CN1883587A - Preparation of 'Xin Ke Shu' tablet for treating coronary heart disease - Google Patents
Preparation of 'Xin Ke Shu' tablet for treating coronary heart disease Download PDFInfo
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Abstract
The invention relates to a process for preparing medicinal tablets with the following constituents: kudzu vine root 600g, haw 600g, root of red rooted saliva 600g, notoginseng 40g,and banksia rose 40g.
Description
Technical field:
The present invention relates to a kind of preparation of Chinese medicine preparation, particularly a kind of Fructus Crataegi, Radix Puerariae, Radix Salviae Miltiorrhizae, Radix Notoginseng, the Radix Aucklandiae is the preparation of the raw material XINKESHU PIAN agent of making.
Background technology:
The heart can relax and be the Chinese medicine preparation of blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain.Uncomfortable in chest, dizzy, the headache that is used for that qi stagnation and blood stasis type coronary heart disease causes, neck pain and arrhythmia, hyperlipidemia etc.Domestic have tablet, capsule, the launch of dosage forms such as granule at present.
At present XINKESHU JIAONANG is recorded in 15 of Chinese medicine ministry standards, and its prescription, method for making are as follows:
[prescription] Fructus Crataegi Radix Puerariae Salvia miltiorrhiza and Panax notoginseng Radix Aucklandiae
[method for making] above five tastes are got Radix Notoginseng, Radix Aucklandiae powder is broken into fine powder, and Fructus Crataegi, Radix Puerariae added 60% ethanol warm macerating after 30 minutes, the heating and refluxing extraction secondary, 2.5 hours for the first time, 2 hours for the second time, merge alcohol extract, decompression recycling ethanol is concentrated into relative density 1.35 (20 ℃); Radix Salviae Miltiorrhizae decocts with water secondary, and 2 hours for the first time, 1.5 hours for the second time, merge decoction liquor, filter, be concentrated into relative density 1.35 (20 ℃); Above-mentioned two kinds of thick pastes are dry under 80 ℃, be ground into fine powder and Radix Notoginseng, Radix Aucklandiae fine powder mixing, make granule, drying is distributed into 1000, promptly.
Because Fructus Crataegi all passes through alcohol extraction, make the alcohol extract that obtains in the above preparation method, the easy moisture absorption is unfavorable for that control produces, particularly in preparation tablet process, and sticking easily, working condition is also very harsh.
The present invention has carried out technological transformation through research to production process, has made respond wellly, and quality is the XINKESHU PIAN of control easily.
Summary of the invention:
The invention provides a kind of preparation technology of XINKESHU PIAN agent, its prescription of XINKESHU PIAN is identical with XINKESHU JIAONANG or granule, and its prescription is composed as follows:
[prescription] Radix Puerariae 600g, Fructus Crataegi 600g, Radix Salviae Miltiorrhizae 600g, Radix Notoginseng 40g, Radix Aucklandiae 40g
Five kinds of raw materials preferably use the raw medicinal material that meets drug standard, and these medical materials can be bought from the market and obtain.The present invention has carried out technological transformation to production process on the basis of this prescription, be mainly:
New technology is broken into fine powder for 1/3 amount Fructus Crataegi powder in the prescription, and 2/3 amount Fructus Crataegi is for extracting; And the Fructus Crataegi in the former technology preparation all is to extract.
Therefore, method of the present invention is:
The preparation of XINKESHU PIAN agent may further comprise the steps,
1) Fructus Crataegi of 1/3 amount, Radix Notoginseng, the Radix Aucklandiae are pulverized,
2) Fructus Crataegi, the Radix Puerariae ethanol extraction of 2/3 amount;
3) Radix Salviae Miltiorrhizae decocting in water,
4) extract is mixed with ground product,
5) make tablet.
Concrete processing step is as follows:
[method for making] 1/3 Fructus Crataegi, Radix Notoginseng, Radix Aucklandiae powder are broken into fine powder, and all the other Fructus Crataegis, Radix Puerariae added 60% ethanol warm macerating after 30 minutes, the heating and refluxing extraction secondary, and 2.5 hours for the first time, 2 hours for the second time, merge alcohol extract, decompression recycling ethanol filters filtrate for later use; Radix Salviae Miltiorrhizae decocts with water secondary, and 2 hours for the first time, 1.5 hours for the second time, merge decoction liquor, filter, with above-mentioned filtrate and decoction liquor mix homogeneously, be concentrated into relative density 1.24～1.26 (75 ℃～80 ℃ surveys).With extractum and fine powder mixing, make granule, drying, tabletting, coating, promptly.
More than process modification of the present invention (new technology), have following tangible advantage:
1,1/3 Fructus Crataegi beats the XINKESHU PIAN water absorption rate of making behind the powder and obviously reduces, and is convenient to packing and stores, and has significantly reduced the influence of moisture to pharmaceutical properties and stability.Verify its water absorption rate by the critical relative humidity of measuring XINKESHU PIAN.Core respectively each 12 parts of Xin Ke Shu' tablets, 6 every part, accurate claim surely, be placed on the different humidity environment under placement 10 days, survey its weight change, the results are shown in Table 1, table 2, sucting wet curve is seen Fig. 1.
The XINKESHU PIAN critical relative humidity determination data (n=2) that table 1 new technology is made
| Numbering | | 40％ | 50％ | 60％ | 70％ | 80％ | 90％ |
| 1 | Sheet heavy (g) | 1.8028 | 1.8206 | 1.8244 | 1.8288 | 1.8345 | 1.9298 |
| Moisture heavy (g) | 0.2252 | 0.2287 | 0.2463 | 0.3464 | 0.4353 | 0.6146 | |
| Water absorption rate (%) | 12.49 | 12.56 | 13.50 | 18.94 | 23.73 | 31.85 | |
| 2 | Sheet heavy (g) | 1.8020 | 1.8424 | 1.8524 | 1.8367 | 1.7862 | 1.8288 |
| Moisture heavy (g) | 0.2222 | 0.2299 | 0.2479 | 0.3519 | 0.4344 | 0.5892 | |
| Water absorption rate (%) | 12.33 | 12.48 | 13.38 | 19.16 | 24.32 | 32.22 | |
| Average water absorption rate (%) | 12.41 | 12.52 | 13.44 | 19.05 | 24.03 | 32.04 | |
The XINKESHU PIAN critical relative humidity determination data (n=2) that the former technology of table 2 is made
| Numbering | | 40％ | 50％ | 60％ | 70％ | 80％ | 90％ |
| 1 | Sheet heavy (g) | 1.8833 | 1.8147 | 1.8002 | 1.9356 | 1.9005 | 1.8910 |
| Moisture heavy (g) | 0.2550 | 0.2718 | 0.2976 | 0.5507 | 0.6631 | 0.9120 | |
| Water absorption rate (%) | 13.54 | 14.98 | 16.53 | 28.45 | 34.89 | 48.23 | |
| 2 | Sheet heavy (g) | 1.8500 | 1.9040 | 1.8236 | 1.9008 | 1.8955 | 1.8660 |
| Moisture heavy (g) | 0.2527 | 0.2875 | 0.3009 | 0.5434 | 0.6534 | 0.8961 | |
| Water absorption rate (%) | 13.66 | 15.10 | 16.50 | 28.59 | 34.47 | 48.02 | |
| Average water absorption rate (%) | 13.60 | 15.04 | 16.52 | 28.52 | 34.68 | 48.13 | |
2, after 1/3 Fructus Crataegi in the XINKESHU PIAN prescription beat powder, baking temperature reduced, shortening drying time, and the disintegration of tablet time limit that makes shortens greatly, and effective ingredient content improves greatly, thereby drug effect also improves thereupon.The results are shown in Table 3.
Table 3 XINKESHU PIAN quality situation comparison sheet
| Project | Disintegration | Assay |
| The tablet that former technology is made | Complete disintegrate in 46 minutes | Puerarin: 1.68% salvianolic acid B: 2.36% costunolide: 0.45% hyperin: 0.032% ginsenoside Rg1, ginsenoside Rb1, Panax Notoginseng saponin R g1 summation: 3.83% |
| The tablet that new technology is made | Complete disintegrate in 25 minutes | Puerarin: 2.26% salvianolic acid B: 2.98% costunolide: 0.58% hyperin: 0.041% ginsenoside Rg1, ginsenoside Rb1, Panax Notoginseng saponin R g1 summation: 4.59% |
3, after 1/3 Fructus Crataegi in the XINKESHU PIAN prescription beat powder, the granule that makes was loose, rounding, is easy to tabletting, and medicine is easily molten in water, and the dissolution of medicine active ingredient improves greatly, thereby improves bioavailability of medicament.
Core respectively each 6 parts of Xin Ke Shu' tablets, every part each 1, survey the dissolution of its effective ingredient puerarin at different time, the results are shown in Table 4, table 5, the dissolution curve is seen Fig. 2.
The XINKESHU PIAN different time dissolution determination data (n=2) that table 4 new technology is made
| Numbering | 10 | 20 minutes | 30 | 40 minutes | 50 | 60 minutes |
| 1 | 7.12％ | 20.92％ | 50.71％ | 68.35％ | 80.52％ | 93.81％ |
| 2 | 6.96％ | 20.74％ | 50.19％ | 67.75％ | 80.24％ | 93.60％ |
| 3 | 6.60％ | 20.70％ | 50.02％ | 66.13％ | 79.50％ | 92.83％ |
| 4 | 7.16％ | 21.00％ | 51.38％ | 67.87％ | 80.53％ | 94.14％ |
| 5 | 6.86％ | 20.88％ | 50.41％ | 67.31％ | 78.77％ | 93.68％ |
| 6 | 7.07％ | 20.90％ | 49.49％ | 66.00％ | 79.24％ | 92.52％ |
| On average | 6.96％ | 20.86％ | 50.37％ | 67.24％ | 79.80％ | 93.43％ |
The XINKESHU PIAN different time dissolution determination data (n=2) that the former technology of table 5 is made
| Numbering | 10 | 20 minutes | 30 | 40 minutes | 50 | 60 minutes |
| 1 | 4.33％ | 12.43％ | 20.21％ | 35.28％ | 66.50％ | 78.14％ |
| 2 | 3.91％ | 11.88％ | 19.70％ | 34.30％ | 65.72％ | 77.42％ |
| 3 | 4.04％ | 12.00％ | 19.57％ | 34.82％ | 65.93％ | 77.63％ |
| 4 | 4.80％ | 13.05％ | 21.25％ | 35.35％ | 66.94％ | 80.20％ |
| 5 | 4.55％ | 12.74％ | 20.73％ | 34.94％ | 66.22％ | 79.61％ |
| 6 | 4.54％ | 12.41％ | 21.04％ | 34.73％ | 66.00％ | 79.45％ |
| On average | 4.36％ | 12.42％ | 20.42％ | 34.91％ | 66.22％ | 78.72％ |
From above experimental data as can be seen, after 1/3 Fructus Crataegi beat powder, the dissolution of the XINKESHU PIAN of making improved greatly, thereby bioavailability of medicament also improves thereupon.
4, the main pharmacodynamics index had raising after 1/3 Fructus Crataegi in the XINKESHU PIAN prescription beat powder: this test is a trial drug with the tablet of making by former technology of XINKESHU PIAN and new technology respectively, FUFANG DANSHEN PIAN is according to medicine, the negative contrast of normal saline to the positive, adopt anesthetized dog acute myocardial ischemia model due to the coronary ligation method, observe tablet duodenum perfusion administration that former technology and new technology make influence acute myocardial ischemia.The result: can obviously alleviate the dog acute myocardial ischemia damage that coronary ligation causes by the new technology XINKESHU PIAN, effect obviously is better than former technology XINKESHU PIAN.Result of the test sees Table 6, table 7, table 8, table 9, table 10.
Former technology of table 6. XINKESHU PIAN and new technology are to the influence of anesthetized dog myocardial ischemia scope (N-ST) (X ± SD)
| Dosage (g/kg) | Number of animals | Minute (minute) | |||||||||||
| At once | 5 | 10 | 15 | 30 | 45 | 60 | 90 | 120 | 150 | 180 | |||
| Negative control | Isometric(al) | 5 | 12.3±4.6 | 14.5±2.8 | 15.3±1.7 | 14.9±1.0 | 15.3±1.5 | 15.5±1.0 | 14.8±1.5 | 15.0±1.2 | 15.8±0.5 | 16.0±0.0 | 16.0±0.0 |
| The former technology positive control of new technology | 0.36 0.36 0.30 | 5 5 5 | 11.6±4.6 12.8±2.9 14.1±1.1 | 13.4±1.6 14.7±0.8 14.2±1.5 | 11.4±24.6 * 15.0±1.2 14.6±1.2 | 12.2±32.6 * 14.8±1.7 13.9±2.5 | 10.4±24.2 * 15.1±1.7 12.3±3.3 | 11.50±2.8 * 13.8±1.1 15.2±0.8 | 11.0±2.5 * 14.0±1.3 14.2±1.8 | 11.3±2.5 ** 14.2±1.1 12.4±3.4 | 10.0±3.2 ** 15.2±1.3 12.4±3.0 | 11.2±2.6 ** 15.0±1.2 11.6±4.4 | 9.0±4.7 ** 14.8±1.3 9.6±5.5 |
New technology is corresponding result constantly with former technology compare,
*P＜0.05,
*P＜0.01.
The influence that former technology of table 7. XINKESHU PIAN and new technology are raised epicardial electrogram ST section due to the anesthetized dog myocardial ischemia (X ± SD, mV)
| Dosage (g/kg) | Number of animals | Minute (minute) | |||||||||||
| At once | 5 | 10 | 15 | 30 | 45 | 60 | 90 | 120 | 150 | 180 | |||
| Negative control | Isometric(al) | 5 | 5.5±4.08 | 9.5±5.15 | 8.6±4.59 | 8.7±4.62 | 8.0±3.91 | 8.2±4.39 | 8.3±4.40 | 7.6±5.27 | 7.5±4.89 | 7.5±5.20 | 6.8±6.20 |
| The former technology positive control of new technology | 0.36 0.36 0.30 | 5 5 5 | 4.5±1.78 4.2±4.27 5.3±0.98 | 4.1±1.91 6.2±2.71 6.8±1.71 | 4.2±2.02 6.8±3.06 6.6±1.53 | 4.7±2.10 7.6±2.20 5.2±2.95 | 3.1±3.44 * 8.1±2.20 3.7±2.03 | 4.1±2.38 7.6±2.41 4.9±1.14 | 3.9±1.53 7.3±2.31 4.4±2.31 | 3.7±1.67 7.2±2.61 4.0±3.50 | 3.5±1.84 7.5±2.88 4.5±4.33 | 3.8±1.77 7.0±3.00 4.3±4.49 | 3.2±2.78 6.6±2.50 3.0±4.68 |
New technology is corresponding result constantly with former technology compare,
*P＜0.05
Former technology of table 8 XINKESHU PIAN and new technology are to the influence of anesthetized dog coronary ligation myocardial infarct size after 3 hours
(X±SD)
| Dosage (g/kg) | Number of animals | Ischemia scope (%) | |
| Negative control | Isometric(al) | 5 | 0.038±0.014 |
| The former technology positive control of new technology | 0.36 0.36 0.30 | 5 5 5 | 0.018±0.003 * 0.036±0.013 0.025±0.011 |
New technology is compared with former technology,
*P＜0.05
The granule that table 9. is made by former technology of XINKESHU PIAN and new technology is in the serum before and after the anesthetized dog coronary ligation
The influence of LDH level (X ± SD)
| Number of animals | Dosage (g/kg) | Before the ligation | After the ligation 3 hours | Difference before and after the ligation | |
| Negative control | 5 | Isometric(al) | 74.8±23.6 | 161.3±21.4 | 86.5±23.6 |
| The former technology positive control of new technology | 5 5 5 | 0.36 0.36 0.30 | 75.4±11.5 64.9±18.1 72.2±22.7 | 121.6±26.3 141.4±22.3 128.0±14.0 | 46.2±25.5 * 76.5±25.1 55.8±20.1 |
New technology is compared with former technology,
*P＜0.05
Former technology of table 10 XINKESHU PIAN and new technology are to the influence of CK level in the serum before and after the anesthetized dog coronary ligation
(X±SD)
| Number of animals | Dosage (g/kg) | Before the ligation | After the ligation 3 hours | Difference before and after the ligation | |
| Negative control | 5 | Isometric(al) | 311.4±143.5 | 1740.9±579.9 | 1429.5±651.0 |
| The former technology positive control of new technology | 5 5 5 | 0.36 0.36 0.30 | 403.8±88.9 367.6±145.8 224.4±65.7 | 1110.2±242.2 * 1684.4±583.6 963.0±382.2 | 706.4±232.2 * 1316.8±518.1 738.6±370.2 |
New technology is compared with former technology,
*P＜0.05
5, after 1/3 Fructus Crataegi beats powder, can utilize Fructus Crataegi medicated powder to serve as excipient, remove the excipient starch of former employing, save resource, reduced cost.
Description of drawings:
The XINKESHU PIAN sucting wet curve figure that Fig. 1 makes by new technology, former technology
The XINKESHU PIAN different time dissolution curve chart that Fig. 2 makes by former technology and new technology
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1
[prescription] Radix Puerariae 600g, Fructus Crataegi 600g, Radix Salviae Miltiorrhizae 600g, Radix Notoginseng 40g, Radix Aucklandiae 40g
[method for making] 1/3 Fructus Crataegi, Radix Notoginseng, Radix Aucklandiae powder are broken into fine powder, and all the other Fructus Crataegis, Radix Puerariae added 60% ethanol warm macerating after 30 minutes, the heating and refluxing extraction secondary, and 2.5 hours for the first time, 2 hours for the second time, merge alcohol extract, decompression recycling ethanol filters filtrate for later use; Radix Salviae Miltiorrhizae decocts with water secondary, and 2 hours for the first time, 1.5 hours for the second time, merge decoction liquor, filter, with above-mentioned filtrate and decoction liquor mix homogeneously, be concentrated into relative density 1.24～1.26 (75 ℃～80 ℃ surveys).With extractum and fine powder mixing, make granule, drying, tabletting, coating, promptly.
Claims (10)
1, a kind of preparation method of XINKESHU PIAN agent is characterized in that, with Fructus Crataegi, and Radix Puerariae, Radix Salviae Miltiorrhizae, Radix Notoginseng, the Radix Aucklandiae is a raw material, through pulverizing, alcohol extraction, water is carried, and mixes the tabletting step.
2, the preparation method of claim 1 is characterized in that, described pulverizing be will part amount Fructus Crataegi and Radix Notoginseng, the Radix Aucklandiae pulverize.
3, the preparation method of claim 1 is characterized in that, described alcohol extraction is Fructus Crataegi and the Radix Puerariae ethanol extraction with the part amount.
4, the preparation method of claim 1 is characterized in that, it is that Radix Salviae Miltiorrhizae is carried with decocting in water that described water is carried.
5, the preparation method of claim 1 is characterized in that, described mixing is the alcohol extract with raw material, and water extract and ground product mix.
6, the preparation method of claim 1 is characterized in that, described tabletting is according to galenic pharmacy routine techniques tabletting.
7, the preparation method of claim 2 is characterized in that, the Fructus Crataegi of described part amount is the Fructus Crataegi of 1/3 amount.
8, the preparation method of claim 3 is characterized in that, the Fructus Crataegi of described part amount is the Fructus Crataegi of 2/3 amount.
9, the preparation method of claim 1 is characterized in that, through following steps,
1) Fructus Crataegi of 1/3 amount, Radix Notoginseng, the Radix Aucklandiae are pulverized,
2) Fructus Crataegi, the Radix Puerariae ethanol extraction of 2/3 amount,
3) Radix Salviae Miltiorrhizae decocting in water,
4) extract is mixed with ground product,
5) make tablet.
10, the preparation method of claim 1, it is characterized in that through following steps, 1/3 Fructus Crataegi, Radix Notoginseng, Radix Aucklandiae powder are broken into fine powder, all the other Fructus Crataegis, Radix Puerariae added 60% ethanol warm macerating after 30 minutes, the heating and refluxing extraction secondary, 2.5 hours for the first time, 2 hours for the second time, merge alcohol extract, decompression recycling ethanol filters filtrate for later use; Radix Salviae Miltiorrhizae decocts with water secondary, and 2 hours for the first time, 1.5 hours for the second time, merge decoction liquor, filter, with above-mentioned filtrate and decoction liquor mix homogeneously, be concentrated into relative density 1.24～1.26, with extractum and fine powder mixing, make granule, drying, tabletting, coating, promptly.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102210763A (en) * | 2011-05-30 | 2011-10-12 | 湖南恒伟药业股份有限公司 | Chinese medicinal composition for promoting blood circulation, removing blood stasis, promoting qi circulation and relieving pain and preparation method thereof |
| CN103610786A (en) * | 2013-12-13 | 2014-03-05 | 山东沃华医药科技股份有限公司 | Chinese medicinal composition for treating coronary heart disease and preparation method thereof |
| CN103720810A (en) * | 2012-10-16 | 2014-04-16 | 吉林吉春制药股份有限公司 | Medicine for treating qi-stagnation and blood stasis coronary heart disease and complication of disease and preparation method of medicine |
| CN103829238A (en) * | 2014-02-17 | 2014-06-04 | 大连圣弘医药有限公司 | Blood lipid lowering health food and preparation method thereof |
| CN105434583A (en) * | 2015-12-29 | 2016-03-30 | 山东沃华医药科技股份有限公司 | Semi-bionic preparation method for Xinkeshu preparations |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1362193A (en) * | 2001-01-02 | 2002-08-07 | 杨孟君 | Namo xinkeshu medicine and its preparation |
| CN1714836A (en) * | 2004-06-30 | 2006-01-04 | 天津天士力制药股份有限公司 | Use of medicine in preparing medicine for treating anti-aspirin |
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2006
- 2006-05-19 CN CNB200610081419XA patent/CN100339096C/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102210763A (en) * | 2011-05-30 | 2011-10-12 | 湖南恒伟药业股份有限公司 | Chinese medicinal composition for promoting blood circulation, removing blood stasis, promoting qi circulation and relieving pain and preparation method thereof |
| CN102210763B (en) * | 2011-05-30 | 2012-08-22 | 湖南恒伟药业股份有限公司 | Chinese medicinal composition for promoting blood circulation, removing blood stasis, promoting qi circulation and relieving pain and preparation method thereof |
| CN103720810A (en) * | 2012-10-16 | 2014-04-16 | 吉林吉春制药股份有限公司 | Medicine for treating qi-stagnation and blood stasis coronary heart disease and complication of disease and preparation method of medicine |
| CN103610786A (en) * | 2013-12-13 | 2014-03-05 | 山东沃华医药科技股份有限公司 | Chinese medicinal composition for treating coronary heart disease and preparation method thereof |
| CN103829238A (en) * | 2014-02-17 | 2014-06-04 | 大连圣弘医药有限公司 | Blood lipid lowering health food and preparation method thereof |
| CN105434583A (en) * | 2015-12-29 | 2016-03-30 | 山东沃华医药科技股份有限公司 | Semi-bionic preparation method for Xinkeshu preparations |
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| Publication number | Publication date |
|---|---|
| CN100339096C (en) | 2007-09-26 |
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