CN100339068C - Dripping pill for treating coronary heart disease and preparing method - Google Patents
Dripping pill for treating coronary heart disease and preparing method Download PDFInfo
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- CN100339068C CN100339068C CN 200510107900 CN200510107900A CN100339068C CN 100339068 C CN100339068 C CN 100339068C CN 200510107900 CN200510107900 CN 200510107900 CN 200510107900 A CN200510107900 A CN 200510107900A CN 100339068 C CN100339068 C CN 100339068C
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Abstract
The present invention discloses a novel dripping pill for treating coronary disease and angina pectoris. The dripping pill is prepared from 20.1 parts by weight of tree peony bark, 33.6 parts by weight of chuanxiong rhizome and 2.18 parts by weight of borneol. The preparation method comprises: preparing the percolate of the tree peony bark, and recovering ethanol; extracting the volatile oil of the chuanxiong rhizome with water; decocting medicine dregs with water; filtering decocting liquor; mixing the filter liquor with the water solution; concentrating the mixture of the filter liquor and the water solution into clear paste; adding ethanol into the clear paste and stirring; settling the mixture of the ethanol and the clear paste; sucking supernatant liquor and recovering ethanol; mixing the tree peony bark and the medicine liquor of the chuanxiong rhizome; decompressing and concentrating the tree peony bark and the medicine liquor of the chuanxiong rhizome into thick paste; heating polyethylene glycol; adding the totally molten polyethylene glycol into the thick paste, the volatile oil of the chuanxiong rhizome and the borneol; stirring the mixture evenly; dripping the thick paste into liquid paraffin from top to bottom; draining the formed dripping pill and removing the liquid paraffin; the dripping pill is obtained. The dripping pill has the functions of clearing heat, cooling blood, promoting blood circulation and alleviating pain. The dripping pill has obvious pain alleviating effects on coronary disease and angina pectoris and is safe in clinical application.
Description
Technical field
The present invention relates to a kind of drop pill, relating in particular to a kind of is the drop pill of the treatment angina pectoris that forms of feedstock production with Cortex Moutan, Rhizoma Chuanxiong and Borneolum Syntheticum, belongs to field of traditional Chinese.
Background technology
The quick-acting cardiac pain aerosol is prepared from accordance with the following methods by Cortex Moutan 240g, Rhizoma Chuanxiong 401g, Borneolum Syntheticum 26g: above three flavors, and Cortex Moutan, Rhizoma Chuanxiong pulverize separately become coarse powder; Cortex Moutan extracts secondary with 90% ethanol merceration, for the first time with 90% ethanol 5300ml, stirs 6 hours, leaves standstill 12 hours, for the second time with 90% ethanol 4000ml, stirs 4 hours, leaves standstill 12 hours, draws supernatant, filters, and reclaims ethanol to volume and is about 500ml.Rhizoma Chuanxiong extracts volatile oil, and the aqueous solution after the distillation filters, and concentrating under reduced pressure becomes clear paste (about 120g), adds ethanol equivalent, stirs, and leaves standstill, and draws supernatant, filters, and filtrate and above-mentioned concentrated solution merge.Rhizoma Chuanxiong volatile oil, Borneolum Syntheticum are used an amount of dissolve with ethanol respectively, add the 4ml Tween 80, mixing adds above-mentioned amalgamation liquid, mixing, water are adjusted total amount to 1000ml, and mixing filters, the filtrate embedding is pressed into propellant (dichlorodifluoromethane) 5g, promptly in special bottle.This aerosol has clearing away heat and cooling blood, the effect of promoting blood circulation and stopping pain,, moderate obstruction of qi in the chest and cardialgia light to the partial heat type, the double dysphoria with smothery sensation of pain, diseases such as tongue fur yellow skin have certain curative effect, but there is following defective simultaneously in this aerosol: the interference factor that the dosage accuracy is not high, absorb because of pulmonary when medicine sucks is more, so absorption is incomplete and variability is bigger; Need withstand voltage device and valve system, its cost is higher.So provide the alternative dosage form of this aerosol that a kind of dosage is accurate, preparation cost is low, curative effect is more definite to have important practical significance.
Summary of the invention
Technical problem to be solved by this invention is to overcome the existing existing deficiency of quick-acting cardiac pain aerosol, and on existing drop pill preparation technology basis, improve, the drop pill of the treatment angina pectoris that a kind of dosage is accurate, preparation cost is low, curative effect is more definite is provided.
Technical problem to be solved by this invention realizes by following technological approaches: a kind of drop pill for the treatment of angina pectoris, and this drop pill is prepared from accordance with the following methods by Cortex Moutan 20.1 weight portions, Rhizoma Chuanxiong 33.6 weight portions and Borneolum Syntheticum 2.18 weight portions:
1) Cortex Moutan is pulverized the preparation percolate, reclaimed ethanol, it is standby to get the Cortex Moutan medicinal liquid;
2) Rhizoma Chuanxiong extracting in water volatile oil, aqueous solution after the distillation separates with medicinal residues, and medicinal residues decoct with water, and decoction liquor filters, filtrate and above-mentioned aqueous solution merge, relative density is 1.20～1.25 clear paste when being condensed into 70 ℃ of mensuration, adds ethanol in clear paste, stirs, leave standstill, draw supernatant, reclaim ethanol, it is standby to get the Rhizoma Chuanxiong medicinal liquid;
3) with the Cortex Moutan medicinal liquid and the step 2 of step 1) gained) the Rhizoma Chuanxiong medicinal liquid of gained merges, and is evaporated to thick paste;
4) get substrate, behind the heating and melting, add Rhizoma Chuanxiong volatile oil, Borneolum Syntheticum and above-mentioned thick paste, stir, from top to bottom, splash into condensing agent, with the drop pill drop that is shaped to the greatest extent and wipe condensing agent, promptly get drop pill of the present invention.
When preparing the Cortex Moutan percolate with percolation in the preparation method of above-mentioned drop pill, step 2), preferably make solvent with 90% ethanol, merceration 24 hours, slowly percolation is collected percolate.Preferred Rhizoma Chuanxiong extracting in water volatile oil is 2 hours in the step 3), and medicinal residues decoct with water 1 hour again; Preferably in clear paste add alcoholic acid amount to contain amount of alcohol be 50% in order to make, stirring was left standstill 24 hours; Matrix optimization described in the step 4) is any one or more in Macrogol 2000～20000, sodium stearate, glycerin gelatine, stearic acid, glyceryl monostearate, hydrogenated vegetable oil or the insect wax, more preferably polyethylene glycol 6000 or sodium stearate; Described condensing agent is selected from liquid paraffin, vegetable oil, dimethicone or water, more preferably liquid paraffin or dimethicone.Preferred overall weight that thick paste, Borneolum Syntheticum and Rhizoma Chuanxiong volatile oil is added together and the substrate behind the heating and melting mix by 1: 1～1: 10 weight proportion scope in the step 4), more preferably mix by 1: 2～1: 5 weight proportion scope.
In the preparation method of quick-acting cardiac pain aerosol, Cortex Moutan adopts 90% alcohol dipping to extract, and makes extracts active ingredients incomplete, and a large amount of tests of the present invention's process find to adopt 90% ethanol as solvent, and merceration is the percolation extraction after 24 hours, extraction effect the best.The present invention tests by a large amount of in addition, optimal relative density and ethanol consumption when the aqueous solution after having found out Best Times, the Rhizoma Chuanxiong decoction liquor of Rhizoma Chuanxiong extraction volatile oil and having extracted volatile oil merges the back precipitate with ethanol; Simultaneously, also found out optimal substrate and condensing agent, these process conditions all contribute to the improvement of the aspects such as roundness of high efficiency, quick-acting and the drop pill molding of this drop pill curative effect.
The quick-acting cardiac pain drop pill that this process is prepared had both kept the characteristics of quick-acting cardiac pain aerosol instant effect, also had steady quality simultaneously, the active constituent content height, and advantage such as bioavailability height and production cost are low, its performance is far superior to aerosol.
Drop pill of the present invention has clearing away heat and cooling blood, the effect of promoting blood circulation and stopping pain, and, moderate obstruction of qi in the chest and cardialgia light for the partial heat type, the double dysphoria with smothery sensation of pain, all diseases such as tongue fur yellow skin all have significant curative effect.
Further describe preparation method of the present invention and beneficial effect by the following examples, it should be understood that these embodiment only are used for the purpose of illustration, never limit protection scope of the present invention.
The specific embodiment
[embodiment 1]
Take by weighing each raw material by following weight: Cortex Moutan 20.1g, Rhizoma Chuanxiong 33.6g, Borneolum Syntheticum 2.18g.More than three flavors, Cortex Moutan is ground into coarse powder, according to the following percolation of fluid extract and extractum item (" appendix I of Chinese pharmacopoeia version in 2000), makes solvent with 90% ethanol, merceration 24 hours, percolation slowly, collection percolate, recovery ethanol.Rhizoma Chuanxiong power is broken into fragment, extracting in water volatile oil 2 hours, the aqueous solution after the distillation inclines and, and medicinal residues decoct with water 1 hour again, filter, filtrate and above-mentioned aqueous solution merge, and being condensed into relative density is the clear paste of 1.20～1.25 (70 ℃), add ethanol and make that to contain the alcohol amount be 50%, stir, left standstill 24 hours, and drew supernatant, reclaim ethanol.Merge Cortex Moutan and Rhizoma Chuanxiong medicinal liquid, continue to be evaporated to thick paste (about 6.6～6.8g).Taking polyethylene glycol 6000 31.2g in addition, heating, treat whole fusions after, add above-mentioned thick paste, Rhizoma Chuanxiong volatile oil and Borneolum Syntheticum, stir, from top to bottom, splash in the liquid paraffin, with the drop pill drop that is shaped to the greatest extent and the erasing liquor paraffin body, make 1000 balls, promptly.
[embodiment 2]
Take by weighing each raw material by following weight: Cortex Moutan 20.1g, Rhizoma Chuanxiong 33.6g, Borneolum Syntheticum 2.18g.More than three flavors, Cortex Moutan is ground into coarse powder, according to the following percolation of fluid extract and extractum item (" appendix I of Chinese pharmacopoeia version in 2000), makes solvent with 90% ethanol, merceration 24 hours, percolation slowly, collection percolate, recovery ethanol.Rhizoma Chuanxiong power is broken into fragment, extracting in water volatile oil 2 hours, the aqueous solution after the distillation inclines and, and medicinal residues decoct with water 1 hour again, filter, filtrate and above-mentioned aqueous solution merge, and being condensed into relative density is the clear paste of 1.20～1.25 (70 ℃), add ethanol and make that to contain the alcohol amount be 50%, stir, left standstill 24 hours, and drew supernatant, reclaim ethanol.Merge Cortex Moutan and Rhizoma Chuanxiong medicinal liquid, continue to be evaporated to thick paste (about 6.6～6.8g).Taking polyethylene glycol 4000 31.2g in addition, heating, treat whole fusions after, add above-mentioned thick paste, Rhizoma Chuanxiong volatile oil and Borneolum Syntheticum, stir, from top to bottom, splash in the liquid paraffin, with the drop pill drop that is shaped to the greatest extent and the erasing liquor paraffin body, make 1000 balls, promptly.
[embodiment 3]
Take by weighing each raw material by following weight: Cortex Moutan 20.1g, Rhizoma Chuanxiong 33.6g, Borneolum Syntheticum 2.18g.More than three flavors, Cortex Moutan is ground into coarse powder, according to the following percolation of fluid extract and extractum item (" appendix I of Chinese pharmacopoeia version in 2000), makes solvent with 90% ethanol, merceration 24 hours, percolation slowly, collection percolate, recovery ethanol.Rhizoma Chuanxiong power is broken into fragment, extracting in water volatile oil 2 hours, the aqueous solution after the distillation inclines and, and medicinal residues decoct with water 1 hour again, filter, filtrate and above-mentioned aqueous solution merge, and being condensed into relative density is the clear paste of 1.20～1.25 (70 ℃), add ethanol and make that to contain the alcohol amount be 50%, stir, left standstill 24 hours, and drew supernatant, reclaim ethanol.Merge Cortex Moutan and Rhizoma Chuanxiong medicinal liquid, continue to be evaporated to thick paste (about 6.6～6.8g).Taking polyethylene glycol 4000 45g in addition, heating, treat whole fusions after, add above-mentioned thick paste, Rhizoma Chuanxiong volatile oil and Borneolum Syntheticum, stir, from top to bottom, splash into dimethicone, with the drop pill drop that is shaped to the greatest extent and wipe dimethicone, make 1000 balls, promptly.
[embodiment 4]
Take by weighing each raw material by following weight: Cortex Moutan 20.1g, Rhizoma Chuanxiong 33.6g, Borneolum Syntheticum 2.18g.More than three flavors, Cortex Moutan is ground into coarse powder, according to the following percolation of fluid extract and extractum item (" appendix I of Chinese pharmacopoeia version in 2000), makes solvent with 90% ethanol, merceration 24 hours, percolation slowly, collection percolate, recovery ethanol.Rhizoma Chuanxiong power is broken into fragment, extracting in water volatile oil 2 hours, the aqueous solution after the distillation inclines and, and medicinal residues decoct with water 1 hour again, filter, filtrate and above-mentioned aqueous solution merge, and being condensed into relative density is the clear paste of 1.20～1.25 (70 ℃), add ethanol and make that to contain the alcohol amount be 50%, stir, left standstill 24 hours, and drew supernatant, reclaim ethanol.Merge Cortex Moutan and Rhizoma Chuanxiong medicinal liquid, continue to be evaporated to thick paste (about 6.6～6.8g).Other gets sodium stearate 80g, heating, treat whole fusions after, add above-mentioned thick paste, Rhizoma Chuanxiong volatile oil and Borneolum Syntheticum, stir, from top to bottom, splash in the dimethicone, with the drop pill drop that is shaped to the greatest extent and wipe dimethicone, make 1000 balls, promptly.
The technology stability of [test example 1] drop pill preparation method of the present invention is investigated test
One, investigates the prepared product of object: embodiment 1,2,3,4, be numbered 1,2,3,4 respectively.
Two, investigation project:
Examination and test of products result sees Table 1.
Table 1 technology stability is investigated result of the test
| Sequence number | 1 2 3 4 |
| Character weight differential dissolve scattered time limit | Rounding is even, color and luster is consistent, no adhesion phenomenon, and surperficial frozen-free liquid sticks up to specification |
Result of the test shows that preparation technology of the present invention is rationally feasible.
The clinical observation on the therapeutic effect test of [test example 2] drop pill treatment angina pectoris of the present invention
One, physical data
Select angina pectoris patient 88 examples altogether.
1, sex: male's 40 examples among this group patient, women's 48 examples, man: woman=1: 1.2
2, the age: minimum 27 years old of age, maximum 68 years old, 50.26 ± 6.14 years old mean age.Wherein≤and 35 years old 3 example, 35～44 years old 11 example, 45～54 years old 42 example, 55～65 years old 32 example.
3, state of an illness classification: 32 examples that this group state of an illness is slight, moderate 56 examples.
4, the course of disease: the longest 60 months the course of disease the shortest January, average course of disease 18.71 ± 12.01 months, wherein 1～March 12 example, the 3-6 months 2 example, 〉=June 74 example.
Two, trial drug
For the reagent thing: the drop pill that the embodiment of the invention 1 is prepared.
Positive control medicine: quick-acting cardiac pain aerosol.
Three, Therapeutic Method
The treatment group is with for the treatment of reagent thing, sublingual administration, one time 3～9,3 times on the one, during acute attack 12～18.Matched group quick-acting cardiac pain treatment by aerosol, sublingual spraying sucks, and once presses and inhales 1～3 time; Spray is used during pain.
Four, curative effect determinate standard
(1) chest pain symptom curative effect determinate standard (according to " the clinical research guideline of the treatment by Chinese herbs thoracic obstruction ")
Produce effects: disappeared with interior (containing 3 minutes) pain in 3 minutes after the medication.
Effectively: pain disappearance 3～5 minutes (containing 5 minutes) after the medication.
Invalid: after the medication more than 5 minutes pain just disappear.
Increase the weight of: pain does not disappear or the pain person of increasing the weight of after the medication.
(2) ECG curative effect evaluation criteria: (according to " the clinical research guideline of the treatment by Chinese herbs thoracic obstruction ")
Produce effects: electrocardiogram returns to normally (or roughly normal) during rest.
Effectively: S-T section reduction person more than the treatment back rise 0.05mv, but does not return to normal; (reaching 25% above person) shoals at the negative T wave that mainly leads; Or the T ripple is upright by smooth change; Chamber or intraventricular block improver.
Invalid: electrocardiogram is preceding identical with treatment substantially.
Increase the weight of: the S-T section reduces more than the 0.05mv before the treatment, deepens (reaching more than 25%) at the T ripple that mainly leads, or upright T ripple flattens smoothly, and smooth T ripple becomes to be inverted, and ectopic cardiac rhythm occurs, atrioventricular block or intraventricular block.
Five, observed result
Observed result sees Table 2.
Table 2 pharmaceutical composition clinical observation on the therapeutic effect of the present invention result
| The example number | Produce effects | Effectively | Invalid | Total effective rate | |
| Treatment group matched group | 49 39 | 32 examples, 25 examples | 17 examples, 10 examples | 2 examples | 100％ 91.1％ |
Drop pill of the present invention has clearing away heat and cooling blood, and the effect of promoting blood circulation and stopping pain is used for that chest pain is double sees that sensation of oppression over the chest with shortness of breath, dysphoria with smothery sensation are restless, palpitation and uneasiness, dry mouth and throat, red tongue companion petechia, diseases such as wiry and frequent pulse.Inferior by clinical observation 88 examples, total effective rate reaches 100%, its clinical efficacy will be higher than positive control medicine-quick-acting cardiac pain aerosol on the whole, the angina pectoris patient there is tangible alleviating pain effect, the ischemic electrocardiogram also there is good improvement effect, to sensation of oppression over the chest with shortness of breath, the palpitation and uneasiness due to the heart arteries and veins stagnant heat card, dysphoria with smothery sensation is restless, the dry mouth and throat symptom also has some improvement, clinical observation 49 examples are not found untoward reaction, detect hepatic and renal function before and after the treatment, blood, urine, just safety indexes such as routine all in normal range.
Clinical observation on the therapeutic effect presentation of results drop pill of the present invention has tangible analgesic effect to angina pectoris, clinical practice safety.
Claims (7)
1, a kind of drop pill for the treatment of angina pectoris is prepared from accordance with the following methods by Cortex Moutan 20.1 weight portions, Rhizoma Chuanxiong 33.6 weight portions and Borneolum Syntheticum 2.18 weight portions:
1) Cortex Moutan is pulverized the preparation percolate, reclaimed ethanol, it is standby to get the Cortex Moutan medicinal liquid;
2) Rhizoma Chuanxiong extracting in water volatile oil is 2 hours, and the aqueous solution after the distillation separates with medicinal residues, and medicinal residues decoct with water 1 hour, decoction liquor filters, filtrate and above-mentioned aqueous solution merge, and relative density is 1.20～1.25 clear paste when being condensed into 70 ℃ of mensuration, adds ethanol in clear paste, pure content is 50% in the clear paste in order to make to add alcoholic acid amount, stir, leave standstill, draw supernatant, reclaim ethanol, it is standby to get the Rhizoma Chuanxiong medicinal liquid;
3) with the Cortex Moutan medicinal liquid and the step 2 of step 1) gained) the Rhizoma Chuanxiong medicinal liquid of gained merges, and is evaporated to thick paste;
4) get substrate, behind the heating and melting, overall weight that thick paste, Borneolum Syntheticum and Rhizoma Chuanxiong volatile oil is added together and substrate mix by 1: 1～1: 10 weight proportion, stir, from top to bottom, splash into condensing agent, with the drop pill drop that is shaped to the greatest extent and wipe condensing agent, promptly.
2, according to the drop pill of claim 1, when it is characterized in that preparing the Cortex Moutan percolate in the step 1), adopt 90% ethanol to make solvent, merceration 24 hours, slowly percolation is collected the gained percolate.
3,, it is characterized in that substrate described in the step 4) is selected from any of any one or two kinds of above mixture in Macrogol 2000～20000, sodium stearate, glycerol, gelatin, stearic acid, glyceryl monostearate, hydrogenated vegetable oil or the insect wax according to the drop pill of claim 1.
4,, it is characterized in that described substrate is selected from polyethylene glycol 6000 or sodium stearate according to the drop pill of claim 3.
5,, it is characterized in that condensing agent described in the step 4) is selected from liquid paraffin, vegetable oil, dimethicone or water according to the drop pill of claim 1.
6,, it is characterized in that described condensing agent is selected from liquid paraffin or dimethicone according to the drop pill of claim 5.
7,, it is characterized in that overall weight in the step 4) that thick paste, Borneolum Syntheticum and Rhizoma Chuanxiong volatile oil is added together and substrate mix by 1: 2～1: 5 weight proportion according to the drop pill of claim 1.
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101856398B (en) * | 2009-04-10 | 2013-05-29 | 北京亚东生物制药有限公司 | Detection method of Chinese medicinal composition for clearing heat and cooling blood, promoting blood circulation and stopping pain |
| CN103006810A (en) * | 2012-12-27 | 2013-04-03 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Method for preparing dropping pill for removing heat to cool blood and promoting blood circulation to stop pain |
| CN104688837A (en) * | 2013-12-06 | 2015-06-10 | 天津中新药业集团股份有限公司第六中药厂 | Preparation method of Suxiaoxintong tablets |
| CN104688841A (en) * | 2013-12-06 | 2015-06-10 | 天津中新药业集团股份有限公司第六中药厂 | Preparation method of Suxiaoxintong granules |
| CN104688838A (en) * | 2013-12-06 | 2015-06-10 | 天津中新药业集团股份有限公司第六中药厂 | Preparation method of Suxiaoxintong oral liquid |
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