CN104367908A - Pharmaceutical composition treating cardiovascular disease, and preparation method and application thereof - Google Patents
Pharmaceutical composition treating cardiovascular disease, and preparation method and application thereof Download PDFInfo
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/10—Preparation or pretreatment of starting material
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Abstract
A provided pharmaceutical composition treating cardiovascular disease is a prepared from a submicron powder of bulk drugs in parts by weight: 230.4 parts of radix salviae miltiorrhizae, 25.6 parts of lignum santali albi, 51.2 parts of lignum dalbergiae odoriferae, 38.4 parts of galanga resurrectionlily rhizome, 76.8 parts of semen myristicae, 76.8 parts of fructus choerospondiatis, and 76.8 parts of fructus hippophae. Research shows that when the above disclosed medicinal materials employed by a Guanxin seven-composition prescription are subjected to superfine grinding to form a superfine powder of 10-80 mu m, the effective compositions in the medicinal materials can be relatively well kept, the pharmacological activity is substantially improved, and the activity especially of the superfine powder of 20 mu m is most substantial.
Description
Technical field
The present invention relates to pharmaceutical composition of a kind of Cardiovarscular and its production and use.
Background technology
Coronary disease seven taste side, the prescription be made up of Radix Salviae Miltiorrhizae, Lignum Santali Albi, Lignum Dalbergiae Odoriferae, Rhizoma Kaempferiae, Semen Myristicae, Fructus Choerospondiatis, Fructus Hippophae seven flavor medicine material, blood circulation promoting and blood stasis dispelling, heart tonifying pain relieving, for coronary heart disease, vexed cardiopalmus, angina pectoris.
The two lifting manipulation of this prescription many employings alcohol water carries out the extraction of medical material at present, in order to guarantee effectively to be extracted by the fat-soluble and water soluble ingredient in medical material, thus improves the utilization rate of medical material and ensures good drug activity.
Extraction process as coronary disease seven taste drop pill is: above seven tastes, and fragrant ﹑ mountain falls in Tan Xiang ﹑, and how ﹑ Semen Myristicae extracts volatile oil, and the another device of the aqueous solution after distillation is collected; Three taste medical materials, the 95% ethanol extraction secondaries such as medicinal residues and all the other Radix Salviae Miltiorrhizaes, each 1 hour, filter, medicinal residues decoct with water secondary, each 1.5 hours, filter, concentrated each extracting solution is to thick paste respectively, merge each concentrated solution, drying under reduced pressure, is ground into fine powder, obtains extract powder, add volatile oil and PEG is mixed and made into 1000 balls, to obtain final product.
The extraction process of coronary disease tablet of seven ingredients is: above seven tastes, Lignum Santali Albi, Lignum Dalbergiae Odoriferae, Rhizoma Kaempferiae, Semen Myristicae four taste mixed powder are broken into fine powder, and three tastes such as all the other Radix Salviae Miltiorrhizaes extract three times, and first time adds alcohol reflux 2 hours, second time adds 70% ethanol extraction 2 hours, filtrate merges, and filters, and reclaims ethanol and obtains thick shape ointment, third time decocts with water 2 hours, filter, filtrate is condensed into thick paste, and two cream merge, the fine powders such as Lignum Santali Albi and thick paste are merged, cold drying, is ground into fine powder, granulates, dry, be pressed into 1000, sugar coating, obtain final product.
Summary of the invention
The present invention relates to pharmaceutical composition of a kind of Cardiovarscular and its production and use.
The invention provides a kind of pharmaceutical composition of Cardiovarscular, it is the preparation be prepared from by the superfine powder of following weight proportion crude drug:
Radix Salviae Miltiorrhizae 230.4 parts, 25.6 parts, Lignum Santali Albi, Lignum Dalbergiae Odoriferae 51.2 parts, Rhizoma Kaempferiae 38.4 parts, Semen Myristicae 76.8 parts, Fructus Choerospondiatis 76.8 parts, Fructus Hippophae 76.8 parts; Wherein, the particle diameter of described superfine powder is 10 ~ 80 μm.
Preferably, the particle diameter of described superfine powder is 20 μm.
Wherein, described preparation is oral formulations.
Further, described oral formulations is tablet, capsule, pill, powder, granule.
Present invention also offers the preparation method of aforementioned pharmaceutical compositions, it comprises following operating procedure:
(1) weighting raw materials by weight ratio:
(2) get each crude drug, adopt superfine communication technique preparation to be crushed to the superfine powder that particle diameter is 10 ~ 80 μm, add pharmaceutically conventional adjuvant or complementary composition is prepared into preparation.
Further, the particle diameter of described superfine powder is 20 μm.
Present invention also offers the purposes of aforementioned pharmaceutical compositions in the medicine of preparation treatment myocardial ischemia.
Present invention also offers the purposes of aforementioned pharmaceutical compositions in the medicine of preparation treatment coronary heart disease.
The present invention's research shows, during superfine powder by medical material micronizing to 10 ~ 80, coronary disease seven taste side μm, can retain the effective ingredient in medical material preferably, improve drug activity significantly, wherein especially remarkable with 20 μm of superfine powder activity.
Detailed description of the invention
The preparation of embodiment 1 capsule
[prescription] raw material: Radix Salviae Miltiorrhizae 230.4g Lignum Santali Albi 25.6g Lignum Dalbergiae Odoriferae 51.2g
Rhizoma Kaempferiae 38.4g Semen Myristicae 76.8g Fructus Choerospondiatis 76.8g
Fructus Hippophae 76.8g
Adjuvant: microcrystalline Cellulose 150g lactose 75g
Make 1000 capsules
Above seven tastes, adopt superfine communication technique mixing or are ground into separately the medicinal powder that particle diameter is 20 μm, add microcrystalline Cellulose and the lactose mixing of recipe quantity, add Diluted Alcohol appropriate, mix, make granule with above powder, dry, encapsulated, to obtain final product.
The preparation of embodiment 2 tablet
[prescription] raw material: Radix Salviae Miltiorrhizae 230.4g Lignum Santali Albi 25.6g Lignum Dalbergiae Odoriferae 51.2g
Rhizoma Kaempferiae 38.4g Semen Myristicae 76.8g Fructus Choerospondiatis 76.8g
Fructus Hippophae 76.8g
Adjuvant: starch 150g dextrin 75g Pulvis Talci 50g
Make 1000 altogether
Above seven tastes, adopt superfine communication technique mixing or are ground into separately the medicinal powder that particle diameter is 20 μm, add starch and the dextrin mixing of recipe quantity, add Diluted Alcohol appropriate, mix with above powder, make granule, dry, mix after adding Pulvis Talci, tabletting, sugar coating, to obtain final product.
The preparation of embodiment 3 soft capsule
[prescription] raw material: Radix Salviae Miltiorrhizae 115.2g Lignum Santali Albi 12.8g Lignum Dalbergiae Odoriferae 25.6g
Rhizoma Kaempferiae 19.2g Semen Myristicae 38.4g Fructus Choerospondiatis 38.4g
Fructus Hippophae 38.4g
Adjuvant: soybean oil 300g
Make 1000 soft capsules
Above seven tastes, adopt superfine communication technique mixing or be ground into separately the medicinal powder that particle diameter is 20 μm, adding soybean oil, mixing, is pressed into soft capsule, obtains final product.
The drug effect contrast of coronary disease seven taste sample prepared by embodiment 4 different process
1 laboratory animal
KM mice, SPF level, ♀/♂ half and half, body weight 18.5 ~ 22.5g, by Chengdu, Da Shuo bio tech ltd provides, the Quality of Experimental Animals quality certification number: scxkc (111) 2008-24.
2 Experimental agents
Radix Salviae Miltiorrhizae 230.4g, Lignum Santali Albi 25.6g, Lignum Dalbergiae Odoriferae 51.2g, Rhizoma Kaempferiae 38.4g, Semen Myristicae 76.8g, Fructus Choerospondiatis 76.8g, Fructus Hippophae 76.8g.
Sample one: get Lignum Santali Albi, Lignum Dalbergiae Odoriferae, Rhizoma Kaempferiae, Semen Myristicae four Chinese medicine thing mixed powder be broken into fine powder, three herbal medicines such as all the other Radix Salviae Miltiorrhizaes extract three times, and first time adds alcohol reflux 2 hours, second time adds the ethanol extraction 2 hours of 70%, and filtrate merges, and filters, reclaim ethanol and obtain paste thing, third time decocts with water 2 times, filters, filtrate is condensed into thick paste, and two cream merge, and the fine powders such as Lignum Santali Albi and thick paste are mixed thoroughly, cold drying, be ground into fine powder, granulate, be drying to obtain.
Sample two: get the 7 taste medical materials such as recipe quantity Radix Salviae Miltiorrhizae, adopts superfine communication technique to become particle diameter to be about the superfine powder of 10 μm 7 taste pulverizing medicinal materials.
Sample three: get the 7 taste medical materials such as recipe quantity Radix Salviae Miltiorrhizae, adopts superfine communication technique to become particle diameter to be about the superfine powder of 20 μm 7 taste pulverizing medicinal materials.
Sample four: get the 7 taste medical materials such as recipe quantity Radix Salviae Miltiorrhizae, adopts superfine communication technique to become particle diameter to be about the superfine powder of 40 μm 7 taste pulverizing medicinal materials.
Sample five: get the 7 taste medical materials such as recipe quantity Radix Salviae Miltiorrhizae, adopts superfine communication technique to become particle diameter to be about the superfine powder of 80 μm 7 taste pulverizing medicinal materials.
Sample six: above seven tastes, fragrant ﹑ mountain falls in Tan Xiang ﹑, and how ﹑ Semen Myristicae extracts volatile oil, and the another device of the aqueous solution after distillation is collected; Three taste medical materials, the 95% ethanol extraction secondaries such as medicinal residues and all the other Radix Salviae Miltiorrhizaes, each 1 hour, filter, medicinal residues decocted with water secondary, each 1.5 hours, filtered, and concentrated each extracting solution is to thick paste respectively, merges each concentrated solution, drying under reduced pressure, is ground into fine powder, obtain extract powder.
3 test kits
(1) Mice ATP Elisa test kit.
(2) Mice CPK Elisa test kit.
(3) Mice LDH Elisa test kit.
4 statistical method
Statistical analysis is carried out with SPSS17.0 software.Data with mean ± standard deviation (
) represent, adopt one factor analysis of variance between group, carry out LSD inspection between the neat person's group of variance, heterogeneity of variance person carries out Tamhane ' s T2 and checks.
5 experiment contents and method
5.1 experiment grouping and administrations
KM mice is divided into 9 groups at random by body weight, often organizes 10, respectively as: 1. model control group: equal-volume pure water; 2. sample one group: 2.4gkg
-1; 3. sample two groups: 2.4gkg
-1; 4. sample three groups: 2.4gkg
-1; 5. sample four groups: 2.4gkg
-1; 6. sample five groups: 2.4gkg
-1; 7. sample six groups: 2.4gkg
-1; 8. positive group (coronary disease seven taste drop pill group): 2.4gkg
-1.Separately take 10 normal mouses at random as Normal group 9. by body weight: equal-volume pure water.Often organize mice gavage every day 1 time, continuous 10d.Chinese drug-treated group is all with crude drug gauge.
5.2 mouse cardiac muscle ischemia model clone methods
Test 9d to start, except blank group, all the other respectively organize mice by 3mg/kg dosage lumbar injection isoproterenol, continuous two days.Naive mice lumbar injection gives Isodose normal saline.
5.3 Testing index
1. myocardial metabolism index determining: mouse heart donor source blood, 4000rmin
-1centrifugal 10min, collects supernatant, and Elisa method measures ATP (adenosine triphosphate), CPK (creatine phosphokinase) and LDH (lactic acid dehydrogenase) content in blood plasma.
2. myocardial ischemia and infarction size: take each experimental mice heart, after ice normal saline flushing bloodstain, is fixed in the neutral formalin of 10%, paraffin is fixed, tissue dewatering, embedded section, HE dyes, microscopic examination each experimental mice myocardial ischemia infarction size.
5.4 experimental result
5.4.1 2 be the results are shown in Table on the impact of mice plasma ATP content.
ATP content in each experimental mice blood plasma of table 2 (
n=10)
Note: compare with model group:
*p<0.01;
*p<0.05; Compare with one group, sample:
△ △p<0.01,
△p<0.05; Compare with positive group:
▲ ▲p<0.01,
▲p<0.05.
As shown in Table 2, compare with blank group, model group mice plasma ATP content has extremely significantly reduction (P<0.01); Compare with model group, positive group, one group, sample, two groups, four groups, five groups, six groups mice plasma ATP content all have remarkable rising (P<0.05), and three groups, sample has extremely significantly rising (P<0.01); Compare with one group, sample, sample two to six group mice plasma ATP content all has remarkable rising (P<0.05); Compare with positive group, sample three groups of mice plasma ATP content have remarkable rising (P<0.05).
5.4.2 3 be the results are shown in Table on the impact of mice plasma CPK content.
CPK content in each experimental mice blood plasma of table 3 (
n=10)
Note: compare with model group:
*p<0.01;
*p<0.05; Compare with one group, sample:
△ △p<0.01,
△p<0.05; Compare with positive group:
▲ ▲p<0.01,
▲p<0.05.
As shown in Table 3, compare with blank group, model group mice plasma CPK content has extremely significantly rising (P<0.01); Compare with model group, one group, sample, two groups, four groups, five groups, six groups mice plasma CPK content all have remarkable reduction (P<0.05), and three groups, sample has extremely significantly reduction (P<0.01); Compare with one group, sample, two groups, sample, four groups, five groups, six groups mice plasma CPK content all have remarkable reduction (P<0.05), and three groups, sample has extremely significantly reduction (P<0.01); Compare with positive group, sample three groups of mice plasma CPK content have remarkable reduction (P<0.05).
5.4.3 4 be the results are shown in Table on the impact of mice plasma LDH content.
LDH content in each experimental mice blood plasma of table 4 (
n=10)
Note: compare with model group:
*p<0.01;
*p<0.05; Compare with one group, sample:
△ △p<0.01,
△p<0.05; Compare with positive group:
▲ ▲p<0.01,
▲p<0.05.
As shown in Table 4, compare with blank group, model group mice plasma LDH content has extremely significantly rising (P<0.01); Compare with model group, sample two to six group mice plasma CPK content all has extremely significantly reduction (P<0.01); Compare with one group, sample, two groups, sample, four groups, five groups, six groups mice plasma LDH content all have remarkable reduction (P<0.05), and three groups, sample has extremely significantly reduction (P<0.01); Compare with positive group, sample three groups of mice plasma LDH content have remarkable reduction (P<0.05).
5.4.4 5 be the results are shown in Table on the impact of mouse cardiac muscle ischemic infarction area.
Table 5 each experimental mice myocardial tissue damage index (
n=10)
Note: compare with model group:
*p<0.01;
*p<0.05; Compare with one group, sample:
△ △p<0.01,
△p<0.05; Compare with positive group:
▲ ▲p<0.01, ▲ P<0.05.
As shown in Table 5, compare with blank group, model group murine myocardial infarction area enlarges markedly (P<0.05); Compare with model group, sample two to six group murine myocardial infarction area all has remarkable reduction (P<0.05); Compare with one group, sample, two groups, sample, four groups, five groups, six groups murine myocardial infarction areas all have remarkable reduction (P<0.05), and three groups, sample has extremely significantly reduction (P<0.01); Compare with positive group, sample three groups of murine myocardial infarction areas have remarkable reduction (P<0.05).
6 experiment conclusion
Coronary disease seven taste side adopts superfine communication technique directly to make powder and takes than adopting coronary disease tablet of seven ingredients preparation technology to have curative effect more, and its ultra micro particle size range is: 10 μm ~ 80 μm, and wherein, the medicated powder particle diameter of drug effect the best is 20 μm.
Claims (8)
1. a pharmaceutical composition for Cardiovarscular, is characterized in that: it is the preparation be prepared from by the superfine powder of following weight proportion crude drug:
Radix Salviae Miltiorrhizae 230.4 parts, 25.6 parts, Lignum Santali Albi, Lignum Dalbergiae Odoriferae 51.2 parts, Rhizoma Kaempferiae 38.4 parts, Semen Myristicae 76.8 parts, Fructus Choerospondiatis 76.8 parts, Fructus Hippophae 76.8 parts; The particle diameter of described superfine powder is 10 ~ 80 μm.
2. pharmaceutical composition according to claim 1, is characterized in that: the particle diameter of described superfine powder is 20 μm.
3. pharmaceutical composition according to claim 1 and 2, is characterized in that: described preparation is oral formulations.
4. pharmaceutical composition according to claim 3, is characterized in that: described oral formulations is tablet, capsule, pill, powder, granule.
5. the preparation method of pharmaceutical composition described in Claims 1 to 4 any one, is characterized in that: it comprises following operating procedure:
(1) weighting raw materials by weight ratio:
(2) get each crude drug, adopt superfine communication technique preparation to be crushed to the superfine powder that particle diameter is 10 ~ 80 μm, add pharmaceutically conventional adjuvant or complementary composition is prepared into preparation.
6. preparation method according to claim 5, is characterized in that: the particle diameter of described superfine powder is 20 μm.
7. the purposes of pharmaceutical composition described in Claims 1 to 4 any one in the medicine of preparation treatment myocardial ischemia.
8. the purposes of pharmaceutical composition described in Claims 1 to 4 any one in the medicine of preparation treatment coronary heart disease.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410339490.8A CN104367908B (en) | 2013-08-12 | 2014-07-16 | It is a kind of to treat pharmaceutical composition of angiocardiopathy and its production and use |
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| CN201310349159X | 2013-08-12 | ||
| CN201310349159 | 2013-08-12 | ||
| CN201410339490.8A CN104367908B (en) | 2013-08-12 | 2014-07-16 | It is a kind of to treat pharmaceutical composition of angiocardiopathy and its production and use |
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| CN104367908A true CN104367908A (en) | 2015-02-25 |
| CN104367908B CN104367908B (en) | 2017-09-15 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018090380A1 (en) * | 2016-11-21 | 2018-05-24 | 内蒙古天奇中蒙制药股份有限公司 | Capsule and preparation process therefor |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1839905A (en) * | 2005-03-30 | 2006-10-04 | 海口绿科南药研究开发有限公司 | Supermicropowder soft capsule formulation and preparation method thereof |
| CN1846722A (en) * | 2006-02-21 | 2006-10-18 | 修涞贵 | Superfine Chinese medicine powder prepn for treating cardiovascular diseases and its prepn process |
-
2014
- 2014-07-16 CN CN201410339490.8A patent/CN104367908B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1839905A (en) * | 2005-03-30 | 2006-10-04 | 海口绿科南药研究开发有限公司 | Supermicropowder soft capsule formulation and preparation method thereof |
| CN1846722A (en) * | 2006-02-21 | 2006-10-18 | 修涞贵 | Superfine Chinese medicine powder prepn for treating cardiovascular diseases and its prepn process |
Non-Patent Citations (3)
| Title |
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| 内蒙古自治区药品检验所: "《卫生部颁蒙药标准（分册）》", 31 December 1998 * |
| 张丽华等: "蒙药冠心活血散治疗冠心病心绞痛60例临床观察", 《中国民族民间医药》 * |
| 邓雯等: "中药超微粉碎技术的研究进展", 《食品与药品》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018090380A1 (en) * | 2016-11-21 | 2018-05-24 | 内蒙古天奇中蒙制药股份有限公司 | Capsule and preparation process therefor |
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| CN104367908B (en) | 2017-09-15 |
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