CN101721456A - Antiatherosclerotic Chinese traditional medicine for treating cardiovascular and cerebrovascular diseases and method for preparing phospholipid complex formulation thereof - Google Patents
Antiatherosclerotic Chinese traditional medicine for treating cardiovascular and cerebrovascular diseases and method for preparing phospholipid complex formulation thereof Download PDFInfo
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Abstract
The invention relates to an antiatherosclerotic Chinese traditional medicine for treating cardiovascular and cerebrovascular diseases, comprising the following components of szechuan lovage rhizome, the root of kudzu vine, Panax notoginsenosides and red yeast rice. The method for preparing phospholipid complex formulation of the antiatherosclerotic Chinese traditional medicincomprises (1) preparation of dry extract of the root of kudzu vine, (2) preparation of szechuan lovage rhizome oil and dry extract of Ligusticum wallichii and (3) preparation of formulation. By enriching effective parts of medicinal materials, the purity of effective components of the antiatherosclerotic Chinese traditional medicine is enhanced greatly, thereby meeting the request of formulation. The invention is formed by trial of medicinal effectiveness separation and innovation of the medicine and realizes organic combination of traditional formulation process and modern pharmaceutical technology, thereby not only enhancing medicine-loading rate but also enhancing bioavailability of medicine used by a human body.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof, refer in particular to and to treat cardiovascular and cerebrovascular disease and antiatherogenic Chinese medicine preparation, be specially a kind of Chinese medicine of atherosclerosis treatment cardiovascular and cerebrovascular disease and the preparation method of phospholipid complex formulation thereof.
Background technology
Current society is because the quickening of rhythm of life, and unhealthy life style is popular, and the cardiovascular and cerebrovascular disease sickness rate rises year by year, and the trend of rejuvenation is arranged, prevalence, disability rate and the highest disease of mortality rate have been become, serious health that is threatening people and life.Therefore controlling spreading of cardiovascular and cerebrovascular disease becomes the task of top priority.The main inducing of cardiovascular and cerebrovascular disease is an atherosclerosis, in case atherosclerosis has taken place, As time goes on be easy to take place cardiovascular and cerebrovascular disease, and atherosclerosis is the pathological change that is caused by multiple factor, and control one or more factor wherein all will help reducing the sickness rate of cardiovascular and cerebrovascular disease.Selecting the little Drug therapy primary disease of good effect side reaction for use is optimum selection, and Chinese medicine has these advantages, at the employ new technology flourish today new medicine preparation of atherosclerosis treatment cardiovascular and cerebrovascular disease of exploitation high-efficiency low-toxicity of science and technology, will point the day and await for it.
At present, the Chinese medicine preparation of treatment cardiovascular and cerebrovascular disease is of a great variety, yet because a variety of causes, as curative effect, absorption, drug loading etc., restrict the development of the Chinese medicine preparation of existing treatment cardiovascular and cerebrovascular disease, can not satisfy patient's actual demand well, solving patient's slight illness.
Summary of the invention
The present invention is directed to the problems referred to above of the Chinese medicine preparation existence of existing treatment cardiovascular and cerebrovascular disease, a kind of Chinese medicine of atherosclerosis treatment cardiovascular and cerebrovascular disease and the preparation method of phospholipid complex formulation thereof are provided.
To achieve these goals, the present invention has adopted following technical scheme: a kind of Chinese medicine of atherosclerosis treatment cardiovascular and cerebrovascular disease, form by following components in weight percentage: Rhizoma Chuanxiong 59%-79%, Radix Puerariae 17%-37%, Radix Notoginseng total arasaponins 0.1%-1%, Monas cuspurpureus Went 1%--5%.
In order to maximize the curative effect of above-mentioned Chinese medicine, improve its drug loading and absorbance, through inventor's experimental exploring for many years, the preparation method of having invented the phospholipid complex formulation of above-mentioned Chinese medicine:
(1) preparation of Radix Puerariae dry extractum
The Radix Puerariae pulverizing medicinal materials of above-mentioned percentage ratio is become coarse powder, alcohol reflux with 70% three times, each reflux extracting time is 1--3 hour, and the extracting solution with three gained merges then, through reclaim under reduced pressure ethanol wherein and after concentrating, form once concentration liquid, once concentration liquid thin up is become every milliliter of upper prop liquid that contains 0.2g Radix Puerariae medical material, upper prop liquid discards upper prop liquid by behind the macroporous adsorptive resins again, wash resin column then with water to sugar-free, with 10 times of 30% ethanol elution resins, collect eluent, behind the decompression recycling ethanol to the resin column volume, formation liquid to be made, to wait to make liquid and concentrate, vacuum drying just gets dry extract, pulverize, standby.
(2) preparation of Rhizoma Chuanxiong oil and Rhizoma Chuanxiong dry extract becomes coarse powder with the Rhizoma Chuanxiong pulverizing medicinal materials of above-mentioned percentage ratio, adding 85% ethanol soaked 20--26 hour at ambient temperature, then with the speed percolation of 3%--9% per hour, collect 6 times to the percolate of Rhizoma Chuanxiong medical material weight, after reclaiming the ethanol in the percolate, form and treat separatory, will treat the separatory static layering, upper strata liquid is through extracting the refining Rhizoma Chuanxiong oil that obtains, the subnatant thin up becomes every milliliter of upper prop liquid that contains 1g Rhizoma Chuanxiong medical material, makes upper prop liquid by behind the macroporous adsorptive resins, discards upper prop liquid, wash resin column then with water to sugar-free, with 6 times of 65% ethanol elution resins to the resin column volume, form eluent, collect eluent, form liquid to be made behind the reclaim under reduced pressure ethanol wherein, to wait to make liquid and concentrate, vacuum drying just gets the Rhizoma Chuanxiong dry extract, pulverize, standby.
(3) preparation process
Take by weighing the Monas cuspurpureus Went powder of above-mentioned percentage ratio, after adding an amount of alcohol dipping, the Radix Notoginseng total arasaponins, Rhizoma Chuanxiong dry extract and the Radix Puerariae dry extractum ethanol liquid that add above-mentioned percentage ratio, add lecithin ethanol liquid again, mixing also stirs, and decompression recycling ethanol concentrates, add corresponding disintegrating agent according to existing preparation process, promptly can be made into phospholipid complex formulation.
The Chinese medicinal ingredients complexity, effective ingredient is many, has the effect of many target spots, but its contained active component is often on the low side, reach clinical Expected Results, also needs the other side's Chinese crude drug to discard the dross and select the essential, and the effective site in the medical material has been carried out enrichment and purification.
The present invention's process is to medicinal material extract, concentrated, enrichment and purification, effective ingredient purity improves greatly, can satisfy the preparation needs, simultaneously, consider the weakness that exists on the active ingredient of Chinese herbs self property, active component is difficult by the biomembrane barrier, can influence the performance of its curative effect to a certain extent, limit its application clinically.
The research of phosphatide complexes in recent years enjoys attention, and phosphatide complexes is the comparatively stable material that medicine and phospholipid molecule form by the electric charge migration.After medicine and phospholipid form complex, physics and chemistry fat, biologic activity etc. all can take place to change significantly, show the characteristic different with the parent medicine, the change of physicochemical property such as fat-soluble obvious enhancing, the change of biologic activity are stronger than parent drug as the activity of phosphatide complexes, bioavailability is higher, toxic and side effects is littler.
Phosphatide complexes is regarded as a breakthrough in traditional medicine field, and the active ingredient of Chinese herbs phosphatide complexes all has important theory and practical significance for the modernization of quickening Chinese medicine compound preparation, raising Chinese medicine preparation technical merit and clinical application quality.After making phosphatide complexes as Semen Ginkgo extrac, blood pressure lowering and antiinflammatory action all significantly strengthen, this preparation phosphatide complexes, not only fat-soluble enhancing, drug effect strengthen but also drug powder good fluidity, nonhygroscopic, drug loading is big, does not need to add adjuvant, directly compressible and encapsulated.
Consider effective ingredient Lovastatin, the puerarin in the dried cream of ferulic acid, Radix Puerariae in the Rhizoma Chuanxiong extract and the saponins in the Radix Notoginseng total arasaponins in the Chinese crude drug Monas cuspurpureus Went of the present invention, all has certain polarity, has the possibility that forms complex with lecithin, in order to improve drug effect of the present invention, obtained the phosphatide complexes of above four kinds of compositions through test, solubility test shows that the Monas cuspurpureus Went ethanol extraction is insoluble to petroleum ether, and Monas cuspurpureus Went phospholipid dissolves in petroleum ether after compound; The dried cream of Rhizoma Chuanxiong be insoluble to chloroform and with lecithin compound after, its dried cream dissolves in chloroform; The dried cream of Radix Puerariae is insoluble to chloroform, and the dried cream with lecithin after compound dissolves in chloroform; Dried cream after same Radix Notoginseng total arasaponins and phospholipid are compound also dissolves in chloroform, fat-soluble all enhancings greatly.Measure above each composition in the dried cream with the compound mistake of lecithin with the method for Lovastatin, ferulic acid, puerarin and the Radix Notoginseng total arasaponins of compound mistake not measured, all can detect, and recall rate is all more than 95%, though the compound fat-soluble enhancing in back is described, but do not form new chemical compound, and recombination rate is all more than 95%.Because the composition of every kind of extract in the middle of above four kinds of extracts is more complicated all, except four kinds of compositions that detected, other compositions also might form phosphatide complexes, but after anyway forming phosphatide complexes with lecithin, lecithin can promote medicine to enter cell from the enterocyte film that hydrophilic environment shifts by the lipophilic environment better as pharmaceutical carrier, arrive blood at last, play a role.
The present invention is that the inventor is on the basis of years'experiences, form by the drug effect side of tearing open test innovation again our medicine, realized the combination of conventional formulation technology and modern pharmaceutical technology, not only improved drug loading but also improved human body bioavailability of medicament.Below be the drug effect of the present invention side's of tearing open test:
One, test objective
To three kinds of Chinese medicines among the present invention: Radix Notoginseng total arasaponins (A), Rhizoma Chuanxiong (B), Radix Puerariae (C) extract, every kind of extract is set two dosage, adopt orthogonal design, duplicate the acute complete cerebral ischemic model and measure brain water content and cerebral index is an index with ligation rat bilateral common carotid arteries, find out best compatibility.
Two, test material
1, medicine
Trematodiasis rhizome of chuanxiong capsule, 0.3g/ grain (3 of adult's consumptions one time, 2 times on the one 0.06g/kg/ days) is produced lot number: 090101. by Shanxi Qian Hui pharmaceutcal corporation, Ltd
XUESAITONG PIAN 0.1g/ grain (1 of adult's consumption one time, 3 times on the one 0.005g/kg/ days) is produced lot number: 20080906 by the Yunnan Province Yuxi City Weihe Pharmaceutical Co.ltd
Radix Notoginseng total arasaponins, Rhizoma Chuanxiong, Radix Puerariae extract are provided by magnificent pharmaceutical companies of a specified duration.
2, animal
The Wistar rat, male and female half and half, body weight 250-300g is provided by Shandong Traditional Chinese Medicine University's Experimental Animal Center, the quality certification number: SYXK (Shandong) 20050043.
3, instrument
Thermostatic drying chamber (202A-1, state Rui Shiyanyiqichang), electronic balance (JA2004, Shanghai balance equipment factory)
Three, method
According to table 1, use L
8(2
7) the orthogonal table experiment arrangement, wherein Radix Notoginseng total arasaponins, Rhizoma Chuanxiong, Radix Puerariae extract are respectively A, B and C, and every kind of extract is set two dosage (being low dosage 1 and high dose 2).Test is established 12 groups, the 1st group of Radix Notoginseng total arasaponins: Rhizoma Chuanxiong altogether: three kinds of medicine proportionings of Radix Puerariae are 1: 1: 1; The 2nd group of Radix Notoginseng total arasaponins: Rhizoma Chuanxiong: three kinds of medicine proportionings of Radix Puerariae are 1: 1: 2; The 3rd group of Radix Notoginseng total arasaponins: Rhizoma Chuanxiong: three kinds of medicine proportionings of Radix Puerariae are 1: 2: 1; The 4th group of Radix Notoginseng total arasaponins: Rhizoma Chuanxiong: three kinds of medicine proportionings of Radix Puerariae are 1: 2: 2; The 5th group of Radix Notoginseng total arasaponins: Rhizoma Chuanxiong: three kinds of medicine proportionings of Radix Puerariae are 2: 1: 1; The 6th group of Radix Notoginseng total arasaponins: Rhizoma Chuanxiong: Radix Puerariae three medicine proportionings are 2: 1: 2; The 7th group of Radix Notoginseng total arasaponins: Rhizoma Chuanxiong: three kinds of medicine proportionings of Radix Puerariae are 2: 2: 1; The 8th group of Radix Notoginseng total arasaponins: Rhizoma Chuanxiong: three kinds of medicine proportionings of Radix Puerariae are 2: 2: 2 (wherein 1 is 7.5 times of the clinical consumptions of adult, and 2 is 15 times); The 9th group is trematodiasis rhizome of chuanxiong Capsules group (be grown up clinical consumption 7.5 times); The 10th group is XUESAITONG group (be grown up clinical consumption 7.5 times), is gastric infusion; The 11st group is model group; The 12nd group is sham operated rats, and sham-operation and model group are given the equivalent normal saline, and 1 time/day, administration is 7 days altogether.
Brain water content and cerebral index are measured: the last administration is after 1 hour, pentobarbital sodium anesthesia, the ligation bilateral common carotid arteries forms the imperfection cerebral ischemic model, after the ligation 4 hours, open cranium and get brain, weigh, calculate cerebral index (heavy * 100/ body weight of cerebral index=brain), roasting at 110 ℃ of baking ovens then to constant weight, calculate brain water content %=(cutaneous horn weight-brain stem is heavy)/cutaneous horn heavy * 100%.
Table 1 factor level table
Four, result
See Table 2, table 3, table 4.
Table 2 each treated animal brain water content and cerebral index
Annotate: with the sham operated rats ratio
△ △P<0.01,
△P<0.05; With the model group ratio
※P<0.05
The single factor statistics of table 3 scale
The A medicine
Dependent Variable: brain water content
The B medicine
Dependent Variable: brain water content
The C medicine
Dependent Variable: brain water content
Table 4A, B, C three medicine compatibility analysiss of variance table
Dependent Variable: brain water content
Source | Type?III Sum?of | df | Mean Square | F | Sig. |
Squares | |||||
Corrected Model Intercept A B C Error Total Corrected Total | .442(a) 50648.692 .052 .288 .101 .109 50649.243 .551 | 3 1 1 1 1 4 8 7 | .147 50648.692 .052 .288 .101 .027 | 5.432 1866587 .755 1.928 10.629 3.740 | .068 .000 .237 .031 .125 |
a?R?Squared=.803(Adjusted?R?Squared=.655)
Table 5 brain water content orthogonal experiments is analyzed
Therefore three kinds of medicines improve the animal pattern cerebral edema and reduce brain water content effect B>C>A, wherein B (P<0.05=significance, adding C effect has downward trend, but the animal brain water content is added up nonsignificance.Three kinds of medicine high doses (2) effect simultaneously all is better than low dosage (1).Comprehensive various factors, B is a principal agent as can be known, A
2B
2C
2Be best compatibility program,, can further observe by other tests of pesticide effectiveness for further verifying its prescription correctness.
The specific embodiment
Embodiment 1: a kind of Chinese medicine of atherosclerosis treatment cardiovascular and cerebrovascular disease, form by following components in weight percentage: Rhizoma Chuanxiong 59%, Radix Puerariae 37%, Radix Notoginseng total arasaponins 0.5%, Monas cuspurpureus Went 3.5%.
The preparation method of the phospholipid complex formulation of above-mentioned Chinese medicine:
(1) preparation of Radix Puerariae dry extractum
The Radix Puerariae pulverizing medicinal materials of above-mentioned percentage ratio is become coarse powder, alcohol reflux with 70% three times, each reflux extracting time is 1 hour, extracting solution with three gained merges then, through reclaim under reduced pressure ethanol wherein and after concentrating, forms once concentration liquid, again once concentration liquid thin up is become every milliliter of upper prop liquid that contains 0.2g Radix Puerariae medical material, and make upper prop liquid by macroporous adsorptive resins, and discarding post liquid, the washed resin post is to sugar-free, with 10 times of 30% ethanol elution resins to the resin column volume, collect eluent, form liquid to be made behind the reclaim under reduced pressure ethanol wherein, will wait to make liquid and concentrate, vacuum drying, just get dry extract, pulverize, standby.
(2) preparation of Rhizoma Chuanxiong oil and Rhizoma Chuanxiong dry extract becomes coarse powder with the Rhizoma Chuanxiong pulverizing medicinal materials of above-mentioned percentage ratio, adding 85% ethanol soaked 20 hours at ambient temperature, then with 3% speed percolation per hour, collect 6 times to the percolate of Rhizoma Chuanxiong medical material weight, after reclaiming the ethanol in the percolate, separatory is treated in formation, to treat the separatory static layering, upper strata liquid is through extracting refining Rhizoma Chuanxiong oil, and the subnatant thin up becomes every milliliter of upper prop liquid that contains 1g Rhizoma Chuanxiong medical material, upper prop liquid is by behind the macroporous adsorptive resins, discard upper prop liquid, wash resin column with water to sugar-free, with 6 times of 65% ethanol elution resins to column volume, collect eluent, form liquid to be made behind the reclaim under reduced pressure ethanol wherein, will wait to make liquid and concentrate vacuum drying, just get the Rhizoma Chuanxiong dry extract, pulverize, standby.
(3) formulation preparation
Take by weighing the Monas cuspurpureus Went powder of above-mentioned percentage ratio, after adding an amount of alcohol dipping, the Radix Notoginseng total arasaponins, Rhizoma Chuanxiong dry extract and the Radix Puerariae dry extractum ethanol liquid that add above-mentioned percentage ratio, add lecithin ethanol liquid again, stir mixing, decompression recycling ethanol, concentrate, add corresponding disintegrating agent, promptly can be made into phospholipid complex formulation according to existing preparation process.
Can make red rhizome of chuanxiong capsule:
Take by weighing the Monas cuspurpureus Went powder of above-mentioned percentage ratio, add 10 times to the ethanol of Monas cuspurpureus Went powder weight, dipping is 40 minutes under 60 ℃ condition, and then add Radix Notoginseng total arasaponins, Rhizoma Chuanxiong dry extract and the Radix Puerariae dry extractum ethanol liquid of above-mentioned percentage ratio, add lecithin ethanol liquid again, mixing, under 30 ℃ condition, stirred 10 minutes, decompression recycling ethanol concentrates vacuum drying, add disintegrating agent, pulverize, sieve, promptly encapsulated.
Embodiment 2: a kind of Chinese medicine of atherosclerosis treatment cardiovascular and cerebrovascular disease, form by following components in weight percentage: Rhizoma Chuanxiong 79%, Radix Puerariae 17%, Radix Notoginseng total arasaponins 1%, Monas cuspurpureus Went 3%.
The preparation method of the phospholipid complex formulation of above-mentioned Chinese medicine:
(1) preparation of Radix Puerariae dry extractum
The Radix Puerariae pulverizing medicinal materials of above-mentioned percentage ratio is become coarse powder, alcohol reflux with 70% three times, each reflux extracting time is 2 hours, extracting solution with three gained merges then, through reclaim under reduced pressure ethanol wherein and after concentrating, forms once concentration liquid, again once concentration liquid thin up is become every milliliter of upper prop liquid that contains 0.2g Radix Puerariae medical material, and make upper prop liquid by macroporous adsorptive resins, and discarding post liquid, the washed resin post is to sugar-free, with 10 times of 30% ethanol elution resins to the resin column volume, collect eluent, form liquid to be made behind the reclaim under reduced pressure ethanol wherein, will wait to make liquid and concentrate, vacuum drying, just get dry extract, pulverize, standby.
(2) preparation of Rhizoma Chuanxiong oil and Rhizoma Chuanxiong dry extract becomes coarse powder with the Rhizoma Chuanxiong pulverizing medicinal materials of above-mentioned percentage ratio, adding 85% ethanol soaked 24 hours at ambient temperature, then with 6% speed percolation per hour, collect 6 times to the percolate of Rhizoma Chuanxiong medical material weight, after reclaiming the ethanol in the percolate, separatory is treated in formation, to treat the separatory static layering, upper strata liquid obtains Rhizoma Chuanxiong oil through extracting to make with extra care, and the subnatant thin up becomes every milliliter of upper prop liquid that contains 1g Rhizoma Chuanxiong medical material, upper prop liquid is crossed macroporous adsorptive resins, discarded post liquid, the washed resin post is to sugar-free, with 6 times of 65% ethanol elution resins to column volume, collect eluent, form liquid to be made behind the reclaim under reduced pressure ethanol wherein, will wait to make liquid and concentrate vacuum drying, just get the Rhizoma Chuanxiong dry extract, pulverize, standby.
(3) formulation preparation
Take by weighing the Monas cuspurpureus Went powder of above-mentioned percentage ratio, after adding an amount of alcohol dipping, the Radix Notoginseng total arasaponins, Rhizoma Chuanxiong dry extract and the Radix Puerariae dry extractum ethanol liquid that add above-mentioned percentage ratio, add lecithin ethanol liquid again, mixing also stirs, and decompression recycling ethanol concentrates, add corresponding disintegrating agent according to existing preparation process, promptly can be made into phospholipid complex formulation.
Can make red rhizome of chuanxiong soft capsule:
Take by weighing above-mentioned percentage ratio Monas cuspurpureus Went powder, add 10 times to the ethanol of Monas cuspurpureus Went powder weight, dipping under 60 ℃ of conditions 40 minutes, centrifugal, 5 times of ethanol repeated impregnations under 60 ℃ condition to the Monas cuspurpureus Went powder weight of medicinal residues reuse once merge centrifugal liquid, add above-mentioned percentage ratio Radix Notoginseng total arasaponins, Rhizoma Chuanxiong oil and Radix Puerariae dry extractum ethanol liquid, add lecithin ethanol liquid again, mixing, the stirring under 30 ℃ of conditions 10 minutes, decompression recycling ethanol, concentrate, add adjuvant palmitic acid oil 10%, the peak is cured 5%, supplies final quantity with vegetable oil, make suspension, be pressed into soft capsule rolling automatically on the film machine.Through washing ball, drying, polishing, packing are promptly.
Embodiment 3: a kind of Chinese medicine of atherosclerosis treatment cardiovascular and cerebrovascular disease, form by following components in weight percentage: Rhizoma Chuanxiong 60%, Radix Puerariae 35%, Radix Notoginseng total arasaponins 1%, Monas cuspurpureus Went 4%.
The preparation method of the phospholipid complex formulation of above-mentioned Chinese medicine:
(1) preparation of Radix Puerariae dry extractum
The Radix Puerariae pulverizing medicinal materials of above-mentioned percentage ratio is become coarse powder, alcohol reflux with 70% three times, each reflux extracting time is 3 hours, extracting solution with three gained merges then, through reclaim under reduced pressure ethanol wherein and after concentrating, forms once concentration liquid, again once concentration liquid thin up is become every milliliter of upper prop liquid that contains 0.2g Radix Puerariae medical material, upper prop liquid discards upper prop liquid by macroporous adsorptive resins, and the washed resin post is to sugar-free, with 10 times of 30% ethanol elution resins to the resin column volume, collect eluent, form liquid to be made behind the reclaim under reduced pressure ethanol wherein, will wait to make liquid and concentrate, vacuum drying, just get dry extract, pulverize, standby.
(2) preparation of Rhizoma Chuanxiong oil and Rhizoma Chuanxiong dry extract becomes coarse powder with the Rhizoma Chuanxiong pulverizing medicinal materials of above-mentioned percentage ratio, adding 85% ethanol soaked 26 hours at ambient temperature, then with 9% speed percolation per hour, collect 6 times to the percolate of Rhizoma Chuanxiong medical material weight, after reclaiming the ethanol in the percolate, separatory is treated in formation, will treat the separatory static layering, and upper strata liquid is through extracting refining Rhizoma Chuanxiong oil, the subnatant thin up becomes every milliliter of upper prop liquid that contains 1g Rhizoma Chuanxiong medical material, after upper prop liquid is crossed macroporous adsorptive resins, discard upper prop liquid, the washed resin post is to sugar-free, with 6 times of 65% ethanol elution resins to column volume, collect eluent, form liquid to be made behind the reclaim under reduced pressure ethanol wherein, will wait to make liquid and concentrate, vacuum drying, just get the Rhizoma Chuanxiong dry extract, pulverize, standby.
(3) formulation preparation
Take by weighing the Monas cuspurpureus Went powder of above-mentioned percentage ratio, after adding an amount of alcohol dipping, the Radix Notoginseng total arasaponins, Rhizoma Chuanxiong dry extract and the Radix Puerariae dry extractum ethanol liquid that add above-mentioned percentage ratio, add lecithin ethanol liquid again, mixing also stirs, and decompression recycling ethanol concentrates, add corresponding disintegrating agent according to existing preparation process, promptly can be made into phospholipid complex formulation.
Can make red rhizome of chuanxiong sheet:
Take by weighing the Monas cuspurpureus Went powder of above-mentioned percentage ratio, add 10 times to the ethanol of Monas cuspurpureus Went powder weight, dipping is 40 minutes under 60 ℃ condition, add Radix Notoginseng total arasaponins, Rhizoma Chuanxiong dry extract and the Radix Puerariae dry extractum ethanol liquid of above-mentioned percentage ratio, add lecithin ethanol liquid again, mixing, under 30 ℃ condition, stirred 10 minutes, decompression recycling ethanol concentrates vacuum drying, add disintegrating agent, pulverize, sieve, tabletting promptly.
Disintegrating agent is a prior art, as carboxymethyl starch sodium, low substituted hydroxy-propyl methylcellulose, gas-producing disintegrant etc.
Macroporous adsorptive resins can be the AB-8 type.
Claims (5)
1. the Chinese medicine of an atherosclerosis treatment cardiovascular and cerebrovascular disease is characterized in that: be made up of following components in weight percentage: Rhizoma Chuanxiong 59%-79%, Radix Puerariae 17%-37%, Radix Notoginseng total arasaponins 0.1%-1%, Monas cuspurpureus Went 1%--5%.
2. the preparation method of the phospholipid complex formulation of the Chinese medicine of atherosclerosis treatment cardiovascular and cerebrovascular disease according to claim 1:
(1) preparation of Radix Puerariae dry extractum
The Radix Puerariae pulverizing medicinal materials of above-mentioned percentage ratio is become coarse powder, alcohol reflux with 70% three times, each reflux extracting time is 2 hours, extracting solution with three gained merges then, through reclaim under reduced pressure ethanol wherein and after concentrating, forms once concentration liquid, again once concentration liquid thin up is become every milliliter of upper prop liquid that contains 0.2g Radix Puerariae medical material, upper prop liquid discarded post liquid by AB-8 type macroporous adsorptive resins, and the washed resin post is to sugar-free, with 10 times of 30% ethanol elution resins to the resin column volume, collect eluent, form liquid to be made behind the reclaim under reduced pressure ethanol wherein, will wait to make liquid and concentrate, vacuum drying, just get dry extract, pulverize, standby.
(2) preparation of Rhizoma Chuanxiong oil and Rhizoma Chuanxiong dry extract becomes coarse powder with the Rhizoma Chuanxiong pulverizing medicinal materials of above-mentioned percentage ratio, adding 85% ethanol soaked 24 hours at ambient temperature, then with 6% speed percolation per hour, collect 6 times to the percolate of Rhizoma Chuanxiong medical material weight, after reclaiming the ethanol in the percolate, separatory is treated in formation, to treat the separatory static layering, upper strata liquid obtains Rhizoma Chuanxiong oil through extracting to make with extra care, and subnatant becomes every milliliter of upper prop liquid that contains 1g Rhizoma Chuanxiong medical material through thin up, upper prop liquid is crossed AB-8 type macroporous adsorptive resins, discarded post liquid, the washed resin post is to sugar-free, with 6 times of 65% ethanol elution resins to column volume, collect eluent, form liquid to be made behind the reclaim under reduced pressure ethanol wherein, will wait to make liquid and concentrate vacuum drying, just get the Rhizoma Chuanxiong dry extract, pulverize, standby.
(3) formulation preparation
Take by weighing the Monas cuspurpureus Went powder of above-mentioned percentage ratio, after adding an amount of alcohol dipping, the Radix Notoginseng total arasaponins, Rhizoma Chuanxiong dry extract and the Radix Puerariae dry extractum ethanol liquid that add above-mentioned percentage ratio, add lecithin ethanol liquid again, mixing also stirs, and decompression recycling ethanol concentrates, add corresponding disintegrating agent according to existing preparation process, promptly can be made into phospholipid complex formulation.
3. as the preparation method of the phospholipid complex formulation of the Chinese medicine of atherosclerosis treatment cardiovascular and cerebrovascular disease as described in the claim 2, it is characterized in that: the capsular preparation method of red rhizome of chuanxiong: the Monas cuspurpureus Went powder that takes by weighing above-mentioned percentage ratio, add 10 times to the ethanol of Monas cuspurpureus Went powder weight, dipping is 40 minutes under 60 ℃ condition, and then add the Radix Notoginseng total arasaponins of above-mentioned percentage ratio, Rhizoma Chuanxiong dry extract and Radix Puerariae dry extractum ethanol liquid, add lecithin ethanol liquid again, mixing stirred 10 minutes decompression recycling ethanol under 30 ℃ condition, concentrate, vacuum drying adds disintegrating agent, pulverizes, sieve, promptly encapsulated.
4. as the preparation method of the phospholipid complex formulation of the Chinese medicine of atherosclerosis treatment cardiovascular and cerebrovascular disease as described in the claim 2, it is characterized in that: red rhizome of chuanxiong preparation of soft capsule method: take by weighing above-mentioned percentage ratio Monas cuspurpureus Went powder, add 10 times to the ethanol of Monas cuspurpureus Went powder weight, dipping under 60 ℃ of conditions 40 minutes, centrifugal, repeated impregnations is once under 60 ℃ condition to the ethanol of Monas cuspurpureus Went powder weight for 5 times of medicinal residues reuse, merge centrifugal liquid, add above-mentioned percentage ratio Radix Notoginseng total arasaponins, Rhizoma Chuanxiong oil and Radix Puerariae dry extractum ethanol liquid, add lecithin ethanol liquid again, mixing, the stirring under 30 ℃ of conditions 10 minutes, decompression recycling ethanol, concentrate, add adjuvant palmitic acid oil 10%, the cured 5% usefulness vegetable oil in peak is supplied final quantity, make suspension, be pressed into soft capsule rolling automatically on the film machine.Through washing ball, drying, polishing, packing are promptly.
5. as the preparation method of the phospholipid complex formulation of the Chinese medicine of atherosclerosis treatment cardiovascular and cerebrovascular disease as described in the claim 2, it is characterized in that: the preparation method of red rhizome of chuanxiong sheet: the Monas cuspurpureus Went powder that takes by weighing above-mentioned percentage ratio, add 10 times to the ethanol of Monas cuspurpureus Went powder weight, dipping is 40 minutes under 60 ℃ condition, the Radix Notoginseng total arasaponins that adds above-mentioned percentage ratio, Rhizoma Chuanxiong dry extract and Radix Puerariae dry extractum ethanol liquid, add lecithin ethanol liquid again, mixing stirred 10 minutes decompression recycling ethanol under 30 ℃ condition, concentrate, vacuum drying adds disintegrating agent, pulverizes, sieve, tabletting promptly.
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2013155995A1 (en) * | 2012-04-20 | 2013-10-24 | 北京北大维信生物科技有限公司 | Red yeast and kudzu root pharmaceutical composition for regulating blood lipids and preparation method therefor |
CN105641509A (en) * | 2016-01-14 | 2016-06-08 | 吕海峰 | Traditional Chinese medicine composition for preventing and treating cardiovascular and cerebrovascular disease and application |
CN111213882A (en) * | 2020-03-11 | 2020-06-02 | 北京康立生医药技术开发有限公司 | Plant mixed extraction process and application thereof |
CN116035210A (en) * | 2022-12-30 | 2023-05-02 | 广州白云山汉方现代药业有限公司 | Method for solving layering of content and application of method in preparation of plant sterol ester red yeast soft capsules |
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CN101167773A (en) * | 2006-10-27 | 2008-04-30 | 冯仗林 | Medicine composition for treating cardiac and cerebral vascular diseases |
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CN101167773A (en) * | 2006-10-27 | 2008-04-30 | 冯仗林 | Medicine composition for treating cardiac and cerebral vascular diseases |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2013155995A1 (en) * | 2012-04-20 | 2013-10-24 | 北京北大维信生物科技有限公司 | Red yeast and kudzu root pharmaceutical composition for regulating blood lipids and preparation method therefor |
CN105641509A (en) * | 2016-01-14 | 2016-06-08 | 吕海峰 | Traditional Chinese medicine composition for preventing and treating cardiovascular and cerebrovascular disease and application |
CN111213882A (en) * | 2020-03-11 | 2020-06-02 | 北京康立生医药技术开发有限公司 | Plant mixed extraction process and application thereof |
CN116035210A (en) * | 2022-12-30 | 2023-05-02 | 广州白云山汉方现代药业有限公司 | Method for solving layering of content and application of method in preparation of plant sterol ester red yeast soft capsules |
CN116035210B (en) * | 2022-12-30 | 2024-08-20 | 广州白云山汉方现代药业有限公司 | Method for solving layering of content and application of method in preparation of plant sterol ester red yeast soft capsules |
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