CN1279919C - Pharmaceutical compositions containing ginsenoside, safflor yellow and its preparation and application - Google Patents
Pharmaceutical compositions containing ginsenoside, safflor yellow and its preparation and application Download PDFInfo
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- CN1279919C CN1279919C CN 200410058102 CN200410058102A CN1279919C CN 1279919 C CN1279919 C CN 1279919C CN 200410058102 CN200410058102 CN 200410058102 CN 200410058102 A CN200410058102 A CN 200410058102A CN 1279919 C CN1279919 C CN 1279919C
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Abstract
The present invention discloses a pharmaceutical composition containing ginsenoside and safflor yellow pigment, preparation thereof and an application thereof. The present invention is characterized in that the pharmaceutical composition is prepared from the ginsenoside which is an extracted and purified effective part of ginseng, and safflor yellow pigments which is an effective part of safflower, and pharmaceutical adjuvants. The pharmaceutical composition is prepared into various pharmaceutically acceptable preparations for treating cardio-cerebrovascular diseases, such as solid preparations and injection preparations. The result of pharmacological experiments indicates that the pharmaceutical composition preparation overcomes hemorrhage danger caused by using the safflower applied for a long term, has obvious effects for reducing the adverse reaction of safflower preparations, is safe to use. As compared with the same type of medicine sold in the market, the pharmaceutical composition has good pharmacological action and high safety.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of pharmaceutical composition and preparation and application that contains Radix Ginseng total saponins, Carthamus yellow
Background technology
Flos Carthami CarthamustinctorinsL. is 1 year this plant of SHENGCAO of Compositae, its dry tubular flower is a conventional Chinese medicine simply, has the effect of promoting blood circulation to remove obstruction in the collateral, stasis-dispelling and pain-killing, is commonly used to treat metremia clinically, disease such as cardiovascular, thrombosis is also made pain relieving, antiinflammatory; Flos Carthami injection is to be that raw material extracts the injection made from the Flos Carthami, effect with blood circulation promoting and blood stasis dispelling, the clinical obliterated cerebral vascular disease that is used for the treatment of, coronary heart disease, vasculitis. according to relevant bibliographical information, 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.″。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.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; Because the Flos Carthami preparation has good activating blood circulation to dissipate blood stasis function, in treatment cardiovascular and cerebrovascular disease clinical, use very extensively, the patient suffering has made significant contribution for releasing; But in the long-term clinical application process, find that also the Flos Carthami preparation is in activating blood circulation to dissipate blood stasis, particularly prolonged application easily causes the human body bleeding, relevant report such as Fujian Chinese medicine the 33rd the 2nd phase of volume of April in 2002, Flos Carthami untoward reaction clinically, these untoward reaction not only make the patient be subjected to its hardship deeply, also make the doctor be difficult to hold in clinical practice.
Radix Ginseng is one of genuine medicinal materials of abounding with of Changbaishan area, is used as medicine with its root, has good actions such as " strongly invigorating primordial QI promote the production of body fluid admittedly take off, the Fructus Alpiniae Oxyphyllae of calming the nerves ", is famous valuable ingredient of Chinese medicine.Radix Ginseng has better curative effect for diseases such as hemorrhage, shock, heart failure, can use the Radix Ginseng strongly invigorating primordial QI, saves collapse, reaches QI invigorating to hold up arteries and veins, strengthens the effect of patient's body constitution.
Summary of the invention
For these reasons, the present invention is under Chinese medical theory instructs, in conjunction with the clinical practice experience, dispel when becoming silted up, note the conditioning of edema caused by disorder of QI, making it battalion and defend mediation. the side adopts the modern pharmaceutical technology to extract purification Radix Ginseng effective site ginsenoside and Flos Carthami effective site Carthamus yellow with Radix Ginseng, Flos Carthami, is mixed with into solid preparation, the ejection preparation of treatment cardiovascular and cerebrovascular disease with pharmaceutic adjuvant.Adopt ginsenoside's compatibility Carthamus yellow treatment cardiovascular and cerebrovascular disease, remove the tissue regeneration promoting that becomes silted up when can play removing blood stasis, strengthen patient's body constitution, reinforcing body resistance reaches and invigorates blood circulation and not random blood, QI invigorating and do not help the purpose of heresy.
The present invention is achieved by the following scheme.
One. process recipes
The raw medicinal material that the present invention uses is:
Flos Carthami 4-6 weight portion, Radix Ginseng 1-2 weight portion;
1. the preparation of Carthamus yellow: get Flos Carthami, add water 20-60 doubly, transferring pH value with acid is 2.0-5.0, steaming and decocting 1-3 hour, extract 1-4 time with this condition, merging filtrate, the 3-4 that is concentrated into medical material weight doubly, last D101 type macroporous adsorptive resins, wash with water to colourless, the eluent concentrating under reduced pressure, drying obtains Carthamus yellow;
2. ginsenoside's preparation: get the Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with 50%-80% ethanol extraction 1-3 hour, extract 4-8 time, extracting solution filters and merges, and reclaims ethanol to most, residue after the extraction is standby, the ratio that extracting solution adds water to medical material and medicinal liquid is 1: 1, leaves standstill, and is centrifugal, last D-101 type macroporous adsorptive resins, earlier with the distillation washing, be 3-5 times of column volume with distilled water, water liquid discards, reuse 50%-80% ethanol elution, eluting ethanol is 2-6 times of column volume, and eluent reclaims ethanol to dry to the greatest extent, pulverizing, promptly gets the ginsenoside.
3. respectively organizing the raw material prescription of preparation forms:
(1) tablet consists of: Carthamus yellow 100-180 weight portion, and ginsenoside 40-60 weight portion, pharmaceutic adjuvant are the 160-260 weight portion;
(2) capsule consists of: Carthamus yellow 100-180 weight portion, and ginsenoside 40-60 weight portion, pharmaceutic adjuvant are the 160-260 weight portion;
(3) aqueous injection consists of: Carthamus yellow 100-180 weight portion, ginsenoside 40-60 weight portion.
(4) infusion solution consists of: Carthamus yellow 100-180 weight portion, ginsenoside 40-60 weight portion.
(5) injectable powder consists of: Carthamus yellow 100-180 weight portion, ginsenoside 40-60 weight portion, pharmaceutic adjuvant are the 60-160 weight portion.
4. the preparation of solid preparation: the preparation of tablet: get Carthamus yellow, ginsenoside and pharmaceutic adjuvant mix homogeneously, pulverize,
Sieve, granulate, dry, tabletting, test, packing both.
The preparation of capsule: get Carthamus yellow, ginsenoside and pharmaceutic adjuvant mix homogeneously pulverize, sieve, granulate, dry, encapsulated, test, packing both.
5. the preparation of ejection preparation: the preparation of hydro-acupuncture preparation: get Carthamus yellow, ginsenoside,, transfer pH value 5-8, filter, sterilization, check, preparation hydro-acupuncture preparation with meglumine with the water for injection dissolving.
The preparation of infusion preparation: get Carthamus yellow, ginsenoside,, add glucose, transfer pH value 5-8, filter with meglumine with the water for injection dissolving, sterilization, check is prepared into infusion preparation.
The preparation of powder injection formulation: get Carthamus yellow, ginsenoside,, add excipient, use the 0.22um filtering with microporous membrane with the water for injection dissolving, drying, check is packaged to be powder injection formulation.
Medicinal adjuvant is one or more a mixture of starch, glucose or magnesium stearate in the preparation of solid preparation.
Excipient is a kind of of mannitol or sucrose or lactose in the powder injection formulation preparation.
Two. check and analysis
The present invention is respectively organized preparation carry out check and analysis
1. the content of spectrophotometry Carthamus yellow
Experiment medicine: the ejection preparation (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides, and solid bosom friend, entry needle preparation and Flos Carthami injection are processed into the solution of equal densities) of respectively organizing of the present invention
Commercially available Flos Carthami injection (Sichuan Sanjiu Pharmaceutical Industry Co., Ltd., Ya'an City)
S-A Hydroxysafflor yellow A (providing) by Shenyang Pharmaceutical University crude drug chamber
Experimental technique: get the present invention respectively and respectively organize ejection preparation and Flos Carthami injection, use acid extraction respectively 3 times, get its water extract, remove magazine with the polyamide method, through the separation and purification of sephadexLH-20 gel filtration chromatography, recrystallization gets chemical compound.
By analysis, it is as shown in table 1 to obtain data:
2. the check and analysis of Radix Ginseng total saponins
Experiment medicine: of the present inventionly respectively organize ejection preparation (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides, and solid preparation, injection and Flos Carthami injection are processed into the solution of equal densities.)
Commercially available Flos Carthami injection (Sichuan Sanjiu Pharmaceutical Industry Co., Ltd., Ya'an City)
Experimental technique:
The check and analysis of Radix Ginseng total saponins
According to the method check and analysis of check and analysis Radix Ginseng total saponins among the WS3-B-3809-98,, see Table 1 through calculating Radix Ginseng total saponins (in the ginsenoside Re's) content:
Table 1 is respectively organized ejection preparation content relatively
| Group | Carthamus tinctorius yellow color content mg/ ampoule | Radix Ginseng total saponins mg/ ampoule |
| Flos Carthami injection tablet of the present invention | 2.72 7.89 | - 35.91. |
| Capsule of the present invention aqueous injection of the present invention infusion solution of the present invention injectable powder of the present invention | 7.91 3.96 3.91 3.94 | 36.02 18.26 18.31 18.06 |
Conclusion: by above check and analysis, we can learn that the content of ginsenoside's content and Flos Carthami flavochrome organizes respectively in the present invention that content improves greatly in the preparation, prove absolutely that technology of the present invention has practical significance.(annotate: oral solid formulation, because the reason of blood drug level, each dose is 2 times of ejection preparation)
Three. pharmacology embodiment
Embodiment 1
The pharmacological evaluation of mice bleeding time and amount of bleeding
Experiment medicine: preparation (Qianluchun Science and Technology Co., Ltd., Beijing provides) commercially available Flos Carthami injection (Sichuan Sanjiu Pharmaceutical Industry Co., Ltd., Ya'an City) normal saline (Qianluchun Science and Technology Co., Ltd., Beijing provides) of respectively organizing of the present invention
Laboratory animal: the Swiss mice is bought by laboratory animal portion of Beijing University of Chinese Medicine.
Method and result: get 50 mices, body weight 20 ± 2g, male and female half and half are divided equally 5 groups at random.
Ejection preparation and Flos Carthami injection of the present invention is pressed 5g/kg and is given the mouse tail vein administration, and 1 time/d, continuous 30d, matched group gives the equivalent normal saline.1h behind the last medicine drives in mice in the special holder, cuts off the about 3mm of Mus tail point then, treats that blood overflows voluntarily, inhales gently to dehematize with filter paper every 30s and drips.With artificial formation wound surface to stopped bleeding institute through the time as the bleeding time, the bloodstain area of measuring filter paper with 1mm * 1mm * 1mm lattice is an amount of bleeding.The results are shown in Table 2: animal grouping and dosage and natural law are the same, and 1h gets the blood that is about 5cm with capillary glass-tube (internal diameter is 1mm, uniformity) behind the last medicine behind left socket of the eye, every fracture one little section of capillary glass-tube of 30s, check blood clotting silk phenomenon whether occurs then.Record is taken a blood sample to from the capillary glass-tube and the blood clotting silk time occurred as the blood clotting time.Extract the opposite side eyeball simultaneously, drip 2 respectively and bleed in the slide two ends of cleaning, the drop of blood diameter is about about 5mm, and till the 30s examination was provoked blood 1 time with dry syringe needle, can be provoked fiber protein yarn to syringe needle, the record blood clotting time saw Table 2:
Table 2 is respectively organized the comparison of preparation to mice bleeding time and amount of bleeding
| Group | Bleeding time (s) | Amount of bleeding (mm 3) |
| The commercially available Flos Carthami injection of normal saline aqueous injection of the present invention infusion solution of the present invention injectable powder of the present invention | 179.7±14.1 203.4±12.9** 182.7±10.4*# 184.1±11.0*# 183.5±11.1*# | 67.1±10.1 97.1±8.6** 73.6±5.2*# 73.1±4.3*# 72.9±5.0*# |
Compare with the normal saline group: * * P＜0.01, compare with positive control: * P＜0.05 #P＞0.05
Conclusion: we can learn that the pharmaceutical preparation of Carthamus yellow and the preparation of ginsenoside's compatibility can effectively stop bleeding to take place by this pharmacological evaluation.
Embodiment 2
Utilize the thrombosis method to measure the present invention and respectively organize preparation and commercially available Flos Carthami injection the thrombotic influence of rat.
The experiment medicine: normal saline (blank group) is provided by Qianluchun Science and Technology Co., Ltd., Beijing's laboratory.
Commercially available Flos Carthami injection (Sichuan Sanjiu Pharmaceutical Industry Co., Ltd., Ya'an City)
The present invention respectively organizes preparation (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides)
50 of the rat of laboratory animal: body weight 300-400 gram, male and female are regardless of.Be divided into 5 groups, 10 every group.
Experimental technique: with rat anesthesia (pentobarbital sodium 30-40mg/kg, ip), dorsal position is fixed, separate trachea, insert a plastic bushing, and separation right common carotid artery and left external jugular vein, 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, after an end of polyethylene tube inserts left external jugular vein, inject anticoagulant heparin accurately by polyethylene tube, and then the other end of polyethylene tube inserted right common carotid artery, and open bulldog clamp, blood flow to polyethylene tube from right common carotid artery, return left external jugular vein, open blood flow Herba Clinopodii after 15 minutes takes out silk thread rapidly and weighs, and gross weight deducts silk thread weight and promptly gets thrombus weight.The animal wet weight of thrombus of blank group and other 5 groups of administration groups is carried out record, calculate, as shown in table 3:
Table 3 is respectively organized the comparison of preparation wet weight of thrombus
| Group | Wet weight of thrombus (mg) |
| The commercially available Flos Carthami injection of normal saline liquid drugs injection the present invention of the present invention injectable powder of the present invention of infusing | 1.92±0.36 1.03±0.24** 0.62±0.02**[*] 0.61±0.02**[*] 0.59±0.03**[*] |
Compare * * P＜0.01 with the blank group, compare [*] P＜0.05 with positive controls
Embodiment 3
Utilization is measured the present invention in body-centered flesh infarction method and is respectively organized the influence to rat myocardial infarction situation of preparation and commercially available Flos Carthami injection.
Experiment medicine: commercially available Flos Carthami injection (Sichuan Sanjiu Pharmaceutical Industry Co., Ltd., Ya'an City)
The present invention respectively organizes preparation (Qianluchun Science and Technology Co., Ltd., Beijing's laboratory provides)
Laboratory animal: 60 of male rat 250-300 grams are divided into 6 groups.
Experimental technique: get 60 of male rats, after the urethane 0.65g/kg abdominal cavity light anaesthesia, back of the body position is fixing, be connected to artificial respirator with more than half rubber bulb, practice artificial respiration, rat chest unhairing, sterilization, cut about 2 centimetres of skin along left mid-clavicular line, separate basic unit in the 4th or the 5th intercostal passivity, open the thoracic cavity, cut off pericardium, the light right side thorax of pressing, extrude heart, after Coronary vein place joint is pricked left coronary artery between arterial cone and the left auricle, heart is put back to the thoracic cavity, sew up the thoracic cavity rapidly, stop the artificial respiration, with each group preparation 10 rats are experimentized respectively, it is as shown in table 4 to obtain data computation:
The pharmacology that table 4 is respectively organized preparation compares
| Group | Obvious effective rate % | Effective percentage % | Inefficiency % | Total effective rate % |
| Commercially available Flos Carthami injection liquid drugs injection the present invention of the present invention injectable powder of the present invention of infusing | 25.3 29.6 29.1 30.3 | 54.2 59.1 59.0 60.4 | 20.7 11.3 11.9 9.3 | 79.3 88.7 88.1 90.7 |
Conclusion: by above pharmacological evaluation, the present invention respectively organizes preparation and has stronger pharmacological action than commercially available similar preparation.
Experimental technique according to pharmacological evaluation 1,2,3 carries out the experiment of safflower yellow tablet and solid preparation of the present invention, and experimental result sees Table 5,6,7.
Table 5 is respectively organized the comparison of preparation to mice bleeding time and amount of bleeding
| Group | Bleeding time (s) | Amount of bleeding (mm 3) |
| Normal saline safflower yellow tablet tablet of the present invention capsule of the present invention | 181.6±13.8 209.8±12.1** 184.1±10.1*# 185.0±10.2*# | 71.1±11.4 99.1±8.8** 74.1±5.8*# 74.3±4.1*# |
Compare with the normal saline group: * * P＜0.01, compare with positive control: * P＜0.05 #P＞0.05
Conclusion: we can learn that the pharmaceutical preparation of Carthamus yellow and the preparation of ginsenoside's compatibility can effectively stop bleeding to take place by this pharmacological evaluation.
Table 6 is respectively organized the comparison of preparation wet weight of thrombus
| Group | Wet weight of thrombus (mg) |
| Normal saline safflower yellow tablet tablet of the present invention capsule of the present invention | 2.01±0.41 1.46±0.36** 0.91±0.10**[*] 0.90±0.10**[*] |
Compare * * P＜0.01 with the blank group, compare [*] P＜0.05 with positive controls
The pharmacology that table 4 is respectively organized preparation compares
| Group | Obvious effective rate % | Effective percentage % | Inefficiency % | Total effective rate % |
| Safflower yellow tablet tablet of the present invention capsule of the present invention | 21.3 25.6 26.1 | 50.2 54.9 55.0 | 28.5 19.5 18.9 | 71.5 80.5 81.1 |
Conclusion: by above pharmacological evaluation, the present invention respectively organizes preparation and has stronger pharmacological action than commercially available similar preparation.
Four. preparation embodiment
Embodiment 1
The raw medicinal material that the present invention uses is: Flos Carthami 2000 grams, Radix Ginseng 500 grams;
(1) preparation of Carthamus yellow: get Flos Carthami, add 20 times in water, transferring pH value with acid is 2.0, steaming and decocting 1 hour, extract 1 time with this condition, merging filtrate is concentrated into 3 times of medical material weight, last D101 type macroporous adsorptive resins, wash with water to colourless, the eluent concentrating under reduced pressure, drying obtains Carthamus yellow;
(2) ginsenoside's preparation: get the Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with 50% ethanol extraction 1 hour, extract 4 times, extracting solution filters and merges, and reclaims ethanol to most, residue after the extraction is standby, the ratio that extracting solution adds water to medical material and medicinal liquid is 1: 1, leaves standstill, and is centrifugal, last D-101 type macroporous adsorptive resins, earlier with the distillation washing, be 3 times of column volume with distilled water, water liquid discards, reuse 50% ethanol elution, eluting ethanol is 2 times of column volume, and eluent recovery ethanol both got the ginsenoside to dry to the greatest extent, pulverizing.
(3) preparation of solid preparation:
The preparation of tablet: Carthamus yellow 100 grams, ginsenoside's 40 grams, pharmaceutic adjuvant starch and glucose are 260 grams.Mix homogeneously is pulverized, sieves, is granulated, dry, tabletting, test, packing both 1000.
The preparation of capsule: Carthamus yellow 100 gram, ginsenoside's 40 grams, pharmaceutic adjuvant starch and glucose are 260 grams, mix homogeneously pulverizes, sieves, granulates, dry, encapsulated, tests, and packs and promptly gets 1000.
(4) preparation of ejection preparation:
The preparation of hydro-acupuncture preparation: get Carthamus yellow 100 grams, ginsenoside's 40 grams,, transfer pH value 5, filter, sterilization, check, 1000 of preparation hydro-acupuncture preparations with meglumine with the water for injection dissolving.
The preparation of infusion preparation: get Carthamus yellow 100 grams, ginsenoside's 40 grams,, add glucose, transfer pH value 5, filter with meglumine with the water for injection dissolving, sterilization, check is prepared into 500 bottles of infusion preparations.
The preparation of powder injection formulation: get Carthamus yellow 100 grams, ginsenoside's 40 grams,, add excipient mannitol 160 grams, use the 0.22um filtering with microporous membrane with the water for injection dissolving, drying, check is packaged to be 1000 of powder injection formulations.
Embodiment 2
The raw medicinal material that the present invention uses is: Flos Carthami 3000 grams, Radix Ginseng 1000 grams;
(1) preparation of Carthamus yellow: get Flos Carthami, add 60 times in water, transferring pH value with acid is 5.0, steaming and decocting 3 hours, extract 4 times with this condition, merging filtrate is concentrated into 4 times of medical material weight, last D101 type macroporous adsorptive resins, wash with water to colourless, the eluent concentrating under reduced pressure, drying obtains Carthamus yellow;
(2) ginsenoside's preparation: get the Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with 80% ethanol extraction 3 hours, extract 8 times, extracting solution filters and merges, and reclaims ethanol to most, residue after the extraction is standby, the ratio that extracting solution adds water to medical material and medicinal liquid is 1: 1, leaves standstill, and is centrifugal, last D-101 type macroporous adsorptive resins, earlier with the distillation washing, be 5 times of column volume with distilled water, water liquid discards, reuse 80% ethanol elution, eluting ethanol is 6 times of column volume, and eluent recovery ethanol both got the ginsenoside to dry to the greatest extent, pulverizing.
(3) preparation of solid preparation:
The preparation of tablet: Carthamus yellow 180 grams, ginsenoside's 60 grams, pharmaceutic adjuvant starch are 160 grams.Mix homogeneously is pulverized, sieves, is granulated, dry, tabletting, test, packing both 1000.
The preparation of capsule: Carthamus yellow 180 gram, ginsenoside's 60 grams, pharmaceutic adjuvant starch are 140 grams, mix homogeneously pulverizes, sieves, granulates, dry, encapsulated, tests, and packs and promptly gets 1000.
(4) preparation of ejection preparation:
The preparation of hydro-acupuncture preparation: get Carthamus yellow 180 grams, ginsenoside's 60 grams,, transfer pH value 8, filter, sterilization, check, 1000 of preparation hydro-acupuncture preparations with meglumine with the water for injection dissolving.
The preparation of infusion preparation: get Carthamus yellow 180 grams, ginsenoside's 60 grams,, add glucose, transfer pH value 8, filter with meglumine with the water for injection dissolving, sterilization, check is prepared into 500 bottles of infusion preparations.
The preparation of powder injection formulation: get Carthamus yellow 180 grams, ginsenoside's 60 grams,, add excipient sucrose 60 grams, use the 0.22um filtering with microporous membrane with the water for injection dissolving, drying, check is packaged to be 1000 of powder injection formulations.
Embodiment 3
The raw medicinal material that the present invention uses is: Flos Carthami 25000 grams, Radix Ginseng 8000 grams;
(1) preparation of Carthamus yellow: get Flos Carthami, add 30 times in water, transferring pH value with acid is 3.0 steaming and decoctings 1.5 hours, extracts 2 times merging filtrate with this condition, be concentrated into 3 times of medical material weight, last D101 type macroporous adsorptive resins washes to colourless the eluent concentrating under reduced pressure with water, drying obtains Carthamus yellow;
(2) ginsenoside's preparation: get the Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with 65% ethanol extraction 2 hours, extract 5 times, extracting solution filters and merges, and reclaims ethanol to most, residue after the extraction is standby, the ratio that extracting solution adds water to medical material and medicinal liquid is 1: 1, leaves standstill, and is centrifugal, last D-101 type macroporous adsorptive resins, earlier with the distillation washing, be 4 times of column volume with distilled water, water liquid discards, reuse 50%-80% ethanol elution, eluting ethanol is 4 times of column volume, and eluent recovery ethanol both got the ginsenoside to dry to the greatest extent, pulverizing.
(3) preparation of solid preparation:
The preparation of tablet: Carthamus yellow 1400 grams, ginsenoside's 500 grams, pharmaceutic adjuvant starch and magnesium stearate are 2100 grams.Mix homogeneously is pulverized, sieves, is granulated, dry, tabletting, test, packing both 10000.
The preparation of capsule: Carthamus yellow 1400 gram, ginsenoside's 50 grams, pharmaceutic adjuvant starch and magnesium stearate are 2100 grams, mix homogeneously pulverizes, sieves, granulates, dry, encapsulated, tests, and packs and promptly gets 10000.
(4) preparation of ejection preparation:
The preparation of hydro-acupuncture preparation: get Carthamus yellow 1400 grams, ginsenoside's 500 grams,, transfer pH value 6, filter, sterilization, check, 10000 of preparation hydro-acupuncture preparations with meglumine with the water for injection dissolving.
The preparation of infusion preparation: get Carthamus yellow 1400 grams, ginsenoside's 500 grams,, add glucose, transfer pH value 6, filter with meglumine with the water for injection dissolving, sterilization, check is prepared into 5000 of infusion preparations.
The preparation of powder injection formulation: get Carthamus yellow 1400 grams, ginsenoside's 500 grams,, add excipient lactose 1100 grams, use the 0.22um filtering with microporous membrane with the water for injection dissolving, drying, check is packaged to be 10000 of powder injection formulations.
Embodiment 4
The raw medicinal material that the present invention uses is: Flos Carthami 2600 grams, Radix Ginseng 850 grams;
(1) preparation of Carthamus yellow: get Flos Carthami, add 40 times in water, transferring pH value with acid is 4.0, steaming and decocting 2 hours, extract 3 times with this condition, merging filtrate is concentrated into 4 times of medical material weight, last D101 type macroporous adsorptive resins, wash with water to colourless, the eluent concentrating under reduced pressure, drying obtains Carthamus yellow;
(2) ginsenoside's preparation: get the Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with 65% ethanol extraction 3 hours, extract 4 times, extracting solution filters and merges, and reclaims ethanol to most, residue after the extraction is standby, the ratio that extracting solution adds water to medical material and medicinal liquid is 1: 1, leaves standstill, and is centrifugal, last D-101 type macroporous adsorptive resins, earlier with the distillation washing, be 5 times of column volume with distilled water, water liquid discards, reuse 65% ethanol elution, eluting ethanol is 5 times of column volume, and eluent recovery ethanol both got the ginsenoside to dry to the greatest extent, pulverizing.
(3) preparation of solid preparation:
The preparation of tablet: Carthamus yellow 165 grams, ginsenoside's 55 grams, pharmaceutic adjuvant starch, magnesium stearate and glucose are 180 grams.Mix homogeneously is pulverized, sieves, is granulated, dry, tabletting, test, packing both 1000.
The preparation of capsule: Carthamus yellow 165 gram, ginsenoside's 55 grams, pharmaceutic adjuvant starch, magnesium stearate and glucose are 180 grams, mix homogeneously pulverizes, sieves, granulates, dry, encapsulated, tests, and packs and promptly gets 1000.
(4) preparation of ejection preparation:
The preparation of hydro-acupuncture preparation: get Carthamus yellow 165 grams, ginsenoside's 55 grams,, transfer pH value 6.5, filter, sterilization, check, 1000 of preparation hydro-acupuncture preparations with meglumine with the water for injection dissolving.
The preparation of infusion preparation: get Carthamus yellow 165 grams, ginsenoside's 55 grams,, add glucose, add glucose, transfer pH value 6.5, filter with meglumine with the water for injection dissolving, sterilization, check is prepared into 500 bottles of infusion preparations.
The preparation of powder injection formulation: get Carthamus yellow 165 grams, ginsenoside's 55 grams,, add excipient mannitol 80 grams, use the 0.22um filtering with microporous membrane with the water for injection dissolving, drying, check is packaged to be 1000 of powder injection formulations.
Embodiment 5
The raw medicinal material that the present invention uses is: Flos Carthami 2800 grams, Radix Ginseng 900 grams;
(1) preparation of Carthamus yellow: get Flos Carthami, add 45 times in water, transferring pH value with acid is 3.5, steaming and decocting 2.5 hours, extract 4 times with this condition, merging filtrate is concentrated into 3 times of medical material weight, last D101 type macroporous adsorptive resins, wash with water to colourless, the eluent concentrating under reduced pressure, drying obtains Carthamus yellow;
(2) ginsenoside's preparation: get the Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with 75% ethanol extraction 1 hour, extract 8 times, extracting solution filters and merges, and reclaims ethanol to most, residue after the extraction is standby, the ratio that extracting solution adds water to medical material and medicinal liquid is 1: 1, leaves standstill, and is centrifugal, last D-101 type macroporous adsorptive resins, earlier with the distillation washing, be 5 times of column volume with distilled water, water liquid discards, reuse 50%-80% ethanol elution, eluting ethanol is 6 times of column volume, and eluent recovery ethanol both got the ginsenoside to dry to the greatest extent, pulverizing.
(3) preparation of solid preparation:
The preparation of tablet: Carthamus yellow 175 grams, ginsenoside's 58 grams, pharmaceutic adjuvant starch and magnesium stearate are 167 grams.Mix homogeneously is pulverized, sieves, is granulated, dry, tabletting, test, packing both 1000.
The preparation of capsule: Carthamus yellow 175 gram, ginsenoside's 58 grams, pharmaceutic adjuvant starch and magnesium stearate are 167 grams, mix homogeneously pulverizes, sieves, granulates, dry, encapsulated, tests, and packs and promptly gets 1000.
(4) preparation of ejection preparation:
The preparation of hydro-acupuncture preparation: get Carthamus yellow 175 grams, ginsenoside's 58 grams,, transfer pH value 7, filter, sterilization, check, 1000 of preparation hydro-acupuncture preparations with meglumine with the water for injection dissolving.
The preparation of infusion preparation: get Carthamus yellow 175 grams, ginsenoside's 58 grams,, add glucose, transfer pH value 7, filter with meglumine with the water for injection dissolving, sterilization, check is prepared into 500 bottles of infusion preparations.
The preparation of powder injection formulation: get Carthamus yellow 175 grams, ginsenoside's 58 grams,, add excipient mannitol 67 grams, use the 0.22um filtering with microporous membrane with the water for injection dissolving, drying, check is packaged to be 1000 of powder injection formulations.
Embodiment 6
The raw medicinal material that the present invention uses is: Flos Carthami 2600 grams, Radix Ginseng Rubra 850 grams;
(1) preparation of Carthamus yellow: get Flos Carthami, add 40 times in water, transferring pH value with acid is 4.0, steaming and decocting 2 hours, extract 3 times with this condition, merging filtrate is concentrated into 4 times of medical material weight, last D101 type macroporous adsorptive resins, wash with water to colourless, the eluent concentrating under reduced pressure, drying obtains Carthamus yellow;
(2) preparation of Radix Ginseng Rubra effective site: get the Radix Ginseng Rubra decoction pieces, put into the Chinese medicine multi-function extractor, with 65% ethanol extraction 3 hours, extract 4 times, extracting solution filters and merges, and reclaims ethanol to most, residue after the extraction is standby, the ratio that extracting solution adds water to medical material and medicinal liquid is 1: 1, leaves standstill, and is centrifugal, last D-101 type macroporous adsorptive resins, earlier with the distillation washing, be 5 times of column volume with distilled water, water liquid discards, reuse 65% ethanol elution, eluting ethanol is 5 times of column volume, and eluent recovery ethanol both got Radix Ginseng Rubra effective site to dry to the greatest extent, pulverizing.
(3) preparation of solid preparation:
The preparation of tablet: Carthamus yellow 165 grams, Radix Ginseng Rubra effective site 60 grams, pharmaceutic adjuvant starch, magnesium stearate and glucose are 175 grams.Mix homogeneously is pulverized, sieves, is granulated, dry, tabletting, test, packing both 1000.
The preparation of capsule: Carthamus yellow 165 gram, Radix Ginseng Rubra effective site 60 grams, pharmaceutic adjuvant starch, magnesium stearate and glucose are 175 grams, mix homogeneously pulverizes, sieves, granulates, dry, encapsulated, tests, and packs and promptly gets 1000.
(4) preparation of ejection preparation:
The preparation of hydro-acupuncture preparation: get Carthamus yellow 165 grams, Radix Ginseng Rubra effective site 60 grams,, transfer pH value 7.5, filter, sterilization, check, 1000 of preparation hydro-acupuncture preparations with meglumine with the water for injection dissolving.
The preparation of infusion preparation: get Carthamus yellow 165 grams, Radix Ginseng Rubra effective site 60 grams,, add glucose, add glucose, transfer pH value 7.5, filter with meglumine with the water for injection dissolving, sterilization, check is prepared into 500 bottles of infusion preparations.
The preparation of powder injection formulation: get Carthamus yellow 165 grams, Radix Ginseng Rubra effective site 60 grams,, add excipient mannitol 75 grams, use the 0.22um filtering with microporous membrane with the water for injection dissolving, drying, check is packaged to be 1000 of powder injection formulations.
Embodiment 7
The raw medicinal material that the present invention uses is: Flos Carthami 2800 grams, Radix Panacis Quinquefolii 900 grams;
(1) preparation of Carthamus yellow: get Flos Carthami, add 45 times in water, transferring pH value with acid is 3.5, steaming and decocting 2.5 hours, extract 4 times with this condition, merging filtrate is concentrated into 3 times of medical material weight, last D101 type macroporous adsorptive resins, wash with water to colourless, the eluent concentrating under reduced pressure, drying obtains Carthamus yellow;
(2) preparation of Radix Panacis Quinquefolii effective site: get the Radix Panacis Quinquefolii decoction pieces, put into the Chinese medicine multi-function extractor, with 75% ethanol extraction 1 hour, extract 8 times, extracting solution filters and merges, and reclaims ethanol to most, residue after the extraction is standby, the ratio that extracting solution adds water to medical material and medicinal liquid is 1: 1, leaves standstill, and is centrifugal, last D-101 type macroporous adsorptive resins, earlier with the distillation washing, be 5 times of column volume with distilled water, water liquid discards, reuse 50%-80% ethanol elution, eluting ethanol is 6 times of column volume, and eluent recovery ethanol both got Radix Panacis Quinquefolii effective site to dry to the greatest extent, pulverizing.
(3) preparation of solid preparation:
The preparation of tablet: Carthamus yellow 175 grams, Radix Panacis Quinquefolii effective site 51 grams, pharmaceutic adjuvant starch and magnesium stearate are 174 grams.Mix homogeneously is pulverized, sieves, is granulated, dry, tabletting, test, packing both 1000.
The preparation of capsule: Carthamus yellow 175 gram, Radix Panacis Quinquefolii effective site 51 grams, pharmaceutic adjuvant starch and magnesium stearate are 174 grams, mix homogeneously pulverizes, sieves, granulates, dry, encapsulated, tests, and packs and promptly gets 1000.
(4) preparation of ejection preparation:
The preparation of hydro-acupuncture preparation: get Carthamus yellow 175 grams, Radix Panacis Quinquefolii effective site 51 grams,, transfer pH value 5.5, filter, sterilization, check, 1000 of preparation hydro-acupuncture preparations with meglumine with the water for injection dissolving.
The preparation of infusion preparation: get Carthamus yellow 175 grams, Radix Panacis Quinquefolii effective site 51 grams,, add glucose, transfer pH value 5.5, filter with meglumine with the water for injection dissolving, sterilization, check is prepared into 500 bottles of infusion preparations.
The preparation of powder injection formulation: get Carthamus yellow 175 grams, Radix Panacis Quinquefolii effective site 51 grams,, add excipient mannitol 74 grams, use the 0.22um filtering with microporous membrane with the water for injection dissolving, drying, check is packaged to be 1000 of powder injection formulations.
Annotate: the preparation of respectively organizing among the preparation embodiment in this description is carried out long-term pharmacological evaluation, find that the preparation of respectively organizing of the present invention is having better curative effect aspect the treatment cardiovascular and cerebrovascular disease, does not find single bleeding that occurs with Flos Carthami.
Claims (8)
1. a pharmaceutical composition that is used for cardiovascular and cerebrovascular disease is characterized in that this pharmaceutical composition is by Carthamus yellow 100-180 weight portion, and ginsenoside 40-60 weight portion is formed.
2. the application of pharmaceutical composition as claimed in claim 1 in the medicine of preparation treatment cardiovascular and cerebrovascular disease.
3. pharmaceutical composition as claimed in claim 1 is characterized in that it being this pharmaceutical composition to be added pharmaceutic adjuvant make tablet, capsule, aqueous injection, infusion solution, injectable powder.
4. the preparation method of tablet in the pharmaceutical composition as claimed in claim 3 is characterized by: add Carthamus yellow 100-180 weight portion, ginsenoside 40-60 weight portion, pharmaceutic adjuvant are the 160-260 weight portion; Mix homogeneously is pulverized, sieves, is granulated, dry, tabletting, test, packing both, wherein pharmaceutic adjuvant is one or more of starch, glucose, magnesium stearate.
5. the preparation method of capsule is in the pharmaceutical composition as claimed in claim 3: add Carthamus yellow 100-180 weight portion, ginsenoside 40-60 weight portion, pharmaceutic adjuvant is the 160-260 weight portion, mix homogeneously pulverizes, sieves, granulates, dry, encapsulated, test, packing promptly.
6. the preparation method of aqueous injection agent in the pharmaceutical composition as claimed in claim 3 is characterized by: add Carthamus yellow 100-180 weight portion, ginsenoside 40-60 weight portion, with the water for injection dissolving, transfer pH value 5-8 with meglumine, filter, sterilization, hydro-acupuncture preparation is made in check.
7. the preparation method of infusion solution in the pharmaceutical composition as claimed in claim 3, it is characterized by: add Carthamus yellow 100-180 weight portion, ginsenoside 40-60 weight portion, with the water for injection dissolving, add glucose, transfer pH value 5-8 with meglumine, filter, sterilization, check is prepared into infusion preparation.
8. the preparation method of injectable powder in the pharmaceutical composition as claimed in claim 3, it is characterized by: Carthamus yellow 100-180 weight portion, ginsenoside 40-60 weight portion, excipient is the 60-160 weight portion, dissolves with water for injection, add excipient, use the 0.22um filtering with microporous membrane, drying, check, be packaged to be powder injection formulation, wherein excipient is mannitol, sucrose or lactose.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410058102 CN1279919C (en) | 2004-08-13 | 2004-08-13 | Pharmaceutical compositions containing ginsenoside, safflor yellow and its preparation and application |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410058102 CN1279919C (en) | 2004-08-13 | 2004-08-13 | Pharmaceutical compositions containing ginsenoside, safflor yellow and its preparation and application |
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| CN1602883A CN1602883A (en) | 2005-04-06 |
| CN1279919C true CN1279919C (en) | 2006-10-18 |
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| CN101049338B (en) * | 2006-04-05 | 2011-05-04 | 山西亚宝药业集团股份有限公司 | Composition of Chinese traditional medicine for treating cardiovascular disease and cerebrovascular disease |
| CN101474195B (en) * | 2008-12-24 | 2012-06-27 | 贵州信邦远东药业有限公司 | Medicament composition for treating cardiac and cerebral vascular disease |
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