CN1628685A - Medicine combination containing panax pseudo-ginseng saponin triol and preparation method thereof - Google Patents
Medicine combination containing panax pseudo-ginseng saponin triol and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicinal composition containing panax pseudo-ginseng saponin triol and preparation method thereof, which comprises mixing effective components of notoginseng triol saponin obtained from traditional Chinese medicine notoginseng with medicinal adjuvant, preparing solid preparation, injection. The composition is characterized by that, the content of panax ginseng saponin Rg1 in the notoginseng triol saponin is not lower than 65%, the panax ginseng saponin Re content is no less than 6%, the notoginseng saponin R1 content is no less than 11%. Pharmacological experiment has shown that each groups of the preparation have better pharmaceutical actions.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of pharmaceutical composition that contains protoparaxotriol saporlirs and preparation method thereof.
Technical background
Cardiovascular and cerebrovascular disease seizes 1,200 ten thousand people's life every year, near 1/4 of the dead sum of world population, become the No.1 formidable enemy of human health, the extensive scholar in island says among the Secretary General of The World Health Organization (WHO): " today in the world; cardiovascular and cerebrovascular disease kills more people than other any diseases, and millions upon millions of people are disabled." although the most countries of cardiovascular and cerebrovascular disease mortality rate except that East Bloc all has decline in various degree over nearly 30 years; it is still majority state primary cause of death of male more than 45 years old; in the women then is second cause of the death that is only second to tumor, is having a strong impact on human life expectancy and life quality.Along with social senilization and growth in the living standard, the sickness rate and the case fatality rate of cardiovascular and cerebrovascular disease rise day by day.Studies show that according to nearest one, comprise that in 8 major areas, the whole world investigation of both developed and developing country shows that ischemic heart desease and cerebrovascular disease have become the main cause of death.As in the U.S., cardiovascular disease far surpasses cancer, accounts for 42% of whole death, becomes underlying cause of death.In China, there are 1.1 hundred million people to suffer from cardiovascular and cerebrovascular diseases such as hypertension, arteriosclerosis approximately, 6,000 ten thousand people suffer from coronary heart disease, and 7,000 ten thousand people suffer from cerebral infarction or cerebral hemorrhage, and the philtrum more than 40 years old has 57% people to suffer from various degree cardiovascular and cerebrovascular disease approximately.Cardiovascular and cerebrovascular disease also becomes one of old people's common frdquently encountered disease, cerebrovascular disease especially, and prevalence is up to 491.8/10 ten thousand people, apparently higher than western countries.
Radix Notoginseng is a kind of rare Chinese medicine, has the effect of dissipating blood stasis hemostasis, subduing swelling and relieving pain, is used for hemostasis, analgesia and traumatic injury; Sanchi effective-component is a Radix Notoginseng total arasaponins, and Radix Notoginseng total arasaponins is divided into protoparaxotriol saporlirs, panasadiol saponio; Protoparaxotriol saporlirs is mainly the ginsenoside Rg
1, ginsenoside Re, Panax Notoginseng saponin R
1, belong to effective ingredient in Chinese, can be developed to the Chinese medicine new medicine; Through a large amount of experimentatioies, we adopt, and (literature method adopts the ethanol elution macroporous adsorbent resin of 55%-75% than literature method, obtaining Radix Notoginseng total arasaponins) the eluent concentration of alcohol is 40%, adopt high performance liquid chromatography control terminal point, enrichment effective site protoparaxotriol saporlirs, this method yield is higher, simple to operate, be easy to suitability for industrialized production; Tradition is used the root of Radix Notoginseng plant, experimental studies have found that through us, also contains a large amount of effective ingredient in the stem and leaf of Radix Notoginseng, in order to make full use of existing resource, we carry out extraction separation with Radix Notoginseng, stem and leaf when selecting raw medicinal material for use, the effective site that obtains is identical.
According to bibliographical information, protoparaxotriol saporlirs is the effective site of class treatment cardiovascular and cerebrovascular disease, consult document and patent, mostly be the treatment that utilizes Radix Notoginseng crude extract or total saponins to be used for cardiovascular and cerebrovascular disease, do not have the Chinese medicine preparation of patent report exploitation protoparaxotriol saporlirs to treat cardiovascular and cerebrovascular disease.
Summary of the invention
For these reasons, the present invention adopts ethanol extraction, the method of purification with macroreticular resin, obtain protoparaxotriol saporlirs, mix with pharmaceutic adjuvant, be prepared into tablet, capsule, aqueous injection, infusion solution, injectable powder, be used for the treatment of cardiovascular and cerebrovascular disease, pharmacological evaluation shows that the preparation of respectively organizing of the present invention has better pharmacological action.
The present invention is achieved through the following technical solutions.
One. process recipes
(1) gets Radix Notoginseng, pulverize, with 4-8 times of 70%-80% ethanol extraction 3-5 time, each 0.5-1 hour, merge extractive liquid, reclaimed ethanol to most, macroporous adsorptive resins on the concentrated solution, with 8-12 times of column volume washing, eluent discards earlier, 40% ethanol of reuse carries out eluting, high performance liquid chromatography control terminal point, enrichment eluent, reclaim ethanol to the greatest extent, concentrate drying, obtain protoparaxotriol saporlirs effective site, wherein ginsenoside Rg in the protoparaxotriol saporlirs
1Content be not less than 65%, ginsenoside Re's content is not less than 6%, Panax Notoginseng saponin R
1Content is not less than 11%, is this pharmaceutical composition.
(2) preparation prescription of the present invention is:
Tablet consists of protoparaxotriol saporlirs 80-120 weight portion, pharmaceutic adjuvant 80-120 weight portion, capsule consists of protoparaxotriol saporlirs 80-120 weight portion, pharmaceutic adjuvant 80-120 weight portion, aqueous injection consists of protoparaxotriol saporlirs 10-20 weight portion, and infusion solution consists of protoparaxotriol saporlirs 20-40 weight portion, pharmaceutic adjuvant 60-80 weight portion, injectable powder consists of protoparaxotriol saporlirs 10-20 weight portion, pharmaceutic adjuvant 80-90 weight portion;
(3) get Sanchi effective-component protoparaxotriol saporlirs and pharmaceutic adjuvant, be prepared into tablet, capsule according to the conventional method of tablet, capsule;
(4) get Sanchi effective-component, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains aqueous injection;
(5) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains infusion solution;
(6)) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant excipient, add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, the filtrate drying obtains injectable powder.The pharmaceutic adjuvant of tablet, capsule is one or more a mixture of starch, glucose, magnesium stearate.
The pharmaceutic adjuvant of infusion solution is a kind of of sodium chloride, glucose.
Excipient is one or more in mannitol, sucrose, the lactose in the preparation of powder injection formulation.
Two. check and analysis
Ginsenoside Rg in the effective site protoparaxotriol saporlirs
1, ginsenoside Re, Panax Notoginseng saponin R
1Content detection
Measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D).
Chromatographic condition: use octadecylsilane chemically bonded silica as filler; Second is fine-and water (20: 80) is mobile phase.
Reference substance solution preparation: the ginsenoside Rg who learnt from else's experience dry 24 hours
1, ginsenoside Re, Panax Notoginseng saponin R
1Reference substance is an amount of, accurate claims surely, adds mobile phase and is diluted to and contains the ginsenoside Rg among the 1ml
1, ginsenoside Re, Panax Notoginseng saponin R
1Be respectively 0.8,0.6,0.4 solution, promptly get reference substance solution.
The preparation of need testing solution: get the about 100mg of this product, the accurate title, decide, and puts in the 25ml volumetric flask, adds mobile phase and be diluted to scale, shakes up, and obtains need testing solution.
Assay method: precision is measured reference substance solution and need testing solution 10ul, injects high performance liquid chromatograph respectively, according to external standard method with calculated by peak area content, promptly.(testing three times)
Experimental result: see Table 1.
Content of effective in table 1 protoparaxotriol saporlirs
Experiment time ginsenoside Rg
1Meansigma methods ginsenoside Re's meansigma methods Radix Notoginseng soap is average
Content (%) content (%) the glycosides R of number
1(%) value
(％) (％) (％)
1 66.4 11.6 6.8
2 67.1 66.8 11.7 11.6 6.9 6.9
3 66.8 11.6 6.9
Conclusion: show ginsenoside Rg in the protoparaxotriol saporlirs of the present invention by the check and analysis experiment
1Content surpasses 65%, ginsenoside Re's content surpasses 11%, Panax Notoginseng saponin R
1Content surpass 6%, prove absolutely that technology of the present invention has practical significance.
Three. pharmacology embodiment
Embodiment 1
To the Acute Myocardial Ischemia in Rats protective effect
The experiment medicine: the present invention respectively organizes preparation (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides)
XUESAITONG PIAN (Daphne Pharmaceutical (Group) Co., Ltd.Yunnan)
XUESAITONG ZHUSHEYE (Kunming Medicine Group Stock Co., Ltd)
Normal saline (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides)
Laboratory animal: 60 of animal Wister rat, male, body weight (300 ± 20) g.
Experimental technique: the solid preparation gastric infusion, ejection preparation tail intravenously administrable once a day, is pressed
According to adult's dosage conversion rat dosage, successive administration three days is by literary composition
The ramus descendens anterior arteriae coronariae sinistrae of offering method ligation rat causes acute myocardial ischemia
Model.(1g/kg, ip) anesthesia separates common carotid artery to 20% urethane, and is parallel
Trachea is inserted art, connects animal respirator.Left side the 4th intercostal is opened breast, cuts off pericardium,
Separate ramus descendens anterior arteriae coronariae sinistrae, the ligation position is done in flat right auricle.Take out heart
Weigh ,-10 ℃ of freezing 30～50min, under the heart ligature, parallel crown
Ditch becomes 5 with the ventricle crosscut, behind the normal saline flushing, places pH value 8.0 phosphorus
The concentration of acid buffer preparation is 1% triphenyltetrazolium chloride (TTC)
In the solution, the 10min that in 38 ℃ of waters bath with thermostatic control, dyes, normal myocardium dyeing
Become kermesinus, infarcted myocardium is dyed lark, cuts off the part that myocardium sheet is colored,
The ischemic infarction district cardiac muscle that is not colored is weighed, calculate ischemia scope (ischemia stalk
Unleavened dough is long-pending to account for heavy whole-heartedly percentage ratio, the results are shown in Table 2, table 3.
Table 2 solid preparation is to the Acute Myocardial Ischemia in Rats protective effect
Group
The dirty infarction percentage rate of the dirty infarction center of gravity of heart center of gravity
(g) (g) (％)
Normal saline 0.985 0.213 21.6
XUESAITONG PIAN 0.976 0.154 15.8[
*]
Tablet 0.981 0.141 14.3 of the present invention
*
Capsule 0.976 0.140 14.4 of the present invention
*
Annotate: [
*] P＜0.05,
*P＜0.01
Table 3 ejection preparation is to the Acute Myocardial Ischemia in Rats protective effect
The dirty infarction percentage rate of the dirty infarction center of gravity of heart center of gravity
Group
(g) (g) (％)
Normal saline 0.986 0.216 21.9
XUESAITONG ZHUSHEYE 0.981 0.113 11.5
*[
*]
Aqueous injection 0.943 0.066 7.0 of the present invention
*[
*]
Infusion solution 0.952 0.062 6.5 of the present invention
*[
*]
Injectable powder 0.923 0.067 7.2 of the present invention
*[
*]
Annotate: compare with normal saline
*P＜0.01, compare with positive controls [
*] P＜0.05
Embodiment 2
Influence to rat suppository formation
The experiment medicine: the present invention respectively organizes preparation (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides)
XUESAITONG PIAN (Daphne Pharmaceutical (Group) Co., Ltd.Yunnan)
XUESAITONG ZHUSHEYE (Kunming Medicine Group Stock Co., Ltd)
Normal saline (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides)
Laboratory animal: 60 of animal Wister rat, male, body weight (300 ± 20) g.
Experimental technique: (pentobarbital sodium 30-40mg/kg, ip), dorsal position is solid with rat anesthesia
Fixed, separate trachea, insert a plastic bushing, and separate a right common carotid artery and a left side
External jugular vein is put into a long silk thread of 6 centimetres in the stage casing of polyethylene tube,
With heparin-saline solution, be full of polyethylene tube, when an end of polyethylene tube
After inserting left external jugular vein, inject anticoagulant heparin accurately by polyethylene tube, right
After again the other end of polyethylene tube is inserted right common carotid artery, open bulldog clamp,
Blood flow to polyethylene tube from right common carotid artery, returns left external jugular vein, and is open
Blood flow is Herba Clinopodii after 15 minutes, takes out silk thread rapidly and weighs, and gross weight deducts
Silk thread weight promptly gets thrombus weight.The animal thrombosis of blank group and administration group is wet
Heavily carry out record, calculate, see Table 4, table 5:
Table 4 solid preparation is to thrombotic influence
The number of animals wet weight of thrombus
Group
(only) (mg)
Normal saline 10 1.93
XUESAITONG PIAN 10 1.61[
*]
Tablet 10 1.30 of the present invention
*
Capsule 10 1.28 of the present invention
*
Annotate: [
*] P＜0.05,
*P＜0.01
Table 5 ejection preparation is to thrombotic influence
The number of animals wet weight of thrombus
Group
(only) (mg)
Normal saline 10 1.90
XUESAITONG ZHUSHEYE 10 1.01
*
Aqueous injection 10 0.75 of the present invention
*[
*]
Infusion solution 10 0.74 of the present invention
*[
*]
Injectable powder 10 0.70 of the present invention
*[
*]
Annotate: compare with normal saline
*P＜0.01, compare with positive controls [
*] P＜0.05
Conclusion: show that by above pharmacological evaluation the preparation of respectively organizing of the present invention has better pharmacological action.
Four. preparation embodiment
Embodiment 1
(1) gets dry Radix Notoginseng 10000 grams, pulverize, with 4 times of 70% ethanol extraction 3 times, each 0.5 hour, merge extractive liquid, reclaimed ethanol to most, D101 type macroporous adsorptive resins on the concentrated solution, with 8 times of column volume washings, eluent discards earlier, reuse 40% ethanol carries out eluting, high performance liquid chromatography control terminal point, enrichment eluent, eluent reclaims ethanol to most, concentrate, drying obtains protoparaxotriol saporlirs effective site.
(2) preparation prescription of the present invention is:
Tablet consists of protoparaxotriol saporlirs 80g, pharmaceutic adjuvant starch, glucose 120g, capsule consists of protoparaxotriol saporlirs 80g, pharmaceutic adjuvant starch, glucose 120g, aqueous injection consists of protoparaxotriol saporlirs 10g, and infusion solution consists of protoparaxotriol saporlirs 20g, pharmaceutic adjuvant sodium chloride 80g, injectable powder consists of protoparaxotriol saporlirs 10g, pharmaceutic adjuvant mannitol 90g;
(3) get Sanchi effective-component protoparaxotriol saporlirs and pharmaceutic adjuvant, be prepared into 1000 in tablet, 1000 of capsules according to the conventional method of tablet, capsule;
(4) get Sanchi effective-component, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains 1000 of aqueous injection;
(5) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains 1000 bottles of infusion solutions;
(6)) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant excipient, add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, the filtrate drying obtains 1000 bottles of injectable powder.
Embodiment 2
(1) gets dry stem and leaf of Radix Notoginseng 10000 grams, pulverize, with 8 times of 80% ethanol extraction 5 times, each 1 hour, merge extractive liquid, reclaimed ethanol to most, AB-8 type macroporous adsorptive resins on the concentrated solution, with 12 times of column volume washings, eluent discards earlier, reuse 40% ethanol carries out eluting, high performance liquid chromatography control terminal point, enrichment eluent, eluent reclaims ethanol to most, concentrate, drying obtains protoparaxotriol saporlirs effective site.
(2) preparation prescription of the present invention is:
Tablet consists of protoparaxotriol saporlirs 120 grams, pharmaceutic adjuvant starch, glucose, magnesium stearate 80 grams, capsule consists of protoparaxotriol saporlirs 120 grams, pharmaceutic adjuvant starch, glucose, magnesium stearate 80 grams, aqueous injection consists of protoparaxotriol saporlirs 20 grams, and infusion solution consists of protoparaxotriol saporlirs 40 grams, pharmaceutic adjuvant glucose 60 grams, injectable powder consists of protoparaxotriol saporlirs 20 grams, pharmaceutic adjuvant sucrose 80 grams;
(3) get Sanchi effective-component protoparaxotriol saporlirs and pharmaceutic adjuvant, be prepared into 1000 in tablet, 1000 of capsules according to the conventional method of tablet, capsule;
(4) get Sanchi effective-component, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains 1000 of aqueous injection;
(5) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains 1000 bottles of infusion solutions;
(6)) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant excipient, add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, the filtrate drying obtains 1000 bottles of injectable powder.
Embodiment 3
(1) gets dry Radix Notoginseng 10000 grams, pulverize, with 5 times of 75% ethanol extraction 4 times, each 0.6 hour, merge extractive liquid, reclaimed ethanol to most, NKA type macroporous adsorptive resins on the concentrated solution, with 9 times of column volume washings, eluent discards earlier, reuse 40% ethanol carries out eluting, high performance liquid chromatography control terminal point, enrichment eluent, eluent reclaims ethanol to most, concentrate, drying obtains protoparaxotriol saporlirs effective site.
(2) preparation prescription of the present invention is:
Tablet consists of protoparaxotriol saporlirs 90 grams, pharmaceutic adjuvant starch, magnesium stearate 110 grams, capsule consists of protoparaxotriol saporlirs 90 grams, pharmaceutic adjuvant starch, magnesium stearate 110 grams, aqueous injection consists of protoparaxotriol saporlirs 12 grams, and infusion solution consists of protoparaxotriol saporlirs 24 grams, pharmaceutic adjuvant sodium chloride 76 grams, injectable powder consists of protoparaxotriol saporlirs 12 grams, pharmaceutic adjuvant lactose 88 grams;
(3) get Sanchi effective-component protoparaxotriol saporlirs and pharmaceutic adjuvant, be prepared into 1000 in tablet, 1000 of capsules according to the conventional method of tablet, capsule;
(4) get Sanchi effective-component, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains 1000 of aqueous injection;
(5) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains 1000 bottles of infusion solutions;
(6) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant excipient, add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, the filtrate drying obtains 1000 bottles of injectable powder.
Embodiment 4
(1) gets dry stem and leaf of Radix Notoginseng 10000 grams, pulverize, with 6 times of 75% ethanol extraction 4 times, each 0.8 hour, merge extractive liquid, reclaimed ethanol to most, D101 type macroporous adsorptive resins on the concentrated solution, with 10 times of column volume washings, eluent discards earlier, reuse 40% ethanol carries out eluting, high performance liquid chromatography control terminal point, enrichment eluent, eluent reclaims ethanol to most, concentrate, drying obtains protoparaxotriol saporlirs effective site.
(2) preparation prescription of the present invention is:
Tablet consists of protoparaxotriol saporlirs 100 grams, pharmaceutic adjuvant glucose, magnesium stearate 100 grams, capsule consists of protoparaxotriol saporlirs 100 grams, pharmaceutic adjuvant glucose, magnesium stearate 100 grams, aqueous injection consists of protoparaxotriol saporlirs 15 grams, and infusion solution consists of protoparaxotriol saporlirs 30 grams, pharmaceutic adjuvant glucose 70 grams, injectable powder consists of protoparaxotriol saporlirs 15 grams, pharmaceutic adjuvant sucrose, lactose 85 grams;
(3) get Sanchi effective-component protoparaxotriol saporlirs and pharmaceutic adjuvant, be prepared into 1000 in tablet, 1000 of capsules according to the conventional method of tablet, capsule;
(4) get Sanchi effective-component, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains 1000 of aqueous injection;
(5) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains 1000 bottles of infusion solutions;
(6) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant excipient, add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, the filtrate drying obtains 1000 bottles of injectable powder.
Embodiment 5
(1) gets dry Radix Notoginseng 10000 grams, pulverize, with 7 times of 75% ethanol extraction 4 times, each 0.9 hour, merge extractive liquid, reclaimed ethanol to most, AB-8 type macroporous adsorptive resins on the concentrated solution, with 11 times of column volume washings, eluent discards earlier, reuse 40% ethanol carries out eluting, high performance liquid chromatography control terminal point, enrichment eluent, eluent reclaims ethanol to most, concentrate, drying obtains protoparaxotriol saporlirs effective site.
(2) preparation prescription of the present invention is:
Tablet consists of protoparaxotriol saporlirs 110 grams, pharmaceutic adjuvant starch, magnesium stearate 90 grams, capsule consists of protoparaxotriol saporlirs 110 grams, pharmaceutic adjuvant starch, magnesium stearate 90 grams, aqueous injection consists of protoparaxotriol saporlirs 18 grams, and infusion solution consists of protoparaxotriol saporlirs 36 grams, pharmaceutic adjuvant sodium chloride 64 grams, injectable powder consists of protoparaxotriol saporlirs 18 grams, pharmaceutic adjuvant mannitol, sucrose, lactose 82 grams;
(3) get Sanchi effective-component protoparaxotriol saporlirs and pharmaceutic adjuvant, be prepared into 1000 in tablet, 1000 of capsules according to the conventional method of tablet, capsule;
(4) get Sanchi effective-component, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains 1000 of aqueous injection;
(5) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains 1000 bottles of infusion solutions;
(6) get Sanchi effective-component protoparaxotriol saporlirs, pharmaceutic adjuvant excipient, add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, the filtrate drying obtains 1000 bottles of injectable powder.
Claims (4)
1. pharmaceutical composition that contains protoparaxotriol saporlirs is characterized in that it is prepared from by following method:
(1) get notoginseng decoction piece, pulverize, with 4-8 times of 70%-80% ethanol extraction 3-5 time, each 0.5-1 hour, merge extractive liquid, reclaimed ethanol to most;
(2) macroporous adsorptive resins on the concentrated solution, earlier with 8-12 times of column volume washing, eluent discards, and 40% ethanol of reuse carries out eluting, high performance liquid chromatography control terminal point, the enrichment eluent, reclaim ethanol to the greatest extent, concentrate drying, obtain protoparaxotriol saporlirs effective site, wherein ginsenoside Rg in the protoparaxotriol saporlirs
1Content be not less than 65%, ginsenoside Re's content is not less than 6%, Panax Notoginseng saponin R
1Content is not less than 11%, is this pharmaceutical composition.
2. according to the described pharmaceutical composition that contains panasadiol saponio of claim 1, wherein the Radix Notoginseng raw material is meant stem and leaf and the Radix Notoginseng of Radix Notoginseng.
3. macroporous adsorbent resin according to claim 1 is nonpolar or the low pole macroporous adsorbent resin.
4. a medicine for the treatment of cardiovascular and cerebrovascular disease is characterized in that it being that above-mentioned protoparaxotriol saporlirs is mixed with pharmaceutic adjuvant, makes tablet, capsule, aqueous injection, infusion solution or injectable powder:
(1) get protoparaxotriol saporlirs 80-120 weight portion, pharmaceutic adjuvant 80-120 weight portion is prepared into tablet, capsule according to the conventional method of tablet, capsule;
(2) get protoparaxotriol saporlirs 10-20 weight portion, add the dissolving of injection water fully, transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains aqueous injection;
(3) get protoparaxotriol saporlirs 20-40 weight portion, pharmaceutic adjuvant 60-80 weight portion adds the dissolving of injection water fully, and transferring pH value with meglumine is 5-8, uses the 0.22um filtering with microporous membrane, and filtrate is carried out fill, and check obtains infusion solution;
(4) get protoparaxotriol saporlirs 10-20 weight portion, pharmaceutic adjuvant excipient 80-90 weight portion adds the dissolving of injection water fully, uses the 0.22um filtering with microporous membrane, and the filtrate drying obtains injectable powder.
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100455291C (en) * | 2006-03-29 | 2009-01-28 | 广西梧州制药（集团）股份有限公司 | Notoginseng medicine composition for treating cardiac and cerebral vascular diseases |
| CN1919243B (en) * | 2005-08-24 | 2011-03-23 | 天津天士力制药股份有限公司 | Traditional medicine composition for treating cardiovascular and cerebrovascular diseases |
| CN1919248B (en) * | 2005-08-24 | 2011-04-27 | 天津天士力制药股份有限公司 | Traditional Chinese medicinal formulation for treating cardiovascular and cerebrovascular disease |
| CN1771978B (en) * | 2004-11-09 | 2011-06-08 | 成都华神集团股份有限公司制药厂 | Notoginseng triol-saponin composition and its preparation and use |
| CN1919252B (en) * | 2005-08-24 | 2011-09-21 | 天津天士力制药股份有限公司 | Medicine for treating cardiovascular and cerebrovascular disease |
| CN1919237B (en) * | 2005-08-24 | 2011-10-05 | 天津天士力制药股份有限公司 | Medicine for treating cardiovascular and cerebrovascular diseases |
| CN1919238B (en) * | 2005-08-24 | 2011-10-05 | 天津天士力制药股份有限公司 | Medicine for treating cardiovascular and cerebrovascular disease |
| CN101597314B (en) * | 2008-06-06 | 2012-01-04 | 北京本草天源药物研究院 | Preparation method of ginsenoside Rg1 |
| CN102988437A (en) * | 2011-09-19 | 2013-03-27 | 昆明制药集团股份有限公司 | Panaxtrial saponins chewable tablet and preparation method thereof |
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2004
- 2004-09-07 CN CN 200410073881 patent/CN1628685A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1771978B (en) * | 2004-11-09 | 2011-06-08 | 成都华神集团股份有限公司制药厂 | Notoginseng triol-saponin composition and its preparation and use |
| CN1919243B (en) * | 2005-08-24 | 2011-03-23 | 天津天士力制药股份有限公司 | Traditional medicine composition for treating cardiovascular and cerebrovascular diseases |
| CN1919248B (en) * | 2005-08-24 | 2011-04-27 | 天津天士力制药股份有限公司 | Traditional Chinese medicinal formulation for treating cardiovascular and cerebrovascular disease |
| CN1919252B (en) * | 2005-08-24 | 2011-09-21 | 天津天士力制药股份有限公司 | Medicine for treating cardiovascular and cerebrovascular disease |
| CN1919237B (en) * | 2005-08-24 | 2011-10-05 | 天津天士力制药股份有限公司 | Medicine for treating cardiovascular and cerebrovascular diseases |
| CN1919238B (en) * | 2005-08-24 | 2011-10-05 | 天津天士力制药股份有限公司 | Medicine for treating cardiovascular and cerebrovascular disease |
| CN100455291C (en) * | 2006-03-29 | 2009-01-28 | 广西梧州制药（集团）股份有限公司 | Notoginseng medicine composition for treating cardiac and cerebral vascular diseases |
| CN101597314B (en) * | 2008-06-06 | 2012-01-04 | 北京本草天源药物研究院 | Preparation method of ginsenoside Rg1 |
| CN102988437A (en) * | 2011-09-19 | 2013-03-27 | 昆明制药集团股份有限公司 | Panaxtrial saponins chewable tablet and preparation method thereof |
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