CN1039784C - Traditional Chinese proprietary medicine for curing hypertension - Google Patents

Abstract

The present invention discloses a medicament which is prepared from pine needle, kudzuvine root and pearl powder. The medicament has obvious therapeutic effect on various kinds of hypertension.

Description

A kind of Chinese patent medicine for the treatment of hypertension

The present invention is a kind of Chinese patent medicine for the treatment of hypertension, and it is to be the Chinese patent medicine with hypotensive effect that raw material is made by particular formulations technology with the natural Chinese medicine.

Hypertension is a kind of global common disease, the prevalence of countries in the world is up to 10-20%, also be ascendant trend year by year in China, 30 provinces and cities in the whole nation in 1991, municipal large-scale survey, China's hypertension prevalence reaches 11.88%, calculate by present 1,200,000,000 populations, the ill population of the hypertension of China has reached 100,000,000.By the heart of caused by hypertension, the mortality rate of cerebrovascular complication, the first place that occupies China's disease death rate.Though existing antihypertensive drug is various in style, bringing high blood pressure down, reduce cerebral hemorrhage sickness rate aspect certain effect is arranged, but because these medicines are to fat, sugar, calcium metabolism and electrolyte, hemorheology and the adverse effect on quality of life, failing to reduce ischemic angiocardiopathy and cerebrovascular takes place unexpectedly, essential hypertension (being hypertension) accounts for more than 90% of hyperpietic, although its pathogeny is unclear fully as yet at present, but domestic and international many scholars think relevant with following factors through research for many years: 1. hemodynamic change, because the change of blood viscosity directly influences resistance of blood flow, so hemorheological change such as blood viscosity increase are to cause one of hypertensive key factor; 2. cell membrane function defective, abnormal calcium metabolism; 3. kidney sodium retention; 4. antiotasis increases, and tube wall thickens, or the like.Therefore, study a kind of can blood pressure lowering, can regulate the disorder of calcium metabolism of vascular hypertension again, and can blood fat reducing, reduce blood plasma and whole blood contrast viscosity, thereby improving the Altace Ramipril of hemorheology properties, is the problem that remains further research and development in the current medical domain.

It is documented, pine is the length of hundred wood, Folium Pini is good medicine (Compendium of Material Medica), food Folium Pini energy life lengthening (Everyman's Science 1986 (1): 7), someone is on the basis of collecting a large amount of domestic and foreign literatures in recent years, to being that the feasibility that raw material is made various pharmaceutical dosage forms is carried out some tests with the Folium Pini, extract as volatile oil, the preparation of extractum, with the Folium Pini spray, pine needle wine, the Folium Pini oral liquid, the Folium Pini electuary, the trial-production of dosage forms such as pine needle tea (the medicinal exploitation of Folium Pini resource, " basic unit's Chinese medicine magazine ", 19926 (3) 3-4): it is the pine needle hypoglycemic oral liquid of Main Ingredients and Appearance with Folium Pini or Cacumen Platycladi (Cacumen Biotae) that Chinese patent application CN1089142A discloses a kind of, can be used for the treatment of diabetes.Chinese patent application CN1097333A discloses a kind of pure plant health preparation glycolipid and has disappeared, and it is to be the medicine that can be used for treating diabetes that Main Ingredients and Appearance is made with Cacumen Platycladi or Folium Pini.

The inventor has confirmed the hypotensive activity of Folium Pini, and according to traditional tcm theory, has carried out the prescription compatibility through for many years scientific research and clinical experiment, utilizes modern science and technology will make medicament.

Therefore, the object of the invention provides the hypertensive Chinese patent medicine of a kind of treatment:

The object of the invention also be to provide a kind of can regulate the disorder of calcium metabolism of vascular hypertension, again can blood fat reducing, reduce blood plasma, whole blood contrast viscosity and platelet aggregation rate, and improve the Altace Ramipril of hemorheology properties.

The present invention also aims to provide a kind of preparation medicine production technology of the present invention.

The composition of raw materials of medicine of the present invention is as follows:

Folium Pini 1000-2000 gram Radix Puerariae 400-800 gram

Margarita layer powder 50-120 gram.

The optimum weight proportioning of each component is in the above-mentioned prescription:

Folium Pini 1800 gram Radix Puerariaes 600 gram Margarita layer powder 90 grams

The said Folium Pini of the present invention, Radix Puerariae and Margarita layer powder all use Chinese crude drug or the decoction pieces that meets Chinese Pharmacopoeia and local medical material standard.Margarita layer powder wherein will be pulverized behind 80 mesh sieves standby.

Adopt the conventional formulation technology in present medical industry field, the pharmaceutical dosage form that the feedstock production of above-mentioned prescription can be become the various patients of being suitable for to use.

Because Folium Pini and Margarita layer powder contain aminoacid and protein in the prescription, make the liquid preparation less stable.And pack, transport, store and carry inconvenience.In the side Margarita layer powder contain calcareous in a large number owing to water insolublely also should not make liquid preparation.Receive the cream rate according to recipe quantity and extraction, make capsule through this formula optimization of prerun.

The production method of medicine capsule of the present invention is as follows:

Get Folium Pini, the Radix Puerariae of formula ratio, decoct with water twice, add 6-9 times of water gaging for the first time, decocted 1-2 hour, add 5-8 times of water gaging for the second time, decocted 1-2 hour, filter, merging filtrate is concentrated into about 1.08 (70 ℃) of relative density, and spray drying gets extract powder.Get the Margarita layer powder that extract powder adds recipe quantity, granulate in right amount with ethanol, 60-70 ℃ of drying, granulate, encapsulated, packing is promptly.

Discover that through preparation process amount of water is 8 times for the first time, decocted 1.5 hours that amount of water is 6 times for the second time, decocted 1.5 hours, 65 ℃ of granulation after drying temperature, 40 order granulate are by best production technology (referring to accompanying drawing).

Folium Pini in the pharmaceutical formulation of the present invention can replace with Cacumen Platycladi (Cacumen Biotae), and the pearl pear powder layer can be used Margarita powder.

Although the extraction process of the inventive method is to use the technology that decocts with water lixiviate; those skilled in the art can be according to the contained active ingredient of each raw material; take different extracting method; for example extract Folium Pini volatile oil earlier; or adopt the water extract-alcohol precipitation technology, these variations all belong to the scope of protection of the invention.

Although the preferred capsule of pharmaceutical dosage form of the present invention,, as long as taked the composition of raw materials of medicine of the present invention, but make the pharmaceutical formulation that any other patients uses, all within protection scope of the present invention.

Medicine of the present invention has tangible blood pressure lowering, blood fat reducing, reduction blood plasma and whole blood contrast viscosity, reduces platelet aggregation rate and regulates the effect of the disorder of calcium metabolism of vascular hypertension.

In order to confirm the medical function of medicine of the present invention, carried out following a series of experiment and clinical observation:

One, acute drop test:

Acute drop test shows that medicine of the present invention had no effect (P＞0.05) to normal rat blood pressure, can significantly reduce the arteriotony of renal hypertension and SP rat, hypotensive effect occurred in 30 minutes, reaches the peak in 2 hours, and effect continued above 3 hours.Its hypotensive effect is dose dependent, and action intensity and persistent period all obviously are better than the compound Herba Apocyni veneti (Folium Apocyni Veneti) group.

Two, long-term drop test:

The result shows that medicine of the present invention is to normal rat blood pressure have no effect (P＞0.05), it is 24.5 ± 4.37% that small dose group is controlled metanephros hypertensive rat blood pressure rate of descent, the SP rate of descent is 32.6 ± 4.02%, middle dosage group renal hypertensive rat rate of descent 28.6 ± 3.06%, SP is 41.9 ± 3.77%, heavy dose of group kidney is 39.2 ± 5.06%, SP is 47.90 ± 3.93%, all than the decline (P＜0.001) that highly significant is arranged before the treatment, with the blank group, the Herba Apocyni veneti group is compared, rate of descent is apparently higher than these 2 groups (P＜0.001), the drug withdrawal of heavy dose of group SP rat after 20 days blood pressure still can maintain 114.0 ± 5.44mmHg, rate of descent reaches 40.68% ± 3.03%.External blood pressure and mean arterial pressure are remarkable positive correlation (r=0.977 t=19.581, P＜0.001).

Three, blood fat reducing experiment:

Experiment shows, medicine of the present invention has significant treatment and preventive effect to hyperlipemia, can obviously suppress the hyperlipemia that high-fat meal brings out, significantly reduce serum total cholesterol, triglyceride and the low density lipoprotein, LDL of hyperlipemia animal, but and high density lipoprotein increasing, its effect for reducing fat is with prevention group the best, and is dose dependent, and curative effect is better than niacin inositol lipid.The reduction of blood fat is significant for the generation of sample sclerosis of control tremulous pulse and minimizing coronary heart disease, also is one of characteristic of this medicine.

Four, to hemorheological effect:

The animal high blood viscosity that medicine of the present invention causes after to high-fat meal has good curing and preventive effect, prophylactic can significantly suppress blood plasma specific viscosity height that high-fat meal causes, whole blood contrast viscosity increases increases (P＜0.001) with hematocrit, its effect is better than the niacin inositol lipid group, but difference with insignificance (P＞0.05) between group.High shearing whole blood viscosity has been reacted erythrocytic rigidity, the low-rate-of-shear whole blood viscosity has been represented erythrocyte aggregation, medicine of the present invention is to hemorheological good effect, for reducing the blood vessel internal resistance, reduce the erythrocyte rigidity, improve its deformability, reduce erythrocyte aggregation, microcirculation improvement is significant, meets the effect of traditional Chinese medical science blood circulation promoting and blood stasis dispelling.

Five, extracorporeal platelet aggregation inhibition test:

The result shows that medicine of the present invention has the obvious suppression effect to platelet aggregation, and its effect obviously is better than liquid salvia, and this test shows that this medicine has inhibitory action for the platelet overactivity of coronary heart disease of hypertension and cerebral infarction existence.

Six, to the regulating action of Hypertensive Rats parathyroid function:

Experimental results show that, medicine of the present invention has significant regulating action to the parathyroid function of SP rat, after the treatment of 3 weeks, the parathyroid hormone of SP rat obviously descends, calcitonin significantly raises, medicine of the present invention has the Chinese medicinal ingredients that is rich in activated calcium, and hypertensive disorder of calcium metabolism and parathyroid function are significant unusually for correcting.

Seven, clinical research:

1994 at Affiliated Hospital of Chengdu College of Traditional Chinese Medicine, three hospitals of attached institute of traditional Chinese medicine of Annex II institute of Medical University Of Chongqing and state, Shanghai hospital have carried out the clinical trial of medicine of the present invention, observe hypertension case 165 examples altogether, wherein 102 examples are organized in treatment, matched group 63 examples, result show that total obvious effective rate of hypertension therapy disease of the present invention is 57.84%, total effective rate reaches 84.31%, obviously is better than matched group (compound Herba Apocyni veneti (Folium Apocyni Veneti)).Clinical symptoms such as dizzy, headache, flushing conjunctival congestion, bitter taste xerostomia, dysphoria with feverish sensation in the chest palms and soles are significantly improved, and the patient for merging hyperlipemia, coronary heart disease also has obvious treatment effect (seeing Table 12,13).Short term therapy is not seen obvious toxic-side effects and untoward reaction.

Embodiment:

The raw material prescription:

Folium Pini 1800 gram Radix Puerariaes 600 gram Margarita layer powder 90 grams

Method for making:

Get Folium Pini, Radix Puerariae two flavors, decoct with water twice, for the first time 8 times of water gagings, decocted 1.5 hours, 6 times of water gagings decocted 1.5 hours for the second time, filter, merging filtrate is concentrated into about 1.08 (70 ℃) of relative density, spray drying gets extract powder, and Margarita layer powder was pulverized 80 mesh sieves, gets the Margarita layer powder that extract powder adds recipe quantity, granulate 65 ℃ of dryings, 40 order granulate in right amount with ethanol, load 1000 of No. 0 capsules, every suitable crude drug 2.49 grams.

Accompanying drawing 1 is the technological process of production figure of medicine capsule of the present invention.

Claims (8)

1, a kind of medicine for the treatment of vascular hypertension is characterized in that the composition of raw materials of this medicine is:

Folium Pini 1000-2000 gram Radix Puerariae 400-800 gram

Margarita layer powder 50-120 gram.

2, according to the medicine of claim 1, the weight proportion of each component is in its described prescription: Folium Pini 1800 grams, Radix Puerariae 600 grams, Margarita layer powder 90 grams.

3, according to the medicine of claim 1 or 2, Folium Pini wherein replaces with Cacumen Platycladi (Cacumen Biotae).

4, according to the medicine of claim 1 or 2, Margarita layer powder wherein replaces with Margarita powder.

5, according to the medicine of claim 1 or 2, the dosage form that it is characterized in that this medicine is a capsule.

6, the described medicine production technology of claim 1 is characterized in that getting Folium Pini, the Radix Puerariae of formula ratio, decocts with water twice, for the first time add 6-9 times of water gaging, decocted 1-2 hour, add 5-8 times of water gaging for the second time, decocted 1-2 hour, and filtered merging filtrate, being concentrated into that relative density detects in the time of 70 ℃ is 1,08, and spray drying gets extract powder, get the Margarita layer powder that extract powder adds recipe quantity, granulate 60-70 ℃ of drying with ethanol in right amount, granulate, encapsulated.

7, according to the method for claim 6, wherein amount of water is 8 times for the first time, decocts 1.5 hours, and amount of water is 6 times for the second time, decocts 1.5 hours.

8, according to the method for claim 6, wherein the particle drying temperature after the pelletize is 65 ℃.