CN1543977A - Medicine for treating cerebrovascular and cardiovascular diseases and preparation process thereof - Google Patents
Medicine for treating cerebrovascular and cardiovascular diseases and preparation process thereof Download PDFInfo
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- CN1543977A CN1543977A CNA2003101121448A CN200310112144A CN1543977A CN 1543977 A CN1543977 A CN 1543977A CN A2003101121448 A CNA2003101121448 A CN A2003101121448A CN 200310112144 A CN200310112144 A CN 200310112144A CN 1543977 A CN1543977 A CN 1543977A
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- medicine
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- cerebrovascular disease
- danshensu
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- 239000003814 drug Substances 0.000 title claims abstract description 32
- 208000026106 cerebrovascular disease Diseases 0.000 title claims abstract description 16
- 238000002360 preparation method Methods 0.000 title claims abstract description 8
- 208000024172 Cardiovascular disease Diseases 0.000 title claims description 17
- 229940079593 drug Drugs 0.000 title claims description 11
- 244000080767 Areca catechu Species 0.000 claims abstract description 13
- 235000006226 Areca catechu Nutrition 0.000 claims abstract description 13
- -1 catechu aldehyde Chemical class 0.000 claims abstract description 13
- RXUWDKBZZLIASQ-UHFFFAOYSA-N Puerarin Natural products OCC1OC(Oc2c(O)cc(O)c3C(=O)C(=COc23)c4ccc(O)cc4)C(O)C(O)C1O RXUWDKBZZLIASQ-UHFFFAOYSA-N 0.000 claims abstract description 12
- HKEAFJYKMMKDOR-VPRICQMDSA-N puerarin Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1C1=C(O)C=CC(C2=O)=C1OC=C2C1=CC=C(O)C=C1 HKEAFJYKMMKDOR-VPRICQMDSA-N 0.000 claims abstract description 12
- 239000000843 powder Substances 0.000 claims abstract description 11
- 238000000034 method Methods 0.000 claims abstract description 6
- 238000001914 filtration Methods 0.000 claims abstract description 4
- PAFLSMZLRSPALU-MRVPVSSYSA-N (2R)-3-(3,4-dihydroxyphenyl)lactic acid Chemical compound OC(=O)[C@H](O)CC1=CC=C(O)C(O)=C1 PAFLSMZLRSPALU-MRVPVSSYSA-N 0.000 claims description 13
- PAFLSMZLRSPALU-QMMMGPOBSA-N Danshensu Natural products OC(=O)[C@@H](O)CC1=CC=C(O)C(O)=C1 PAFLSMZLRSPALU-QMMMGPOBSA-N 0.000 claims description 13
- PAFLSMZLRSPALU-UHFFFAOYSA-N Salvianic acid A Natural products OC(=O)C(O)CC1=CC=C(O)C(O)=C1 PAFLSMZLRSPALU-UHFFFAOYSA-N 0.000 claims description 13
- 238000005516 engineering process Methods 0.000 claims description 13
- 230000002526 effect on cardiovascular system Effects 0.000 claims description 12
- 239000011858 nanopowder Substances 0.000 claims description 10
- 239000002775 capsule Substances 0.000 claims description 9
- 238000002347 injection Methods 0.000 claims description 9
- 239000007924 injection Substances 0.000 claims description 9
- 239000002671 adjuvant Substances 0.000 claims description 6
- 239000003610 charcoal Substances 0.000 claims description 6
- 238000004519 manufacturing process Methods 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 239000003826 tablet Substances 0.000 claims description 5
- 239000000463 material Substances 0.000 claims description 4
- 229940023488 pill Drugs 0.000 claims description 4
- 239000006187 pill Substances 0.000 claims description 4
- 238000000194 supercritical-fluid extraction Methods 0.000 claims description 4
- 238000005303 weighing Methods 0.000 claims description 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 3
- 238000009472 formulation Methods 0.000 claims description 3
- 238000010438 heat treatment Methods 0.000 claims description 3
- 238000007689 inspection Methods 0.000 claims description 3
- 239000008101 lactose Substances 0.000 claims description 3
- 239000012982 microporous membrane Substances 0.000 claims description 3
- 239000000203 mixture Substances 0.000 claims description 3
- 238000012856 packing Methods 0.000 claims description 3
- 238000012859 sterile filling Methods 0.000 claims description 3
- 239000008215 water for injection Substances 0.000 claims description 3
- 229940046011 buccal tablet Drugs 0.000 claims description 2
- 239000006189 buccal tablet Substances 0.000 claims description 2
- 238000001514 detection method Methods 0.000 claims description 2
- 238000000605 extraction Methods 0.000 claims description 2
- 239000003978 infusion fluid Substances 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 238000005498 polishing Methods 0.000 claims description 2
- 238000001556 precipitation Methods 0.000 claims description 2
- 238000000746 purification Methods 0.000 claims description 2
- 239000002510 pyrogen Substances 0.000 claims description 2
- 239000011347 resin Substances 0.000 claims description 2
- 229920005989 resin Polymers 0.000 claims description 2
- 238000000926 separation method Methods 0.000 claims description 2
- 239000000243 solution Substances 0.000 claims description 2
- 238000002137 ultrasound extraction Methods 0.000 claims description 2
- 239000013543 active substance Substances 0.000 claims 1
- 235000018927 edible plant Nutrition 0.000 claims 1
- 125000002485 formyl group Chemical class [H]C(*)=O 0.000 claims 1
- 241000304195 Salvia miltiorrhiza Species 0.000 abstract 1
- 235000011135 Salvia miltiorrhiza Nutrition 0.000 abstract 1
- 238000004806 packaging method and process Methods 0.000 abstract 1
- 201000010099 disease Diseases 0.000 description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 4
- 206010020772 Hypertension Diseases 0.000 description 3
- 208000029078 coronary artery disease Diseases 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 206010019280 Heart failures Diseases 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 210000004351 coronary vessel Anatomy 0.000 description 2
- 230000003203 everyday effect Effects 0.000 description 2
- 235000008216 herbs Nutrition 0.000 description 2
- 208000010125 myocardial infarction Diseases 0.000 description 2
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 229940127291 Calcium channel antagonist Drugs 0.000 description 1
- 206010007559 Cardiac failure congestive Diseases 0.000 description 1
- 206010008088 Cerebral artery embolism Diseases 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 208000031226 Hyperlipidaemia Diseases 0.000 description 1
- 206010020741 Hyperpyrexia Diseases 0.000 description 1
- 206010061216 Infarction Diseases 0.000 description 1
- 229910002651 NO3 Inorganic materials 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- NHNBFGGVMKEFGY-UHFFFAOYSA-N Nitrate Chemical compound [O-][N+]([O-])=O NHNBFGGVMKEFGY-UHFFFAOYSA-N 0.000 description 1
- 238000003723 Smelting Methods 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 206010000891 acute myocardial infarction Diseases 0.000 description 1
- 230000001800 adrenalinergic effect Effects 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000000480 calcium channel blocker Substances 0.000 description 1
- 210000001627 cerebral artery Anatomy 0.000 description 1
- 206010008118 cerebral infarction Diseases 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000006196 drop Substances 0.000 description 1
- 235000006694 eating habits Nutrition 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 230000007574 infarction Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 201000010849 intracranial embolism Diseases 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 230000001613 neoplastic effect Effects 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000003716 rejuvenation Effects 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 230000033764 rhythmic process Effects 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000002110 toxicologic effect Effects 0.000 description 1
- 231100000027 toxicology Toxicity 0.000 description 1
Landscapes
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to a medicament for treating cerebrovascular diseases and process for preparation, wherein the medicament is prepared from high purity radix salvia miltiorrhiza, catechu aldehyde and puerarin through the steps of purifying, mixing, preparing sub-nano grade powder, filtering, degerming, packaging, detecting, and obtaining medicine with high biological availability.
Description
(1) technical field
The present invention relates to a kind of medicine and production technology thereof for the treatment of cardiovascular and cerebrovascular disease, is the Chinese patent medicine secondary exploitation technology, belongs to the Chinese medicine technical field.
(2) background technology
Cardiovascular disease is to threaten one of the most serious human disease in the world today, its M ﹠ M surpasses neoplastic disease and leaps to the first in the world, have people more than 5,750 ten thousand to suffer from more than one cardiovascular disease approximately in the U.S., wherein 5,000 ten thousand suffer from hypertension; 1,370 ten thousand suffer from myocardial infarction; 7,100,000 suffer from angina pectoris; 4,800,000 suffer from congestive heart failure, and 4,500,000 suffer from arrhythmia.There are every day 2600 Americans of surpassing to die from cardiovascular disease, become the first cause of death of the U.S..
Along with infectious disease is controlled in China, the progressively raising of living standards of the people, the acceleration of aged tendency of population, work, rhythm of life are accelerated, dietary habit is also to hyperpyrexia, high fat development, cardiovascular disease such as coronary heart disease, hypertension, hyperlipidemia, heart failure have become one of the most serious disease that threatens health and life, and its M ﹠ M also has the trend that rises year by year, become Chinese city human mortality's three big reasons with tumor, cerebrovascular disease.Present Chinese hypertension is suffered from the patient and is surpassed 100,000,000.The age of China's incidence of coronary heart disease is tending towards rejuvenation, and 40 years old following patients of acute myocardial infarction accounted for the heart infarction patient's that is admitted to hospital the same period 13% (only being 3-4% the seventies), and wherein the minimus sudden coronary death patient age reported of Fuwai Hospital, Beijing is 28 years old.Coronary heart disease and cerebral infarction are common clinical, frequently-occurring disease, and present treatment to cardiovascular and cerebrovascular disease, adopt nitrate preparations, adrenergic, calcium channel blocker and coronary artery dilator clinically mostly, to carry out paracmastic treatment.More than a few class medicines of Cai Yonging are Western medicine preparation, and side effect is more, and the medication Consideration is many, and is dangerous.Use the treatment by Chinese herbs cardiovascular and cerebrovascular disease, have remarkable result.As selling products such as Radix Salviae Miltiorrhizae drop pill, Radix Salviae Miltiorrhizae Injection, puerarin injection at present clinically, aspect curative effect, obviously be better than Western medicine, its year sells all above hundred million yuan, the get the upper hand of drug market of cardiovascular and cerebrovascular disease of formation Chinese medicine.But adopt the compound formulation of Radix Salviae Miltiorrhizae and puerarin not to be reported.Therefore, research and development safety, compound dosage form treatment by Chinese herbs medicine efficiently are significant.
(3) summary of the invention
The present invention relates to a kind of medicine and production technology thereof for the treatment of cardiovascular and cerebrovascular disease, medicine of the present invention is made up of danshensu, catechu aldehyde and puerarin, and it is as follows that its prescription is formed the percent by weight proportioning:
Danshensu, catechu aldehyde 3～25
Puerarin 25～75%
Adjuvant (lactose etc.) is an amount of
Preparation technology of the present invention adopts the following step poly-:
(1). the Chinese crude drug Radix Salviae Miltiorrhizae powder is broken into coarse powder, with supercritical extraction technique extraction danshensu, catechu aldehyde, with the further separation and purification of the polar macroporous resin of XAD-11 (or D160);
(2). the aseptic clean GMP workshop at local 100 grades, take by weighing danshensu, catechu aldehyde, puerarin, adjuvant by prescription, put with supersonic jet mill and be ground into inferior nano powder;
(3). in inferior nano powder, add the water for injection heating for dissolving, adding pin adsorbed 10～20 minutes with charcoal, take off charcoal, 0.2 the degerming of μ filtering with microporous membrane, sterile filling, put in the freeze dryer lyophilizing to water content less than 5%, tamponade, roll lid, lamp inspection, detection, aseptic, pyrogen, finger printing are qualified, label, and packing promptly gets freeze-dried powder.
(4). inferior nano powder formulation material put in the three-dimensional hybrid device mixed 30 minutes, the powder branch is installed in the capsule, polish the aluminum-plastic packaged capsule that promptly gets with the high speed Autocapsulefillingmachine.
Danshensu of the present invention, catechu aldehyde can be used supercritical extraction technique, also can extract with ultrasonic extraction or aqueous extraction-alcohol precipitation technology.To add puerarin with danshensu, the catechu aldehyde of said extracted, be equipped with appropriate amount of auxiliary materials again, be ground into inferior nano powder through supersonic jet mill, can make the high injection of bioavailability (freeze-dried powder, little liquid drugs injection, infusion solutions), tablet (or buccal tablet, slow releasing tablet), capsule, drop pill, oral administration solution etc.
(4) beneficial effect
New drug of the present invention shows through multinomial pharmacology, toxicological test: process stabilizing, can increase cerebral arteries and crown blood flow volume, and improve myocardial oxygen delivery, adjust the blood ester, enhancing immunity, effectively coronary artery dilator.The injection effect is fast, is available as the first aid medication and a line medication of cardiovascular and cerebrovascular disease such as myocardial infarction, cerebral embolism, and tablet, capsule or drop pill are easy to use, and is cheap and treat medication as long-term prevention at ordinary times and smelting, has near preferably, late result.
The present invention has listed national great special project " 863 Program project " in, belongs to national requirements to the Chinese patent medicine secondary exploitation technology, and Technology has very big innovation.
(5) embodiment
Embodiment 1 (preparation injection)
In local 100 grades aseptic clean GMP workshop, take by weighing danshensu, catechu aldehyde 10mg, puerarin 100mg, right amount of auxiliary materials by prescription, be ground into inferior nano powder with supersonic jet mill, add the water for injection heating for dissolving, add pin, take off charcoal with charcoal absorption 10～20 minutes, 0.2 μ filtering with microporous membrane degerming, sterile filling, put in the freeze dryer lyophilizing to water content less than 5%, tamponade, roll lid, lamp inspection, detect, label, packing promptly gets injectable lyophilised powder.
Embodiment 2 (preparation capsule)
Every contains:
Danshensu, catechu aldehyde 15mg
Puerarin 150mg
Adjuvant (lactose etc.) is an amount of
In the GMP workshop of relative humidity below 45%, take by weighing danshensu, catechu aldehyde, puerarin, adjuvant by prescription, put in the three-dimensional hybrid device and mixed 30 minutes, be ground into inferior nano powder with supersonic jet mill, put again in the three-dimensional hybrid device and mixed 30 minutes, install in No. 3 capsules with dividing in the high speed Autocapsulefillingmachine, polishing, promptly aluminum-plastic packaged.
Usage and consumption: each 1～2, every day 1～2 time.
Claims (5)
1, a kind of medicine for the treatment of cardiovascular and cerebrovascular disease is characterized in that the percent by weight proportioning of this medicine is as follows:
Danshensu, catechu aldehyde 3～25%
Puerarin 25～75%
Adjuvant (lactose) is an amount of
2,, it is characterized in that this medicine can be made into injection (little liquid drugs injection, freeze-dried powder, infusion solutions), tablet (or buccal tablet, slow releasing tablet), capsule, drop pill, oral administration solution series of products according to the medicine of the described treatment cardiovascular and cerebrovascular disease of claim 1.
3, a kind of medicine production technology for the treatment of cardiovascular and cerebrovascular disease is characterized in that this preparation process comprises that the following step poly-:
(1). the Chinese crude drug Radix Salviae Miltiorrhizae powder is broken into coarse powder, with supercritical extraction technique extraction danshensu, youngster bitter edible plant aldehyde, with the further separation and purification of the polar macroporous resin of XAD-11 (or D160);
(2). take by weighing danshensu, catechu aldehyde, puerarin, adjuvant by prescription, be ground into inferior nano powder with supersonic jet mill;
(3). in inferior nano powder, add the water for injection heating for dissolving, adding pin adsorbed 10～20 minutes with charcoal, take off charcoal, 0.2 the degerming of μ filtering with microporous membrane, sterile filling, put in the freeze dryer lyophilizing to water content less than 5%, tamponade, roll lid, lamp inspection, detection, aseptic, pyrogen, finger printing are qualified, label, and packing promptly gets injection;
(4). inferior nano powder formulation material is put the three-dimensional hybrid device again mixed 30 minutes, the powder branch is installed in the capsule, polishing, the aluminum-plastic packaged capsule that promptly gets with the high speed Autocapsulefillingmachine.
4. the medicine production technology of treatment cardiovascular and cerebrovascular disease according to claim 3 is characterized in that extracting danshensu, catechu aldehyde from Radix Salviae Miltiorrhizae, can use supercritical extraction technique, also can extract with ultrasonic extraction or aqueous extraction-alcohol precipitation technology.
5. the medicine production technology of treatment cardiovascular and cerebrovascular disease according to claim 3 is characterized in that: its active substance, can pulverize with conventional jet mill, and also can be ground into inferior nano powder with supersonic jet mill.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2003101121448A CN100488513C (en) | 2003-11-14 | 2003-11-14 | Medicine for treating cerebrovascular and cardiovascular diseases and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2003101121448A CN100488513C (en) | 2003-11-14 | 2003-11-14 | Medicine for treating cerebrovascular and cardiovascular diseases and preparation process thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1543977A true CN1543977A (en) | 2004-11-10 |
| CN100488513C CN100488513C (en) | 2009-05-20 |
Family
ID=34336406
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2003101121448A Expired - Lifetime CN100488513C (en) | 2003-11-14 | 2003-11-14 | Medicine for treating cerebrovascular and cardiovascular diseases and preparation process thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100488513C (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1943584B (en) * | 2006-10-20 | 2010-05-12 | 中国医学科学院药用植物研究所 | Medicinal composition for treating cardio-cerebral vascular disease and its preparing method |
| CN1872079B (en) * | 2005-06-01 | 2011-04-27 | 天津天士力制药股份有限公司 | Drop pills for treating cardiovascular diseases and cerebrovascular disease, and preparation method |
-
2003
- 2003-11-14 CN CNB2003101121448A patent/CN100488513C/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1872079B (en) * | 2005-06-01 | 2011-04-27 | 天津天士力制药股份有限公司 | Drop pills for treating cardiovascular diseases and cerebrovascular disease, and preparation method |
| CN1943584B (en) * | 2006-10-20 | 2010-05-12 | 中国医学科学院药用植物研究所 | Medicinal composition for treating cardio-cerebral vascular disease and its preparing method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100488513C (en) | 2009-05-20 |
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| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: GUANGDONG SHUNFENG PHARMACEUTICAL CO.,LTD. Assignor: Liu Xianying|Lin Wenhong Contract record no.: 2011440000875 Denomination of invention: Medicine for treating cerebrovascular and cardiovascular diseases and preparation process thereof Granted publication date: 20090520 License type: Exclusive License Open date: 20041110 Record date: 20110809 |
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| ASS | Succession or assignment of patent right |
Free format text: FORMER OWNER: LIN WENHONG Effective date: 20130130 Owner name: GUANGDONG SHUNFENG PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: LIU XIANYING Effective date: 20130130 |
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| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20130130 Address after: Shunde street Daliang District Guangdong city Foshan province 528300 mouth kumquat Patentee after: GUANGDONG CHINA RESOURCES SHUNFENG PHARMACEUTICAL Co.,Ltd. Address before: 528300 Guangdong Province, Foshan city Shunde District Daliang Jingui garden of Yang Lin Street No. 816 Patentee before: Liu Xianying Patentee before: Lin Wenhong |
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| CX01 | Expiry of patent term |
Granted publication date: 20090520 |
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| CX01 | Expiry of patent term |