CN102327401B - Method for preparing medicament for treating uterine bleeding - Google Patents
Method for preparing medicament for treating uterine bleeding Download PDFInfo
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- CN102327401B CN102327401B CN2011102857523A CN201110285752A CN102327401B CN 102327401 B CN102327401 B CN 102327401B CN 2011102857523 A CN2011102857523 A CN 2011102857523A CN 201110285752 A CN201110285752 A CN 201110285752A CN 102327401 B CN102327401 B CN 102327401B
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Abstract
The invention discloses a method for preparing a medicament for treating uterine bleeding, which relates to a method for preparing a Chinese medicinal preparation. A hyperpin tablet is prepared by uniformly mixing, granulating, laminating and coating rehmannia root, processed rhubarb, garden burnet, pseudo-ginseng, cuttle-bone, india madder root and pollen typhae (fried) serving as raw materials with modern extraction separation technologies such as ultrafine smashing, supercritical fluid extraction, ultrasonic extraction, micro-pore membrane filtration, extraction with water and sedimentation with alcohol and the like. The invention has the beneficial effects that: the method has high extraction and separation efficiency and high extracting rate; degradation of heat-sensitive components is avoided, fully utilization of the medicinal materials is facilitated, and energy and cost are saved; and the method has the characteristics of short extraction time, high yield, no need of heating, and the like.
Description
Technical field
The present invention relates to a kind of preparation method of Chinese medicine preparation, be specifically related to a kind of preparation method for the treatment of the medicine of metrorrhagia.
Background technology
Metrorrhagia belongs to the dysfunctional uterine hemorrhage category of modern medicine, is called for short anovulatory dysfunctional uterine hemorrhage, is a kind of common gynaecopathia.The medicine that the traditional Chinese medical science adopts is to be prepared from by Radix Rehmanniae, Radix Et Rhizoma Rhei, Radix Sanguisorbae, Radix Notoginseng, Endoconcha Sepiae, Radix Rubiae, Pollen Typhae seven flavor Chinese medicine extraction, has heat clearing and blood stasis dispersing, the effect of blood-arresting catamenia-regulating.Be used for holding metrorrhagia due to the stasis of blood under the arm because of heat in blood, card is seen the confusion of the menstrual cycle, when menses are non-and descend, menorrhagia, or dripping urine endlessly, color depth is red, the matter thickness, hold clot under the arm, accompanied vexed xerostomia, diseases such as constipation, effect with heat clearing and blood stasis dispersing, blood-arresting catamenia-regulating, synergism strengthens, and is evident in efficacy, is the classics side for the treatment of gynaecopathia.At present, Related product is the medicine for the treatment of metrorrhagia on the market, it is to be prepared from by more traditional extraction and separation technologies such as reflux, decoction, water extract-alcohol precipitations, preparation technology is more coarse, the not enough scientific and precise of extracting method, cause that extraction ratio is low, the Chinese crude drug waste is serious, the easily degraded of being heated of some thermal sensitivity compositions increases production cost and influences the quality of product.
Summary of the invention
The objective of the invention is provides a kind of extract and separate excellent in efficiency at top described defective, and the extraction ratio height is avoided the preparation method of medicine of the treatment metrorrhagia of thermal sensitivity composition degraded.
The objective of the invention is to be achieved by the following technical programs.
A kind of preparation method for the treatment of the medicine of metrorrhagia, made by following bulk drugs, Radix Rehmanniae 150-450 part, Radix Et Rhizoma Rhei 60-180 part, Radix Sanguisorbae 150-450 part, Radix Notoginseng 60-180 part, Endoconcha Sepiae 100-300 part, Radix Rubiae 100-300 part, Pollen Typhae (stir-fry) 100-300 part, it is characterized in that, adopt the following steps preparation:
1. adopt superfine communication technique that Radix Notoginseng powder is broken into fine powder, it is standby to get half fine powder;
2. with step 1. in second half Radix Notoginseng medicated powder and Radix Et Rhizoma Rhei, Radix Rehmanniae mix, adopt supercritical CO
2Fluid extraction technology extracts fat-soluble and the thermal sensitivity composition;
3. the medicinal residues after step being extracted in 2. add the water supersound extraction of 8 times of quality of half and other medical material amount of Radix Notoginseng amount with Radix Sanguisorbae, Endoconcha Sepiae, Radix Rubiae, Pollen Typhae, extract the back and filter;
Relative density is the extractum of 1.1-1.2 when 4. step filtrate decompression 3. being concentrated into 60 ℃;
5. step extractum is 4. carried out precipitate with ethanol;
6. with the 5. extractum filtering with microporous membrane behind the precipitate with ethanol of step, decompression recycling ethanol, and relative density is the extractum of 1.2-1.4 when being condensed into 60 ℃;
7. with step 2. the fat-soluble and thermal sensitivity composition that extracts and step 6. extractum and step 1. one increase Radix Notoginseng fine powder mixing, 80 ℃ of dryings become the dry drug mixture;
8. step drying composite is 7. pulverized, added starch, mixing with ethanol soft material processed, is granulated, and 60 ℃ of dryings add magnesium stearate again, mixing, and tabletting, film coating, namely.
Step 1. described micronizing refers to Radix Notoginseng powder is broken into the fine powder that particle diameter is the 3-20 micron.
Step is described supercritical CO 2.
2The extracting pressure of fluid extraction technology is 20-45Mpa, and extraction temperature is 35-70 ℃, and the extraction time is 1-3h.
Step 3. described supersound extraction number of times is 2 times, each 0.25-0.75h, and ultrasonic power is 40-80kw, temperature is 20-40 ℃.
Step 5. described precipitate with ethanol temperature is 5-10 ℃, contains the alcohol amount and is 50-80%, precipitate with ethanol 24h.
The medicine of described treatment metrorrhagia also can be prepared into powder, granule or capsule.
The invention has the beneficial effects as follows: the present invention is by supercritical fluid CO
2Abstraction technique extracts the fat-soluble and thermal sensitivity composition in the medical material, the extract and separate excellent in efficiency, and the extraction ratio height has been avoided the degraded of thermal sensitivity composition, is conducive to taking full advantage of of medical material, energy savings and cost; Overcome some shortcomings with dipping, percolation and water boiling and extraction simultaneously, have extraction time short, productive rate is high and need not characteristics such as heating, has saved the production time, has improved extraction ratio, has reduced the degraded of effective ingredient, has reduced production cost; Improved bioavailability of medicament.
The specific embodiment
Below the invention will be further described by specific embodiment, it should be understood that these embodiment only are used for explanation the present invention, do not limit the scope of the invention.
Embodiment 1.
Prescription is formed: Radix Rehmanniae 45Kg, and Radix Et Rhizoma Rhei 18Kg, Radix Sanguisorbae 45Kg, Radix Notoginseng 18Kg, Endoconcha Sepiae 30Kg, Radix Rubiae 30Kg, Pollen Typhae (stir-fry) 30Kg, starch 0.5Kg, magnesium stearate 0.2Kg makes 100000 altogether.
Employing following steps preparations: adopting superfine communication technique that Radix Notoginseng powder is broken into particle diameter is 10 microns fine powder, gets that half is standby; Second half Radix Notoginseng fine powder is mixed with Radix Et Rhizoma Rhei, Radix Rehmanniae, adopt supercritical CO
2Fluid extraction technology extracts (extracting pressure is 30MPa, and extraction temperature is 60 ℃, extraction 2h), with medicinal residues and the Radix Sanguisorbae after extracting, Endoconcha Sepiae, Radix Rubiae, Pollen Typhae adds the water of 8 times of quality of half and other medical material amount of Radix Notoginseng amount, supersound extraction 2 times, each 0.5h(ultrasonic power 57kw together, temperature is 25 ℃), filter, it is 1.10-1.15(60 ℃ that filtrate decompression is concentrated into relative density) extractum, adding ethanol makes and contains the alcohol amount and reach 60%, stir evenly, 5 ℃ leave standstill 24h, filtering with microporous membrane, decompression recycling ethanol, and to be condensed into relative density be 1.25-1.30(60 ℃) extractum, add the extract of above-mentioned Radix Notoginseng fine powder and supercritical technology extraction, mixing, 80 ℃ of dryings, pulverize, add starch, with 85% ethanol soft material processed, 60 ℃ of dryings, add magnesium stearate, mixing, tabletting, film coating, namely.
Differentiate: (1) gets 15 of this product, removes film-coat, and porphyrize adds dehydrated alcohol 10ml, and supersound process 30 minutes filters, and filtrate is as need testing solution.Other gets the gallic acid reference substance, adds dehydrated alcohol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2010 B) test, draw each 5 microlitre of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with chloroform-ethyl acetate-formic acid (6:4:1), launch, take out, dry, spray is with 2% ferric chloride alcoholic solution.In the test sample chromatograph, with reference substance chromatograph relevant position on, show the speckle of same color.
(2) get 4 of this product, porphyrize adds methanol 30ml supersound process 30 minutes, filter, filtrate evaporate to dryness, residue add water 20ml makes dissolving, adds dilute hydrochloric acid adjust pH to 1～2, ethyl acetate extraction 2 times, each 20ml merges ethyl acetate liquid, evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution.Other gets Radix Rubiae control medicinal material 0.5g, adds little the boiling 30 minutes of water 100ml heating, puts coldly, filters, filtrate adds dilute hydrochloric acid adjust pH to 1～2, ethyl acetate extraction 2 times, and each 20ml merges ethyl acetate liquid, evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution.Draw each 5～10 microlitre of above-mentioned two solution, put in same be on the silica gel g thin-layer plate of adhesive with the carboxymethylcellulose sodium solution that contains 0.5% sodium hydroxide, be developing solvent with ethyl acetate-methanol-water (12:3:1), launch, taking-up is dried.Spray is with 50% alcoholic solution of 10% sodium hydroxide, in the test sample chromatograph, with control medicinal material chromatograph relevant position on, show the same color speckle.
Assay:Measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2010 D).
Chromatographic condition and system suitability test: be filler with octadecylsilane chemically bonded silica; Methanol-0.1% phosphoric acid solution (88:12) is mobile phase; Detect wavelength 254nm.Number of theoretical plate calculates by the emodin peak should be not less than 3500.
The preparation of reference substance solution: precision takes by weighing emodin, the chrysophanol reference substance is an amount of, adds methanol and makes the solution that contains emodin 4.0 micrograms, chrysophanol 5.0 micrograms among every 1ml, namely.
The preparation of need testing solution: get this product, remove film-coat, porphyrize, get about 1g, the accurate title, decide, and puts in the tool plug conical flask, the accurate methanol 25ml that adds claims to decide weight, reflux 1 hour, put coldly, claim again to decide weight, supply the weight that subtracts mistake with methanol, shake up, filter, the accurate subsequent filtrate 5ml that draws, put in the flask, evaporate to dryness adds 2.5mol/L sulfuric acid solution 10ml, add chloroform 10ml again, reflux 1 hour, taking-up is put cold, put in the separatory funnel, divide and get chloroform liquid, the sour water layer extracts 2 times with the chloroform jolting, each 10ml merges chloroform liquid, the low temperature evaporate to dryness, residue adds methanol makes dissolving in right amount, is transferred in the 25ml measuring bottle, adds methanol to scale, shake up, filter with microporous filter membrane (0.45 micron), get subsequent filtrate, namely.
Algoscopy: precision is drawn reference substance solution and each 20 microlitre of need testing solution respectively, injects chromatograph of liquid, measures, namely.
Every of this product contains Radix Et Rhizoma Rhei with emodin (C
15H
10O
5) and chrysophanol (C
15H
10O
4) the total amount meter, must not be less than 0.2mg.
Embodiment 2.
Prescription is formed: Radix Rehmanniae 90Kg, and Radix Et Rhizoma Rhei 36Kg, Radix Sanguisorbae 90Kg, Radix Notoginseng 36Kg, Endoconcha Sepiae 60Kg, Radix Rubiae 60Kg, Pollen Typhae (stir-fry) 60Kg, starch 1.2Kg, magnesium stearate 0.6Kg, Huang make 200000.
Employing following steps preparation: adopt superfine communication technique that Radix Notoginseng is pulverized, get that half is standby; Second half Radix Notoginseng fine powder is mixed with Radix Et Rhizoma Rhei, Radix Rehmanniae, adopt supercritical CO
2Fluid extraction technology extracts (extracting pressure is 20MPa, and extraction temperature is 70 ℃, extraction 3h), with medicinal residues and the Radix Sanguisorbae after extracting, Endoconcha Sepiae, Radix Rubiae, Pollen Typhae adds the water of 8 times of quality of half and other medical material amount of Radix Notoginseng amount, supersound extraction 2 times, each 0.75h(ultrasonic power 80kw together, temperature is 30 ℃), filter, it is 1.15-1.2(60 ℃ that filtrate decompression is concentrated into relative density) extractum, adding ethanol makes and contains the alcohol amount and reach 65%, stir evenly, 10 ℃ leave standstill 24h, filtering with microporous membrane, decompression recycling ethanol, and to be condensed into relative density be 1.25-1.30(60 ℃) extractum, add the extract of above-mentioned Radix Notoginseng fine powder and supercritical technology extraction, mixing, 80 ℃ of dryings, pulverize, add starch, with 70% ethanol soft material processed, 60 ℃ of dryings, add magnesium stearate, mixing, tabletting, film coating, namely.
Embodiment 3.
Prescription is formed: Radix Rehmanniae 15Kg, and Radix Et Rhizoma Rhei 6Kg, Radix Sanguisorbae 15Kg, Radix Notoginseng 6Kg, Endoconcha Sepiae 10Kg, Radix Rubiae 10Kg, Pollen Typhae (stir-fry) 10Kg, starch 0.2Kg, magnesium stearate 0.08Kg makes 35000 altogether.
Employing following steps preparation: adopt superfine communication technique that Radix Notoginseng is pulverized, get that half is standby; Second half Radix Notoginseng fine powder is mixed with Radix Et Rhizoma Rhei, Radix Rehmanniae, adopt supercritical CO
2Fluid extraction technology extracts (extracting pressure is 40MPa, and extraction temperature is 35 ℃, extraction 1h), with medicinal residues and the Radix Sanguisorbae after extracting, Endoconcha Sepiae, Radix Rubiae, Pollen Typhae add the water of 8 times of quality of half and other medical material amount of Radix Notoginseng amount, supersound extraction 2 times together, each 25min(ultrasonic power 55kw, temperature is 25 ℃), filter, it is 1.15-1.2(60 ℃ that filtrate decompression is concentrated into relative density) extractum, add ethanol and make and contain the alcohol amount and reach 70%, stir evenly, 8 ℃ leave standstill 24h, filtering with microporous membrane, decompression recycling ethanol, and to be condensed into relative density be 1.25-1.30(60 ℃) extractum, the extract that adds the extraction of above-mentioned Radix Notoginseng fine powder and supercritical technology, mixing, 80 ℃ of dryings are pulverized, add starch, with 90% ethanol soft material processed, 60 ℃ of dryings, add magnesium stearate, mixing, tabletting, film coating, namely.
Embodiment 4.
Prescription is formed: Radix Rehmanniae 9Kg, and Radix Et Rhizoma Rhei 3.6Kg, Radix Sanguisorbae 9Kg, Radix Notoginseng 3.6Kg, Endoconcha Sepiae 6Kg, Radix Rubiae 6Kg, Pollen Typhae (stir-fry) 6Kg, starch 0.15Kg makes 2000 bags of granules altogether.
Employing following steps preparation: adopt superfine communication technique that Radix Notoginseng is pulverized, get that half is standby; Second half Radix Notoginseng fine powder is mixed with Radix Et Rhizoma Rhei, Radix Rehmanniae, adopt supercritical CO
2Fluid extraction technology extracts (extracting pressure is 30MPa, and extraction temperature is 60 ℃, extraction 1h), with medicinal residues and the Radix Sanguisorbae after extracting, Endoconcha Sepiae, Radix Rubiae, Pollen Typhae adds half of Radix Notoginseng amount and the water of 8 times of quality of other medical material amount together, supersound extraction 2 times, each 0.25h(ultrasonic power 40kw, temperature is 20 ℃), filter, it is 1.15-1.2(60 ℃ that filtrate decompression is concentrated into relative density) extractum, add ethanol and make and contain the alcohol amount and reach 65%, stir evenly, 5-10 ℃ leaves standstill 24h, filtering with microporous membrane, decompression recycling ethanol, and to be condensed into relative density be 1.25-1.30(60 ℃) extractum, the extract that adds the extraction of above-mentioned Radix Notoginseng fine powder and supercritical technology, mixing, 80 ℃ of dryings, pulverize, add starch, with 90% ethanol soft material processed, granulate, 60 ℃ of dryings, granulate, pack namely gets granule.
Claims (4)
1. preparation method for the treatment of the medicine of metrorrhagia, made by following bulk drugs, Radix Rehmanniae 150-450 part, Radix Et Rhizoma Rhei 60-180 part, Radix Sanguisorbae 150-450 part, Radix Notoginseng 60-180 part, Endoconcha Sepiae 100-300 part, Radix Rubiae 100-300 part, Pollen Tyjphae (parched) 100-300 part, it is characterized in that, adopt the following steps preparation:
1. adopt superfine communication technique that Radix Notoginseng powder is broken into fine powder, it is standby to get half fine powder;
2. with step 1. in second half Radix Notoginseng medicated powder and Radix Et Rhizoma Rhei, Radix Rehmanniae mix, adopt supercritical CO
2Fluid extraction technology extracts fat-soluble and the thermal sensitivity composition;
3. the medicinal residues after step being extracted in 2. add the water supersound extraction of 8 times of quality of half and other medical material amount of Radix Notoginseng amount with Radix Sanguisorbae, Endoconcha Sepiae, Radix Rubiae, Pollen Typhae, extract the back and filter;
Relative density is the extractum of 1.1-1.2 when 4. step filtrate decompression 3. being concentrated into 60 ℃;
5. step extractum is 4. carried out precipitate with ethanol;
6. with the 5. extractum filtering with microporous membrane behind the precipitate with ethanol of step, decompression recycling ethanol, and relative density is the extractum of 1.2-1.4 when being condensed into 60 ℃;
7. with the step fat-soluble and thermal sensitivity composition that extracts and step extractum and step half Radix Notoginseng fine powder mixing 1. 6. 2., 80 ℃ of dryings become the dry drug mixture;
8. step drying composite is 7. pulverized, added starch, mixing with ethanol soft material processed, is granulated, and 60 ℃ of dryings add magnesium stearate again, mixing, and tabletting, film coating, namely;
Step is described supercritical CO 2.
2The extracting pressure of fluid extraction technology is 20-45Mpa, and extraction temperature is 35-70 ℃, and the extraction time is 1-3h;
Step 3. described supersound extraction number of times is 2 times, each 0.25-0.75h, and ultrasonic power is 40-80kw, temperature is 20-40 ℃.
2. a kind of preparation method for the treatment of the medicine of metrorrhagia according to claim 1, it is characterized in that: step 1. described micronizing refers to Radix Notoginseng powder is broken into the fine powder that particle diameter is 3-20mm.
3. a kind of preparation method for the treatment of the medicine of metrorrhagia according to claim 1, it is characterized in that: step 5. described precipitate with ethanol temperature is 5-10 ℃, contains the alcohol amount and is 50-80%, precipitate with ethanol 24h.
4. a kind of preparation method for the treatment of the medicine of metrorrhagia according to claim 1, it is characterized in that: the medicine of described treatment metrorrhagia also can be prepared into powder, granule or capsule.
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| CN2011102857523A CN102327401B (en) | 2011-09-23 | 2011-09-23 | Method for preparing medicament for treating uterine bleeding |
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| CN104547317B (en) * | 2013-10-16 | 2018-09-21 | 西安千禾药业有限责任公司 | A kind of preparation method that pharmaceutical composition blood that treating uterine bleeding is flat |
| CN105456688A (en) * | 2015-12-14 | 2016-04-06 | 江西京通美联药业有限公司 | Preparation method of medicinal preparation with efficacies of benefiting qi for activating blood circulation and eliminating fatigue |
| CN105521439A (en) * | 2016-01-14 | 2016-04-27 | 江西京通美联药业有限公司 | Preparation method of pharmaceutical preparation for promoting blood circulation and removing stasis, diminishing inflammation and relieving pain |
| CN105641008A (en) * | 2016-01-27 | 2016-06-08 | 韩志强 | Pseudo-ginseng tablets and preparation method thereof |
| CN110988248B (en) * | 2019-12-23 | 2021-06-18 | 河北中医学院 | Rapid thin-layer identification method for radix puerariae intestine clearing granules |
| CN111012848A (en) * | 2020-01-08 | 2020-04-17 | 江西普正制药股份有限公司 | Application of Xueping tablet in preparing medicine for treating ectopy uterus |
| CN111265602A (en) * | 2020-03-31 | 2020-06-12 | 江西普正制药股份有限公司 | Application of Xueping preparation in preparing medicine for treating hysteromyoma |
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Address after: 343100 Innovation Avenue 278, Jinggangshan Economic and Technological Development Zone, Ji'an City, Jiangxi Province Patentee after: Jiangxi Puzheng Pharmaceutical Co., Ltd. Address before: 331409 Puzheng Industrial Park, Xiajiang County, Ji'an City, Jiangxi Province Patentee before: Jiangxi Pozin Pharmaceutical Co., Ltd. |