CN100391452C - Red sage root preparation for injection and its preparation method - Google Patents
Red sage root preparation for injection and its preparation method Download PDFInfo
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Abstract
The present invention discloses an injected preparation agent of a red sage root and a preparation method. The injected preparation agent comprises injected liquid, a powder injected agent and a frozen dry power injected agent. The present invention is characterized in that the agent is mainly composed of a tanshinone hydroxypropyl beta-cyclodextrin containing compound and an aqueous extract of the red sage root, tanshinone lipid solubility ingredients in the red sage root is extracted by the supercritical fluid extraction technology, and the tanshinone is covered by hydroxypropyl beta-cyclodextrin (HP-beta-CD); thereby, the solubility and the content of the tanshinone ingredients in the injected liquid can be greatly improved so that the quality and the clinic treating effect of the injected preparation agent of the red sage root can be obviously improved. The injected preparation agent of the red sage root of the present invention has the advantages of high content for effective ingredients, high stability, and obvious treating effect.
Description
Affiliated technical field
The invention belongs to field of traditional Chinese medicine pharmacy, be specifically related to a kind of main component of injection of danshen preparation and the preparation method of ejection preparation thereof.
Background technology
Coronary heart disease, angina pectoris are commonly encountered diseases, frequently-occurring disease clinically, and along with the raising of people's living standard, sickness rate is the trend that rises year by year in recent years.Radix Salviae Miltiorrhizae is traditional blood circulation promoting and blood stasis dispelling conventional Chinese medicine, and being used for the treatment of cardiovascular system diseases such as angina pectoris, myocardial infarction clinically has good effect.Modern pharmacological research shows that the pharmacological action of Radix Salviae Miltiorrhizae mainly is to cardiovascular system, and the energy blood vessel dilating is accelerated blood flow, and microcirculation improvement changes viscosity of blood, increases blood supply of cardiac muscle amount, oxygen-supplying amount, reduction myocardial oxygen consumption etc.In addition, Radix Salviae Miltiorrhizae is also had effects such as antitumor, antibiotic, antiinflammatory.Therefore, the application of Radix Salviae Miltiorrhizae is very extensive.Pharmacological research shows to have the active effective site of blood circulation promoting and blood stasis dispelling in the Radix Salviae Miltiorrhizae two classes are arranged: fat-soluble tanshinone and water solublity salvianolic acid.Fat-soluble tanshinone: comprise compositions such as tanshinone, cryptotanshinone, Tanshinone I, dehydro tanshinone I.Pharmacological research shows that tanshinone has antiplatelet aggregative activity, anti thrombotic action and expeirmental myocardial ischemia and reperfusion injury are had protective effect.Sodium tanshinone IIA sulfate can be by the myocardial mitochondria calcium overload that calcium antagonism reduces or the inhibition isoproterenol causes; thereby play protective wire plastochondria and myocardial cell and cause the necrocytosis effect, and can promote synthesizing of ischemic myocardium ATP because of impacted by high calcium.Water solublity salvianolic acid: comprise compositions such as salvianolic acid A～C, rosmarinic acid and methyl ester thereof, danshensu, protocatechualdehyde, protocatechuic acid.Pharmacological research shows that the salvianolic acid constituents has antiplatelet aggregative activity, anti-thrombosis function, microcirculation improvement effect, anti-oxidative damage and multipath performance myocardium protecting action.
At present, Radix Salviae Miltiorrhizae Injection adopts decocting in water alcohol precipitation process (ministry standard WS
3-B-3766-98), because liposoluble constituent dissolubility in water is little or almost insoluble, so adopt aqueous extraction-alcohol precipitation technology liposoluble constituent major part not to be suggested or to propose seldom, and the injection less stable pH value often occurs behind the storage certain hour and changes, and appearance luster deepens, even appearance muddiness and precipitation etc., make clarity defective, therefore, the technology of Radix Salviae Miltiorrhizae Injection is needed badly and is improved and raising.
Supercritical fluid extraction is a kind of novel extraction isolation technics, and pharmaceutically active ingredient was not destroyed or takes place time biochemically during it can be preserved more in good condition, was particularly suitable for, the easily extraction of the Chinese medicine ingredients of oxidation Decomposition strong to heat sensitivity.Supercritical carbon dioxide extraction extraction efficiency height, when effective ingredient obtained enrichment, no solvent residue was convenient to control product quality.Therefore, adopt supercritical liquid extraction technique that the fat-soluble tanshinone component in the Radix Salviae Miltiorrhizae is extracted, can prevent, and have and extract advantage completely heat-labile TANSHINONES degraded.
Cyclodextrin forms the inclusion coordination compound with molecular structure and many guest molecules of its special " interior hydrophobic, outer hydrophilic ", pharmaceutically be mainly used in the stability of raising medicine in preparation, increase the dissolubility of insoluble drug in water etc., but (β-CD) low solubility of itself has limited its application to beta-schardinger dextrin-, and (HP-β-CD) derivant is considered to the most promising senior drug carrier material to hydroxypropyl beta cyclodextrin in numerous cyclodextrin derivative.The dissolubility 75% of HP-β-CD in water is far longer than β-CD1.85% (25 ℃), improves nearly 40 times than the water solubility of β-CD.Insoluble drug by the HP-β-CDBao He after, can not only increase the dissolubility and the dissolution velocity of medicine, can also improve drug bioavailability and stability.Zoopery shows that the safety of HP-β-CD own is good, have no side effect, and HP-β-CD is recorded as pharmaceutic adjuvant by American Pharmacopeia.Therefore, adopt tanshinone component in the HP-β-CDBao He injection of danshen preparation, can the little problem of fine solution tanshinone liposoluble constituent dissolubility in injection.
In conjunction with TANSHINONES instability in the injection of danshen preparation, degraded and the little characteristics of TANSHINONES dissolubility in water take place easily, the present invention adopts the fat-soluble tanshinone component in the supercritical fluid extraction extraction Radix Salviae Miltiorrhizae, TANSHINONES is adopted the hydroxypropyl enclose, adopt water to carry to the Radix Salviae Miltiorrhizae behind the supercritical extraction, make ejection preparation with tanshinone hydroxypropyl clathrate.Patent CN99117379 discloses active component supercritical CO 2 extraction technology method in the salviamiltiorrhizabung, adopt entrainer to extract TANSHINONES, the easy so bigger composition of polarity that extracts, and the objective of the invention is to extract fat-soluble tanshinone component for the HP-β-CDBao He, solve the problem that liposoluble constituent is insoluble in water.Patent CN01141436.7 has reported the preparation method of water soluble tanshinone, adopt the ethanol extraction Radix Salviae Miltiorrhizae, directly use beta-cyclodextrin inclusion compound then, more because of the composition that adopts ethanol extraction to go out, except that tanshinone component was arranged, water soluble ingredient such as danshensu, protocatechualdehyde etc. also can be proposed by ethanol, such beta-cyclodextrin inclusion compound of directly using, do not have specific aim, and the required beta-schardinger dextrin-amount of enclose is bigger, the enclose effect is also undesirable.The present invention adopts supercritical extraction to extract the tanshinone liposoluble constituent, adopts HP-β-CD to carry out enclose targetedly, and it is better than adopting β-CDBao He to adopt the HP-β-CDBao He, and its water solublity is greatly enhanced, and improves about 40 times.Adopt supercritical fluid technology to extract the tanshinone component in the Radix Salviae Miltiorrhizae and it is adopted the hydroxypropyl enclose, increased its stability and water solublity; Therefore, by the present invention, solved that TANSHINONES dissolubility in injection is little, content is few, problem of unstable, made preparation more stable, active constituent content improves greatly, thereby the quality of preparation finished product and clinical efficacy are guaranteed.
Summary of the invention
The object of the present invention is to provide a kind of active constituent content height, stable, rational injection of danshen preparation of preparation technology and preparation method thereof.The present invention adopts the tanshinone effective ingredient in the co_2 supercritical fluid extraction technology extraction Radix Salviae Miltiorrhizae, utilize hydroxypropyl (HP-β-CD) it is carried out enclose, thereby promoted the dissolubility of tanshinone component in injection, solve liposoluble constituent and in injection, dissolved difficult problem, improved the quality and the clinical efficacy of preparation.Red rooted salvia powder behind the supercritical fluid extraction is decocted with water extraction, after the water extract concentrates, precipitate with ethanol purification secondary, be concentrated in right amount, add TANSHINONES HP-beta-CD inclusion, stir, activated carbon decolorizing with 0.2%, filter, low-temperature vacuum drying or lyophilization promptly get the main component of injection of danshen preparation.Get the main component of injection of danshen preparation, add the injection water and make dissolving, it is an amount of to add tween 80, regulates pH value, filter, and fill, sterilization promptly gets Radix Salviae Miltiorrhizae Injection; Get the main component of injection of danshen preparation, add an amount of water for injection dissolving, add an amount of freeze-dried excipient, lyophilization promptly gets red sage root freezing-dried powder injection.Injection of danshen preparation of the present invention, the active constituent content height, evident in efficacy.
The present invention is achieved through the following technical solutions:
One, the pre-treatment of medical material
Get red rooted salvia, selection,, oven dry clean with deionized water are ground into coarse powder.
Two, extraction, preparation technology
1, get the Radix Salviae Miltiorrhizae coarse powder, put in the supercritical fluid extraction device, extraction 2h gets the red sage root super critical extract; Get the red sage root super critical extract, use an amount of dissolve with ethanol, join in saturated HP-β-CD solution, constant temperature stirs certain hour, and put the refrigerator and cooled Tibetan and spend the night, sucking filtration, cold drying gets HP-beta-CD inclusion powder.Get the Radix Salviae Miltiorrhizae coarse powder behind the supercritical extraction, with deionization water boiling and extraction three times, extracting solution merges, and is evaporated to the crude drug that every 1ml is equivalent to 2g, puts coldly, slowly adds ethanol and makes and contain the alcohol amount and reach 75%, and cold preservation is left standstill, and filters; The supernatant decompression recycling ethanol, being concentrated into relative density of medicine liquid is 1.15-1.20 (50 ℃), puts coldly, adds ethanol and makes and contain the alcohol amount and reach 80-85%, cold preservation is left standstill, and filters, decompression filtrate recycling ethanol is to doing, the Radix Salviae Miltiorrhizae water extract, standby.TANSHINONES HP-beta-CD inclusion and Radix Salviae Miltiorrhizae water extract are dissolved with an amount of water for injection, and the active carbon with 0.2% boiled 30 minutes, filter, vacuum dehydrating at lower temperature and/or lyophilization, the main component of injection of danshen preparation.
Get the main component of injection of danshen preparation, with an amount of water for injection dissolving, the adding tween 80 is an amount of, filters, and regulates pH value, filter, and embedding, sterilization promptly gets Radix Salviae Miltiorrhizae Injection.
Get the main component of injection of danshen preparation, add an amount of water for injection dissolving, add an amount of freeze-dried excipient, stir evenly, filter, regulate pH value, filter, fill, lyophilization promptly gets the Radix Salviae Miltiorrhizae for injection freeze-dried powder.
2, the injection of danshen preparation mainly is made up of tanshinone hydroxypropyl clathrate, salvia-soluble effective ingredient.
3, tanshinone hydroxypropyl clathrate adopts the tanshinone component in the supercritical extraction technique extraction Radix Salviae Miltiorrhizae, utilizes paddling process to carry out enclose with hydroxypropyl.
4, a kind of red-rooted salvia injection freeze-dried powder, its freeze-dried excipient can be the mixture of a kind of in mannitol and the lactose or two kinds.
The injection of danshen preparation is to the influence of Acute Myocardial Ischemia in Rats
1, experimental apparatus and material
Animal: Wistar rat; The pituitrin injection, Beijing biochemical-pharmaceutical factory is produced.
2, method and result
2.1 the injection of danshen preparation is to the influence of rat ischemia ECG T wave due to the pituitrin: get 40 of body weight 250～300g Wistar rats, male and female half and half are divided into 4 groups at random, and 10 every group, ip administration 7d continuously, dosage sees Table 1.Each treated animal is behind last administration 30min, and lumbar injection 25% urethane 0.4ml/100g anaesthetizes, and it is fixing to lie on the back, normal voltage 1mv=15mm, chart drive speed 50mm/s, record II lead electrocardiogram.Sublingual vein injection of pituitrin 0.75u/kg has injected in 5s.Electrocardiogram of every 30s record.In the rat intravenous injection pituitrin 1min, great majority show as decreased heart rate, and the T wave height is alarmmed, and the ST section such as raises at variation.Observe the variation that 30s, 1min and 50min go up T ripple propagation before and after the medication respectively, from the influence of table 1 Radix Salviae Miltiorrhizae Injection and injection of danshen preparation of the present invention to rat ischemia ECG T wave due to the pituitrin.
Compare with the normal saline group: * P＜0.05, * * P＜0.01
Can find out from above result, the T ripple propagation when Radix Salviae Miltiorrhizae Injection of the present invention can significantly reduce 30s, 1min and 5min is more obvious than common Radix Salviae Miltiorrhizae Injection effect.
Concrete form of implementation
Embodiment 1
1, prescription Radix Salviae Miltiorrhizae 1500g
2, extract: get above-mentioned recipe quantity medical material, selection,, oven dry clean with deionized water are ground into coarse powder.Get the Radix Salviae Miltiorrhizae coarse powder, put in the supercritical fluid extraction device, with the extracting pressure of 22Mpa, 45 ℃ extraction temperature extraction 2 hours gets the red sage root super critical extract.Get the red sage root super critical extract, use an amount of dissolve with ethanol, join in saturated HP-β-CD solution, 50 ℃ of constant temperature are stirred to the appearance muddiness, continue to stir 1.5h, and put the refrigerator and cooled Tibetan and spend the night, sucking filtration, cold drying gets HP-beta-CD inclusion powder; Get the Radix Salviae Miltiorrhizae medicated powder behind the supercritical extraction, with deionization water boiling and extraction three times, extracting solution merges, and is evaporated to every 1ml and is equivalent to 2 crude drug, slowly adds ethanol and makes and contain the alcohol amount and reach 75%, and cold preservation is left standstill, and filters; The supernatant decompression recycling ethanol, being concentrated into relative density of medicine liquid is 1.15-1.20 (50 ℃), adds ethanol and makes and contain the alcohol amount and reach 85%, cold preservation is left standstill, and filters, decompression filtrate recycling ethanol is to doing, the Radix Salviae Miltiorrhizae water extract, standby.TANSHINONES HP-beta-CD inclusion and Radix Salviae Miltiorrhizae water extract are dissolved with an amount of water for injection, and the active carbon with 0.2% boiled 30 minutes, filter, vacuum dehydrating at lower temperature and/or lyophilization, the main component of injection of danshen preparation.
3, preparation
(1) preparation of Radix Salviae Miltiorrhizae Injection: get the main component of injection of danshen preparation, with the dissolving of an amount of water for injection, it is an amount of to add tween 80 again, stirs evenly, and filters, and regulates pH value, filters, and adds the injection water to 1000ml, embedding, and sterilization promptly gets Radix Salviae Miltiorrhizae Injection.
(2) preparation of red sage root freezing-dried powder injection: get the main component of injection of danshen preparation, add an amount of water for injection dissolving, add freeze-dried excipient mannitol 30g, stir evenly, filter, regulate pH value, filter, sterilization, lyophilization promptly gets the Radix Salviae Miltiorrhizae for injection lyophilized injectable powder.
(3) preparation of Radix Salviae Miltiorrhizae sterile powder injection: get the main component of injection of danshen preparation, aseptic subpackaged, promptly.
Embodiment 2
1, prescription Radix Salviae Miltiorrhizae 1500g
2, extract: get above-mentioned recipe quantity medical material, selection,, oven dry clean with deionized water are ground into coarse powder.Get the Radix Salviae Miltiorrhizae coarse powder, put in the supercritical fluid extraction device, with the extracting pressure of 22Mpa, 45 ℃ extraction temperature extraction 2 hours gets the red sage root super critical extract.Get the red sage root super critical extract, use an amount of dissolve with ethanol, join in saturated HP-β-CD solution, 50 ℃ of constant temperature are stirred to the appearance muddiness, continue to stir 1.5h, and put the refrigerator and cooled Tibetan and spend the night, sucking filtration, cold drying gets HP-beta-CD inclusion powder; Get the Radix Salviae Miltiorrhizae medicated powder behind the supercritical extraction, with deionization water boiling and extraction three times, extracting solution merges, and is evaporated to the crude drug that every 1ml is equivalent to 2g, slowly adds ethanol and makes and contain the alcohol amount and reach 75%, and cold preservation is left standstill, and filters; The supernatant decompression recycling ethanol, being concentrated into relative density of medicine liquid is 1.15-1.20 (50 ℃), adds ethanol and makes and contain the alcohol amount and reach 85%, cold preservation is left standstill, and filters, decompression filtrate recycling ethanol is to doing, the Radix Salviae Miltiorrhizae water extract, standby.TANSHINONES HP-beta-CD inclusion and Radix Salviae Miltiorrhizae water extract are dissolved with an amount of water for injection, and the active carbon with 0.2% boiled 30 minutes, filter, vacuum dehydrating at lower temperature and/or lyophilization, the main component of injection of danshen preparation.
3, preparation
(1) preparation of Radix Salviae Miltiorrhizae Injection: get the main component of injection of danshen preparation, with the dissolving of an amount of water for injection, it is an amount of to add tween 80 again, stirs evenly, and filters, and regulates pH value, filters, and adds the injection water to 1000ml, embedding, and sterilization promptly gets Radix Salviae Miltiorrhizae Injection.
(2) preparation of red sage root freezing-dried powder injection: get the main component of injection of danshen preparation, add an amount of water for injection dissolving, add freeze-dried excipient mannitol 20g, lactose 10g, stir evenly, filter, regulate pH value, filter, sterilization, lyophilization promptly gets the Radix Salviae Miltiorrhizae for injection lyophilized injectable powder.
(3) preparation of Radix Salviae Miltiorrhizae sterile powder injection: get the main component of injection of danshen preparation, aseptic subpackaged, promptly.
Embodiment 3
1, prescription Radix Salviae Miltiorrhizae 1500g
2, extract: get above-mentioned recipe quantity medical material, selection,, oven dry clean with deionized water are ground into coarse powder.Get the Radix Salviae Miltiorrhizae coarse powder, put in the supercritical fluid extraction device, with the extracting pressure of 22Mpa, 45 ℃ extraction temperature extraction 2 hours gets the red sage root super critical extract.Get the red sage root super critical extract, use an amount of dissolve with ethanol, join in saturated HP-β-CD solution, 50 ℃ of constant temperature are stirred to the appearance muddiness, continue to stir 1.5h, and put the refrigerator and cooled Tibetan and spend the night, sucking filtration, cold drying gets HP-beta-CD inclusion powder; Get the Radix Salviae Miltiorrhizae medicated powder behind the supercritical extraction, with deionization water boiling and extraction three times, extracting solution merges, and is evaporated to the crude drug that every 1ml is equivalent to 2g, slowly adds ethanol and makes and contain the alcohol amount and reach 75%, and cold preservation is left standstill, and filters; The supernatant decompression recycling ethanol, being concentrated into relative density of medicine liquid is 1.15-1.20 (50 ℃), adds ethanol and makes and contain the alcohol amount and reach 85%, cold preservation is left standstill, and filters, decompression filtrate recycling ethanol is to doing, the Radix Salviae Miltiorrhizae water extract, standby.TANSHINONES HP-beta-CD inclusion and Radix Salviae Miltiorrhizae water extract are dissolved with an amount of water for injection, and the active carbon with 0.2% boiled 30 minutes, filter, vacuum dehydrating at lower temperature and/or lyophilization, the main component of injection of danshen preparation.
3, preparation
(1) preparation of Radix Salviae Miltiorrhizae Injection: get the main component of injection of danshen preparation, with the dissolving of an amount of water for injection, it is an amount of to add Tween 80 again, stirs evenly, and filters, and regulates pH value, filters, and adds the injection water to 1000ml, embedding, and sterilization promptly gets Radix Salviae Miltiorrhizae Injection.
(2) preparation of red sage root freezing-dried powder injection: get the main component of injection of danshen preparation, add an amount of water for injection dissolving, add freeze-dried excipient lactose 40g, stir evenly, filter, regulate pH value, filter, sterilization, lyophilization promptly gets the Radix Salviae Miltiorrhizae for injection lyophilized injectable powder.
(3) preparation of Radix Salviae Miltiorrhizae sterile powder injection: get the main component of injection of danshen preparation, aseptic subpackaged, promptly.
Claims (2)
1. the preparation method of an injection of danshen preparation is characterized in that being finished by following step:
(1) get the Radix Salviae Miltiorrhizae coarse powder, put in the supercritical fluid extraction device, extraction 2h gets the red sage root super critical extract; Get the red sage root super critical extract, use an amount of dissolve with ethanol, join in the saturated hydroxypropyl solution, constant temperature stirs certain hour, and put the refrigerator and cooled Tibetan and spend the night, sucking filtration, cold drying gets tanshinone hydroxypropyl clathrate powder; Get the Radix Salviae Miltiorrhizae coarse powder behind the supercritical extraction, with deionization water boiling and extraction three times, extracting solution merges, and is evaporated to the crude drug that every 1ml is equivalent to 2g, puts coldly, slowly adds ethanol and makes and contain the alcohol amount and reach 75%, and cold preservation is left standstill, and filters; The supernatant decompression recycling ethanol, being concentrated into medicinal liquid relative density in the time of 50 ℃ is 1.15-1.20, puts coldly, adds ethanol and makes and contain the alcohol amount and reach 80-85%, cold preservation is left standstill, and filters, decompression filtrate recycling ethanol is to doing, water-soluble extract of red sage root, standby; Tanshinone HP-beta-CD inclusion and water-soluble extract of red sage root are dissolved with an amount of water for injection, and the active carbon with 0.2% boiled 30 minutes, filter, vacuum dehydrating at lower temperature and/or lyophilization, the main component of injection of danshen preparation;
(2) preparation of Radix Salviae Miltiorrhizae Injection: get the main component of injection of danshen preparation, with an amount of water for injection dissolving, it is an amount of to add tween 80, filters, and regulates pH value, embedding, and sterilization, promptly;
The preparation of red sage root freezing-dried powder injection: get the main component of injection of danshen preparation, with the dissolving of an amount of water for injection, add a kind of or two kinds mixture in an amount of mannitol and the lactose, mixing filters, and regulates pH value, fill, and lyophilization, gland, promptly.
2. injection of danshen preparation that preparation method according to claim 1 makes.
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| CN100391452C true CN100391452C (en) | 2008-06-04 |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100423711C (en) * | 2006-09-08 | 2008-10-08 | 秦引林 | Sodium sulfonate injection of tanshinone IIA, and preparation method |
| CN107625787B (en) * | 2017-09-22 | 2019-08-30 | 广东药科大学 | A kind of pharmaceutical composition for treating tympanitis |
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| CN1256142A (en) * | 1999-11-26 | 2000-06-14 | 化学工业部西南化工研究设计院 | Supercritical CO2 extraction process of the active component in red sage as one Chinese medicine material |
| CN1410068A (en) * | 2001-09-25 | 2003-04-16 | 房其年 | Preparation method of water soluble tanshinone |
| CN1421239A (en) * | 2002-12-23 | 2003-06-04 | 北京采瑞医药有限公司 | Compound red sage prepn for treating cardiac and cerebral vascular diseases and its prepn process |
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2003
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1256142A (en) * | 1999-11-26 | 2000-06-14 | 化学工业部西南化工研究设计院 | Supercritical CO2 extraction process of the active component in red sage as one Chinese medicine material |
| CN1410068A (en) * | 2001-09-25 | 2003-04-16 | 房其年 | Preparation method of water soluble tanshinone |
| CN1421239A (en) * | 2002-12-23 | 2003-06-04 | 北京采瑞医药有限公司 | Compound red sage prepn for treating cardiac and cerebral vascular diseases and its prepn process |
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| 丹参制剂的研究现状及对其开发的几点思考. 张军等.中草药，第32卷第10期. 2001 |
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| 丹参注射液及其活性成分与低强度He-Ne激光联用对牛中性粒细胞呼吸暴发的抑制效应. 李艳玲等.中国中医基础医学杂志，第9卷第9期. 2003 * |
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