alba by 10~90 parts of Radix Notoginseng, perhaps is made for 90~10 parts with Radix Paeoniae Rubra by 10~90 parts of Radix Notoginseng.
3. a kind of drug regimen as claimed in claim 1 or 2 and preparation method thereof, it is characterized in that: this drug regimen adopts conventional extracting method, comprise backflow, percolation, warm macerating etc., it both can be united extraction, also can be independent extraction, can also take to extract separately earlier the method for back united extraction; Extract solvent and comprise water and Different concentrations of alcohol.After the extraction, extracting solution or refining or not refining.
4. a kind of drug regimen as claimed in claim 1 or 2 and preparation method thereof, it is characterized in that: preparation of the present invention is the preparation that allows on the pharmaceuticss such as injection and oral formulations.Injection comprises liquid drugs injection and powder pin etc.; Oral formulations comprises all acceptable dosage forms on other pharmaceuticss such as tablet, dispersible tablet, effervescent tablet, oral cavity disintegration tablet, capsule, soft capsule, granule.
5. a kind of drug regimen as claimed in claim 3 and preparation method thereof, it is characterized in that: the extraction solvent volume is 4~20 times of medical material, extraction time is 1~5 time, and extraction time is 0.5~3.0 hour, can proper extension to 72 hour as adopting diafiltration or warm macerating extraction time; Process for purification comprises solvent extraction, water precipitating, precipitate with ethanol, membrane filtration, macroporous adsorbent resin separation, polyamide separation etc., and other unites use at one or more of industrial operable process for purification.
6. a kind of drug regimen as claimed in claim 1 and preparation method thereof is characterized in that: this drug regimen is mainly used in cardio-cerebralvascular diseases such as treatment coronary heart disease, angina pectoris, arrhythmia, cerebral ischemia, myocardial ischemia.
CN 201010034358 2010-01-20 2010-01-20 Medicinal composition and preparation method thereof Pending CN102125607A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103223047A (en) * 2013-05-21 2013-07-31 卫斌 Medicine for treating hyperlipemia and preparation method thereof
CN105079436A (en) * 2015-09-07 2015-11-25 上海善力健生物科技有限公司 Biological agent with myocardial ischemia prevention and treatment function and anti-hypoxia function and preparation method of biological agent

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103223047A (en) * 2013-05-21 2013-07-31 卫斌 Medicine for treating hyperlipemia and preparation method thereof
CN105079436A (en) * 2015-09-07 2015-11-25 上海善力健生物科技有限公司 Biological agent with myocardial ischemia prevention and treatment function and anti-hypoxia function and preparation method of biological agent

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Application publication date: 20110720