CN101084996B - Traditional Chinese medicine containing red sage root and its preparation - Google Patents
Traditional Chinese medicine containing red sage root and its preparation Download PDFInfo
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- CN101084996B CN101084996B CN2006100142050A CN200610014205A CN101084996B CN 101084996 B CN101084996 B CN 101084996B CN 2006100142050 A CN2006100142050 A CN 2006100142050A CN 200610014205 A CN200610014205 A CN 200610014205A CN 101084996 B CN101084996 B CN 101084996B
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Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a Chinese medicinal composition for treating cardiovascular disease. The composition is mainly prepared from Salvia miltiorrhiza, Borneo or Dalbergia odoriferous oil or styrax or musk or musk ketone as raw material; also can further comprises Angelica sinensis or Herba Leonuri or further step comprises Astragalus membranaceus or ginseng or radix codonopsis. Its processing steps comprises preparing Salvia miltiorrhiza into water extract or alcohol extract or preparing Salvia miltiorrhiza and Angelica sinensis or Herba Leonuri or Salvia miltiorrhiza and Astragalus membranaceus or ginseng or radix codonopsis pilosulae into water extract or alcohol extract respectively or together, performing primary clarification, performing ultra filtration treatment, concentrating, and mixing with Borneo or Dalbergia odoriferous oil or styrax or musk or musk ketone. The invention also discloses a preparation with any of the aforesaid Chinese medicinal composition as effective ingredient, preferably dripping pill. Its dripping pill substrate adjuvant can be polyethylene glycol or plant original substrate adjuvant. Inventive medicament has rapid action, and good therapeutic action in treating angina pectoris of coronary heart disease.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation thereof of treating cardiovascular disease, particularly relating to a kind of is the pharmaceutical composition of the treatment cardiovascular disease processed of raw material with the Chinese medicine medical material.
Background technology
According to China's Epidemiological study, though over nearly 50 years in the rural area or the city, the M & M of cardiovascular and cerebrovascular disease is all in rising trend.50-60 age China population cause of death central vessel disease and cerebrovascular occupy the five or six respectively, then rise to the two or three respectively later in 1970, and cardiovascular and cerebrovascular disease death person has accounted for first of whole disease cause of the death.China accounts for part proportioning of total dead population because of cardiovascular and cerebrovascular disease death person; Rise to 42.6% of calendar year 2001 by 12.07% of nineteen fifty-seven; The person reaches 2,000,000 to die from the cardiovascular and cerebrovascular disease every year, though other has the part patient to survive through rescuing, majority stays deformity; Can't take care of oneself, cause serious burden to relatives and society.Cardiovascular and cerebrovascular disease also is western countries crowd main causes of death.Infer that according to present existing epidemiologic data advancing of disease trend is: to the year two thousand twenty, the human diseases cause of the death puts in order great change is arranged, but coronary heart disease and apoplexy will be first and second of the human cause of the death.Till that time, estimate that global coronary heart disease death number will increase to 1,100 ten thousand from 6,300,000 of nineteen ninety; Apoplexy increases to 7,700,000 from 4,400,000.Blood circulation cause of the death formation will increase 59.6% in 30 years, and coronary heart disease and apoplexy increase 74.6% and 75% respectively.These data prove absolutely, cardiovascular and cerebrovascular disease is not only the healthy principal disease of harm humans, especially at present with following 20 years in human " the No.1 killer " who causes death, disables.
In the medicine of cardiovascular and cerebrovascular disease, the application of Chinese medicine and western medicine emphasizes particularly on different fields, and Chinese medicine also occupies the bigger market share with the little advantage of its side effect.For example: the benefiting QI for activating blood circulation side [Zhu Weifeng, Shandong College of Traditional Chinese Medicine's journal, 1994,18 (5)] that forms by Radix Ginseng, Radix Codonopsis, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami; Add the red stilbene SHENGMAI YIN that Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Notoginseng, Flos Carthami, Rhizoma Corydalis, Fructus Crataegi are formed, [Chen Yuchun, the bright traditional Chinese medical science, 1999,14 (5)] by SHENGMAI YIN; The coronary heart disease of being made up of Radix Ginseng, Radix Codonopsis, Radix Ophiopogonis, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Lignum Dalbergiae Odoriferae is square [Wang Jinrong etc., Liaoning Journal of Traditional Chinese Medicine, 2001,28 (8)] basically; By Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Radix Ginseng, Radix Paeoniae Rubra, Rhizoma Chuanxiong, when the Shuxintongmai sheet that is grouped into [Wang Xiue etc., Shandong journal of Chinese medicine, 1997,16 (8)]; Or the like.But above clinical prescription and Chinese patent medicine all have certain weak point, or are partial to QI invigorating, or relatively activate yang, or relatively invigorate blood circulation, and do not obtain clinically popularizing in an all-round way.And mostly dosage form is traditional conventional tablet, capsule etc.; Production technology is more backward, and active constituent content is low, no quality control standard; Therefore, utilize the new treatment cardiovascular disease of new technology development particularly the Chinese medicine of coronary heart disease be the target that vast medical worker makes great efforts.
Membrane separation technique (Membrane Separation Technique) is an emerging high efficient separation technology, by internationally recognized be a most rising great high production tech of mid-term 20 end of the centurys to 21 century.Ultrafiltration (Ultrafiltration, UF) technology is a kind of membrane separation technique, its ultimate principle is to utilize fenestra selectivity sieve performance, with separation, purification and condensed matter.Hyperfiltration process is that the anisotropic membrane (being asymmetric membrane) that utilizes macromolecular material to process is a filter medium, under normal temperature condition, relies on certain pressure and flow velocity, makes flow of solution through face, forces low molecular weight substance to see through film, and polymer substance is trapped.
The relevant practical application that utilizes ultrafiltration to prepare compound red sage root preparation, the rare report of present document, particularly, utilize ultrafiltration to carry out suitability for industrialized production is a technical barrier in this area always.The inventor is through the effort of long-term and unremitting ground; Through a large amount of experimental datas are analyzed; Verified that ultrafiltration prepares the feasibility of compound red sage root preparation, and confirmed suitable process condition, for the suitability for industrialized production of utilizing ultrafiltration to carry out compound red sage root preparation provides concrete solution.
Drop pill then has the characteristics of quick acting, relatively is fit to the need of the first aid of coronary disease with angina pectoris.Although drop pill had had very big development on production equipment, preparation technology and types of drugs in recent years, go up slower development for the research and the application of drop pill new medium adjuvant.So far, most of drop pill substrate is selected Polyethylene Glycol for use, selects polyoxyethylene monostearate, gelatin, poloxamer, polyethers etc. individually for use.From the source, Polyethylene Glycol, polyoxyethylene monostearate, poloxamer, polyethers etc. all adopt making of synthetic, though gelatin from natural, it mainly comes from skin and the bone of animal.From safety perspective,, hemolytic is in various degree arranged all though that these chemical synthetic materials such as Polyethylene Glycol, polyoxyethylene monostearate, poloxamer, polyethers all can be done is medicinal; And in the chemosynthesis process, can mix unavoidably some to the chemical constituent of toxic elements in human body side effect like oxirane, expoxy propane etc.; In addition, these synthetic materials and many medicines have incompatibility, like salicylic acid, diphenhydramine, potassium penicillin G, tetracycline etc., thereby have reduced the curative effect of these medicines.With regard to gelatin, the supplementary material of present many animal origins is carried out forbidding for avoiding zoonosis such as bovine spongiform encephalopathy, foot and mouth disease etc., and its purposes is limited.Therefore, in order to improve the product quality of drop pill, widen the application of drop pill in medical product, promote the development of drop pill dosage form, promote the internationalization of drop pill product, the drop pill new medium adjuvant of research, exploitation safety non-toxic has profound significance.But; Because dropping pill formulation technology is very strict for the requirement of substrate adjuvant; Often be difficult to prepare the drop pill that conforms to quality requirements after changing the substrate adjuvant, therefore, seek suitable substrate adjuvant and replace the current direction that ethanol becomes medical personnel effort always of gathering.
Summary of the invention
One of the object of the invention is to overcome the deficiency of prior art, and a kind of compositions of treating cardiovascular disease is provided.
It is the preparation of effective ingredient that another object of the present invention provides with the said composition.
The present invention implements through following technical scheme:
Compositions of the present invention is mainly processed by following raw materials in weight portion medicine: Radix Salviae Miltiorrhizae 100, Borneolum Syntheticum or Lignum Dalbergiae Odoriferae oil or Styrax or Moschus or muscone 0.2～3; Also can add Radix Angelicae Sinensis or Herba Leonuri in the crude drug, its weight portion proportioning is a Radix Salviae Miltiorrhizae 100, Radix Angelicae Sinensis or Herba Leonuri 5～25, Borneolum Syntheticum or Lignum Dalbergiae Odoriferae oil or Styrax or Moschus or muscone 0.2～3; Perhaps add the Radix Astragali or Radix Ginseng or Radix Codonopsis, its weight portion proportioning is a Radix Salviae Miltiorrhizae 100, the Radix Astragali or Radix Ginseng or Radix Codonopsis 10～40, Borneolum Syntheticum or Lignum Dalbergiae Odoriferae oil or Styrax or Moschus or muscone 0.2～3.
But above-mentioned raw materials medicine both medication powder directly is mixed with compositions, also can be with processing preparation again behind whole crude drug or the part material medicine extraction extractum.Available decoction and alcohol sedimentation technique obtains extractum; Also available alcohol or water alcohol extracting method obtain extractum, and wherein alcohol is lower alcohol such as methanol, ethanol, normal propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutanol etc.; Further coarse filtration, ultrafiltration of the extracting solution that decoction and alcohol sedimentation technique or alcohol extracting method or water alcohol extracting method obtain, the ultrafiltrate reconcentration becomes extractum.The preferred for preparation method may further comprise the steps:
(a) Radix Salviae Miltiorrhizae is processed water extract or alcohol extract, perhaps separately or be mixed and made into water extract or alcohol extract with Radix Salviae Miltiorrhizae and Radix Angelicae Sinensis or Herba Leonuri or Radix Salviae Miltiorrhizae and the Radix Astragali or Radix Ginseng or Radix Codonopsis;
(b) described extracting solution being carried out predefecation handles;
(c) further described extracting solution is carried out hyperfiltration treatment;
(d) ultrafiltrate is condensed into extractum, adds Borneolum Syntheticum or Lignum Dalbergiae Odoriferae oil or Styrax or Moschus or muscone, promptly get.
Wherein in the step (a), alcohol extract can be the extracting solution of lower alcohol such as methanol, ethanol, normal propyl alcohol, isopropyl alcohol, n-butyl alcohol, isobutanol of variable concentrations etc. or the extracting solution of its mixture.Carrying out next step predefecation after alcohol extract can not concentrate or suitably concentrate handles.
In the step (b); Preliminary clarifying treatment can be carried out coarse filtration with general material such as gauze, tiffany etc.; The also available material such as the ceramic membrane of specialty carry out microfiltration; Also can behind high speed centrifugation, obtain supernatant, adsorption clarification such as also available flocculating agent such as flocculate with chitosan clarifier, 101 fruit juice clarifiers, ZTC1+1 natural clarifying agent, Ovum Gallus domesticus album flocculating agent and remove particle bigger in the medicinal liquid, also available alcohol deposition method is removed most impurity.Both can singly use above-mentioned defecation method, but also Combined application, coarse filtration-adsorption clarification for example, adsorption clarification-high speed centrifugation, coarse filtration-microfiltration, coarse filtration-precipitate with ethanol etc.After can not concentrating or suitably concentrate, the solution that predefecation is handled carries out next step ultrafiltration; Preferably do not concentrate the ultrafiltration of promptly carrying out next step.
In the step (c); The used ultrafilter membrane of ultrafiltration can be cellulose diacetate film (CA), three cellulose acetate membrane (CTA), cyanoethyl cellulose film (CN-CA), PS membrane (PS), sulfonated polysulfone membrane (SPS), poly (ether sulfone) film (PES), sulfonated polyether sulfone film (SPES), polysulfonamides film (PSA), phenolphthalein side group polyarylsulfone (PAS) film (PDS), polyvinylidene fluoride film (PVDF), polyacrylonitrile film (PAN), polyimide film (N), cellulose membrane, methyl methacrylate-acrylonitrile copolymer film (MMA-AN), polyacrylonitrile/cellulose diacetate (PAN/CA) blend film; The ultrafilter membrane that dynamically forms, and the Modified Membrane of above-mentioned film.Be preferably cellulose diacetate film (CA), three cellulose acetate membrane (CTA), PS membrane (PS), sulfonated polysulfone membrane (SPS), poly (ether sulfone) film (PES), sulfonated polyether sulfone film (SPES), polysulfonamides film (PSA), polyvinylidene fluoride film (PVDF), polyacrylonitrile film (PAN).
The molecular cut off of above-mentioned ultrafilter membrane is generally 6000～80000, is preferably 10000～70000, and the best is 20000～50000.
Ultrafiltration both can be adopted cross flow filter, also can adopt dead-end filtration, but preferred cross flow filter.
The operating condition of ultrafiltration technology is following:
(1) the inlet pressure of ultrafiltration is 0.1～0.5MPa, is preferably 0.1～0.35Mpa, and the best is 0.25～0.35Mpa; The liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.5～0.25kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1～0.2Mpa.
(2) the feed liquid flow velocity is 1.0～4.0m/s, is preferably 2.0～3.0m/s.In the ultra-filtration process, adopt the fluctuation of periodicity flow so that in membrane channels, produce pulsating flow or non-stationary flow, the flow speed wave moment is 1.0～2.0m/s.
(3) feed high-pressure inert gas such as nitrogen in the ultrafiltration system discontinuous, form the gas-liquid stream of pulses, the cycle is that 0.5h～2h ventilates once, each 1 minute.
(3) feed temperature is 15～50 ℃, is preferably 20～40 ℃.
(4) when feed liquid stock solution is concentrated 1/15～1/5, add water or dilute alcohol solution ultrafiltration 1～2 time again; Be preferably when feed liquid stock solution is concentrated 1/12～1/8, add water or dilute alcohol solution ultrafiltration 1～2 time again.
(5) pH value of feed liquid is controlled at 5～9, is preferably 6.0～7.5;
(6) backwash condition: backwashing pressure is 0.15～2.5MPa, and backwashing period is that 0.5～1.5h, backwashing time are 1min～10min.When the method for alternately recoil is used in the ultrafiltration module parallel connection; Wherein a cover or a few cover carry out normal ultrafiltration and distribute the recoil ultrafilter membrane of another set of or several grip assemblies of a part of filtrating; Exchange is carried out behind the certain interval of time, generally is work 10～20min, recoil 30sec～3min.
(7) the Chemical cleaning cycle is 0.5 month～2 months; The Chemical cleaning medicament is generally diluted acid, diluted alkaline, surfactant; Be preferably for example 0.5%～4.0% sodium hydroxide of diluted alkaline; The mixed solution of 1.5% sodium hydroxide and 2% sodium hypochlorite etc., pH value is 10～12, cleaning pressure is 0.05～1.0MPa.After cleaning with chemical, the flushing of reuse water is near neutral.
In ultra-filtration process; Both periodic pressure oscillation or the fluctuation of periodicity flow or periodicity fed noble gas separately; Also can unite use, i.e. periodic pressure fluctuation and periodically flow fluctuation associating use, perhaps the periodic pressure fluctuation is with periodically feeding noble gas unites use; Perhaps periodically the flow fluctuation is with periodically feeding noble gas unites use, and perhaps the three unites use together.
In the step (d), ultrafiltrate is condensed into extractum after, mix with Borneolum Syntheticum or Lignum Dalbergiae Odoriferae oil or Styrax or Moschus or muscone, promptly get Chinese medicine composition of the present invention.
The present invention also provides a kind of preparation of treating cardiovascular disease; Said preparation is processed by the adjuvant of accepting on above-mentioned any Chinese medicine composition and any or more than one pharmaceuticss; Wherein preparation can be but be not limited to tablet, capsule, granule, oral liquid, slow releasing preparation, controlled release preparation, gel, ointment, ointment, cream, suppository, injection, injectable powder, patch, drop pill, suspensoid, or the like; Be preferably tablet, capsule, granule, injection, drop pill; The best is a drop pill.
Drop pill of the present invention is prepared from as effective ingredient and adjuvant above-mentioned any Chinese medicine composition, perhaps is prepared from as effective ingredient and substrate adjuvant and plasticity adjuvant above-mentioned any Chinese medicine composition.
The substrate adjuvant of drop pill can be used Polyethylene Glycol, can be cetomacrogol 1000, polyethylene glycol 1500, Macrogol 4000, gathers one or more the mixture in the ethanol 6000; Preferred Macrogol 4000, polyethylene glycol 6000; The best is a polyethylene glycol 6000; Addition is 2～10 times of Chinese medicine composition weight, preferred 2～6 times.
The preferred for preparation method is: with the Chinese medicine composition in the step (d) and adjuvant mixed evenly after, add the transconversion into heat material, move into dripping jar of drop pill machine, in medicine liquid droplet to condensed fluid such as liquid paraffin or the methyl-silicone oil, remove condensed fluid, select ball.
Wherein: adjuvant is for gathering ethanol-6000,53～58 ℃ of its condensation points, and changing the material temperature is 60～100 ℃; The temperature of condensed fluid is 0～10 ℃, and the best is 5～10 ℃; Ball heavily is 5～50mg/ grain, diameter 1.95～4.29mm.
The substrate adjuvant of drop pill preferably from natural, the substrate adjuvant of plant origin particularly, also can contain the plasticity composition in this substrate adjuvant.Specifically, the substrate adjuvant is selected from following one or more adjuvant: at least a substrate adjuvant in pharmaceutically useful monosaccharide, oligosaccharide, polysaccharide, sugar ester, sugar alcohol, fruit acid, advanced higher fatty acid derivative, high fatty alcohol, polyhydric alcohol, carbamide, the polyethylene oxide derivant.
In the above-mentioned substance, monosaccharide such as D-ribose, fructose, glucose, xylose; Oligosaccharide such as trehalose, Raffinose, maltose; Polysaccharide such as agarose; Sugar ester such as sucrose ester, D-ribonic acid-gamma lactone; Sugar alcohol such as erythritol, sorbitol, xylitol, arabitol, isomalt, lactose; Fruit acid such as malic acid, citric acid; Advanced higher fatty acid derivative such as sodium stearate, tristerin, tripalmitin, Lac; High fatty alcohol such as hexadecanol, octadecanol; Polyhydric alcohol such as phenylglycol; Polyethylene oxide derivant such as polyoxyethylene monostearate, polyoxyethylene alkyl ether, and above-claimed cpd contain water of crystallization chemical compound etc.In the above material; The natural adjuvant of plant origin such as erythritol, sorbitol, fructose, D-ribonic acid-gamma lactone, arabitol, trehalose, D-ribose, low melting-point agarose, Lac, xylitol, Raffinose, glucose, malic acid, citric acid, isomalt, lactose, maltose, xylose, sucrose ester etc., and they contain the water of crystallization chemical compound; Chemosynthesis adjuvant and animal origin adjuvant such as phenylglycol, Polyethylene Glycol, hexadecanol, octadecanol, sodium stearate, tristerin, tripalmitin, carbamide, polyoxyethylene monostearate, polyoxyethylene alkyl ether.In the above-mentioned substance, especially preferably from following one or more adjuvant: sorbitol, xylitol, lactose, maltose, sucrose ester, and they contain the water of crystallization chemical compound.
Above-mentioned substrate adjuvant is mainly the natural adjuvant of plant origin, and the content that is meant the adjuvant of plant origin in adjuvant is more than 50 weight %, and the content of chemosynthesis adjuvant and animal origin adjuvant is no more than the natural adjuvant of plant origin.Preferably; The substrate adjuvant of drop pill of the present invention only uses the natural adjuvant of plant origin, perhaps is mainly the natural adjuvant of plant origin and only contains a spot of chemosynthesis adjuvant and animal origin adjuvant, and its content is below 50 weight %; Below the preferred 40 weight %, more preferably below the 30 weight %.The natural adjuvant of above-described so-called plant origin is meant as adjuvant itself and in plant cell or tissue, extracts, or by the material of plant extract through modifications such as derivatizations after the product of gained.So-called chemosynthesis adjuvant is meant synthetic micromolecule or the macromolecular compound that is obtained through chemical synthesis process by simple micromolecule.The natural adjuvant of so-called animal origin is meant as adjuvant itself and in the animal cell or tissue, extracts, or the material that extracts by animal through modifications such as derivatizations after the product of gained.
The substrate adjuvant of above-mentioned plant origin; Have now or in the future possibly have the synthetic article; If the synthetic article are identical or close with the character of the natural substrates adjuvant of original plant origin; Characteristic with safety non-toxic, then the natural substrates adjuvant of alternative plant origin is used as the natural substrates adjuvant that kind of above-mentioned plant origin.
For improving the formability of drop pill of the present invention, preferably also contain the plasticity composition in the adjuvant of drop pill of the present invention.As this plasticity composition, for example can enumerate and be selected from following one or more composition: the natural adjuvant of plant origin such as starch and derivant, cellulose and derivant thereof, arabic gum, dextran, chitin, sesbania gum, carrageenan, Ficus elastica, Furcellaran, tragakanta, carrageenin, tamarind gum, pectin, xanthan gum, alginic acid and salt thereof, dextrin, cyclodextrin, agar, lactose; Chemosynthesis adjuvant and animal origin adjuvant such as polyvinylpyrrolidone, crospolyvinylpyrrolidone, carbomer, polyvinyl alcohol, acrylic resin, poloxamer, silicon dioxide, gelatin etc.
Above-mentioned starch and derivant thereof such as pregelatinized Starch, modified starch, hydroxypropyl starch, carboxymethyl starch etc.Said cellulose and derivant thereof such as methylcellulose, microcrystalline Cellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, cross-linking sodium carboxymethyl cellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose.
In the plasticity composition, preferably from following one or more adjuvant: pregelatinized Starch, carboxymethyl starch, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, arabic gum, alginic acid, dextrin, cyclodextrin, agar, lactose.In addition, glyceryl monostearate, polyoxyethylene monostearate also can be used as the plasticity composition and other substrate supplementary product compatibility is used.
The composition of above-described so-called plant origin is meant as adjuvant itself and in plant cell or tissue, extracts, or by the material of plant extract through modifications such as derivatizations after the product of gained.So-called chemosynthesis adjuvant is meant synthetic micromolecule or the macromolecular compound that is obtained through chemical synthesis process by simple micromolecule.The adjuvant of so-called animal origin is meant as adjuvant itself and in the animal cell or tissue, extracts, or the material that extracts by animal through modifications such as derivatizations after the product of gained.
The plasticity composition of above-mentioned plant origin; Have now or in the future possibly have the synthetic article; If the synthetic article are identical or close with the character of the natural plasticity composition of plant origin; Characteristic with safety non-toxic, then the natural plasticity composition of alternative above-mentioned plant origin is used as the natural plasticity substrate adjuvant that kind of above-mentioned plant origin.
The substrate adjuvant in the above-mentioned substrate adjuvant that is selected from monosaccharide, oligosaccharide, polysaccharide, sugar ester, sugar alcohol, fruit acid, advanced higher fatty acid derivative, high fatty alcohol, polyhydric alcohol, carbamide, polyethylene oxide derivant etc., preferred plant source is selected to arrange in pairs or groups according to medicinal property with above-mentioned plasticity composition; It is preferably arranged in pairs or groups and is xylitol and starch, lactose and starch, xylitol and arabic gum, sucrose ester and glyceryl monostearate, sucrose ester and polyoxyethylene monostearate, sucrose ester and polyoxyethylene monostearate and cross-linking sodium carboxymethyl cellulose, sucrose ester and polyoxyethylene monostearate and cross-linking sodium carboxymethyl cellulose and silicon dioxide etc., but is not limited thereto.
The weight ratio of above-mentioned substrate adjuvant and plasticity composition is 1: 0～1: 1.5, is preferably 1: 0.1～1: 0.9, and the best is 1: 0.1～1: 0.5.
In the above-mentioned substrate adjuvant, xylitol is preferably 1: 0.2 with the ratio of the weight of starch～and 1: 0.3;
In the above-mentioned substrate adjuvant, lactose is preferably 1: 0.2 with the ratio of the weight of starch～and 1: 0.3;
In the above-mentioned substrate adjuvant, the ratio of the weight of xylitol and arabic gum is preferably 1: 0.2～and 1: 0.4;
In the above-mentioned substrate adjuvant, the weight ratio of sucrose ester and glyceryl monostearate is 1: 0.1～1: 1, and the best is 1: 0.5.
In the above-mentioned substrate adjuvant, the weight ratio of sucrose ester and polyoxyethylene monostearate is 1: 0.1 to 1: 1, and the best is 1: 0.5.
In the above-mentioned substrate adjuvant, the weight ratio of sucrose ester and polyoxyethylene monostearate and cross-linking sodium carboxymethyl cellulose is 1: (0.1～1): (0.1～1), the best are 1: 0.4: 0.6.
In the above-mentioned substrate adjuvant, the weight ratio of sucrose ester and polyoxyethylene monostearate and cross-linking sodium carboxymethyl cellulose and silicon dioxide is 15: (7～15): (0.1～2): (0.1～2), the best are 15: 11: 1: 1.
Above-mentioned drop pill substrate adjuvant is 1: 0.1～1: 1 with the ratio of the weight of Chinese medicine composition of the present invention, is preferably 1: 0.1～1: 0.6, and the best is 1: 0.2～1: 0.4.
The preferred for preparation process conditions are: Chinese medicine composition of the present invention mixes mixing time with the substrate adjuvant be 10～30 minutes; A mixed heating and melting temperature of Chinese medicine composition and substrate adjuvant or a system temperature are 45～95 ℃, are preferably 60～95 ℃; Liquid coolant is liquid paraffin, methyl-silicone oil or vegetable oil (Oleum Glycines, Semen Ricini wet goods) etc., is preferably liquid paraffin, methyl-silicone oil; The temperature of liquid coolant is-20～30 ℃, is preferably 0～18 ℃; Dropper mouth internal diameter is 1.0～4.0mm, is preferably 1.2～2.5mm; The difference of dropper mouth external diameter and internal diameter is less for well.
Through medicine of the present invention its beneficial effect is explained in the experiment of the protective effect of Ischemia and Reperfusion in vivo in Rats myocardial damage below.
1. animal model: Wistar strain male rat, open chest anesthetized is kept breathing, between left auricle and pulmonary conus, around left coronary artery, and carries out ligation.
2. method: rat is divided into 4 groups at random: 1. sham operated rats (sham-operated control), normal saline is irritated stomach, 1ml/ days, totally 4 days; 2. myocardial ischemia-reperfusion group (M-IR), it is the same to irritate the stomach method; 3. FUFANG DANSHEN PIAN group (with reference to the preparation of the method for 2000 editions FUFANG DANSHEN PIANs of Chinese Pharmacopoeia) was dissolved in the 1ml normal saline with 2g crude drug/kg/ days, and it is the same to irritate the stomach method; 4. drug group of the present invention (press embodiment 6 method preparation and extractum), be dissolved in the 1ml normal saline with 2g crude drug/kg/ days, it is the same to irritate the stomach method.Not ligation of sham operated rats; Other group is in ligation perfusion again after 1 hour.Take out after injecting 1% her Wen orchid in the ligation left coronary artery once more before sacrifice of animal, ventricle, with the PBS rinsing, freezing 1 hour.After removing unnecessary tissue, 30 minutes (37 ℃) of dyeing in 1%TTC.With weight method calculating myocardium ischemia hazardous area (she does not dye the district by the Wen orchid), infarcted region (TTC does not dye the district).
3. the result of variations of myocardial infarct size
The myocardial infarction phenomenon was not seen in sham-operation in 7 hours; It is obvious that myocardial ischemia poured into after 6 hours myocardial infarction in 1 hour again; Medicine of the present invention can obviously dwindle the myocardial infarct size of myocardial reperfusion rat, shows that medicine of the present invention pours into the variation of myocardium cell necrosis property again to ischemic myocardial cells good protective action (seeing table 1) is arranged.
Table 1 is respectively organized the variation of myocardial infarct size
Annotate: compare * P＜0.05, * * P＜0.01 with the M-IR group; Compare with the FUFANG DANSHEN PIAN group,
△P＜0.05,
△ △P＜0.01.
The specific embodiment
Below in conjunction with embodiment the present invention is done further elaboration.These embodiment only are used to the purpose of giving an example, rather than limit the present invention by any way.
Embodiment 1
Crude drug adopts Radix Salviae Miltiorrhizae 495g, Radix Ginseng 118g, Lignum Dalbergiae Odoriferae oil 4.5g.
Radix Salviae Miltiorrhizae and people participate in 5 times of water gagings, decoct 2 hours, filter, and filtering residue carries out the second time and extracts, and adds 4 times of water gagings, fries in shallow oil 1 hour, filters, and filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 70%, leaves standstill, and filters, and filtrating is concentrated to obtain the extractum that relative density is 1.32～1.40 (55 ℃).Add Lignum Dalbergiae Odoriferae oil, drying is processed granule, and compacting is in blocks, or sugar coating, promptly gets.
Embodiment 2
Radix Salviae Miltiorrhizae 490g, Styrax 4g.
Radix Salviae Miltiorrhizae is used 70% ethanol extraction, and extracting solution carries out microfiltration with ceramic membrane, collects filtrating; The filtrating ultrafiltration, the operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.35Mpa, the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/8, adds water or dilute alcohol solution ultrafiltration 2 times again, and the pH value of feed liquid is controlled at 7.5.
Ultrafiltrate concentrates and to obtain the extractum that relative density is 1.35～1.39 (55 ℃), adds Styrax, adds 3% polyvidone alcoholic solution system soft material, crosses 18 mesh sieve system granules, 60 ℃ of dryings 30～45 minutes, and granulate, the adding Pulvis Talci, mixing fills in capsule, promptly gets.
Embodiment 3
Crude drug Radix Salviae Miltiorrhizae 485g, Radix Angelicae Sinensis 100g, Borneolum Syntheticum 2.2g.
Radix Salviae Miltiorrhizae and Radix Angelicae Sinensis add 5 times of water gagings, decoct 2 hours, filter, and filtering residue carries out the second time and extracts, and adds 4 times of water gagings, fries in shallow oil 1 hour, filters, and filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 70%, leaves standstill, and filters, and filtrating is concentrated to obtain the extractum that relative density is 1.32～1.40 (55 ℃).With extractum and Borneolum Syntheticum in the batch (-type) fluid bed with the lactose fluidisation, drying is processed granule, promptly gets.
Embodiment 4
Crude drug Radix Salviae Miltiorrhizae 135g, Moschus 4g.
Radix Salviae Miltiorrhizae adds 5 times of water gagings, decocts 2 hours, filters, and filtering residue carries out the second time and extracts, and adds 4 times of water gagings, fries in shallow oil 1 hour, filters, and filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 75%, leaves standstill filtration; It is that 6000 three cellulose acetate membrane carries out ultrafiltration that filtrating is used molecular cut off, and filter type adopts cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.5kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1Mpa.The feed liquid flow velocity is 1.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 1.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 0.5h ventilates once each 1 minute.Feed temperature is 15 ℃, when feed liquid stock solution is concentrated 1/15, adds water or dilute alcohol solution ultrafiltration 1 time again, and the pH value of feed liquid is controlled at 5.Backwashing pressure is 0.15MPa, and backwashing period is that 0.5h, backwashing time are 1min.When the method for alternately recoil was used in ultrafiltration module parallel connection, wherein a cover or a few cover carried out normal ultrafiltration and distribute the recoil ultrafilter membrane of another set of or several grip assemblies of part filtrating, and exchange is carried out behind the certain interval of time, work 10min, recoil 30sec.The Chemical cleaning cycle is 0.5 month, and the Chemical cleaning medicament is the mixed solution of 0.5%～4.0% sodium hydroxide, 1.5% sodium hydroxide and 2% sodium hypochlorite, and pH value is 10～12, and cleaning pressure is 0.05MPa.After cleaning with chemical, the flushing of reuse water is near neutral.
Ultrafiltrate concentrates and obtains the extractum that relative density is 1.32～1.40 (55 ℃), adds Moschus, and mix homogeneously adds mannitol 30g, calcium disodium edetate 5g, distilled water 5ml, behind the said components mixing, and lyophilization, packing promptly gets.
Embodiment 5
Crude drug Radix Salviae Miltiorrhizae 50.0g, muscone 0.35g.
Radix Salviae Miltiorrhizae adds 5 times of water gagings, decocts 2 hours, filters, and filtering residue carries out the second time and extracts, and adds 4 times of water gagings, fries in shallow oil 1 hour, filters, and filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 1.1～1.2, adds ethanol and makes medicinal liquid contain determining alcohol 70%, leaves standstill, and filters, and filtrating is concentrated to obtain the extractum that relative density is 1.32～1.40 (55 ℃).Get that extractum, muscone and Polyethylene Glycol-600018g are mixed evenly to be heated to 85 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 85 ℃; In medicine liquid droplet to the 7 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, processes 1000 drop pill, promptly gets.
Embodiment 6
Crude drug Radix Salviae Miltiorrhizae 48g, Borneolum Syntheticum 0.25g.
Radix Salviae Miltiorrhizae adds 5 times of water gagings, decocts 2 hours, filters, and filtering residue carries out the second time and extracts, and adds 4 times of water gagings, fries in shallow oil 1 hour, filters, and filtering residue discards, merging filtrate.It is that 50000 sulfonated polysulfone membrane carries out ultrafiltration that filtrating is used molecular cut off, and filter type adopts cross flow filter.The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/8, adds water or dilute alcohol solution ultrafiltration 2 times again, and the pH value of feed liquid is controlled at 7.5.Backwashing pressure is 2.5MPa, and backwashing period is that 1.5h, backwashing time are 10min.When the method for alternately recoil was used in ultrafiltration module parallel connection, wherein a cover or a few cover carried out normal ultrafiltration and distribute the recoil ultrafilter membrane of another set of or several grip assemblies of part filtrating, and exchange is carried out behind the certain interval of time, work 20min, recoil 3min.The Chemical cleaning cycle is 2 months, and the Chemical cleaning medicament is the mixed solution of 0.5%～4.0% sodium hydroxide, 1.5% sodium hydroxide and 2% sodium hypochlorite, and pH value is 10～12, and cleaning pressure is 1.0MPa.After cleaning with chemical, the flushing of reuse water is near neutral.
Described ultrafiltrate concentrated obtain the extractum that relative density is 1.35～1.39 (55 ℃).Get extractum and Borneolum Syntheticum, evenly be heated to 60 ℃ of temperature, change material after 40 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃ with Polyethylene Glycol-600020g is mixed.In medicine liquid droplet to the 8 ℃ methyl-silicone oil, take out drop pill, oil removing, screen cloth selects ball, processes 1000 drop pill, promptly gets.
Embodiment 7
Crude drug Radix Salviae Miltiorrhizae 48.6g, Lignum Dalbergiae Odoriferae oil 0.35g; Adjuvant lactose 18.0g, pregelatinized Starch 4.5g.
The red rooted salvia of coarse pulverization to extraction pot, is added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 70%, leaves standstill, and filters, and filtrating is concentrated to obtain the extractum that relative density is 1.32～1.40 (55 ℃).
Get above-mentioned extractum and Lignum Dalbergiae Odoriferae oil, evenly mixed with adjuvant lactose and pregelatinized Starch, be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃.In medicine liquid droplet to the 7 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.
The drop pill (newly) that the new substrate adjuvant of above-mentioned usefulness is processed compares (seeing the following form) with dissolve scattered time limit, the weight differential of using polyethylene glycol 6000 to process drop pill (old) as adjuvant
Above test data shows, the Chinese medicine dripping pills of processing with new substrate adjuvant of the present invention to dissolve the speed of loosing faster, be more conducive to medicine and play a role in the shortest time; The ball method of double differences is different all to be controlled in the pharmacopeia prescribed limit, and the alternative present chemosynthesis adjuvant of this natural substrates adjuvant is described, carries out suitability for industrialized production.
Embodiment 8
Crude drug Radix Salviae Miltiorrhizae 46.2g, Moschus 0.31g, Radix Astragali 13.8g; Adjuvant xylitol 15.0g, starch 5.0g.
Learn from else's experience Radix Salviae Miltiorrhizae and the Milkvetch Root of coarse pulverization to extraction pot, add the 0.9g sodium bicarbonate, add 4 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 4 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 75%, leaves standstill, and filters, and filtrating is concentrated to obtain the extractum that relative density is 1.32～1.40 (55 ℃).
Get above-mentioned extractum and Moschus, evenly mixed with adjuvant xylitol and starch, be heated to 65 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 85 ℃.In medicine liquid droplet to the 8 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.78min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 9
Crude drug Radix Salviae Miltiorrhizae 49.8g, Styrax 1.0g, Radix Codonopsis 21.5g; Adjuvant lactose 15.0g, arabic gum 3.0g.
With 85% ethanol extraction Radix Salviae Miltiorrhizae and Radix Codonopsis, obtain the ethanol extract of Radix Salviae Miltiorrhizae and Radix Codonopsis, with this extracting liquid filtering, collect filtrating with gauze.It is that 20000 cellulose diacetate film carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The condition of above-mentioned ultrafiltration is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/8, adds the water ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 7.5.
Get above-mentioned extractum and Styrax, evenly mixed with adjuvant lactose and arabic gum, be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 85 ℃.In medicine liquid droplet to the 6 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.61min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 10
Crude drug Radix Salviae Miltiorrhizae 46.5g, Borneolum Syntheticum 0.57g, Herba Leonuri 5.5g; Adjuvant xylitol 16.0g, tragakanta 5.0g.
The Radix Salviae Miltiorrhizae of coarse pulverization is added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out the second time and extracts, and adds 4 times of water gagings, fries in shallow oil 1 hour, filters, and filtering residue discards, and merging filtrate, Herba Leonuri are used 70% ethanol extraction, and merging filtrate and extracting solution leave standstill, and filter.It is that 60000 PS membrane carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/8, adds the dilute alcohol solution ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 7.5.
Get above-mentioned extractum and Borneolum Syntheticum, evenly mixed with adjuvant xylitol and tragakanta, be heated to 60 ℃ of temperature, change material after 25 minutes, move in the dropping-pill machine jar that jar temperature remains on 89 ℃.In medicine liquid droplet to the 5 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.62min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 11
Crude drug Radix Salviae Miltiorrhizae 48.0g, Borneolum Syntheticum 0.52g, Radix Angelicae Sinensis 10.0g; Adjuvant sucrose ester 10.0g, polyoxyethylene monostearate 8.0g.
Extract Radix Salviae Miltiorrhizae and Radix Angelicae Sinensis respectively with 80% ethanol, merge the Radix Salviae Miltiorrhizae and the Radix Angelicae Sinensis ethanol extract that obtain, obtaining supernatant behind this extracting solution high speed centrifugation.It is that 50000 sulfonated polysulfone membrane carries out ultrafiltration that this liquid is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.5Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.25kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 4.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 50 ℃, when feed liquid stock solution is concentrated 1/5, adds the water ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 9.
Get above-mentioned extractum and Borneolum Syntheticum, evenly mixed with adjuvant sucrose ester and polyoxyethylene monostearate, be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃.In medicine liquid droplet to the 5 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.64min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 12
Crude drug Radix Salviae Miltiorrhizae 49.0g, muscone 1.1g, Radix Codonopsis 6.0g; Adjuvant sucrose ester 15.0g, glyceryl monostearate 4.0g.
The Radix Salviae Miltiorrhizae of coarse pulverization, codonopsis pilosula to extraction pot, are added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.It is that 60000 poly (ether sulfone) film carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/8, adds the water ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 7.5.
Get above-mentioned extractum and muscone, evenly mixed with adjuvant sucrose ester and glyceryl monostearate, be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃.In medicine liquid droplet to the 6 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.67min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 13
Crude drug Radix Salviae Miltiorrhizae 47.0g, Borneolum Syntheticum 0.40g, Radix Ginseng 23.5g; Adjuvant sucrose ester 10.0g, polyoxyethylene monostearate 2.0g, cross-linking sodium carboxymethyl cellulose 3.0g.
The Radix Salviae Miltiorrhizae of coarse pulverization and ginseng crude drug to extraction pot, are added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.It is that 60000 PS membrane carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.5kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1Mpa.The feed liquid flow velocity is 1.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 1.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 0.5h ventilates once each 1 minute.Feed temperature is 15 ℃, when feed liquid stock solution is concentrated 1/15, adds the water ultrafiltration again 1 time, and the pH value of feed liquid is controlled at 5.
Get above-mentioned extractum and Borneolum Syntheticum, evenly be heated to 65 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃ with adjuvant sucrose ester, polyoxyethylene monostearate and cross-linking sodium carboxymethyl cellulose are mixed.In medicine liquid droplet to the 4 ℃ methyl-silicone oil, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.66min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 14
Crude drug Radix Salviae Miltiorrhizae 47.0g, Moschus 0.36g, Radix Ginseng 12.5g; Adjuvant lactose 10.0g, carrageenan 8.0g, starch 2.0g.
Learn from else's experience Radix Salviae Miltiorrhizae and the ginseng crude drug of coarse pulverization to extraction pot, add the 0.89g sodium bicarbonate, add 4 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 4 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.It is that 50000 polysulfonamides film carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.5Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.25kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 4.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 50 ℃, when feed liquid stock solution is concentrated 1/5, adds the dilute alcohol solution ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 9.
Get above-mentioned extractum and Moschus, evenly be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃ with adjuvant lactose, carrageenan and starch are mixed.In medicine liquid droplet to the 5 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.77min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 15
Crude drug Radix Salviae Miltiorrhizae 48.0g, Moschus 0.19g, Radix Ginseng 25.6g; Adjuvant xylitol 10.0g, lactose 3.0g, arabic gum 5.0g.
The Radix Salviae Miltiorrhizae of coarse pulverization and ginseng crude drug to extraction pot, are added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 75%, leaves standstill filtration.It is that 20000 PS membrane carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1Mpa.The feed liquid flow velocity is 1.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 1.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 0.5h ventilates once each 1 minute.Feed temperature is 15 ℃, when feed liquid stock solution is concentrated 1/15, adds the water ultrafiltration again 1 time, and the pH value of feed liquid is controlled at 6.
Get above-mentioned extractum and Moschus, evenly be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 84 ℃ with adjuvant xylitol, lactose and arabic gum are mixed.In medicine liquid droplet to the 7 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.55mi n of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 16
Crude drug Radix Salviae Miltiorrhizae 18.0g, Borneolum Syntheticum 0.26g, Radix Angelicae Sinensis 7.5g; Adjuvant sucrose ester 10.0g, polyoxyethylene monostearate 6.0g, cross-linking sodium carboxymethyl cellulose 1.0g, silica 1 .0g.
The Radix Salviae Miltiorrhizae of coarse pulverization and Radix Angelicae Sinensis medical material to extraction pot, are added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 70%, leaves standstill filtration.It is that 20000 PS membrane carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1Mpa.The feed liquid flow velocity is 1.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 1.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 0.5h ventilates once each 1 minute.Feed temperature is 15 ℃, when feed liquid stock solution is concentrated 1/15, adds the dilute alcohol solution ultrafiltration again 1 time, and the pH value of feed liquid is controlled at 6.
Get above-mentioned extractum and Borneolum Syntheticum,, mixed evenly be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 84 ℃ with adjuvant sucrose ester, polyoxyethylene monostearate, cross-linking sodium carboxymethyl cellulose and silicon dioxide.In medicine liquid droplet to the 7 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.57min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 17
Crude drug Radix Salviae Miltiorrhizae 23.0g, Lignum Dalbergiae Odoriferae oil 0.21g, Radix Astragali 27.0g; Adjuvant lactose 14.0g, tragakanta 5.0g.
Learn from else's experience Radix Salviae Miltiorrhizae and the Milkvetch Root of coarse pulverization to extraction pot, add the 0.88g sodium bicarbonate, add 4 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 4 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 70%, leaves standstill filtration.It is that 20000 polyvinylidene fluoride film carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/9, adds the water ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 7.5.
Get above-mentioned extractum and Lignum Dalbergiae Odoriferae oil, evenly mixed with adjuvant lactose and tragakanta, be heated to 65 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 85 ℃.In medicine liquid droplet to the 8 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.49min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 18
Crude drug Radix Salviae Miltiorrhizae 24.2g, muscone 0.28g, Radix Ginseng 10.0g; Adjuvant lactose 18.0g, pregelatinized Starch 4.5g.
The Radix Salviae Miltiorrhizae of coarse pulverization and ginseng crude drug to extraction pot, are added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 70%, leaves standstill, and filters, and filtrating is concentrated to obtain the extractum that relative density is 1.32～1.40 (55 ℃).
Get above-mentioned extractum and muscone, evenly mixed with adjuvant lactose and pregelatinized Starch, be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃.In medicine liquid droplet to the 7 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.81min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 19
Crude drug Radix Salviae Miltiorrhizae 26.2g, Borneolum Syntheticum 0.26g, Radix Codonopsis 13.8g; Adjuvant xylitol 15.0g, starch 5.0g.
Learn from else's experience Radix Salviae Miltiorrhizae and the codonopsis pilosula of coarse pulverization to extraction pot, add the 0.9g sodium bicarbonate, add 4 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 4 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 75%, leaves standstill, and filters, and filtrating is concentrated to obtain the extractum that relative density is 1.32～1.40 (55 ℃).
Get above-mentioned extractum and Borneolum Syntheticum, evenly mixed with adjuvant xylitol and starch, be heated to 65 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 85 ℃.In medicine liquid droplet to the 8 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.73min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 20
Crude drug Radix Salviae Miltiorrhizae 30.8g, Lignum Dalbergiae Odoriferae oil 0.25g, Herba Leonuri 8.0g; Adjuvant lactose 15.0g, arabic gum 3.0g.
With 70% ethanol extraction Radix Salviae Miltiorrhizae and Herba Leonuri medical material, obtain Radix Salviae Miltiorrhizae and Herba Leonuri ethanol extract, with this extracting liquid filtering, collect filtrating with gauze.It is that 20000 cellulose diacetate film carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The condition of above-mentioned ultrafiltration is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/8, adds the dilute alcohol solution ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 7.5.
Get above-mentioned extractum and Lignum Dalbergiae Odoriferae oil, evenly mixed with adjuvant lactose and arabic gum, be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 85 ℃.In medicine liquid droplet to the 6 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.60min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 21
Crude drug Radix Salviae Miltiorrhizae 46.5g, Moschus 0.24g, Radix Ginseng 8.5g; Adjuvant xylitol 16.0g, tragakanta 5.0g.
The Radix Salviae Miltiorrhizae and the people of coarse pulverization are participated in 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out the second time and extracts, and adds 4 times of water gagings, fries in shallow oil 1 hour, filters, and filtering residue discards, and merging filtrate gets Radix Salviae Miltiorrhizae and Radix Ginseng extractive solution, leaves standstill, and filters.It is that 60000 PS membrane carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/8, adds the water ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 7.5.
Get above-mentioned extractum and Moschus, evenly mixed with adjuvant xylitol and tragakanta, be heated to 60 ℃ of temperature, change material after 25 minutes, move in the dropping-pill machine jar that jar temperature remains on 89 ℃.In medicine liquid droplet to the 5 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.59min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 22
Crude drug Radix Salviae Miltiorrhizae 26.0g, Borneolum Syntheticum 0.21g, Herba Leonuri 10.0g; Adjuvant sucrose ester 10.0g, polyoxyethylene monostearate 8.0g.
With 80% ethanol extraction Radix Salviae Miltiorrhizae and Herba Leonuri, obtain Radix Salviae Miltiorrhizae and Herba Leonuri ethanol extract, with obtaining supernatant behind this extracting solution high speed centrifugation.It is that 50000 sulfonated polysulfone membrane carries out ultrafiltration that this liquid is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.5Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.25kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 4.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 50 ℃, when feed liquid stock solution is concentrated 1/5, adds the dilute alcohol solution ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 9.
Get above-mentioned extractum and Borneolum Syntheticum, evenly mixed with adjuvant sucrose ester and polyoxyethylene monostearate, be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃.In medicine liquid droplet to the 5 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.61min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 23
Crude drug Radix Salviae Miltiorrhizae 49.0g, Borneolum Syntheticum 0.20g, Radix Ginseng 6.0g; Adjuvant sucrose ester 15.0g, glyceryl monostearate 4.0g.
The Radix Salviae Miltiorrhizae of coarse pulverization and ginseng crude drug to extraction pot, are added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.It is that 60000 poly (ether sulfone) film carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/8, adds the water ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 7.5.
Get above-mentioned extractum and Borneolum Syntheticum, evenly mixed with adjuvant sucrose ester and glyceryl monostearate, be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃.In medicine liquid droplet to the 6 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.62min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 24
Crude drug Radix Salviae Miltiorrhizae 21.0g, Styrax 0.20g, Radix Angelicae Sinensis 9.0g; Adjuvant sucrose ester 10.0g, polyoxyethylene monostearate 2.0g, cross-linking sodium carboxymethyl cellulose 3.0g.
The Radix Salviae Miltiorrhizae of coarse pulverization and Radix Angelicae Sinensis medical material to extraction pot, are added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.It is that 60000 PS membrane carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.1Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.5kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1Mpa.The feed liquid flow velocity is 1.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 1.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 0.5h ventilates once each 1 minute.Feed temperature is 15 ℃, when feed liquid stock solution is concentrated 1/15, adds the water ultrafiltration again 1 time, and the pH value of feed liquid is controlled at 5.
Get above-mentioned extractum and Styrax, evenly be heated to 65 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃ with adjuvant sucrose ester, polyoxyethylene monostearate and cross-linking sodium carboxymethyl cellulose are mixed.In medicine liquid droplet to the 4 ℃ methyl-silicone oil, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.62min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 25
Crude drug Radix Salviae Miltiorrhizae 31.0g, muscone 0.18g, Radix Codonopsis 12.5g; Adjuvant lactose 10.0g, carrageenan 8.0g, starch 2.0g.
Learn from else's experience Radix Salviae Miltiorrhizae and the codonopsis pilosula of coarse pulverization to extraction pot, add the 0.89g sodium bicarbonate, add 4 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 4 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.It is that 50000 polysulfonamides film carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.5Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.25kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 4.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 50 ℃, when feed liquid stock solution is concentrated 1/5, adds the dilute alcohol solution ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 9.
Get above-mentioned extractum and muscone, evenly be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃ with adjuvant lactose, carrageenan and starch are mixed.In medicine liquid droplet to the 5 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.74min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 26
Crude drug Radix Salviae Miltiorrhizae 28.0g, Lignum Dalbergiae Odoriferae oil 0.20g, Herba Leonuri 8.0g; Adjuvant xylitol 10.0g, lactose 3.0g, arabic gum 5.0g.
The Radix Salviae Miltiorrhizae of coarse pulverization and Herba Leonuri medical material to extraction pot, are added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 75%, leaves standstill filtration.It is that 20000 PS membrane carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1Mpa.The feed liquid flow velocity is 1.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 1.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 0.5h ventilates once each 1 minute.Feed temperature is 15 ℃, when feed liquid stock solution is concentrated 1/15, adds the dilute alcohol solution ultrafiltration again 1 time, and the pH value of feed liquid is controlled at 6.
Get above-mentioned extractum and Lignum Dalbergiae Odoriferae oil, evenly be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 84 ℃ with adjuvant xylitol, lactose and arabic gum are mixed.In medicine liquid droplet to the 7 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.57min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 27
Crude drug Radix Salviae Miltiorrhizae 28.0g, Moschus 0.21g, Radix Ginseng 18.7g; Adjuvant sucrose ester 10.0g, polyoxyethylene monostearate 6.0g, cross-linking sodium carboxymethyl cellulose 1.0g, silica 1 .0g.
The Radix Salviae Miltiorrhizae of coarse pulverization and ginseng crude drug to extraction pot, are added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 70%, leaves standstill filtration.It is that 20000 PS membrane carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.1Mpa.The feed liquid flow velocity is 1.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 1.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 0.5h ventilates once each 1 minute.Feed temperature is 15 ℃, when feed liquid stock solution is concentrated 1/15, adds the dilute alcohol solution ultrafiltration again 1 time, and the pH value of feed liquid is controlled at 6.
Get above-mentioned extractum and Moschus,, mixed evenly be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 84 ℃ with adjuvant sucrose ester, polyoxyethylene monostearate, cross-linking sodium carboxymethyl cellulose and silicon dioxide.In medicine liquid droplet to the 7 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.62min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 28
Crude drug Radix Salviae Miltiorrhizae 23.0g, Lignum Dalbergiae Odoriferae oil 0.18g, Radix Ginseng 15.0g; Adjuvant lactose 14.0g, tragakanta 5.0g.
Learn from else's experience Radix Salviae Miltiorrhizae and the ginseng crude drug of coarse pulverization to extraction pot, add the 0.88g sodium bicarbonate, add 4 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 4 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into medicine liquid volume (L) and medical material weight (Kg) than being 1: 0.9～1.1, adds ethanol and makes medicinal liquid contain determining alcohol 70%, leaves standstill filtration.It is that 20000 polyvinylidene fluoride film carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/9, adds the water ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 7.5.
Get above-mentioned extractum and Lignum Dalbergiae Odoriferae oil, evenly mixed with adjuvant lactose and tragakanta, be heated to 65 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 85 ℃.In medicine liquid droplet to the 8 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.44min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 29
Crude drug Radix Salviae Miltiorrhizae 26.0g, Borneolum Syntheticum 0.32g; Adjuvant sucrose ester 10.0g.
With 80% ethanol extraction Radix Salviae Miltiorrhizae, obtain the Radix Salviae Miltiorrhizae ethanol extract, with obtaining supernatant behind this extracting solution high speed centrifugation.It is that 50000 sulfonated polysulfone membrane carries out ultrafiltration that this liquid is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.5Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.25kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 4.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 50 ℃, when feed liquid stock solution is concentrated 1/5, adds the water ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 9.
Get above-mentioned extractum and Borneolum Syntheticum, evenly mixed with adjuvant sucrose ester and polyoxyethylene monostearate, be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃.In medicine liquid droplet to the 5 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.64min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Embodiment 30
Crude drug Radix Salviae Miltiorrhizae 49.0g, Lignum Dalbergiae Odoriferae oil 0.27g; Adjuvant sucrose ester 8.0g, polyoxyethylene monostearate 12.0g.
The red rooted salvia of coarse pulverization to extraction pot, is added 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out second time and extracts, and adds 4 times of water gagings, fried in shallow oil 1 hour, and filtration, filtering residue discards, merging filtrate.It is that 60000 poly (ether sulfone) film carries out ultrafiltration that filtrating is used molecular cut off, and ultrafiltrate concentrates and obtains the extractum that relative density is 1.35～1.39 (55 ℃).The operating condition of ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kPa.The ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa.The feed liquid flow velocity is 3.0m/s, in the ultra-filtration process, adopts periodically flow fluctuation so that in membrane channels, produce pulsating flow or non-stationary flow; The flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous, forms the gas-liquid stream of pulses; Cycle is that 2h ventilates once each 1 minute.Feed temperature is 40 ℃, when feed liquid stock solution is concentrated 1/8, adds the water ultrafiltration again 2 times, and the pH value of feed liquid is controlled at 7.5.
Get above-mentioned extractum and Lignum Dalbergiae Odoriferae oil, evenly mixed with adjuvant sucrose ester and glyceryl monostearate, be heated to 60 ℃ of temperature, change material after 30 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃.In medicine liquid droplet to the 6 ℃ liquid paraffin, take out drop pill, oil removing, screen cloth selects ball, promptly gets.The result shows, prepared drop pill rounding, even, consistent, the no adhesion phenomenon of color and luster of size.By measuring under Chinese Pharmacopoeia version in 2000 the method disintegration item, the result does not add the average 2.67min of baffle plate through screen cloth, meets the pharmacopeia regulation this disintegration.
Claims (1)
1. a Chinese medicine dripping pills of treating angina pectoris is characterized in that, is prepared from the crude drug of following weight:
Crude drug Radix Salviae Miltiorrhizae 48g, Borneolum Syntheticum 0.25g
Radix Salviae Miltiorrhizae adds 5 times of water gagings, decocts 2 hours, filters, and filtering residue carries out second time and extracts, and adds 4 times of water gagings, fries in shallow oil 1 hour, filters, and filtering residue discards, and merging filtrate is that 50000 sulfonated polysulfone membrane carries out ultrafiltration with filtrating use molecular cut off, filter type employing cross flow filter,
The operating condition of wherein said ultrafiltration technology is: the inlet pressure of ultrafiltration is 0.35Mpa, and the liquid outlet pressure ratio inlet pressure of ultrafiltration hangs down 0.20kpa, and the ultrafiltration initial stage is adopted lower pressure, slowly boosts then; In ultra-filtration process, adopt the periodic pressure fluctuation, the pressure wave moment is 0.2Mpa, the feed liquid flow velocity is 3.0m/s; In the ultra-filtration process, adopt the fluctuation of periodicity flow so that in membrane channels, produce pulsating flow or non-stationary flow, the flow speed wave moment is 2.0m/s, feeds nitrogen in the ultrafiltration system discontinuous; Form the gas-liquid stream of pulses, the cycle is that 2h ventilates once, and each 1 minute, feed temperature was 40 ℃; When feed liquid stock solution is concentrated 1/8, add water or dilute alcohol solution ultrafiltration 2 times again, the ph value of feed liquid is controlled at 7.5, and backwashing pressure is 2.5Mpa; Backwashing period is 1.5h, and backwashing time is 10min, and when the method for alternately recoil was used in ultrafiltration module parallel connection, wherein a cover or several covers carried out ultrafiltration and distribute the recoil ultrafilter membrane of another set of or several grip assemblies of part filtrating; Exchange is carried out behind the certain interval of time, work 20min, recoil 3min; The Chemical cleaning cycle is 2 months, and the Chemical cleaning medicament is the mixed solution of 0.5%～4.0% sodium hydroxide, 1.5% sodium hydroxide and 2% sodium hypochlorite, and the ph value is 10～12; Cleaning pressure is 1.0Mpa, and after cleaning with chemical, the flushing of reuse water is near neutral;
It is 1.35～1.39 extractum that described ultrafiltrate is concentrated relative density when obtaining 55 ℃, gets extractum and Borneolum Syntheticum, with Polyethylene Glycol-6000 20g mix homogeneously; Be heated to 60 ℃ of temperature, change material after 40 minutes, move to during a dropping-pill machine that jar temperature remains on 90 ℃ irritates; In medicine liquid droplet to the 8 ℃ methyl-silicone oil, take out drop pill, oil removing; Screen cloth selects ball, processes 1000 drop pill, promptly gets.
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| CN1778341A (en) * | 2004-11-26 | 2006-05-31 | 天津天士力制药股份有限公司 | Medicine dropping ball for treating coronary heart disease and angina cordis |
| CN1778331A (en) * | 2004-11-26 | 2006-05-31 | 秦引林 | Compound injection from ice tablet and Danshen Root extract and its preparation thereof |
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| CN1778341A (en) * | 2004-11-26 | 2006-05-31 | 天津天士力制药股份有限公司 | Medicine dropping ball for treating coronary heart disease and angina cordis |
| CN1778331A (en) * | 2004-11-26 | 2006-05-31 | 秦引林 | Compound injection from ice tablet and Danshen Root extract and its preparation thereof |
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