CN100427065C - Tibetan medicinal preparation of dizziness, blood pressure irregulation and headache, and its preparing method - Google Patents
Tibetan medicinal preparation of dizziness, blood pressure irregulation and headache, and its preparing method Download PDFInfo
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Abstract
The present invention relates to a Tibetan medicine preparation for treating light-headedness and headaches for irregular blood pressure, which is characterized in that 25 Tibetan-medicinal materials including myrobalan, aucklandia roots, acorus calamus l, etc. are prepared into micro powder of 0.01 to 50 mu m through the superfine technology, and then the micro powder is prepared into oral preparation. Compared with the prior art, due to the adoption of the advanced superfine crushing technology, the oral preparation prepared with the present invention has the advantages of stability, high and controllable quality favorable for ensuring medical curative effect, shortened disintegration time for the solid preparation, quick effect, convenient use and carrying, better dissolution and bioavailability than the existing pills, stable quality and easy industrialization for the preparation method.
Description
Technical field
The present invention relates to a kind ofly treat that Light-headedness, blood pressure are uncomfortable, the preparation method of the Tibetan medicine of headache, a kind of specifically improvement technology of preparation method of known Tibetan medicine 25-component coral pill thing.
Background technology
Several ancient civilized countries are arranged in the world, comprise China, India, Egypt, Greece etc., in these ancient civilized countries, the people have created time-honored culture, comprise medical science.Tibetanmedicine in the Chinese medicine, it is with a long history, and is abundant in content, and system, theoretical uniqueness are complete medical system that is only second to Han nationality's medical science.As far back as B.C., Tibetan people in the process of struggling with disease, just have realized that moving, plant, some parts of mineral has the effect of treatment human body diseases, through accumulation in several thousand, formed the complete theoretical system of a cover, and instructed clinical effectively.Though Tibetan medicine's theory is complete, unique, because the influence of region, environment, living habit, the dosage form in the tibetan traditional medicine preparation has powder, decoction, pill, unguentum, medicine oil, medicated wine, drop etc. at present, but great majority are powder.Wherein, powder is the powder preparation that multiple medicine is mixed and made into.Decoction is for after the medicine decocting boils, and the leaching medicine juice is for for oral administration.Pill means that fine drug powder adds the spheroidal preparation that suitable binding agent is made.Unguentum is meant with the medicine process and selects, and removes clean impurity, adds water logging and boils, the dosage form that is smelt.Medicated wine divides Mel medicated wine, folk prescription medicated wine and compound recipe medicated wine.Most powders, pill mostly are the crude drug powder and are used as medicine, and dose is big, and that a traditional Tibetan medicine watered pill ball exists is big and hard, rough surface, disintegration is long, the hygiology index is defective etc. " four big pertinacious diseases ", and mouthfeel is poor, produce effects late, be unfavorable for treating etc.Traditional decoction decocts with the preceding water that needs, and uses extremely inconvenience and inconvenience to carry.For example known 25-component coral ball (being made by 25-component medical materials such as Fructus Chebulae, the Radix Aucklandiae, Tibetan calamus, Radix aconiti szechenyiani), it is used to have one's ideas straightened out, collateral dredging, pain relieving.Be used for obnubilation, the health numbness is had a dizzy spell, brain pain, and blood pressure is uncomfortable, headache, epilepsy and various neuropathic pain.Though but traditional watered pill has the characteristics such as easy, applied widely of taking, and also has many deficiencies, as: manufacturing process is loaded down with trivial details, the production cycle is long, the ball method of double differences is different greatly, absorb not exclusively, disintegrate is overtime and hygiology is defective.Shortcomings such as the granularity that has medicine in addition is big (150-180 μ m), is difficult to absorb, and the medical material loss of effective components is big, affects the treatment, and industrialization degree is low.
Summary of the invention
The present invention seeks to overcome the shortcoming of prior art, on original prescription basis, provide to propose a kind of new preparation method.
Purpose of the present invention can realize by following measure:
A kind of treatment Light-headedness, the Tibetan medicinal preparation of the incongruous headache of blood pressure, it is with the sweet 25g encephalolith of raw material Corallium Japonicum Kishinouye 75g Margarita 15g lazurite 20g Concha Margaritifera 50g Fructus Chebulae 100g Radix Aucklandiae 60g Flos Carthami 80g Flos Caryophylli 35g Lignum Aquilariae Resinatum 70g Cinnabaris 30g Os Draconis 40g 25g Magnetitum 25g Limonitum 25g Semen Sesami 40g calabash 30g Flos Radix Asteris 45g Herba Swertiae bimaculatae 80g Rhizoma Acori Calami 50g Radix Aconiti Kusnezoffii 45g DAJIANJU 75g Radix Glycyrrhizae 75g Stigma Croci 25g Moschus 2g, above 25-component, be ground into the superfine powder of 0.01～50 μ m, behind the mix homogeneously, make medicament again.
Described medicament is a said peroral dosage form on any pharmaceutics.
Described medicament is tablet, capsule or pill.
The formulation preparation method of the Tibetan medicine of described treatment hyperlipemia, be with Corallium Japonicum Kishinouye 75g Margarita 15g lazurite 20g Concha Margaritifera 50g Fructus Chebulae 100g Radix Aucklandiae 60g Flos Carthami 80g Flos Caryophylli 35g Lignum Aquilariae Resinatum 70g Cinnabaris 30g Os Draconis 40g Calamina 25g encephalolith 25g Magnetitum 25g Limonitum 25g Semen Sesami 40g calabash 30g Flos Radix Asteris 45g Herba Swertiae bimaculatae 80g Rhizoma Acori Calami 50g Radix Aconiti Kusnezoffii 45g DAJIANJU 75g Radix Glycyrrhizae 75g Stigma Croci 25g Moschus 2g, above 25-component, super micron mill is ground into 0.01-50 μ m superfine powder, directly make tablet or incapsulate, perhaps add binding agent, disintegrating agent, a kind of in fluidizer and the plasticizer, two or more material is made tablet or capsule.
The superfine powder that described super micron mill is pulverized is 0.01-40 μ m.
The superfine powder that described super micron mill is pulverized is 0.1-40 μ m.
Described binding agent is starch or carboxymethyl starch, and its addition is the 0.1%-5% of total dose; Described fluidizer is magnesium stearate or Pulvis Talci, and its addition is respectively the 0.1%-1% or the 0.5-8% of total dose; Described disintegrating agent is meant carboxymethyl starch sodium or low-substituted hydroxypropyl methylcellulose sodium, and its addition is the 0.5-5% of total dose; Described plasticizer is meant microcrystalline Cellulose or dextrin, and its addition is the 0.5-5% of total dose.
Making described medicament according to a conventional method is said oral agents on any pharmaceutics.(" pharmacy of Chinese materia medica " (using), Shanghai science tech publishing house, in December, 1997 front page for Chinese medicine class specialty; " pharmaceutical preparation research and development and production new technique technology are used complete works of ", the contemporary China audio ﹠ video press.)
The superfine powder that described super micron mill is pulverized granularity preferably is 0.01-40 μ m, and the best is 0.1-40 μ m.
Described super micron mill is an XQCM air-flow vortex pulverizing mill, is Zhejiang new century disintegrating apparatus company limited production.
Superfine communication technique of the present invention is referring to document: 1 phase of " Chinese patent medicine " calendar year 2001; " Chinese patent medicine " 2000 4 phases; " World Science technology " 99 year 3 phase; " Chinese journal of Practical Pharmacy " the 1st rolled up in July, 2003 the 2nd phase.
The advantage of the inventive method is as follows:
1, the medicine made than prior art of the solid dosage forms product made of method of the present invention is more stable, high and the quality controllable system of quality, help guaranteeing curative effect, in quality testing, can set examination criteria, medicament contg is measured and the detection of effective ingredient, to guarantee the quality of Tibetan medicine solid preparation.
2, because method of the present invention has adopted modern advanced person's superfine communication technique, not only keep the active substance in the natural plant crude drugs and the active ingredient of medical material effectively, improved the ratio of crude drug composition again greatly, make curative effect better, the disintegration time of solid preparation shortens greatly simultaneously, onset is rapider, and prolongs the medicine resting period greatly, is convenient to take and carry.
3, the solid dosage forms made of method of the present invention need not added the stabilizing agent of any chemosynthesis, so safe in utilization.The present invention makes the production of Tibetan medicine realize industrialization by the reform of dosage form, and product also can be transported for long-distance and enter the international market towards huge numbers of families' patient.
4, the tablet form made of method of the present invention only needs during use get final product with water delivery service.The more known pill of dissolution and bioavailability is good, and dosage is accurate, steady quality, and mechanical automation production output is big, and cost is low, and the hygiology standard is easily up to standard.The present invention makes the production of Tibetan medicine realize industrialization by the reform of dosage form.
5, the dissolution determination of tablet of the present invention and known Tibetan medicine 25-component coral pill medicinal preparation is relatively as table 1:
The preparation mean diameter is 10 μ m, 50 μ m, three kinds of microgranules of 200 μ m.
Quicken release experiment: the microgranule 500mg of each particle diameter of precision weighing, place 6 100ml culture bottles, accurately add the dissolution fluid 100ml of 0.1M, tighten with the lid of band aluminum film, at once after jolting mixes, use the culture bottle traverse, be fixed on the fixed station, be dipped in advance thermoregulation in 37 ℃ water-bath, 100 vibrations of per minute, culture bottle is taken out in vibration beginning 02,0.3,0.4,0.5,0.8,1 hour, extracts each 10ml of turbid solution in each container.
Chromatographic condition and system suitability test are filler with the octadecylsilane chemically bonded silica; With acetonitrile 0.1% glacial acetic acid (1: 4) is mobile phase; The detection wavelength is 276nm.Number of theoretical plate calculates by the liquirtin peak should be not less than 4000.
The preparation extracting liquorice glycosides reference substance of reference substance solution is an amount of, and accurate the title decides, and adds methanol solution and makes the solution that every 1ml contains 0.1mg, promptly;
The preparation of need testing solution extracts that each 10ml of turbid solution puts in the 100ml tool plug conical flask in each container, accurate 70% alcoholic solution 1ml, supersound process (the power 300W of adding, frequency 25kHz) 30 minutes, take out, weigh again, supply the weight that subtracts mistake with 70% ethanol, filter.Precision is measured subsequent filtrate 5ml, puts in the 100ml measuring bottle,, shakes up to scale with 20% dilution in acetonitrile, gets final product.
The accurate respectively absorption reference substance solution of algoscopy, need testing solution 20 μ l inject chromatograph of liquid, measure, and get final product.
The test of table 1 different grain size dissolution
Table 1 explanation: granularity is more little, and the effective ingredient release concentration is big more.The degree that general mechanical activation comminution reaches at most is 200 μ m, and the present invention is crushed to 0.01-100 μ m, and the release of effective ingredient increases.
The present invention uses the result as follows by clinical drug:
1, observing routine number selects patients with vertigo 30 examples to organize as treatment; Matched group is selected dizzy case 18 examples.
2, test method is according to including the case that standard is listed clinical verification in, inpatient and outpatient all can, as far as possible based on the inpatient.Adopt random packet, single blind trial.The outpatient controls variable factor as far as possible.
3, the observational technique of taking medicine
(1) treatment group: medicine of the present invention, boiled water takes, one time 4 (0.25g/ sheet), 1 time on the one.
(2) matched group: known 25-component coral ball (record in ministry standard Tibetan medicine volume, Gannan Foge Tibetan Medicine Co., Ltd produces), boiled water is taken after being infused in hot water or decoction, a 1g, 1 time on the one.
(3) the January course of treatment;
(4) the relevant medicine of inactive treatment relevant disease;
(5) fill in the observation form.
4, curative effect determinate standard
(1) clinical recovery: the dizzy transference cure that waits.
(2) produce effects: symptom such as dizzy obviously alleviates, and little have murkyly, or it is slight but dynamic without rotation, the rolling of self and scenery to have a dizzy spell, but orthobiosis and work.
(3) effective: dizzy or dizzy alleviating, only dynamic with rotation, the rolling of slight self and scenery, though adhere to work, live and work is affected.
(4) invalid: symptoms such as giddy is heavy and dizzy do not have improvement or increase the weight of.
The result
(1) experimenter is outpatient service and inpatient, and clear and definite clinical diagnosis is arranged, and observes 48 routine patients altogether, adopts random packet, selects 30 examples to organize as treatment, and 18 examples are organized in contrast.Two groups of harmonious inspections are as follows:
1, sex: treatment group male 16 examples, women's 14 examples; Matched group male 10 examples, women's 8 examples.Two groups are compared X
2=0.02237, P＞0.05.Experimenter's sex distributional difference nonsignificance.
2, the age: treatment group 27-66 year, average 52.93 ± 7.44 years old, matched group 29-65 year, average 51.62 ± 7.35, two groups of t=1.877 relatively, P＞0.05.Subject age distributional difference nonsignificance.
3, the Chinese medical discrimination typing sees Table 2.
Table 2 experimenter pattern of syndrome distribution situation
| Group | Excessive rising of liver-YANG | Stagnation of turbid phlegm in middle-JIAO | Blood stagnant in cerebral venation syndrome | Deficiency of qi and blood | Deficiency of kidney yin | Insufficiency of kidney-YANG |
| The treatment group | 5 | 10 | 3 | 6 | 3 | 3 |
| Matched group | 2 | 5 | 3 | 3 | 2 | 2 |
Two groups of experimenter's TCM Syndrome Type distributional difference nonsignificance X
2=0.8193, P＞0.05.
4, dizzy degree sees Table 3.
Table 3 experimenter state of an illness distribution situation
Two groups of experimenter's course of disease distributional difference nonsignificance P＞0.05.
(2) two groups of therapeutic effect index results
Dizzy comprehensive therapeutic effect sees Table 4.
The dizzy comprehensive therapeutic effect of table 4 compares:
| Group | The example number | Clinical recovery | Produce effects | Effectively | Invalid | The u value |
| The treatment group | 30 | 4 | 5 | 18 | 3 | 2.02 |
| Matched group | 18 | 0 | 2 | 10 | 6 |
As seen from the above table, treatment group and matched group total effective rate are respectively 90%, 66.67%, and two groups of comparing results are analyzed through Ridit, treatment group matched group P＜0.05 that is better than evident in efficacy.
(3) safety indexes result
1, the observation of untoward reaction
Treatment group and matched group period in a medicine are not all found obvious adverse reaction.
2, safety detects the index result
Blood urea nitrogen, creatinine, total bilirubin situation of change relatively see Table 5 before and after the treatment of treatment group.
Table 5
| Inspection item | Case load | Before the treatment | After the treatment | T value p value |
| Blood urea nitrogen (mmol/L) creatinine (μ mol/L) total bilirubin (μ mol/L) | 18.0 18.0 18.0 | 5.26±1.87 85.54±17.68 10.59±5.12 | 5.57±1.62 85.78±19.11 10.23±4.59 | 0.53＞0.05 0.09＞0.05 0.22＞0.05 |
Before and after check blood urea nitrogen, creatinine, total bilirubin are treated, do not have obvious change (p＞0.05), illustrate that the treatment group does not have tangible damage to liver, renal function.
The treatment group is treated front and back blood, urine, just conventional situation of change relatively sees Table 5.
6
Through X
2Check, no significant difference (p＞0.05) before and after routine blood test, routine urinalysis, SGPT, the electrocardiogram treatment.
The treatment group has all been carried out blood, urine, the just detection of routine and hepatic and renal function before and after take medicine, and does not find that this medicine is to hepatic and renal function, three big conventional harmful effects.
Discuss and conclusion
1, physical data analysis: treatment group and matched group comparison sex difference do not have significance (P＞0.05).Two groups of comparing differences do not have significance (P＞0.05).Two groups of experimenter's doctors trained in Western medicine are sick plants and TCM Syndrome Type distribution comparing difference does not have significance (P＞0.05).Two groups of experimenter's hypertension, hypotension, cervical spondylosis distributional differences do not have significance (P＞0.05).Two groups of dizzy degree comparing differences of experimenter do not have significance (P＞0.05).
2, efficacy result: treatment group and matched group total effective rate are respectively 90%, 66.67%, and two groups of comparing results are through check, treatment group matched group P＜0.05 that is better than evident in efficacy.
3, the observed result of safety indexes: in the medication process, all do not find untoward reaction for two groups.The treatment group has all been carried out blood, urine, the just detection of routine and hepatic and renal function before and after take medicine, and does not find that this medicine has harmful effect to hepatic and renal function, blood, urine, stool routine.
4, conclusion: this observed result shows, medicine of the present invention has good therapeutical effect, determined curative effect to disease such as dizzy.Do not find that obvious adverse reaction reaches the infringement to blood, urine, stool routine and hepatic and renal function.
The specific embodiment
Be to further specify characteristics of the present invention below by instantiation.
Example 1
With raw material Corallium Japonicum Kishinouye 75g Margarita 15g lazurite 20g Concha Margaritifera 50g Fructus Chebulae 100g Radix Aucklandiae 60g Flos Carthami 80g Flos Caryophylli 35g Lignum Aquilariae Resinatum 70g Cinnabaris 30g Os Draconis 40g Calamina 25g encephalolith 25g Magnetitum 25g Limonitum 25g Semen Sesami 40g calabash 30g Flos Radix Asteris 45g Herba Swertiae bimaculatae 80g Rhizoma Acori Calami 50g Radix Aconiti Kusnezoffii 45g DAJIANJU 75g Radix Glycyrrhizae 75g Stigma Croci 25g Moschus 2g, mix the superfine powder that the atomizer that adopts is ground into 10 μ m, add dextrin 50g, add the 500ml alcohol granulation, oven dry, granulate, add magnesium stearate 3g, tabletting is made tablet, the heavy 0.25g of sheet is distributed into 60 every bottle.
Example 2
Known raw material Corallium Japonicum Kishinouye 75g Margarita 15g lazurite 20g Concha Margaritifera 50g Fructus Chebulae 100g Radix Aucklandiae 60g Flos Carthami 80g Flos Caryophylli 35g Lignum Aquilariae Resinatum 70g Cinnabaris 30g Os Draconis 40g Calamina 25g encephalolith 25g Magnetitum 25g Limonitum 25g Semen Sesami 40g calabash 30g Flos Radix Asteris 45g Herba Swertiae bimaculatae 80g Rhizoma Acori Calami 50g Radix Aconiti Kusnezoffii 45g DAJIANJU 75g Radix Glycyrrhizae 75g Stigma Croci 25g Moschus 2g with Tibetan medicine 25-component coral pill compositions, mix the superfine powder that the super micron mill that adopts is ground into 1 μ m, add carboxymethyl starch 10g, add the 500ml alcohol granulation, oven dry, granulate, adorn No. 1 capsule and make capsule, every capsules 0.28g is distributed into 50 every bottle.
Example 3
With raw material Corallium Japonicum Kishinouye 75g Margarita 15g lazurite 20g Concha Margaritifera 50g Fructus Chebulae 100g Radix Aucklandiae 60g Flos Carthami 80g Flos Caryophylli 35g Lignum Aquilariae Resinatum 70g Cinnabaris 30g Os Draconis 40g Calamina 25g encephalolith 25g Magnetitum 25g Limonitum 25g Semen Sesami 40g calabash 30g Flos Radix Asteris 45g Herba Swertiae bimaculatae 80g Rhizoma Acori Calami 50g Radix Aconiti Kusnezoffii 45g DAJIANJU 75g Radix Glycyrrhizae 75g Stigma Croci 25g Moschus 2g, mix, adopt super micron mill to be ground into the superfine powder of 40 μ m, adorn No. 1 capsule and make capsule, every capsules 0.25g is distributed into 60 every bottle.
Example 4
With raw material Corallium Japonicum Kishinouye 75g Margarita 15g lazurite 20g Concha Margaritifera 50g Fructus Chebulae 100g Radix Aucklandiae 60g Flos Carthami 80g Flos Caryophylli 35g Lignum Aquilariae Resinatum 70g Cinnabaris 30g Os Draconis 40g Calamina 25g encephalolith 25g Magnetitum 25g Limonitum 25g Semen Sesami 40g calabash 30g Flos Radix Asteris 45g Herba Swertiae bimaculatae 80g Rhizoma Acori Calami 50g Radix Aconiti Kusnezoffii 45g DAJIANJU 75g Radix Glycyrrhizae 75g Stigma Croci 25g Moschus 2g, mix the superfine powder that adopts super micron mill to be ground into 0.1 μ m, add 500ml alcohol granulation, oven dry, granulate, adding magnesium stearate 3g, Pulvis Talci 5g, tabletting.Or add sheet alcohol granulation, oven dry, granulate, and add magnesium stearate 3g, microcrystalline Cellulose 10g, compacting is in blocks, and the heavy 0.25g of sheet is distributed into 60 every bottle.
Claims (3)
1, a kind of Light-headedness and uncomfortable Tibetan medicinal preparation of blood pressure for the treatment of, it is characterized in that it being: Corallium Japonicum Kishinouye 75g with following medical material, Margarita 15g, lazurite 20g, Concha Margaritifera 50g, Fructus Chebulae 100g, Radix Aucklandiae 60g, Flos Carthami 80g, Flos Caryophylli 35g, Lignum Aquilariae Resinatum 70g, Cinnabaris 30g, Os Draconis 40g, Calamina 25g, encephalolith 25g, Magnetitum 25g, Limonitum 25g, Semen Sesami 40g, calabash 30g, Flos Radix Asteris 45g, Herba Swertiae bimaculatae 80g, Rhizoma Acori Calami 50g, Radix Aconiti Kusnezoffii 45g, DAJIANJU 75g, Radix Glycyrrhizae 75g, Stigma Croci 25g and Moschus 2g mix, be ground into 0.01-50 μ m superfine powder with super micron mill, directly make tablet or incapsulate, perhaps add binding agent, disintegrating agent, a kind of in fluidizer and the plasticizer, two or more material is made tablet or capsule.
2. according to the described Tibetan medicinal preparation of claim 1, it is characterized in that the superfine powder that described super micron mill is pulverized is 0.01-40 μ m.
3. according to the described Tibetan medicinal preparation of claim 1, it is characterized in that the superfine powder that described super micron mill is pulverized is 0.1-40 μ m.
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| CN1365700A (en) * | 2001-01-15 | 2002-08-28 | 杨孟君 | Nano 25-component coral medicine and its preparing process |
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