CN1264533C - Radix salvia miltiorrhiza capsule compound and method for preparing same - Google Patents
Radix salvia miltiorrhiza capsule compound and method for preparing same Download PDFInfo
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- CN1264533C CN1264533C CN 02111976 CN02111976A CN1264533C CN 1264533 C CN1264533 C CN 1264533C CN 02111976 CN02111976 CN 02111976 CN 02111976 A CN02111976 A CN 02111976A CN 1264533 C CN1264533 C CN 1264533C
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Abstract
The present invention belongs to the pharmacy technical field of traditional Chinese medicines, particularly to a compound red sage root capsule and a preparing method thereof. The compound red sage root capsule of the present invention is composed of the active ingredients of red sage root, notoginseng and borneol and medical adjuvant materials, wherein the extracting liquid of the active ingredients is obtained by mixing the borneol, and the red sage root and the notoginseng after the extracting separation of CO2 supercritical fluid. The compound red sage root capsule of the present invention uses the technology of CO2 supercritical extracting separation for greatly increasing the extracting rate of the active ingredients in the prescription, and has the characteristics of low administration dosage, easy control on the content of effective ingredients, good visual effect and mouth feeling and obvious treating effect. The present invention is particularly suitable for clinically preventing and treating coronary heart diseases.
Description
Technical field:
The invention belongs to the Chinese medicine preparation technical field.Be specifically related to a kind of FUFANG DANSHEN JIAONANG and preparation method.
Background technology:
FUFANG DANSHEN PIAN is come out for many years, is used for clinical treatment, and curative effect is more definite, but exists some problems in the preparation of said preparation:
1. Radix Salviae Miltiorrhizae need be carried once the 5 hours time of three extractions through extraction of ethanol secondary back and water; It is concentrated, dry to extract back recovery ethanol medicinal liquid, makes extractum, in these processes, medical material is boiled extraction, concentrates and receives the temperature required height of cream drying process, time is long, in the medical material some is destroyed light, heat-labile composition, thereby made the product activity component content lower;
2. it is covert to relate to multistep in whole extraction and the dry run, especially when large-scale production owing to receive cream and dryly lack quantized quality control standard, usually in medicated powder, have the part coking with and the comparatively thick outward appearance of medicated powder granule;
3. operations such as the extraction before the fill, receipts cream, especially drying are many, long flow path, and production efficiency is low, and energy resource consumption is big;
4. solvent ethanol consumption is big more with discharging large quantity of exhaust gas, waste water and waste liquid environmental pollution composition.
5. dosage is bigger 3～5 slices/time, and 9～15 slices/day, it is all not too convenient to carry and transport.
Summary of the invention:
Technical problem to be solved by this invention is to overcome above-mentioned not middle part, improves preparation method, obtains effective component content height, the measured FUFANG DANSHEN JIAONANG of matter.
The invention provides a kind of compound recipe capsule, it is characterized in that this FUFANG DANSHEN JIAONANG is by 60～65% Radix Salviae Miltiorrhizaes, 24～32% Radix Notoginseng and 8～11% Borneolum Syntheticums are formed as active ingredient and pharmaceutic adjuvant.It is that 0.620～0.582mg, tanshinone are 0.30～0.25mg, protocatechualdehyde 0.020～0.016mg that wherein every capsules contains danshensu.
Another object of the present invention has provided the preparation method of above-mentioned a kind of FUFANG DANSHEN JIAONANG, and this method comprises the following steps:
1. the preparation of active ingredient extract
(1) CO of Radix Salviae Miltiorrhizae, Radix Notoginseng
2Supercritical extraction
Take by weighing Radix Salviae Miltiorrhizae and Radix Notoginseng two flavor medical materials respectively by recipe quantity, break into the coarse powder shape, be respectively charged in the extraction cylinder,, extract 60～90 minutes, collect the first medicinal liquid of extraction with T:60～70 ℃, P:25～35Mpa.
With the Radix Salviae Miltiorrhizae after the extraction first through 60～70 ℃ of insulation 6～24h, with above-mentioned extraction conditions CO once more
2Supercritical extraction 60～90 minutes is collected and is extracted medicinal liquid for the second time.
Merge the extraction medicinal liquid and behind vacuum filtration, carry out concentrating under reduced pressure, o'clock be the whole medicinal liquid of extraction to density 1.2～1.3.
(2) Borneolum Syntheticum grinds not
(3) preparation of medicinal liquid
To extract whole liquid, and mix stir in water-bath, and be treated to uniform suspension through suspending, and at last the Borneolum Syntheticum fine powder slowly be added in the medicinal liquid to suspension, content of Danshensu is greater than 0.50% in the suspension, and tanshinone content is greater than 0.25%.
2. the preparation of capsule
(1) hard capsule preparation
Measure the medicinal liquid of above-mentioned preparation by prescription, add pharmaceutic adjuvant, make granule, drying, fill promptly gets hard capsule.
(2) soft capsule preparation
Get gelatin and add an amount of distilled water its suction is fully expanded, mix homogeneously, making it to dissolve becomes uniform gelatin solution, leave standstill, and with the seasonal adjustment gelatin viscosity.
With the gelatin solution that has prepared, put in the gelatin storage tank, be controlled at about 50～65 ℃, the medicinal liquid for preparing is poured in the liquor tank, adopted soft capsule maker pill, require to adjust the uniformity of rubber weight and rubber before the fill, make the beginning pill that meets the requirements, fill system soft capsule.
The soft gelatin capsule that fill becomes is inserted the dry rotating cage of rustless steel equably.Frame dish or rotating cage are inserted in dry setting more equably, and through dehumidifying, drying, lamp inspection selects ball, polishing, removes not specification scrap rubber ball, packing after quality inspection is qualified.
Pharmaceutic adjuvant described in the inventive method is conventional adjuvant, and entrainer is that the active ingredient danshensu and the tanshinone content that make with the inventive method of 80-95% is measured:
(1) assay in the medical material
The tanshinone of red rooted salvia has carried out repeatedly measuring, tanshinone content＞0.2% of testing result red rooted salvia,
(2) extract blank assay result
Blank sample is removed the extract blank of Radix Salviae Miltiorrhizae or pseudo-ginseng respectively.To lack blank need testing solution of Radix Salviae Miltiorrhizae or Radix Notoginseng and sample need testing solution sample introduction successively, the result shows and does not contain tanshinone, danshensu in the blank sample solution that lacks Radix Salviae Miltiorrhizae or do not contain and do not disturb the content of Danshensu in the compound Salviae Miltiorrhizae soft capsule (novel) to measure.
(3) the extract content of Danshensu is measured:
Other gets the blank extract sample introduction of scarce Radix Notoginseng of preparation again, and content of Danshensu is the 0.582mg/ grain in its sample, and tanshinone content is the 0.25mg/ grain.
4. novel compound capsule of red sage root of the present invention is compared with the Radix Salviae Miltiorrhizae Tabellae that former extraction process makes has significant advantage:
CO
2Supercritical liquid extraction technique is to be used for food industry and to be applied to new technique in the pharmaceuticals industry gradually from the seventies in 20th century beginning in the world, using in China's pharmaceuticals industry only is the stage at the early-stage, and it can extract and the part water soluble ingredient than abundant and completeness fat-soluble composition.
(1) protects in the medical material light, heat-labile composition
CO
2The supercritical fluid extraction temperature is controlled at below 70 ℃, be fit to for wet, heat, heliosensitivity and aroma substance (as Radix Salviae Miltiorrhizae, the pseudo-ginseng of this preparation) extraction separation, adopts such extractive technique can overcome former extraction boil, receive cream and drying process to wet, the destruction of hot, heliosensitivity and fragrant ingredient.
(2) some compositions of medical material extract more fully and are complete
CO
2The solvability of supercritical fluid extraction changes along with the change of temperature and pressure, therefore can be by adjusting temperature, pressure and CO
2Flow realizes that selective extraction separates, and some component extraction separation in the medical material is got more fully with abundant.Radix Salviae Miltiorrhizae in this preparation recipe mainly contains phenoloid and crystallinity phenanthrenequione compounds: Tanshinone I, tanshinone, Tanshinone II B, cryptotanshinone, hydroxyl tanshinone, Methyl tanshinoate, iso tanshinone I, iso tanshinone IIA, water-soluble portion also contains effective ingredient such as danshensu and protocatechualdehyde in addition.The water solublity injection and the tablet of clinical practice, its effective ingredient mainly are phenol type chemical compounds.Existing bibliographical information utilizes CO
2Tanshinone in the supercritical fluid extraction Radix Salviae Miltiorrhizae, but also do not have bibliographical information to utilize CO
2The supercritical extraction aqueous soluble active constituent.Through CO
2Supercritical extraction, confirmation can be used CO
2Supercritical liquid extraction technique effectively extracts and separates, by the operation of this process conditions receive unsustainable effective ingredient cryptotanshinone, danshensu and protocatechualdehyde in the former Radix Salviae Miltiorrhizae Tabellae.
(3) Radix Notoginseng in this preparation recipe mainly contains saponin component, has selected for use the ethanol insulation to extract, and the medicinal residues after the extraction are more moistening, again through CO
2Supercritical extraction makes effective ingredient than purifying more completely, differentiates by thin layer chromatography, with the feature speckle that detects obvious same color on the corresponding position of reference substance chromatograph, has guaranteed that the quality of the pharmaceutical preparations is stable.
(4) quality standard of raising preparation
Because CO
2Supercritical fluid extraction separates more fully, on quality standard, be significantly increased, only can differentiate Radix Salviae Miltiorrhizae and 2 kinds of medical materials of Radix Ginseng soap ribbon as former FUFANG DANSHEN JIAONANG, and by after the supercritical fluid extraction technological transformation, new preparation can both be differentiated Radix Salviae Miltiorrhizae, Radix Notoginseng and 3 kinds of components of Borneolum Syntheticum of said preparation.
(5) reduce cost such as the preparation energy
CO
2The supercritical fluid extraction operation is few, flow process is short, operation sequenceization and efficient height, can reduce the energy, water, ethanol consumption and save the labour force, reduces cost.
(6) minimizing is to the pollution CO of environment
2
CO
2Colourless, tasteless, nontoxic and no solvent residue, CO
2Can utilize again by refluxing.Medical material is through CO
2Only leave over exsiccant crude drug behind the supercritical fluid extraction, do not produce the three wastes basically.
(7) taking dose diminishes, and patient easily swallows
FUFANG DANSHEN JIAONANG of the present invention adopts CO
2The supercritical extraction isolation technics, active ingredient extraction yield in the prescription is improved greatly, it is little to have taking dose, effective component content is easy to control, the soft capsule of preparation of the present invention has good economic benefit and social benefit, visual effect and mouthfeel are good, and characteristics evident in efficacy more are applicable to clinical prevention coronary heart disease.
Red FUFANG DANSHEN JIAONANG of the present invention and FUFANG DANSHEN PIAN related item comparison sheet
| Project | FUFANG DANSHEN JIAONANG | FUFANG DANSHEN PIAN |
| Dosage form | Capsule (soft, hard capsule) | Tablet |
| Medical material consumption (g) | 599 | 599 |
| Extraction separation method | CO 2Supercritical fluid extraction, alcohol extraction | Alcohol, water extraction |
| Solvent load (ml) | Ethanol 3153, water 540, CO 25kg | Ethanol 4500, water 3000 |
| Abstraction process (road) | 3 | 4 |
| Extract (h) | Alcohol, water extraction 35 | Alcohol, water extraction 8 |
| Concentrate (h) | 1 | 72 |
| Dry (h) | 0 | 72 |
| Amount to (h) | 36 | 152 |
| Character | Magneta colour suspendible medicinal liquid | The brown powder |
| Preparation is differentiated | Tanshinone, cryptotanshinone, ginsenoside Rg 1、Rb 1, Panax Notoginseng saponin R 1, Borneolum Syntheticum | Tanshinone, ginsenoside Rg 1、Rb 1Panax Notoginseng saponin R 1, Borneolum Syntheticum |
| Tanshinone contains in the preparation | (internal control index) | (Chinese Pharmacopoeia) |
| Amount (mg/ grain) | ≥0.25mg | ≥0.20mg |
| Content of Danshensu in the preparation (mg/ grain) | 0.582mg | / |
| Preparation Central Plains catechu aldehyde (mg/ grain) | 0.018mg | / |
| Medication dose (g/ time) | ||
| Granulation quantity (grain) | 500 | 1000 |
| Clinical usage | 1/time (0.25/), 3 times/day | 3 slices/time (0.6/), 3 times/day |
| Suitable crude drug amount | 3.6g/ day dosage | 5.4g/ day dosage |
The specific embodiment:
Example 1
Feed intake with 60% Radix Salviae Miltiorrhizae active component and 32% active component, break into coarse powder, add CO respectively
2Supercritical fluid extraction equipment extracts, to reclaim ethanol after P:30Mpa, the T70 ℃ extraction to the relative density 1.2-1.3.The extract of getting above-mentioned two flavor medical materials mixes stirring in about 50～60 ℃ of water-baths, soybean lecithin limit with 8% adds limit stirring in the medicinal liquid, treat whole mixings, insulation. other gets edible refined oil and heats in the low temperature water-bath and stir evenly, at last with the into the liquid suspension that is mixed into uniformity and good fluidity of borneol powder, suspension is granulated into the soft capsule of 0.25/ ball, and the granulate drying promptly gets the soft capsule finished product.
Example 2
Feed intake with 65% Radix Salviae Miltiorrhizae active component and 29% active component, break into coarse powder, add CO respectively
2Supercritical fluid extraction equipment extracts, to reclaim ethanol after P:28Mpa, the T60 ℃ extraction to relative density about 1.4.The extract of getting above-mentioned two flavor medical materials mixes stirring in about 50～60 ℃ of water-baths, soybean lecithin limit with 6% adds limit stirring in the medicinal liquid, treat behind whole mixings through being spray dried to fine-powdered, borneol powder is gone in the medicated powder to be mixed, with medicated powder: the starch excipient is equivalent to carry out at 1.5: 1.0 batch mixing, granulation, fill becomes 0.25/ hard capsule, and granulate promptly gets the hard capsule finished product.
Example 3
Feed intake with 64% Radix Salviae Miltiorrhizae active component and 32% active component, break into coarse powder, add CO respectively
2Supercritical fluid extraction equipment extracts, to reclaim ethanol after P:30Mpa, the T65 ℃ extraction to relative density about 1.4.The extract of getting above-mentioned two flavor medical materials mixes stirring in about 50～60 ℃ of water-baths, soybean lecithin limit with 4% adds limit stirring in the medicinal liquid, treat behind whole mixings through being spray dried to fine-powdered, borneol powder is gone in the medicated powder to be mixed, with medicated powder: the starch excipient is equivalent to carry out at 1.5: 1.0 batch mixing, granulation, tabletting is 0.25/ a tablet, and granulate promptly gets the tablet finished product.
Claims (2)
1, a kind of FUFANG DANSHEN JIAONANG is characterized in that what this FUFANG DANSHEN JIAONANG was made by following method:
(1) raw material: 60～65% Radix Salviae Miltiorrhizaes, 24～32% Radix Notoginseng and 8～11% Borneolum Syntheticums
1. the CO of Radix Salviae Miltiorrhizae, Radix Notoginseng
2Supercritical extraction
Take by weighing Radix Salviae Miltiorrhizae and Radix Notoginseng two flavor medical materials respectively, break into the coarse powder shape, be respectively charged in the extraction cylinder,, extract 60～90 minutes, collect the first medicinal liquid of extraction with T:60～70 ℃, P:25～35Mpa,
With the Radix Salviae Miltiorrhizae after the extraction first through 60～70 ℃ of insulation 6～24h, with above-mentioned extraction conditions CO once more
2Supercritical extraction 60～90 minutes is collected and to be extracted medicinal liquid for the second time, merges the extraction medicinal liquid and carry out concentrating under reduced pressure behind vacuum filtration, o'clock is the whole medicinal liquid of extraction to density 1.2～1.3;
2. Borneolum Syntheticum grinds not;
3. the preparation of medicinal liquid:
With the whole liquid of step extraction 1., in water-bath, mix and stir, be treated to uniform suspension through suspending, at last the Borneolum Syntheticum fine powder is slowly added in the medicinal liquid to suspension, content of Danshensu is greater than 0.50% in the suspension, and tanshinone content is greater than 0.25%;
(2) preparation of capsule
1. hard capsule preparation
Measure the medicinal liquid of above-mentioned preparation by prescription, add pharmaceutic adjuvant, make granule, drying, fill promptly gets hard capsule,
2. soft capsule preparation
Get gelatin and add an amount of distilled water its suction is fully expanded, mix homogeneously, making it to dissolve becomes uniform gelatin solution, leave standstill, and with the seasonal adjustment gelatin viscosity;
With the gelatin solution that has prepared, put in the gelatin storage tank, be controlled at about 50～65 ℃, the medicinal liquid for preparing is poured in the liquor tank, adopt soft capsule maker pill, require to adjust the uniformity of rubber weight and rubber before the fill, make the beginning pill that meets the requirements, fill system soft capsule is inserted the dry rotating cage of rustless steel equably with the soft gelatin capsule that fill becomes, and frame dish or rotating cage are inserted in dry setting more equably, through dehumidifying, drying, lamp inspection selects ball, polishing, removes not specification scrap rubber ball, packing after quality inspection is qualified.
2, a kind of FUFANG DANSHEN JIAONANG according to claim 1 is characterized in that it is that 0.620～0.582mg, tanshinone are 0.30～0.25mg, protocatechualdehyde 0.020～0.016mg that wherein every capsules contains danshensu.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02111976 CN1264533C (en) | 2002-06-07 | 2002-06-07 | Radix salvia miltiorrhiza capsule compound and method for preparing same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02111976 CN1264533C (en) | 2002-06-07 | 2002-06-07 | Radix salvia miltiorrhiza capsule compound and method for preparing same |
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| Publication Number | Publication Date |
|---|---|
| CN1463711A CN1463711A (en) | 2003-12-31 |
| CN1264533C true CN1264533C (en) | 2006-07-19 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 02111976 Expired - Fee Related CN1264533C (en) | 2002-06-07 | 2002-06-07 | Radix salvia miltiorrhiza capsule compound and method for preparing same |
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1315495C (en) * | 2005-02-04 | 2007-05-16 | 邢为藩 | Danshen root extract, production, medicine preparation and inspection thereof |
| CN101444497B (en) * | 2007-11-28 | 2011-06-22 | 北京本草天源药物研究院 | Salvia miltiorrhiza danshinolic acid A and the application of a medicine composition containing salvia miltiorrhiza danshinolic acid A |
| CN102160872A (en) | 2010-02-23 | 2011-08-24 | 天津天士力制药股份有限公司 | Compound salvia dropping pill capsules |
| CN102240322B (en) * | 2011-07-01 | 2013-04-17 | 天圣制药集团股份有限公司 | Compound red sage root tablet and preparing process thereof |
| CN102670710A (en) * | 2012-06-01 | 2012-09-19 | 吉林大学 | Compound soft capsule with antioxidation function and preparation method of same |
| CN102771791A (en) * | 2012-08-13 | 2012-11-14 | 广州白云山和记黄埔中药有限公司 | Healthcare food and preparation method and application thereof |
| CN106176781A (en) * | 2016-07-01 | 2016-12-07 | 南京大学 | A kind of compound Salviae Miltiorrhizae active ingredient composition and its preparation method and application |
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- 2002-06-07 CN CN 02111976 patent/CN1264533C/en not_active Expired - Fee Related
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| CN1463711A (en) | 2003-12-31 |
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