CN1583041A - Tongmai drops and their preparation - Google Patents
Tongmai drops and their preparation Download PDFInfo
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- CN1583041A CN1583041A CN 200410022732 CN200410022732A CN1583041A CN 1583041 A CN1583041 A CN 1583041A CN 200410022732 CN200410022732 CN 200410022732 CN 200410022732 A CN200410022732 A CN 200410022732A CN 1583041 A CN1583041 A CN 1583041A
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Abstract
A Chinese medicine in the form of dripping pills for treating cardiovascular and cerebrovascular ischemic diseases, arteriosclerosis, cerebral thrombus, cerebral ischemia, coronary heart disease, etc is prepared from red sage root, Chuan-xiong rhizome, pueraria root and auxiliary.
Description
Technical field: the present invention is a kind of pulse invigorating pill and preparation method thereof, belongs to technical field of Chinese medicine.
Background technology: several diseases such as ischemic cardio cerebrovascular diseases, arteriosclerosis, cerebral thrombosis, cerebral ischemia, coronary heart disease, angina pectoris are present frequently-occurring disease, commonly encountered diseases, and in order to treat this class disease, each medicine enterprise develops, developed many kinds; TONGMAI KELI electuary wherein is exactly a kind of medicine wherein; Because choosing side is proper, this medicine has more definite therapeutic effect for above-mentioned disease; But its dosage form is single, is difficult to meet the need of market, and particularly different patients has different situations, and single preparation is obviously too simple, can not offer the doctor and patient best choice; What is more important in addition: contain a certain amount of sugar part in the middle of the dissolved granule, like this, the patient who suffers from diabetes just is not suitable for taking, so have its limitation.
Summary of the invention: the objective of the invention is to: pulse invigorating pill and preparation method thereof is provided, and it is dropping pill formulation that traditional TONGMAI KELI electuary is changed agent, is used to increase the types of drugs of this class disease of treatment, selects for use for doctor and patient, satisfies the demand in market; The present invention constitutes like this: pulse invigorating pill: calculate according to composition by weight: it is mainly by 100～1000 parts of Radix Salviae Miltiorrhizaes, 100～1000 parts of Rhizoma Chuanxiongs, and Radix Puerariae is prepared from for 100～1000 parts.Specifically: it is by Radix Salviae Miltiorrhizae 500g, Rhizoma Chuanxiong 500g, and Radix Puerariae 500g and appropriate amount of auxiliary materials are prepared from.The preparation method of pulse invigorating pill: get Rhizoma Chuanxiong and extract volatile oil according to conventional method, volatile oil device is in addition collected, medicinal residues and all the other two flavor Radix Salviae Miltiorrhizaes and Radix Puerariae decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, it is 1.08 that collecting decoction, filtration, filtrate are concentrated into relative density, filters while hot, and it is 1.38～1.40 clear paste that filtrate is concentrated into relative density; Get Rhizoma Chuanxiong volatile oil, add ethanol and dissolve in right amount, add an amount of tween 80, make solubilising liquid; Get 500g Polyethylene Glycol-6000, behind the heating and melting, add clear paste and volatile oil solubilising liquid, stir, maintain the temperature at 60-90 ℃, splash into temperature and be in 0-5 ℃ the white oil, drip and make ball promptly.Pulse invigorating pill of the present invention can also be prepared into soft pulse wafer or buccal tablet.
Compared with prior art: the present invention has the function of blood circulation and channel invigorating; Be used for ischemic cardio cerebrovascular diseases, arteriosclerosis, cerebral thrombosis, cerebral ischemia, coronary heart disease, anginal treatment, product is convenient to take, and onset is rapid, evident in efficacy, is free from side effects.
Side of the present invention separates: Radix Salviae Miltiorrhizae in the side, is slightly cold at bitter in the mouth.Main GUIXIN, pericardium, Liver Channel.Has the effect that blood circulation promoting and blood stasis dispelling, removing heat from blood eliminating carbuncle, relieving restlessness are calmed the nerves.Be usually used in syndrome of blood stasis, the resistance of the heart arteries and veins stasis of blood, obstruction of qi in the chest and cardialgia, apoplectic hemiplegia etc., Radix Salviae Miltiorrhizae is gone into heart channel, but both clearing away heat and cooling blood, again can promoting blood circulation to remove blood stasis, calm the nerves.We are monarch with the Radix Salviae Miltiorrhizae, just are fit to this product and are used for cardiovascular and cerebrovascular vessel, because of the disease due to the blood-vessel obstructive.The Rhizoma Chuanxiong master returns liver, gallbladder, pericardium channel.Effect is blood-activating and qi-promoting, wind-expelling pain-stopping.Shennong's Herbal carries the original name Rhizoma Chuanxiong, and this medicine is up, specially controls all diseases of headache, and the former Sichuan that produces is so Rhizoma Chuanxiong becomes this product common name.We are minister with the Rhizoma Chuanxiong, get it and can control blood, again can circulation of qi promoting, thus reach stagnant breast, the side of body, the pain of the treatment vim and vigour stasis of blood.The side is an accessory drugs with the Radix Puerariae, Radix Puerariae sweet in the mouth, suffering, cold.Main lung, spleen, the stomach warp of returning.Be suffering, the product that loose can rise outer the reaching of loosing.The disease of heart and brain occupy the part of the body cavity above the diaphragm housing the heart and lungs, then assists a ruler in governing a country the monarch drug ministerial drug and rises diffusing power.Again according to recent studies, the contained puerarin class of Radix Puerariae can make the myocardial oxygen consumption index reduce to cardiovascular and cerebrovascular disease, have again arrhythmia, prevent the formation of cerebral thrombosis.All medicines share, and play altogether and control the merit that blood is promoted blood circulation.Be applicable to ischemic cardio cerebrovascular diseases.Diseases such as arteriosclerosis, cerebral thrombosis, cerebral ischemia, coronary heart disease, angina pectoris.
For understanding the effect of this product provided by the invention, the applicant has carried out clinical observation: pulse invigorating pill treatment angina pectoris 150 routine efficacy analysis
One, physical data.
Pulse invigorating pill is used for angina pectoris 150 examples (matched group 37 examples) efficacy analysis, angina pectoris, and disease is seen the left brain pain of feeling oppressed, with cardiopalmus, the dim ecchymosis of tongue, Chinese medical discrimination belongs to blood stasis impatency type thoracic obstruction patient.Be outpatient service and inpatient, its diagnostic criteria is with reference to International Society of Cardiology and association and World Health Organization (WHO), and clinical name standard association special topic is organized " the ischemic heart desease name and the diagnostic criteria " of report.Merge hypercalcinuria person 75 examples among the 150 routine patients, complicated hypertension patient 45 examples, complication with diabetes person 30 examples.The treatment group, male's 72 examples, women's 41 examples, minimum 40 years old of age, maximum 82 years old, average 59.05 years old; The course of disease is the shortest 20 days, and is the longest 30 years, average 8.6 years.Matched group, male's 21 examples, women's 16 examples; Minimum 40 years old of age, maximum 71 years old, average 55.43 years old; The course of disease is the shortest 28 days, and is the longest 31 years, average 6.4 years.Two groups of sexes, age, courses of disease there are no significant difference has comparability.
Two, angina pectoris typing situation
The angina pectoris typing is with reference to above-mentioned " ischemic heart desease name and diagnostic criteria "
The treatment group, fatigue angina pectoris 72 examples, wherein first hair style 10 examples, stable type 59 examples, deterioration type 3 examples; Spontaneous angina pectoris 17 examples, mixed angina pectoris 24 examples.Matched group, fatigue angina pectoris 25 examples, wherein first hair style 4 examples, stable type 20 examples, deterioration type 1 example, spontaneous angina pectoris 5 examples; Mixed type angina pectoris 7 examples.
Three, thoracic obstruction weight grade scale:
Carry out clinical scale according to therapy of combining Chinese and Western medicine angina pectoris in 1979 and angina pectoris forum " angina pectoris and ECG curative effect evaluation criteria ".The treatment group, slight 33 examples, moderate 67 examples, severe 13 examples; Matched group, slight 12 examples, moderate 23 examples, severe 2 examples.
Four, observational technique: treatment group and matched group carry out single blind trial, treatment group, 10 of each oral pulse invigorating pills, (30mg/ grain) every day 3 times by 3: 1 random packet; Matched group, 3 of each oral administered compound Radix Salviae Miltiorrhizae Tabellae, every day 3 times.3 weeks of the course of treatment.Other treatment treating coronary heart disease and angina pectoris of stopping using during the treatment to wherein can not the person of stopping using, gives nitroglycerine tablets in case of necessity.
Five, efficacy assessment standard
Thoracic obstruction symptom curative effect and ECG curative effect evaluation criteria are with reference to therapy of combining Chinese and Western medicine angina pectoris in 1979 and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria ".
1, thoracic obstruction symptom efficacy assessment standard.
Produce effects: transference cure or basic the disappearance; Effectively: pain attack times, degree and persistent period obviously alleviate; Invalid: symptom is preceding identical with treatment substantially.
2, ECG curative effect evaluation criteria
Produce effects: electrocardiogram returns to roughly normal or normal; Effectively: the ST section reduces, and more than the treatment back rise 0.05MV, the negative T wave that mainly leads shoals, or the T ripple is because smooth change is upright, the room plug or stop up in the conduction block improver; Invalid: electrocardiogram is preceding identical with treatment substantially;
Six, result:
1, analyze before and after the chest pain treatment:
Treatment group: produce effects: 59.3%, effectively: 29.20%, invalid: 11.50%, total effective rate: 92.40%.
Matched group: produce effects: 51.35%, effectively: 27.03%, invalid: 21.62, total effective rate: 78.38%.
2, compare before and after the treatment uncomfortable in chest
Treatment group: produce effects: 57.52%; Effectively: 30.09%, invalid: 12.39%
Total effective rate: 87.61%.
Matched group: produce effects: 54.96%, effectively: 32.43%, invalid: 21.62.
Total effective rate: 78.38%.
3, compare before and after the cardiopalmus treatment
The treatment group, produce effects: 57.52%, effectively: 30.09%; Invalid: 12.39%, total effective rate: 87.62%.
Matched group: produce effects: 45.96%; Effective 32.43%; Invalid: 21.62%; Total effective rate: 45.95%.
4, ECG curative effect analysis
Treatment group: produce effects: 18.58%; Effectively: 33.63%, invalid: 47.79%, total effective rate: 52.21%.
Matched group: produce effects: 13.51%, effectively: 32.43%, invalid: 54.06%, total effective rate: 45.95%.
The present invention will " TONGMAI CHONGJI: change technical characterstic and the advantage thereof of agent for " pulse invigorating pill " through research, exploitation: this kind mainly act as blood circulation and channel invigorating.Be used for treatment, as ischemic cardio cerebrovascular diseases, arteriosclerosis, cerebral thrombosis, cerebral ischemia, coronary heart disease, angina pectoris etc. to the cardiovascular disease class.The general oncoming force of these diseases is violent, and morbidity is anxious, thereby uses electuary, takes inconvenience, is unfavorable for urgent need.Be prepared as drop pill, belong to Chinese medicine emergency case preparation, can reach efficiently, purpose fast.The characteristics of this kind on processing technology: because the medicine of this product consists of water solubility extract, on processing technology, need to select suitable water solublity drop pill substrate, through a large amount of experiments, we have selected substrate PEG6000, its fusing point is 54---60 ℃, no physiological action own, and chemical stability is better, is easy to molten water, can be used for medicine being help solubilization from discharging water solublity or oils medicine.Simultaneously can also holding portion liquid.In selecting the condensing agent of drop pill, our option table surface tension is little, and viscosity is bigger, and the methyl-silicone oil and the Semen Maydis oil that help improving the roundness of drop pill share.
This product is on preparation method: the present invention adopts the dry fine powder of Chinese medicine extract, directly adds in the molten matrix, because this height of thing is big, does not just add adjuvant, fully drops into the drop pill machine behind the mixing, drips and makes ball.Its concrete method for making is: with the dry fine powder of three flavor Chinese medicine extract, taking polyethylene glycol 6000 is heated to whole fusions in water-bath after, add above-mentioned fine powder, be transferred in the liquid containing bottle rapidly after stirring, the sealing insulation is to 80 ℃, drip system from top to bottom with dosing pump drop pill machine, splash in the miscella of coolant dimethicone and Semen Maydis oil.Drip fast 30 balls/minute, with the drop pill drop that forms to the greatest extent and wipe liquid coolant, pour in the dish of absorbent paper, dry back fill promptly.
Rat ventricular test due to TONGMAI CHONGJI, the anti-aconitine of pulse invigorating pill:
Experimental principle: the arrhythmia of bringing out with aconitine is lasting, so the animal model of the treatment that can experimentize.
Experiment material: animal, rat; Equipment: electrocardiograph, electrocardioscope, constant speed syringe; Medicine: TONGMAI CHONGJI aqueous solution: 2g crude drug/ml, pulse invigorating pill aqueous solution: 2g crude drug/ml, aconitine solution 8ug/ml, normal saline.
Method: get 40 of rats, be divided into 4 groups at random, normal saline 5ml/kg, TONGMAI CHONGJI: 5g/kg irritates stomach, and pulse invigorating pill 2.5g/kg irritates stomach, quinidine: 0.001g/kg, after 1 hour, urethane 1.2g/kg, intraperitoneal anesthesia, record II lead electrocardiogram, per minute (0.8ug/200g) 0.1ml/200g, iv constant speed input aconitine solution, the record generation chamber is (VP), chamber speed (VT) early.When (VF) quivered in the chamber, the consumption of aconitine.
The result: TONGMAI CHONGJI, pulse invigorating pill all can increase the aconitine consumption, postpone between the now of VP, VT, VF, and pulse invigorating pill more is better than TONGMAI CHONGJI, and result data is as follows:
Aconitine consumption (mg)
Group: VP VT VF
Normal saline 5.98 ± 1.05 8.16 ± 1.08 9.52 ± 1.15
TONGMAI CHONGJI 9.07 ± 0.40 12.02 ± 1.25 15.48 ± 3.05
Pulse invigorating pill 12.12 ± 1.30 14.02 ± 2.10 17.14 ± 2.42
Quinidine 9.18 ± 0.50 12.26 ± 1.62 15.68 ± 3.06
Estimate: aconitine is brought out arrhythmia, quinidine has been in common knowledge effectively, TONGMAI CHONGJI, pulse invigorating pill, quinidine and normal saline are adopted in this experiment, be divided into four groups and observe, prove from experimental result: the arrhythmia that quinidine, TONGMAI CHONGJI, pulse invigorating pill all have pair aconitine to bring out has antagonism, wherein, pulse invigorating pill equates with the used crude drug amount of TONGMAI CHONGJI, but drop pill and for significantly illustrates that the Absorption of drop pill is better than TONGMAI CHONGJI.
The present invention is a dropping pill formulation with preparation of product, can improve the quality control standard of kind, in process of production, takes the assay to ligustrazine; Thereby, can carry out the thin layer chromatography qualitative test to Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Puerariae, thereby help quality monitoring this product, guarantee the therapeutic effect of this kind.
The specific embodiment:
Embodiments of the invention 1: it is by Radix Salviae Miltiorrhizae 500g, Rhizoma Chuanxiong 500g, and Radix Puerariae 500g and appropriate amount of auxiliary materials are prepared from.Get Rhizoma Chuanxiong and extract volatile oil according to conventional method, volatile oil device is in addition collected, medicinal residues and all the other two flavor Radix Salviae Miltiorrhizaes and Radix Puerariae decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, it is 1.08 that collecting decoction, filtration, filtrate are concentrated into relative density, filters while hot, and it is 1.38～1.40 clear paste that filtrate is concentrated into relative density; Get Rhizoma Chuanxiong volatile oil, add ethanol and dissolve in right amount, add an amount of tween 80, make solubilising liquid; Get 500g Polyethylene Glycol-6000, behind the heating and melting, add clear paste and volatile oil solubilising liquid, stir, maintain the temperature at 60-90 ℃, splash into temperature and be in 0-5 ℃ the white oil, drip and make ball promptly.
Embodiments of the invention 2: it is by Radix Salviae Miltiorrhizae 100g, Rhizoma Chuanxiong 100g, and Radix Puerariae 100g and appropriate amount of auxiliary materials are prepared from.Get Rhizoma Chuanxiong and extract volatile oil according to conventional method, volatile oil device is in addition collected, medicinal residues and all the other two flavor Radix Salviae Miltiorrhizaes and Radix Puerariae decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, it is 1.08 that collecting decoction, filtration, filtrate are concentrated into relative density, filters while hot, and it is 1.38～1.40 clear paste that filtrate is concentrated into relative density; It is mixed with Rhizoma Chuanxiong volatile oil, be prepared into soft capsule according to common process then.
Embodiments of the invention 3: it is by Radix Salviae Miltiorrhizae 1000g, Rhizoma Chuanxiong 1000g, and Radix Puerariae 1000g and appropriate amount of auxiliary materials are prepared from.Get Rhizoma Chuanxiong and extract volatile oil according to conventional method, volatile oil device is in addition collected, medicinal residues and all the other two flavor Radix Salviae Miltiorrhizaes and Radix Puerariae decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, it is 1.08 that collecting decoction, filtration, filtrate are concentrated into relative density, filters while hot, and it is 1.38～1.40 clear paste that filtrate is concentrated into relative density; It is mixed with Rhizoma Chuanxiong volatile oil, be prepared into buccal tablet according to common process then.
Claims (4)
1, a kind of pulse invigorating pill is characterized in that: calculate according to composition by weight: it is mainly by 100～1000 parts of Radix Salviae Miltiorrhizaes, 100～1000 parts of Rhizoma Chuanxiongs, and Radix Puerariae is prepared from for 100～1000 parts.
2, according to the described pulse invigorating pill of claim 1, it is characterized in that: it is by Radix Salviae Miltiorrhizae 500g, Rhizoma Chuanxiong 500g, and Radix Puerariae 500g and appropriate amount of auxiliary materials are prepared from.
3, as the preparation method of claim 1,2 described pulse invigorating pills, it is characterized in that: get Rhizoma Chuanxiong and extract volatile oil according to conventional method, volatile oil device is in addition collected, medicinal residues and all the other two flavor Radix Salviae Miltiorrhizaes and Radix Puerariae decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, it was 1.08 that collecting decoction, filtration, filtrate are concentrated into relative density, filter while hot, it is 1.38～1.40 clear paste that filtrate is concentrated into relative density; Get Rhizoma Chuanxiong volatile oil, add ethanol and dissolve in right amount, add an amount of tween 80, make solubilising liquid; Get 500g Polyethylene Glycol-6000, behind the heating and melting, add clear paste and volatile oil solubilising liquid, stir, maintain the temperature at 60-90 ℃, splash into temperature and be in 0-5 ℃ the white oil, drip and make ball promptly.。
4, according to the described pulse invigorating pill of claim 3, it is characterized in that: described pulse invigorating pill can also be prepared into soft pulse wafer or buccal tablet.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410022732 CN1583041A (en) | 2004-06-02 | 2004-06-02 | Tongmai drops and their preparation |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100358545C (en) * | 2005-07-25 | 2008-01-02 | 西安万隆制药有限责任公司 | Freeze drying powder and injection preparation in use for invigorating pulse-beat, and preparation method |
| CN1839931B (en) * | 2005-02-01 | 2011-08-03 | 成都地奥制药集团有限公司 | Medicine composition for treating cardiovascular and cerebrovascular diseases and preparation method thereof |
| CN103623109A (en) * | 2013-11-03 | 2014-03-12 | 崔合芳 | Traditional Chinese medicine composition for treating ischemic cerebrovascular disease and preparation method thereof |
-
2004
- 2004-06-02 CN CN 200410022732 patent/CN1583041A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1839931B (en) * | 2005-02-01 | 2011-08-03 | 成都地奥制药集团有限公司 | Medicine composition for treating cardiovascular and cerebrovascular diseases and preparation method thereof |
| CN100358545C (en) * | 2005-07-25 | 2008-01-02 | 西安万隆制药有限责任公司 | Freeze drying powder and injection preparation in use for invigorating pulse-beat, and preparation method |
| CN103623109A (en) * | 2013-11-03 | 2014-03-12 | 崔合芳 | Traditional Chinese medicine composition for treating ischemic cerebrovascular disease and preparation method thereof |
| CN103623109B (en) * | 2013-11-03 | 2015-06-03 | 崔合芳 | Traditional Chinese medicine composition for treating ischemic cerebrovascular disease and preparation method thereof |
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