CN104523805A - Storax dispersible tablet for coronary heart disease and preparation method thereof - Google Patents
Storax dispersible tablet for coronary heart disease and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a storax dispersible tablet for a coronary heart disease and a preparation method of the storax dispersible tablet. The storax dispersible tablet is mainly composed of, by weight, 15-30 parts of storax, 40-50 parts of borneol, 40-50 parts of frankincense, 75-90 parts of sandalwood, 75-90 parts of elecampane, 10-20 parts of berberine hydrochloride, 10-20 parts of dextrin, 10-20 parts of microcrystalline cellulose and a proper amount of ethyl alcohol. The storax dispersible tablet is prepared through nano smashing and berberine hydrochloride adding, and is high in content, fast to disintegrate, proper in hardness and easy to press. Meanwhile, the preparation method of the storax dispersible tablet has the advantages of being simple in procedure, controllable in quality and suitable for industrial production.
Description
Technical field
The invention belongs to field of traditional Chinese, be specifically related to a kind of coronary disease Soviet Union and close dispersible tablet and preparation method thereof.
Background technology
Angina pectoris is coronary insufficiency, cardiac muscle ischemia sharply and the clinical syndrome being main manifestations with ictal chest pain or chest discomfort caused by anoxia.New coronary disease Soviet Union closes blood circulation promoting recipe and follows theory of Chinese medical science, select Styrax, Borneolum Syntheticum, Olibanum, Lignum Santali Albi four medicine makes, come from and storax pill for treating coronary heart disease, simplified by Song dynasty " formulary of peaceful benevolent dispensary " Styrax Pilulae to form, there is causing resuscitation with aromatic drugs, promoting blood circulation and stopping pain effect, be usually used in controlling angina pectoris acute attack.
Publication number is that the Chinese patent application of CN101564413A discloses a kind of Guanxinsuhe preparation and preparation method thereof, adopt the Guanxinsuhe preparation that superfine communication technique is obtained, it gets prescription medical material, be ground into coarse powder, to put in vibration-type super micron mill micronizing 10 ~ 80 minutes, after obtained ultra-fine pharmaceutical composition, preparation technique obtains routinely.
Publication number is that the Chinese patent application of CN1362196A discloses a kind of nano coronary heart disease treating Soviet Union conjunction preparation medicine and preparation method thereof, it is for raw material with nano storax, nanometer Borneolum Syntheticum, nanometer Olibanum, nanometer Lignum Santali Albi, nanometer Radix Aristolochiae, prepare in proportion, make new pharmaceutical preparation, its fineness of the particles is 1200-1500 order, particle diameter 0.1-200, wherein most particle diameter is less than 100nm, and it adopts the step such as microwave extracting, concentrating under reduced pressure, supersonic jet technology spraying dry to make.
It is lower that above-mentioned Guanxinsuhe preparation medicine has toxicity, can the advantage of long-term taking, but as a kind of Chinese medicine preparation, also have onset slow simultaneously, the stable not and significant shortcoming of curative effect.
Summary of the invention
The invention provides a kind of coronary disease Soviet Union and close dispersible tablet and preparation method thereof, this coronary disease Soviet Union closes dispersible tablet and has better therapeutic effect to angina pectoris, and dissolution is high, and disintegration time is fast, is conducive to shortening onset time.
Dispersible tablet closes in a kind of coronary disease Soviet Union, is made up of the raw material comprising following weight portion:
In the present invention, by adding berberine hydrochloride in existing Guanxinsuhe preparation prescription, significantly enhance curative effect and the pharmacodynamic stability of preparation; Meanwhile, by selecting suitable adjuvant dextrin and microcrystalline Cellulose, improve dissolution and the disintegration time of preparation, shortening onset time.
Present invention also offers the preparation method that dispersible tablet closes in a kind of described coronary disease Soviet Union, comprise the steps:
(1) respectively Styrax, Borneolum Syntheticum, Olibanum (processed with vinegar), Lignum Santali Albi and Radix Inulae are carried out nano-pulverization, sieve, obtain the nano powder raw material of each medical material;
(2) prepare 4 ~ 6% dextrin in aqueous solution, obtain the aqueous solution of adhesive, put in aerosol can for subsequent use;
(3) after the nano powder raw material ethanol of Styrax being mixed well, again with nano powder raw material and 1/2 ~ 2/3 microcrystalline Cellulose of Olibanum (processed with vinegar), Lignum Santali Albi, Radix Inulae, drop in the truck of one-step-granulating method, opening blower fan and heating makes material be in fluidized state, then spray into the aqueous solution of described adhesive, adopt marumerization to obtain granule;
(4) granule step (3) obtained mixes with Borneolum Syntheticum, berberine hydrochloride and 1/3 ~ 1/2 microcrystalline Cellulose and carries out tabletting, obtains described coronary disease Soviet Union and closes dispersible tablet.
This preparation method, by Styrax, Borneolum Syntheticum, Olibanum (processed with vinegar), Lignum Santali Albi and Radix Inulae are carried out nano-pulverization, coordinates special method of granulating simultaneously, significantly enhances disintegration time and dissolution efficiency, is conducive to the quick absorption of medicine.
As preferably, in step (1), the order number of the sieve used that sieves is 120 ~ 200 orders.As preferably, in step (1), nano-pulverization carries out in nano grinder, and grinding time is 0.5 ~ 6 hour, and the mean diameter of the nano powder obtained is 100 ~ 300nm.As further preferred, the time of nano-pulverization is 1 hour, and the mean diameter of the nano powder obtained is 200nm.Now, the dispersible tablet obtained has good dissolution.
As preferably, in step (3), the feed liquor speed of described adhesive is 25 ~ 32ml/min, and atomizing pressure is 0.10 ~ 0.12MPa.
As preferably, in step (3), inlet temperature is 75 ~ 90 DEG C, and temperature of charge is 40 DEG C-60 DEG C.By the control of above-mentioned parameter, effectively can prevent the loss of active component in preparation process, the granule qualification rate obtained is high, is convenient to subsequent operation, reduces content uniformity.
As preferably, in step (4), incorporation time is 10 ~ 30 minutes, and tableting pressure is 30 ~ 60KN.Now, the performances such as the fineness of the tablet obtained and hardness are better.
Compared with the existing technology, advantage of the present invention is as follows:
(1) Traditional Chinese Medicine dosage after micronization, is only equivalent to 1/10th of former prescription dosage, thus greatly save valuable Chinese material medicine resource, also available protecting Chinese crude drug planting environment.By superfine communication technique, make indissoluble or be slightly soluble in the effective ingredient of water, through cell wall breaking, the bioavailability of medicine can be significantly improved.
(2) the present invention is by the combination of berberine hydrochloride and principal agent, surprisingly finds that not only content is high, and drug effect is fast, and steady quality.
(3) by the meticulous screening of adjuvant, made grain graininess is even, and slice, thin piece hardness, release, slice, thin piece fineness aspect is all better than the granule that traditional handicraft is made.
(4) production technology of the present invention is simple, without the need to abstraction process, decreases the investment of corresponding equipment Factory Building and inspection cost and labor intensity, save time and the energy, and not because of the quality of the experience decision product of workman, final mass is stablized, between batch, difference is little, workable.
Detailed description of the invention
Embodiment 1
(1) adopt nano grinder to carry out nanorize pulverizing to Styrax, Borneolum Syntheticum, Olibanum (processed with vinegar), Lignum Santali Albi and Radix Inulae gomi herbs respectively, grinding time is 1 hour, and after pulverizing, particle diameter is 200nm, for subsequent use;
(2) adhesive: prepare 5% dextrin in aqueous solution, puts in aerosol can for subsequent use;
(3) mixing granulation: the Styrax recipe quantity ethanol after pulverizing is mixed well rear and Olibanum (processed with vinegar), Lignum Santali Albi, the nano powder raw material of Radix Inulae and the microcrystalline Cellulose of 1/2 recipe quantity, drop in the truck of one-step-granulating method, open blower fan and heat, material is evenly heated up under fluidized state, open spraying button, spray into 5% dextrin in aqueous solution, adjustment feed liquor speed 27ml/min, atomizing pressure 0.10 ~ 0.12MPa, inlet temperature 85 DEG C, temperature of charge 50 DEG C, until adhesive all sprays into, dry, cooling discharge, obtains granule;
(4) step (3) gained granule is mixed 25 minutes with the microcrystalline Cellulose of Borneolum Syntheticum, berberine hydrochloride and 1/2 recipe quantity, Stress control carries out tabletting at 45KN, and dispersible tablet closes in obtained coronary disease Soviet Union.
Embodiment 2
(1) adopt nano grinder to carry out nanorize pulverizing to Styrax, Borneolum Syntheticum, Olibanum (processed with vinegar), Lignum Santali Albi and Radix Inulae gomi herbs respectively, grinding time is 1 hour, and after pulverizing, particle diameter is 200nm, for subsequent use;
(2) adhesive: prepare 5% dextrin in aqueous solution, puts in aerosol can for subsequent use;
(3) mixing granulation: Styrax recipe quantity ethanol is mixed well and the nano powder raw material of Olibanum (processed with vinegar), Lignum Santali Albi, Radix Inulae and 1/2 microcrystalline Cellulose, drop in the truck of one-step-granulating method, open blower fan and heat, material is evenly heated up under fluidized state, open spraying button, spray into 5% dextrin in aqueous solution, adjustment feed liquor speed 25ml/min, atomizing pressure 0.10 ~ 0.12MPa, inlet temperature 80 DEG C, temperature of charge 55 DEG C, until adhesive all sprays into, dry, cooling discharge, obtains capsule particle;
(4) step (3) gained granule is mixed 30 minutes with Borneolum Syntheticum, berberine hydrochloride and 1/2 microcrystalline Cellulose, Stress control carries out tabletting at 50KN, and dispersible tablet closes in obtained coronary disease Soviet Union.
Embodiment 3
(1) adopt nano grinder to carry out nanorize pulverizing to Styrax, Borneolum Syntheticum, Olibanum (processed with vinegar), Lignum Santali Albi and Radix Inulae gomi herbs respectively, grinding time is 1 hour, and particle diameter is 200nm, for subsequent use.
(2) adhesive: prepare 5% dextrin in aqueous solution, puts in aerosol can for subsequent use;
(3) mixing granulation: Styrax recipe quantity ethanol is mixed well and the nano powder raw material of Olibanum (processed with vinegar), Lignum Santali Albi, Radix Inulae and 1/2 microcrystalline Cellulose, drop in the truck of one-step-granulating method, open blower fan and heat, material is evenly heated up under fluidized state, open spraying button, spray into 5% dextrin in aqueous solution, adjustment feed liquor speed 30ml/min, atomizing pressure 0.10 ~ 0.12MPa, inlet temperature 75 DEG C, temperature of charge 60 DEG C, until adhesive all sprays into, dry, cooling discharge, obtains capsule particle;
(4) step (3) gained granule is mixed 20 minutes with Borneolum Syntheticum, berberine hydrochloride and 1/2 microcrystalline Cellulose, Stress control carries out tabletting at 60KN, and dispersible tablet closes in obtained coronary disease Soviet Union.
Comparative example 1
Except not adding berberine hydrochloride, other steps are with embodiment 1.
Comparative example 2
Except step (1) does not carry out nano-pulverization, made 100 mesh sieves into, other steps are with embodiment 1.
Comparative example 3
(1) adopt nano grinder to carry out nanorize pulverizing to Styrax, Borneolum Syntheticum, Olibanum (processed with vinegar), Lignum Santali Albi and Radix Inulae gomi herbs respectively, grinding time is 1 hour, and particle diameter is 200nm, for subsequent use.
(2) nano raw material of Olibanum (processed with vinegar), Lignum Santali Albi, Radix Inulae is added wet granulator; then Styrax recipe quantity ethanol is mixed well and add wet granulator mixing 100 ~ 120 seconds; high-speed cutting granulation 100-120 second; cross 10-16 mesh sieve; the granule made is sent into heated-air circulation oven dry, add recipe quantity Borneolum Syntheticum, berberine hydrochloride, dextrin, microcrystalline Cellulose after granulate, mix after 15 ~ 20 minutes; carry out tabletting, dispersible tablet closes in obtained coronary disease Soviet Union.
Comparative example 4
(1) adopt nano grinder to carry out nanorize pulverizing to Styrax, Borneolum Syntheticum, Olibanum (processed with vinegar), Lignum Santali Albi and Radix Inulae gomi herbs respectively, grinding time is 1 hour, and particle diameter is 200nm, for subsequent use.
(2) adhesive: prepare 5% dextrin in aqueous solution, puts in aerosol can for subsequent use;
(3) mixing granulation: Styrax recipe quantity ethanol is mixed well and the nano powder raw material of Olibanum (processed with vinegar), Lignum Santali Albi, Radix Inulae and 1/2 starch, drop in the truck of one-step-granulating method, open blower fan and heat, material is evenly heated up under fluidized state, open spraying button, spray into 5% dextrin in aqueous solution, adjustment feed liquor speed 27ml/min, atomizing pressure 0.10 ~ 0.12MPa, inlet temperature 85 DEG C, temperature of charge 50 DEG C, until adhesive all sprays into, dry, cooling discharge, obtains capsule particle;
(4) step (3) gained granule is mixed 25 minutes with Borneolum Syntheticum, berberine hydrochloride and 1/2 starch, Stress control carries out tabletting at 45KN, and dispersible tablet closes in obtained coronary disease Soviet Union.
Embodiment 1 ~ 3 comparative example 1 ~ 4 is carried out the acceleration quality examination of 6 months (Chinese Pharmacopoeia 2010 editions two annex), the results are shown in Table 1:
Dispersible tablet assay is closed by table 1 coronary disease Soviet Union
Learnt by above data, embodiment 1 ~ 3 dissolution, content, moisture, disintegration are all better than comparative example 1 ~ 4, and visible, the present invention is all better than prior art.Comparative example 1 shows, adding of berberine hydrochloride, has certain Stabilization to effective ingredient in tablet, and the content of added-time berberine hydrochloride effective ingredient does not reduce rapider.Comparative example 2 shows, when not having nano-pulverization, content is on the low side, and onset is slow; Comparative example 3 shows, preparation technology has impact to quality; After comparative example 4 shows that microcrystalline Cellulose changes starch into, even if adopt identical operational approach, dissolution and disintegration all significantly decline, as can be seen here, select specific disintegrating agent and the performance impact of filler to the dispersible tablet obtained larger.
Below by way of experimental data, therapeutic effect of the present invention is described:
Following data are the clinical trial that dispersible tablet closes in the coronary disease Soviet Union entrusting Xi'an Yi Taite pharmaceutical developments company limited to organize and implement by our company, and it is routine, evident in efficacy that dispersible tablet treatment angina pectoris 220 closes in coronary disease Soviet Union, and existing report is as follows:
1, clinical data
Observe altogether treatment angina pectoris to show effect weekly more than 5 times 220 examples, treatment group is totally 110 examples, man 51 example, and female 59 is routine; The oldest person 73 years old, reckling 45 years old, average 62 years old; Matched group is totally 110 examples, man 62 example, female 48 example; The oldest person 75 years old, reckling 46 years old, average 63 years old; Two groups of clinical datas compare without significant difference (P > 0.05), have comparability.
2, Therapeutic Method
Treatment group: close dispersible tablet with the coronary disease Soviet Union that embodiment 1 method is obtained, buccal or swallow.One time 2,1-3 time on the one.Just before going to bed or morbidity time take.
Contrast groups: close dispersible tablet with the coronary disease Soviet Union that comparative example 1 method is obtained, buccal or swallow.One time 2,1-3 time on the one.Just before going to bed or morbidity time take.
Two groups are 4 weeks is a course for the treatment of.
3, therapeutic outcome
After the course for the treatment of, observe respectively the anginal impact getting final product curative effect and angina pectoris frequency.
Table 2 liang group is to angina pectoris immediate effectiveness
| Group | Effective | Effectively | Invalid | Total effective rate % |
| Treat 110 groups | 65(59.1％) | 41(37.3％) | 4(3.6％) | 96.4％ |
| Contrast 110 groups | 46(41.8％) | 48(43.6％) | 16(14.6％) | 85.4％ |
The impact of table 3 liang group angina pectoris frequency
This clinical observation shows, and it is excellent that dispersible tablet treatment Angina closes in coronary disease Soviet Union of the present invention, and finished product treatment is stable, and determined curative effect, as can be seen here, after berberine hydrochloride adds, plays certain synergism with other compositions, create obvious potentiation.
Claims (8)
1. a dispersible tablet closes in coronary disease Soviet Union, it is characterized in that, is made up of the raw material comprising following weight portion:
2. a preparation method for dispersible tablet is closed by coronary disease Soviet Union as claimed in claim 1, it is characterized in that, comprises the steps:
(1) respectively Styrax, Borneolum Syntheticum, Olibanum (processed with vinegar), Lignum Santali Albi and Radix Inulae are carried out nano-pulverization, sieve, obtain the nano powder raw material of each medical material;
(2) prepare 4 ~ 6% dextrin in aqueous solution, obtain the aqueous solution of adhesive, put in aerosol can for subsequent use;
(3) after the nano powder raw material ethanol of Styrax being mixed well, again with nano powder raw material and 1/2 ~ 2/3 microcrystalline Cellulose of Olibanum (processed with vinegar), Lignum Santali Albi, Radix Inulae, drop in the truck of one-step-granulating method, opening blower fan and heating makes material be in fluidized state, then spray into the aqueous solution of described adhesive, adopt marumerization to obtain granule;
(4) granule step (3) obtained mixes with Borneolum Syntheticum, berberine hydrochloride and 1/3 ~ 1/2 microcrystalline Cellulose and carries out tabletting, obtains described coronary disease Soviet Union and closes dispersible tablet.
3. the preparation method of dispersible tablet is closed by coronary disease Soviet Union according to claim 2, and it is characterized in that, in step (1), the order number of the sieve used that sieves is 120 ~ 200 orders.
4. the preparation method of dispersible tablet is closed by coronary disease Soviet Union according to claim 3, it is characterized in that, in step (1), nano-pulverization carries out in nano grinder, grinding time is 0.5 ~ 6 hour, and the mean diameter of the nano powder obtained is 100 ~ 300nm.
5. the preparation method of dispersible tablet is closed by coronary disease Soviet Union according to claim 4, and it is characterized in that, the time of nano-pulverization is 1 hour, and the mean diameter of the nano powder obtained is 200nm.
6. the preparation method of dispersible tablet is closed by coronary disease Soviet Union according to claim 2, and it is characterized in that, in step (3), the feed liquor speed of the aqueous solution of described adhesive is 25 ~ 32ml/min, and atomizing pressure is 0.10 ~ 0.12MPa.
7. the preparation method of dispersible tablet is closed by coronary disease Soviet Union according to claim 2, and it is characterized in that, in step (3), inlet temperature is 75 ~ 90 DEG C, and temperature of charge is 40 DEG C-60 DEG C.
8. the preparation method of dispersible tablet is closed by coronary disease Soviet Union according to claim 2, and it is characterized in that, in step (4), incorporation time is 10 ~ 30 minutes, and tableting pressure is 30 ~ 60KN.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410843659.3A CN104523805B (en) | 2014-12-30 | 2014-12-30 | Dispersible tablet and preparation method thereof closes in coronary disease Soviet Union |
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| CN201410843659.3A CN104523805B (en) | 2014-12-30 | 2014-12-30 | Dispersible tablet and preparation method thereof closes in coronary disease Soviet Union |
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| CN104523805B CN104523805B (en) | 2018-01-16 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1362196A (en) * | 2001-01-02 | 2002-08-07 | 杨孟君 | Nano Guanxinsuhe medicine and its preparation |
| CN1733037A (en) * | 2005-07-29 | 2006-02-15 | 王衡新 | Chinese medicinal preparation for treating cardiovascular diseases and its preparing process |
| CN1843396A (en) * | 2006-02-13 | 2006-10-11 | 浙江大德药业集团有限公司 | Oral disintegration tablet for treating coronary heart disease, its preparation process and quality control method |
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2014
- 2014-12-30 CN CN201410843659.3A patent/CN104523805B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1362196A (en) * | 2001-01-02 | 2002-08-07 | 杨孟君 | Nano Guanxinsuhe medicine and its preparation |
| CN1733037A (en) * | 2005-07-29 | 2006-02-15 | 王衡新 | Chinese medicinal preparation for treating cardiovascular diseases and its preparing process |
| CN1843396A (en) * | 2006-02-13 | 2006-10-11 | 浙江大德药业集团有限公司 | Oral disintegration tablet for treating coronary heart disease, its preparation process and quality control method |
Non-Patent Citations (1)
| Title |
|---|
| 袁建喜等: "黄连素的临床新用", 《现代中西医结合杂志》 * |
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