CN1245180C - Hypertension treating traditional Chinese medicine preparation and its preparing process - Google Patents

Hypertension treating traditional Chinese medicine preparation and its preparing process Download PDF

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CN1245180C
CN1245180C CN 200310105398 CN200310105398A CN1245180C CN 1245180 C CN1245180 C CN 1245180C CN 200310105398 CN200310105398 CN 200310105398 CN 200310105398 A CN200310105398 A CN 200310105398A CN 1245180 C CN1245180 C CN 1245180C
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preparation
chinese medicine
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CN1541681A (en
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张玲
凌沛学
景瑞
于盛茂
尚立霞
时延增
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Shandong Academy of Pharmaceutical Sciences
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Abstract

The present invention relates to a Chinese medicine preparation for treating high blood pressure, which is characterized in that the preparation is composed of cortex moutan radics, common selfheal fruit-spike, sunflower leaf, gambir plant, radix puerariae and other Chinese herbal medicines. The preparation can be prepared into granules, tablets, capsules, oral medicinal liquids, injections, dripping pills and other dosage forms; the preparation has the effects of suppressing hyperactive liver, subsiding yang, clearing away heat and promoting blood circulation; the clinical treatment of 26 cases show that the total effective rate of blood pressure lowering is 84.6%, and the total effective rate in the aspect of single item symptom improvement in Chinese medicine is 96.2%.

Description

Hypertensive Chinese medicine preparation of a kind of treatment and preparation method thereof
The invention belongs to field of traditional Chinese, relate to hypertensive preparation of a kind of treatment and preparation method thereof, its dosage form comprises tablet, capsule, granule, oral liquid, syrup, injection, drop pill and other dosage forms.
China is from annual New Development hypertensive patient more than 100 ten thousand 50~seventies of 20th century, and to annual New Development more than 300 ten thousand 80~nineties, number of patients has exceeded 100,000,000, and the trend of aggravation is arranged.Essential hypertension is not only one of common cardiovascular disease, and be apoplexy, coronary heart disease, the important risk factor of renal failure and retinopathy, has the prevalence height, awareness is low, the characteristics that disability rate is high, active and effective treatment hypertension purpose not only is controlling blood pressure, prior incidence rate and the mortality rate that also is to reduce the cardiovascular and cerebrovascular vessel intercurrent disease, so, control hypertension is as effective formulation of first grade of preventive measures, no matter for hyperpietic's happy family life, for the heavy medical treatment of country is born, all be a very significant thing still.
The present invention is just at hypertension, card belongs to the hyperactivity of YANG due to deficiency of YIN person and establishes, have suppressing the hyperactive liver and subsiding YANG, the effect of heat clearing and blood circulation promoting, dizzy, the headache that can be used for that hypertension causes, the soreness of waist, knee joint are soft, dysphoria with feverish sensation in the chest palms and soles, cardiopalmus, insomnia, tinnitus, forgetful, the few tongue of red tongue, stringy and thready pulse and number person.By clinical observation, blood pressure lowering total effective rate of the present invention is 84.6%, always effectively is 96.2% improving aspect the traditional Chinese medical science individual event symptom, and this shows that the present invention in effective blood pressure lowering, also can obviously improve symptom, and not find untoward reaction, and clinical effectiveness is satisfied.At present, clinically to evident in efficacy, safety is good, and Chinese medicine preparation easy to use is still for being badly in need of.By after the present invention and the hypertensive similar medicine contrast of treatment, we think that curative effect of the present invention is reliable, and have one's own knack on prescription medicine, are the crystallizations of clinical experience for many years.Therefore, exploitation of the present invention is expected to the Chinese medicine preparation that provides a safety, desirable blood pressure lowering effective, cheap, easy to use for clinical, is expected to obtain better economic, social benefit after applying.
The purpose of this invention is to provide a kind of Chinese medicine preparation that hypertension has obvious curative effects for the treatment of.
Technical scheme of the present invention is: the hypertensive Chinese medicine preparation of a kind of treatment is characterized in that by suppressing the hyperactive liver and subsiding YANG the Chinese prescription of heat clearing and blood circulation promoting forms, comprise Ramulus Uncariae Cum Uncis (10~38%), Cortex Moutan (10~35%), Spica Prunellae (5~25%), Folium Helianthi (5~32%), Radix Puerariae (4~30%).
The present invention treats hypertensive Chinese medicine preparation, it is characterized in that: the Chinese medicine of respectively distinguishing the flavor of among the present invention is extracted, and the extracting solution concentrating under reduced pressure becomes concentrated solution; After concentrated solution is dried to extract dry powder by distinct methods,, can be made into solid preparations such as granule, capsule, tablet by adding different auxiliary material respectively; Also can will add an amount of distilled water in the concentrated solution, after water precipitating filters, add adjuvant and antiseptic and make liquid preparations such as oral liquid and injection.Add different auxiliary material in the different dosage form of the present invention, do not influence clinical effectiveness of the present invention, these adjuvants comprise starch, microcrystalline Cellulose, magnesium stearate, dextrin, lactose, sucrose, antiseptic, Polyethylene Glycol etc.Therefore the present invention can satisfy the requirement of numerous hyperpietics to different dosage form.
The Pharmacodynamic test of active extract result of this preparation shows: the doses single-dose has tangible hypotensive activity to anesthetized dog; Single-dose has good acute hypotensive effect to clear-headed spontaneous hypertensive rat and renal hypertensive rat, and especially the hypotensive effect to renal hypertensive rat is bigger, amount-result relation is obvious; Long term administration in continuous 15~21 days, clear-headed spontaneous hypertensive rat and kidney high pressure rat also had the good curing hypotensive effect, and the efficacy of antihypertensive treatment of keeping that a few days is arranged after the drug withdrawal is especially bigger to the renal hypertensive rat hypotensive effect, amount-result relation is obvious.Radix Semiaquilegiae blood pressure lowering administration in continuous 15 days can make the nervous element of renal hypertensive rat blood medium vessels, concentration of cortisol obviously descend.The Radix Semiaquilegiae blood pressure lowering has tangible influence to the anesthetized dog hemodynamic index, left indoor pressure, left chamber EDP, ejection time, total oxygen consumption index and blood vessel total peripheral resistance are descended, and can increase coronary flow, increase arterial oxygen content.Acute toxicity test of the present invention and long term toxicity test result show and do not see overt toxicity reaction.
Use tablet of the present invention clinically 26 routine liver-Yang sthenia type hyperpietics are carried out clinical observation, and compare with QUANTIANMA JIAONANG.The result shows: test blood blood pressure lowering total effective rate is 84.6%, and matched group blood pressure lowering total effective rate is 65%, two group and has compared bright significant difference (P<0.05) that this shows that the Radix Semiaquilegiae hypertension pill has good hypotensive effect; Improving aspect the traditional Chinese medical science individual event symptom, the test group total effective rate is 96.2%, and matched group always has rate to be 70%, two group to have compared significant difference (P<0.05), and this shows that the Radix Semiaquilegiae hypertension pill in effective blood pressure lowering, also can obviously improve symptom.Also observed the influence of tablet of the present invention in the clinical trial process simultaneously, found that treatment front and back Non Apparent Abnormality changes safety indexes such as blood, routine urinalysis, liver, renal functioies.Clinical taking also do not report in the process that gastrointestinal tract and other untoward reaction are arranged, and illustrates that the present invention takes safety.
Traditional Chinese medical science efficacy analysis of the present invention:
1 materials and methods
1.1 physical data diagnostic criteria and standard by stages: hyperpietic diagnostic criteria and grade scale are all with reference to the diagnostic criteria of WHO in 1999 about hypertension [1], tcm diagnosis standard reference new Chinese medicine is treated the liver-Yang sthenia type in the dizzy clinical research guideline.46 routine patients all derive from the outpatient service of intracardiac section of Hospital Attached to Shandong Chinese Medical Univ., are divided into treatment group and matched group at random.Test group 26 examples, wherein male 12 examples, women 14 examples, 55.14 ± 11.45 years old mean age, average course of disease 10.87 ± 7.13 years; Matched group 20 examples, wherein male 11 examples, women 9 examples, mean age 55.97 ± 10.85, average course of disease 11.46 ± 6.98 years.Two groups of pressure values before sex, age, the course of disease, treatment, the traditional Chinese medical science individual event symptom aspect such as relatively all do not have significant difference (P<0.05).
1.2 Therapeutic Method test group tablet of the present invention, each 4, every day 3 times.Matched group is taken QUANTIANMA JIAONANG (Guizhou Shenqi Pharmaceutical Co., Ltd's production), every day 3 times, and each 4 balls, two groups is a course of treatment with 4 weeks all, after finishing for 1 course of treatment, the statistics curative effect.
1.3 observation item is observed two groups of blood pressure level and dizzy, headache, dizziness and distending sensation of the head, stiffness of the neck, flushing conjunctival congestion, being irritable and getting angry easily, nervous, feeling of oppression and pain in the chest, insomnia, tinnitus, blurred vision and constipation red 12 symptoms of urinating before and after the treatment and is showed.
1.4 efficacy assessment standard efficacy of antihypertensive treatment evaluation criteria: the standard of formulating with reference to national cardiovascular epidemiology in 1979 and crowd prevention and treatment forum; Tcm symptom total effects criterion: evaluate with reference to the regulation in " the new Chinese medicine clinical research guideline " of Ministry of Public Health promulgation in 1993.
1.5 statistical procedures adopts Ridit to analyze and the t check is carried out statistical procedures to related data.
2 results
2.1 two groups of efficacy of antihypertensive treatment and blood pressure lowering amplitude relatively see Table 1~3.
Table 1 liang group efficacy of antihypertensive treatment relatively
N Produce effects Effectively Invalid Total effective rate
The test group matched group 26 20 5 5 6 8 2 7 84.6% 65%
Analyze through Ridit, P<0.05, test group is better than matched group.
Table 2 liang group systolic pressure reduction amplitude is (kPa) relatively
Before the treatment After the treatment
The test group matched group 22.9±2.6 22.8±2.5 18.7±2.1 *# 12.1±1.2
*Expression and preceding relatively P<0.01 of treatment, #Expression is compared P<0.01 with matched group.
Table 3 liang group diastolic pressure reduction amplitude is (kPa) relatively
Before the treatment After the treatment
The test group matched group 13.8±1.2 13.9±0.3 11.2±1.0 *# 12.1±1.2
*Expression and preceding relatively P<0.01 of treatment, #Expression is compared P<0.01 with matched group.
As shown in Table 1, produce effects 5 examples in test group 26 examples, effective 6 examples, total effective rate is 84.6%, is better than matched group, two groups of curative effects are compared through the Ridit analysis significant difference (P<0.05).Distinguish self more all utmost point significant difference (P<0.01) by systolic pressure and diastolic pressure before and after table 2, the visible two groups of patient treatments of table 3.
2.2 the tcm symptom curative effect sees Table 4~5.Two groups of curative effects of treatment group as shown in Table 4 and matched group are compared, and analyzing through Ridit has significant difference (P<0.05); As shown in Table 5, the treatment group except that " being irritable and getting angry easily " and " blurred vision ", all is better than matched group improving aspect the traditional Chinese medical science individual event symptom, has compared significant difference (P<0.05 or P<0.01) for two groups.
Table 4 liang group tcm symptom total effects relatively
N Recovery from illness Produce effects Effectively Invalid Total effective rate
The test group matched group 26 20 3 0 7 4 2 10 1 6 96.2% 70%
Analyze through Ridit, P<0.05, test group is better than matched group.
Table 5 liang group traditional Chinese medical science individual event symptom curative effect relatively
Test group Matched group
N Recovery from illness Produce effects Effectively Invalid Total effective rate N Recovery from illness Produce effects Effectively Invalid Total effective rate P
The constipation of the nervous feeling of oppression and pain in the chest insomnia of the strong flushing hot eyes being irritable and getting angry easily of dizziness and headache dizziness and distending sensation of the head neck tinnitus blurred vision is urinated red 26 16 16 8 10 8 14 18 12 10 10 8 6 10 8 4 2 0 4 2 10 6 4 2 14 6 8 4 6 6 6 10 0 2 4 2 6 0 0 0 2 0 4 6 2 2 0 4 0 0 0 0 0 2 0 0 0 0 2 0 100% 100% 100% 100% 100% 75% 100% 100% 100% 100% 80% 100% 17 19 12 15 13 7 4 10 5 4 9 7 1 2 1 1 1 1 0 3 0 0 1 0 2 2 1 2 1 1 1 0 0 0 2 2 10 8 6 8 6 2 2 4 2 1 3 1 4 7 4 4 5 3 1 3 3 3 3 4 76.5% 63.2% 66.7% 73.3% 61.5% 57.1% 75% 70% 40% 25% 66.7% 42.9% <0.05 <0.05 <0.05 <0.05 <0.05 >0.05 <0.05 <0.05 <0.01 <0.01 >0.05 <0.01
Prescription of the present invention also can add other and have suppressing the hyperactive liver and subsiding YANG, the Chinese medicine of heat clearing and blood circulation promoting on the basis of above-mentioned five kinds of Chinese medicine.
Using method of the present invention: oral, every day three times, each 3~4 (or 4~6 capsules, or 1 bag of granule, or 1~2 oral liquid, or 10~20ml syrup, or drop pill 10~15).4 weeks were a course of treatment; Or every day 1 of injection injection liquid, 10 days is a course of treatment.
It below is the specific embodiment of the present invention.
Embodiment 1:
Hook taking rattan 1800g, Radix Puerariae 650g add 80% ethanol extraction secondary, and 2 hours for the first time, 1 hour for the second time, merge extractive liquid, filtered, filtrate recycling ethanol, and be condensed into the concentrated solution that relative density is 1.16~1.18 (60 ℃); Get Cortex Moutan 1300g again, the distillation paeonol; Medicinal residues and Spica Prunellae 700g decoct with water secondary, and each 1 hour, merge extractive liquid, filtered, and filtrate concentrates; Other gets Folium Helianthi 1000g and decocts with water secondary, each 1 hour, merge extractive liquid,, filter, filtrate concentrates, and gets above-mentioned Cortex Moutan, two kinds of concentrated solutions merging of Folium Helianthi, adding ethanol makes and contains the alcohol amount and reach 60%, cold preservation (2~2 ℃) 24 hours filters, and filtrate recycling ethanol also is condensed into the concentrated solution that relative density is 1.16~1.18 (60 ℃); Get above-mentioned two kinds of concentrated solutions, merge, continue to be condensed into thick paste, drying adds paeonol, pulverizes, and is the dried medicated powder of extraction of the present invention; Or get above-mentioned two kinds of concentrated solutions merging, and adding the 200ml distilled water and make dissolving, water precipitating (2~2 ℃) 24 hours filters, and adds paeonol, and filtrate is extraction medicinal liquid of the present invention.
Embodiment 2:
Hook taking rattan 1450g, Radix Puerariae 800g add 80% ethanol extraction secondary, and 2 hours for the first time, 1 hour for the second time, merge extractive liquid, filtered, filtrate recycling ethanol, and be condensed into the concentrated solution that relative density is 1.18~1.20 (60 ℃); Get Cortex Moutan 1700g again, the distillation paeonol; Medicinal residues and Spica Prunellae 500g decoct with water secondary, and each 1 hour, merge extractive liquid, filtered, and filtrate concentrates; Other gets Folium Helianthi 1600g, decoct with water secondary, each 1 hour, merge extractive liquid, filtered, filtrate concentrates, get two kinds of concentrated solutions of above-mentioned Cortex Moutan, Folium Helianthi and merge, add ethanol and make and contain the alcohol amount and reach 70%, cold preservation (2~2 ℃) 24 hours, filter, filtrate recycling ethanol also is condensed into the concentrated solution that relative density is 1.18~1.20 (60 ℃); Get above-mentioned two kinds of concentrated solutions and merge, continue to be condensed into thick paste, the reduced vacuum drying adds paeonol, pulverizes, and is the dried medicated powder of extraction of the present invention; Or get above-mentioned two kinds of concentrated solutions merging, and adding the 300ml distilled water and make dissolving, water precipitating (2~2 ℃) 24 hours filters, and adds paeonol, and filtrate is extraction medicinal liquid of the present invention.
Embodiment 3:
Hook taking rattan 1200g, Radix Puerariae 1000g add 70% ethanol extraction secondary, and 2 hours for the first time, 1 hour for the second time, merge extractive liquid, filtered, filtrate recycling ethanol, and be condensed into the concentrated solution that relative density is 1.20~1.22 (60 ℃); Get Cortex Moutan 2000g again, the distillation paeonol; Medicinal residues and Spica Prunellae 900g decoct with water secondary, and each 1 hour, merge extractive liquid, filtered, and filtrate concentrates; Other gets Folium Helianthi 1400g, decoct with water secondary, each 1 hour, merge extractive liquid, filtered, filtrate concentrates, get two kinds of concentrated solutions of above-mentioned Cortex Moutan, Folium Helianthi and merge, add ethanol and make and contain the alcohol amount and reach 50%, cold preservation (2~2 ℃) 24 hours, filter, filtrate recycling ethanol also is condensed into the concentrated solution that relative density is 1.20~1.24 (60 ℃); Get above-mentioned two kinds of concentrated solutions and merge, continue to be condensed into thick paste, spray drying adds paeonol, pulverizes, and is the dried medicated powder of extraction of the present invention; Or get above-mentioned two kinds of concentrated solutions merging, and adding the 500ml distilled water and make dissolving, water precipitating (2~2 ℃) 24 hours filters, and adds paeonol, and filtrate is extracting solution of the present invention.
Embodiment 4:
Hook taking rattan 1000g, Radix Puerariae 500g add 60% ethanol extraction secondary, and 2 hours for the first time, 1 hour for the second time, merge extractive liquid, filtered, filtrate recycling ethanol, and be condensed into the concentrated solution that relative density is 1.22~1.24 (60 ℃); Get Cortex Moutan 1500g again, the distillation paeonol; Medicinal residues and Spica Prunellae 1000g decoct with water secondary, and each 1 hour, merge extractive liquid, filtered, filtrate concentrates, and adds ethanol and makes and contain the alcohol amount and reach 60%, cold preservation (2~2 ℃) 24 hours, filter, filtrate recycling ethanol, and be condensed into the concentrated solution that relative density is 1.22~1.24 (60 ℃); Other gets Folium Helianthi 1800g, decocts with water secondary, and each 1 hour, merge extractive liquid,, filter, filtrate concentrates, and adds ethanol and makes and contain the alcohol amount and reach 60%, cold preservation (2~2 ℃) 24 hours, filter, filtrate recycling ethanol, and be condensed into the concentrated solution that relative density is 1.22~1.24 (60 ℃); Get above-mentioned three kinds of concentrated solutions and merge, continue to be condensed into thick paste, drying adds paeonol, pulverizes, and is the dried medicated powder of extraction of the present invention; Or get above-mentioned three kinds of concentrated solutions merging, and adding the 400ml distilled water and make dissolving, water precipitating (2~2 ℃) 24 hours filters, and adds paeonol, and filtrate is the present invention and extracts medicinal liquid.
Embodiment 5: capsule
With adding 125g starch in the dried medicated powder of any extraction in the various embodiments described above, mix, granulate, sieve, adorn 1000 capsules, be capsule of the present invention.
Embodiment 6: granule
Will be in the various embodiments described above any one extracts and adds lactose 100g in the dried medicated powder, and dextrin 400g granulates, and granulate sieves, and makes the 1000g granule, granule of the present invention.
Embodiment 7: tablet
To add 130g starch in the dried medicated powder of any extraction in the various embodiments described above, the 20g microcrystalline Cellulose, mixing is granulated, and oven dry is sieved, and adds the 1.5g magnesium stearate, and mixing is pressed into 1000, is tablet of the present invention.
Embodiment 8: oral liquid
Will be in the various embodiments described above any one extracts and adds 0.3% sodium benzoate in the medicinal liquid, the 400ml distilled water, detoxicating, the 1000ml oral liquid is made in fill, oral liquid of the present invention.
Embodiment 9: syrup
Will be in the various embodiments described above any one extracts and adds 0.3% sodium benzoate in the medicinal liquid, adds sucrose 300g, and xanthan gum 100g makes the 1000ml syrup, syrup of the present invention.
Embodiment 10: injection
In the dried medicated powder of any extraction in the foregoing description, add 400ml water for injection, water precipitating (0~-2 ℃) 48 hours, microporous filter membrane filters, and the 500ml injection is made in fill, is injection of the present invention.
Implement just 11: drop pill
To any one extract in the medicinal liquid in the foregoing description, be added among the Polyethylene Glycol of heating and melting-6000 800g, stirring and dissolving is dripped and is made the 1000g ball, is drop pill of the present invention.
According to prescription of the present invention, can also make the preparation of other dosage forms such as suspensoid.
Hypertension is commonly encountered diseases, the frequently-occurring disease of China.At present, China hyperpietic has exceeded 100,000,000, relates to several ten million families.The apoplexy, coronary heart disease, renal failure, the retinopathy that are caused by hypertension have become the modal disease of China, and fatality rate, disability rate are higher.The present invention has acted on ancient Chinese medicine doctor to the hypertension understanding of (traditional Chinese medical science claims " dizzy "), draws elite place wherein, thinks that one of the crucial pathogenesis of hypertension is excessive rising of liver-YANG, obstruction of collaterals by blood stasis, so be principle of treatment with suppressing the hyperactive liver and subsiding YANG, heat clearing and blood circulation promoting.Of the present invention distinguishing controlled the thinking pathogenesis that links closely, giving consideration to both the incidental and fundamental, inside and outside extensively treating; And the flavour of a drug refine, medicine letter power is special, is treatment hypertension excessive rising of liver-YANG, or double obstruction of collaterals by blood stasis person's good recipe.
Therefore development of the present invention is faced with vast market, is wherein containing great social benefit and huge economic benefit.

Claims (4)

1, the hypertensive Chinese medicine preparation of a kind of treatment is characterized in that described Chinese medicine preparation is to be extracted by following flavour of a drug to be prepared from Ramulus Uncariae Cum Uncis 10~38%, Cortex Moutan 10~35%, Spica Prunellae 5~32%, Folium Helianthi 5~28%, Radix Puerariae 4~30%.
2, the preparation method of the described Chinese medicine preparation extracting solution of claim 1, it is characterized in that: hook taking rattan, Radix Puerariae add 60~80% ethanol extraction secondary, 2 hours for the first time, 1 hour for the second time, merge extractive liquid,, filter, filtrate recycling ethanol also is condensed into the concentrated solution of relative density 1.16~1.25; Get Cortex Moutan distillation paeonol again; Medicinal residues and Spica Prunellae decoct with water secondary, and each 1 hour, merge extractive liquid, filtered, and filtrate concentrates; Other gets Folium Helianthi and decocts with water secondary, each 1 hour, merge extractive liquid, filtered, filtrate concentrates, get two kinds of concentrated solutions of above-mentioned Cortex Moutan and Folium Helianthi and merge, add ethanol, make to contain the alcohol amount and reach 50~70%, precipitate with ethanol, cold preservation 24 hours filters, filtrate recycling ethanol and to be condensed into relative density be 1.16~1.25 concentrated solution; Merge above-mentioned two kinds of concentrated solutions, continue to be condensed into thick paste, available distinct methods drying is pulverized, and adds paeonol, and mixing sieves, and is the dried medicated powder of extraction of the present invention; Or with above-mentioned two kinds of concentrated solutions merging, add 100~600ml distilled water and make dissolving, add paeonol, be extraction medicinal liquid of the present invention.
3, preparation method according to claim 2 is characterized in that: add one or more adjuvants in described extraction medicinal liquid, promptly can be made into granule, capsule, tablet, oral liquid, syrup, suspensoid, injection or drop pill.
4, preparation method according to claim 3 is characterized in that: described one or more adjuvants are: starch, dextrin, microcrystalline Cellulose, magnesium stearate, lactose, sucrose, xanthan gum, Polyethylene Glycol.
CN 200310105398 2003-11-07 2003-11-07 Hypertension treating traditional Chinese medicine preparation and its preparing process Expired - Lifetime CN1245180C (en)

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