CN107648479B - Traditional Chinese medicine formula for treating hypertension and product thereof - Google Patents
Traditional Chinese medicine formula for treating hypertension and product thereof Download PDFInfo
- Publication number
- CN107648479B CN107648479B CN201711081193.8A CN201711081193A CN107648479B CN 107648479 B CN107648479 B CN 107648479B CN 201711081193 A CN201711081193 A CN 201711081193A CN 107648479 B CN107648479 B CN 107648479B
- Authority
- CN
- China
- Prior art keywords
- parts
- composition
- chinese medicine
- traditional chinese
- group
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
- A61K36/8988—Gastrodia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/24—Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/287—Chrysanthemum, e.g. daisy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/74—Rubiaceae (Madder family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
- A61K36/8888—Pinellia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
Abstract
The invention discloses a compound traditional Chinese medicine for treating hypertension. The traditional Chinese medicine is prepared into a certain dosage form by taking gastrodia elata, uncaria, ligusticum wallichii, rauwolfia, rhizoma pinellinae praeparata and the like as raw materials and extracting and separating the raw materials by using 0-75% of ethanol water solution. Has effects of calming liver, stopping endogenous wind, clearing heat, and eliminating phlegm, and can be used for treating essential hypertension or intractable hypertension with liver fire hyperactivity and phlegm-heat accumulation. Pharmacodynamic studies show that: the compound traditional Chinese medicine can obviously reduce the systolic pressure and diastolic pressure of model animals with spontaneous hypertension and renal hypertension, and has lasting effect of reducing the blood pressure. The results of clinical studies show that: the medicine can effectively improve various traditional Chinese medicine symptoms of patients with hypertension with liver fire hyperactivity and phlegm-heat internal accumulation, effectively reduces the blood pressure of the patients, and has no obvious adverse drug reactions. The composition is safe and effective for treating hypertension, is convenient to use, and has the functions of calming the liver, stopping endogenous wind, clearing heat and reducing phlegm proved by clinical curative effect and pharmacodynamic research, so that the composition is an effective special medicine for treating hypertension.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a compound traditional Chinese medicine for treating hypertension.
Background
Hypertension is a clinical syndrome characterized by elevated systemic arterial systolic pressure (SBP) and/or diastolic pressure (DBP). Its high disability rate and death rate bring serious physical and mental damage to society and families. The prevalence rate of people over 15 years old in China reaches 11.2 percent, the prevalence rate of old people over 60 years old reaches 43.7 percent, the total number of hypertensive patients is estimated to be about 1.2 hundred million in 13 hundred million people in China, and the hypertensive patients have the characteristic of lifelong medicine taking.
At present, six major medicines for treating hypertension in western medicine are still the main antihypertensive medicines for clinical application. Most western medicines have certain side effects, for example, adrenaline beta receptor blocking medicines such as propranolol and the like cannot be taken by people with asthma, and if the medicines are taken excessively, the heart conduction block and the abnormity of blood fat and blood sugar can be caused; calcium ion antagonists such as nifedipine can cause symptoms such as edema of feet, redness of face, and acceleration of heartbeat; reserpine can cause gastric ulcer, as well as sexual hypofunction. Although the traditional Chinese medicine for treating hypertension has lower blood pressure reduction speed than western medicines, the traditional Chinese medicine has the advantages of overall regulation, mild blood pressure reduction effect, less side effect and the like. Unfortunately, the use of traditional Chinese medicines in the area of treating hypertension has been less successful. Therefore, the development of the compound traditional Chinese medicine which has definite antihypertensive curative effect and small side effect and is suitable for long-term administration has good social and economic significance.
The hypertension belongs to the categories of dizziness, headache and the like in the traditional Chinese medicine, the dizziness can be positioned on the liver and kidney and is the syndrome of deficiency in origin and marked excess, the deficiency in origin is the deficiency of liver and kidney yin and the marked excess is the hyperactivity of liver yang and obstruction of collaterals by blood stasis. Transformation of liver yang into wind and transformation of blood stasis into wind are both classified as internal stirring of wind and qi, so its pathogenesis can be summarized by "deficiency, stasis and wind". Patent ZL201010125992.2 granted by the inventor of the application also discloses a traditional Chinese medicine composition for treating hypertension, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 1-2 parts of ligusticum wallichii, 1.5-2 parts of uncaria and 1-1.5 parts of radix ophiopogonis, but the effects of the traditional Chinese medicine composition on nourishing yin, nourishing liver, calming endogenous wind, promoting blood circulation, dredging collaterals and preventing dizziness are still to be improved. 201410362490X discloses a Chinese medicinal composition for treating hypertension, which is prepared from the following Chinese medicinal raw materials in part by weight: 0.5-2 parts of uncaria, 1-2 parts of ligusticum wallichii, 1-2 parts of angelica sinensis, 0-4 parts of rauwolfia and 0-4 parts of apocynum venetum, and can effectively improve various traditional Chinese medicine symptoms of patients with hypertension of yin deficiency and yang hyperactivity and channel blockage due to blood stasis.
Disclosure of Invention
The invention aims to provide a compound traditional Chinese medicine for treating hypertension aiming at the defects in the prior art so as to improve the function of poor antihypertensive curative effect.
The compound traditional Chinese medicine for treating hypertension comprises the following traditional Chinese medicine raw materials in parts by weight: 0.5-4 parts of gastrodia elata, 0.8-3 parts of uncaria, 0.8-6 parts of rauwolfia, 1-4 parts of ligusticum wallichii and 0.5-4 parts of rhizoma pinellinae praeparata. The preferred weight ratio of the traditional Chinese medicine raw materials is as follows: 2-4 parts of gastrodia elata, 1-3 parts of uncaria, 4-6 parts of rauwolfia, 2-4 parts of ligusticum wallichii and 1-3 parts of rhizoma pinellinae praeparata. More preferably: 3 parts of gastrodia elata, 2 parts of uncaria, 5 parts of rauwolfia, 3 parts of ligusticum wallichii and 2 parts of rhizoma pinellinae praeparata.
The compound traditional Chinese medicine for treating hypertension can be further combined with 0.8-5 parts of wild chrysanthemum flower, 0.5-3 parts of tuckahoe and 0.8-3 parts of dried orange peel. The weight parts of the traditional Chinese medicine raw materials are preferably as follows: 2-5 parts of wild chrysanthemum flower, 1-3 parts of tuckahoe and 0.8-3 parts of dried orange peel; more preferably: 3 parts of wild chrysanthemum flower, 2 parts of tuckahoe and 2 parts of dried orange peel.
The compound traditional Chinese medicine for treating hypertension is prepared from the following raw materials in parts by weight: 3 parts of gastrodia elata, 2 parts of uncaria, 5 parts of rauwolfia, 3 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum, 2 parts of poria cocos and 2 parts of pericarpium citri reticulatae.
Emotional factors are the initiating factors of hypertension. If the emotion is relieved, the liver depression will transform into fire, resulting in hyperactivity of liver fire. When liver wood is in the vicinity of spleen, spleen deficiency will lead to phlegm generation and dampness retention or qi stagnation will transform into fire, and fire will burn body fluid into phlegm, but no phlegm will cause dizziness, phlegm-heat will be stagnated, the vessels will be blocked, blood circulation will not be smooth, the vessels will not be soft, and the blood will be narrow, resulting in blood pressure increase. The depression of the liver-fire may cause the liver-fire to be hyperactivity due to the liver-fire being obstructed by overstrain of the spleen, damp stagnation in the middle energizer, phlegm resolving for a long time, phlegm turbidity disturbing upwards, wood stagnation, liver failure. Therefore, hyperactivity of liver fire and internal accumulation of phlegm-heat are the basic pathogenesis of hypertension. Based on the modern literature data, the syndrome differentiation and classification of hypertension can also be obtained, and the hyperactivity of liver fire and the internal accumulation of phlegm-heat are the main syndromes of hypertension. Pacifying liver and calming endogenous wind, clearing heat and resolving phlegm are the great treatment methods. The "Nei Jing" (the internal classic) means that all wind-syndrome and dizziness are all the liver-syndrome. In the compound traditional Chinese medicine composition, the gastrodia elata is taken as the monarch drug, and is good at calming the liver and stopping wind to stop dizziness due to entering the jueyin channel, aiming at treating wind. Compendium of materia medica. herbage department "cloud: gastrodia elata is a medicine for liver meridian qi system and enters the jueyin meridian to treat various diseases. According to Luoyangui cloud: rotating eyes and blackheads, wind deficiency and internal attack, which cannot be treated by non-Gastrodia elata. Gastrodia elata is a wind-calming herb, so it is a miraculous drug for treating wind, so it is a monarch drug. Uncaria rhynchophylla, ramulus Uncariae cum uncis, radix et rhizoma Rhei, ramulus Uncariae cum uncis, radix Angelicae sinensis. Rauwolfia root, radix Rauvolfiae, for clearing wind-heat and reducing liver fire; the two can help the gastrodia elata strengthen the action of calming the liver and calming the wind, and is used as a ministerial drug. Tuckahoe, Poria has the effects of eliminating dampness, invigorating spleen, calming heart and tranquilizing; tangerine peel, pericarpium Citri Reticulatae eliminates dampness and phlegm, regulates qi and relieves epigastric distention. The spleen is the source of phlegm generation, and the lung is the device for storing phlegm, which is the herb of spleen and lung qi system. Therefore, the phlegm-resolving effect is high because the tangerine peel is used for strengthening the spleen and regulating qi, the tuckahoe is used for strengthening the spleen and excreting dampness, and the rhizoma pinellinae praeparata is used for eliminating dampness and phlegm, and not only can the already-produced phlegm be eliminated, but also the source of the produced phlegm is removed, so the phlegm-resolving effect is high. The three medicines are used as adjuvant medicines. Wild chrysanthemum can not only help Rauwolfia to clear heat, but also dispel wind and calm liver, and is also used as adjuvant drug. Chuan Xiong Xinxiang Sheng powder for treating headache, wind-evil dispelling, pain relieving, blood circulation promoting and blood stasis. The book Jing: stroke mainly enters brain headache. So it can be used as an adjuvant and guiding drug to ascend to the head. The medicines are combined to play the effects of calming the liver, calming the wind, clearing heat and eliminating phlegm.
The compound Chinese medicine can be decocted for administration, or extracted with water or ethanol for administration.
The preparation method of the compound traditional Chinese medicine preparation can be carried out by adopting a conventional method in the pharmaceutical field and using conventional pharmaceutic adjuvants. For example, the extract is mixed with any one or more carriers or auxiliary materials commonly used in pharmaceutics by a common method and then is prepared into various oral dosage forms. Such as excipients, fillers, diluents, lubricants, wetting agents, disintegrants, surfactants, preservatives, sweeteners, flavoring agents, and the like. Specifically, the carrier may be, for example, starch, dextrin, lactose, microcrystalline cellulose, hydroxypropylmethylcellulose, polyethylene glycol, magnesium stearate, aerosil, glucose, mannitol, xylitol, glycine and the like.
According to the requirement, the compound traditional Chinese medicine can be prepared into a preparation suitable for oral administration; can be any of the following dosage forms: tablet, capsule, soft capsule, granule, dripping pill, dispersible tablet, orally disintegrating tablet, pill or oral liquid, etc.
The invention also aims to provide a preparation method of the compound traditional Chinese medicine for treating hypertension, which comprises the following steps: the method comprises the following steps:
weighing traditional Chinese medicine raw materials, adding water or 0-70% ethanol water solution, extracting for 2-3 times, and adding 4-12 times of ethanol solvent each time; extracting for 1-2 hours each time, combining the extracting solutions, filtering, recovering the solvent, concentrating, drying and preparing into clinically acceptable dosage forms. Preferably, the extraction solvent is a 30% to 70% aqueous ethanol solution, more preferably a 70% aqueous ethanol solution.
The invention also aims to provide the application of the compound traditional Chinese medicine in the aspects of preparing medicines for treating hypertension and the like.
The prescription of the invention combines medicines, has the functions of calming liver, stopping endogenous wind, clearing heat and reducing phlegm, and is used for treating hypertension which belongs to the condition of liver fire hyperactivity and phlegm-heat internal accumulation. Pharmacodynamic studies on the compound traditional Chinese medicine extracted by the formula show that: the compound traditional Chinese medicine can obviously reduce the systolic pressure and diastolic pressure of model animals with spontaneous hypertension and renal hypertension, and has lasting effect of reducing the blood pressure; clinical studies have shown that: the compound traditional Chinese medicine can effectively improve various traditional Chinese medicine symptoms of patients with hypertension with liver fire hyperactivity and phlegm-heat internal accumulation, effectively reduces the blood pressure of the patients, and has no obvious adverse drug reactions.
Detailed Description
In order to describe the present invention in further detail, specific examples are given, but the present invention is only illustrative and not intended to limit the scope of the present invention.
EXAMPLE 1 granular dosage forms of the pharmaceutical compositions of the invention
The preparation method comprises the steps of adopting a conventional preparation method of granules, soaking 4 parts of gastrodia elata, 3 parts of uncaria, 6 parts of rauwolfia, 4 parts of ligusticum wallichii and 4 parts of rhizoma pinellinae praeparata in water for 0.5 hour, then extracting for 2 times, wherein the water addition amount is 10 times and 8 times respectively, extracting for 2 hours for the first time and 1.5 hours for the second time, filtering, combining filtrates, concentrating, drying, crushing, adding an appropriate amount of auxiliary materials, mixing uniformly, granulating, sieving and drying to prepare the pharmaceutical composition preparation in the form of granules.
EXAMPLE 2 tablet dosage forms of the pharmaceutical compositions of the invention
Adopting a conventional tablet preparation method, taking 0.5 part of gastrodia elata, 0.8 part of uncaria, 0.8 part of rauwolfia, 1 part of ligusticum wallichii and 0.5 part of rhizoma pinellinae praeparata, adding 70% ethanol, soaking for 0.5 hour, extracting for 2 times, adding water in an amount which is 6 times and 4 times respectively, extracting for 2 hours for the first time and extracting for 1 hour for the second time, filtering, combining filtrates, concentrating, drying, crushing, adding an appropriate amount of auxiliary materials, uniformly mixing, granulating, sieving, drying, further tabletting the prepared granules, and drying to obtain the pharmaceutical composition preparation in the form of tablets.
EXAMPLE 3 Capsule dosage forms of the pharmaceutical composition of the invention
The preparation method comprises the steps of taking 1 part of gastrodia elata, 2 parts of uncaria, 2 parts of rauwolfia, 1 part of ligusticum wallichii, 0.8 part of rhizoma pinellinae praeparata, 1 part of wild chrysanthemum, 1 part of poria cocos and 1 part of dried orange peel, adding 60% ethanol, soaking for 0.5 hour, extracting for 2 times, adding 7 times and 5 times of water, extracting for 2 hours for the first time and extracting for 1 hour for the second time, filtering, combining filtrates, concentrating, drying, crushing, adding an appropriate amount of auxiliary materials, mixing uniformly, granulating, sieving, drying, filling prepared granules into capsule shells, and preparing into capsules to obtain the capsule pharmaceutical composition preparation.
EXAMPLE 4 drop pill dosage forms of the compositions of the invention
The conventional process for preparing the dropping pill is adopted, 2 parts of gastrodia elata, 1.5 parts of uncaria, 1.5 parts of rauwolfia, 2 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 1.5 parts of wild chrysanthemum, 2 parts of poria cocos and 1.5 parts of dried orange peel are taken, 50% ethanol is added for soaking for 0.5 hour and then extracting for 2 times, the water addition amount is 6 times and 4 times respectively, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, filtering is carried out, filtrate is combined, and proper amount of auxiliary materials are added after concentration, drying and crushing, so that the dropping pill of.
EXAMPLE 5 Soft Capsule dosage forms of the pharmaceutical composition of the invention
The preparation method comprises the steps of adopting a conventional soft capsule preparation process, soaking 3 parts of gastrodia elata, 2 parts of uncaria, 4 parts of rauwolfia, 2.5 parts of ligusticum wallichii, 1.5 parts of rhizoma pinellinae praeparata, 2 parts of wild chrysanthemum, 1.5 parts of poria cocos and 1 part of dried orange peel in 40% ethanol for 0.5 hour, extracting for 2 times, adding 7 times and 5 times of water amount respectively, extracting for 2 hours for the first time and 1 hour for the second time, filtering, combining filtrates, concentrating, drying, crushing, adding an appropriate amount of auxiliary materials, mixing uniformly, using gelatin as a capsule shell material, and pressing into soft capsules to obtain the soft capsules of the pharmaceutical composition.
EXAMPLE 6 pellet form of the pharmaceutical composition of the invention
Preparation: a conventional process for preparing the micro-pills is adopted, 2.5 parts of gastrodia elata, 3 parts of uncaria, 4 parts of rauwolfia, 2 parts of ligusticum wallichii and 3 parts of rhizoma pinellinae praeparata are taken, 30% ethanol is added for soaking for 0.5 hour and then extracted for 2 times, the water addition amount is 6 times and 4 times respectively, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtration is carried out, the filtrates are combined, and a proper amount of auxiliary materials are added after the concentration, the drying and the crushing, so that the micro-pills.
EXAMPLE 7 pellet form of the pharmaceutical composition of the invention
Preparation: a conventional process for preparing the pellet is adopted, 4 parts of gastrodia elata, 3 parts of uncaria, 5 parts of rauwolfia, 3 parts of ligusticum wallichii, 3 parts of rhizoma pinellinae praeparata, 1 part of wild chrysanthemum, 1 part of poria cocos and 1 part of dried orange peel are taken, water is added for soaking for 0.5 hour and then extracted for 2 times, the water addition amount is respectively 6 times and 4 times, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtration is carried out, the filtrate is combined, and an appropriate amount of auxiliary materials are added after concentration, drying and crushing, so that the.
EXAMPLE 8 pharmacological test of the invention
The purpose of the experiment is to observe the therapeutic effect of the compound traditional Chinese medicine on the hypertension model rat. The test composition A, B, C was a dry powdered extract formulated for use in purified water to the desired concentration.
The test compositions were prepared in the same manner, specifically as follows:
composition A: soaking rhizoma Gastrodiae 3 parts and ramulus Uncariae cum uncis 2 parts in water for 0.5 hr, extracting for 2 times with water amount of 12 times and 10 times respectively, extracting for 2 hr for the first time and 1 hr for the second time, filtering, mixing filtrates, concentrating, drying, and pulverizing to obtain composition A dry extract powder.
Composition B: soaking 3 parts of gastrodia elata, 2 parts of uncaria, 5 parts of rauwolfia, 3 parts of ligusticum wallichii and 2 parts of rhizoma pinellinae praeparata in water for 0.5 hour, extracting for 2 times, adding 12 times and 10 times of water respectively, extracting for 2 hours for the first time and 1 hour for the second time, filtering, combining filtrates, concentrating, drying and crushing to obtain the dry extract powder of the composition B.
Composition C: soaking 3 parts of gastrodia elata, 2 parts of uncaria, 5 parts of rauwolfia, 3 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum flower, 2 parts of poria cocos and 2 parts of dried orange peel in water for 0.5 hour, extracting for 2 times, wherein the water addition amount is 12 times and 10 times respectively, extracting for 2 hours for the first time and 1 hour for the second time, filtering, combining filtrates, concentrating, drying and crushing to obtain the composition C dry extract powder.
1. Effect on blood pressure in SHR rats
50 male SHRs (sex hormone replacement receptor) with the age of 6 weeks are selected for experimental animals, are layered according to blood pressure and are randomly divided into 5 groups, and each group comprises 10 animals: control group of model, nifedipine 3.6 mg.kg-1·d-1Group, composition A group 2.0 g.kg-1·d-1Composition group B2.0 g/kg-1·d-1Composition C2.0 g/kg-1·d-1Composition A, B, C group is in a pharmaceutical dosage form. In addition, 10 WKY rats were used as a normal control group. What is needed isThe medicine is prepared into required concentration by distilled water, the medicine is administrated by intragastric administration at a volume of 10ml/kg at 8:00 a day, the administration volume is 10ml/kg for 1 time a day, and the medicine is continuously administrated for 35 days. The model group and the normal control group were given equal volumes of distilled water, respectively.
Index measurements groups started measuring blood pressure 1h after gavage. Blood pressure was measured once a week. The measuring environment is quiet and constant (26 ℃), a BP-2006A intelligent noninvasive sphygmomanometer is adopted to measure the systolic pressure and the diastolic pressure of a rat in a waking state and a non-irritating state, the measurement is carried out for 4 times continuously, and the average value is taken.
The data from this experiment were processed with EXCEL software and the results were examined between groups using a t-test analysis.
1.1 Effect on systolic blood pressure in SHR rats
As shown in Table 1, the systolic pressure of SHR rats in each group before administration is close, the difference is not statistically significant, and the differences are significantly higher than those in WKY group (P < 0.01).
At each measurement time point after administration, the systolic pressure of the model group rat is obviously higher than that of the WKY group, and the difference has statistical significance (P is less than 0.01).
Compared with the model group, the positive nifedipine group has the advantages that the systolic blood pressure is obviously reduced (P is less than 0.01) after the continuous administration for 1-5 weeks. The systolic pressure of the composition C group is obviously reduced after administration for 1-5 weeks, the difference is statistically significant (P is less than 0.01) compared with that of a model group, and the systolic pressure level of rats in the composition C group is similar to that of a nifedipine group, and the difference is not statistically significant (P is more than 0.05). After the composition B is administrated for 1-5 weeks, the systolic pressure of SHR rats is reduced, wherein the effect of reducing the systolic pressure is obvious after the administration for 1-4 weeks (compared with a model group, P is less than 0.01), and when the composition B is administrated for 5 weeks, although the level of the systolic pressure of the rats is reduced, no significant difference is observed compared with the model group. The systolic blood pressure of the composition A group after 1-5 weeks of administration has no significant difference compared with the model group (P > 0.05). It is demonstrated that both compositions B and C have significant systolic blood pressure lowering effect in SHR rats, but no significant systolic blood pressure lowering effect was observed for composition a.
Comparing the hypotensive effect intensity of composition A, B, C: there was no significant difference in the systolic blood pressure levels in rats between composition B and composition C when measured 1-3 weeks after administration (P >0.05), but at 4-5 weeks after administration, the systolic blood pressure in rats was significantly lower in composition C than in composition B (P < 0.01). The systolic blood pressure level was significantly lower in the group of composition C than in the group of composition A (P <0.01) for 1-5 weeks after administration, and significantly lower in the group of composition B than in the group of composition A (P <0.01 or P <0.05) for 1-5 weeks after administration. It is suggested that composition B is superior to composition A in its effect of reducing systolic blood pressure in SHR rats, and that composition C is superior to compositions A and B in its effect of reducing systolic blood pressure in SHR rats.
From the duration of the hypotensive effect, the composition group C exhibited a significant SBP-lowering effect (P <0.01) with respect to the model group for 1-5 weeks, whereas the composition group B exhibited a significant SBP-lowering effect (P <0.01) with respect to the model group only for 1-4 weeks after the administration, and the composition B exhibited a reduced intensity of the effect of lowering the systolic blood pressure in SHR rats for 4-5 weeks. It is suggested that composition C has a superior long-lasting hypotensive effect than composition B.
TABLE 1 Effect of continuous 5 weeks of administration of the compositions of the invention on SHR systolic blood pressure: (
n＝10)
Note: p <0.05, P <0.01 compared to WKY group; comparing with model group, # P <0.05, # P < 0.01; comparing with composition C, wherein P is less than 0.05, P is less than 0.01; comparison with composition a: it is <0.05, it is < 0.01.
1.2 Effect on SHR diastolic pressure
As shown in Table 2, the diastolic pressure of the SHR groups before administration is close, the difference is not statistically significant, and the differences are significantly higher than those of the WKY group (P < 0.01).
When distilled water is given for 1-5 weeks at each measurement time point, the mean diastolic pressure level of the model group rats is significantly higher than that of the WKY group (P <0.01), and the diastolic pressure level of the model group rats tends to increase with the increase of the experimental time.
Compared with the model group, the diastolic pressure of the positive nifedipine group and the composition C group of the invention at each measuring time point after being administrated for 1-5 weeks is obviously reduced, and the difference has statistical significance (P is less than 0.01); the diastolic blood pressure of the composition B group is obviously reduced after 1-4 weeks of administration, and the difference has statistical significance (P is less than 0.05 or P is less than 0.01); the diastolic blood pressure of the composition A group after 1-5 weeks of administration has no significant difference compared with the model group (P > 0.05). Both compositions B and C demonstrated significant diastolic lowering effect in SHR rats, but no significant diastolic lowering effect was observed with composition a.
1-2 weeks after administration, there was no significant difference in diastolic blood pressure levels between composition B and composition C (P > 0.05); the diastolic blood pressure level of the rats in the composition C group was significantly lower than that in the composition B group 3-5 weeks after administration, and the difference was statistically significant (P <0.05 or P < 0.01). The mean diastolic water pressure of the rats in group C was significantly lower than that in group A (P <0.01) at 1-5 weeks after administration of composition C, and the mean diastolic water pressure of the rats in group B was significantly lower than that in group A (P <0.01) at 1-4 weeks after administration of composition B. It is suggested that composition B has better effect on reducing the diastolic pressure of SHR rats than composition A, and composition C has better effect on reducing the diastolic pressure of SHR rats than compositions A and B.
From the duration of the hypotensive effect, the composition group C showed a significant diastolic blood pressure lowering effect (P <0.01) with respect to the model group at 1-5 weeks after administration, whereas the composition group B showed a significant DBP lowering effect (P <0.05 or P <0.01) with respect to the model group only at 1-4 weeks after administration, and the composition group B had a reduced level of diastolic blood pressure lowering effect in SHR rats at 5 weeks without significant difference from the model group. It is suggested that composition C has a superior long-lasting hypotensive effect than composition B.
TABLE 2 Effect of the composition of the invention on SHR diastolic blood pressure for 5 weeks of continuous administration: (
n＝10)
Note: p <0.05 and P <0.01 compared to WKY group, # P <0.05 and # P <0.01 compared to model group; comparing with composition C, wherein P is less than 0.05, P is less than 0.01; comparison with composition a: it is <0.05, it is < 0.01.
2. Influence on blood pressure of renal hypertensive rats
The experimental animal replicates the renal hypertension rat model using a two-kidney one-clamp method. The 50 successfully modeled RHR model rats were stratified according to blood pressure and randomly divided into 5 groups of 10 animals per group: control group of model, nifedipine 3.6 mg.kg-1·d-1Group, composition A group 2.0 g.kg-1·d-1Composition group B2.0 g/kg-1·d-1Composition C2.0 g/kg-1·d-1. The A, B, C groups are all crude drug dosage. In addition, 10 sham-operated rats were set as a sham-operated control group. All drugs were formulated with distilled water to the desired concentration and administered by gavage at 10ml/kg at 10:00 doses per day, 1 time per day for 6 weeks. The sham-operated group and the model control group were given the same volume of distilled water.
The indexes are detected by using a BP-2006A intelligent noninvasive sphygmomanometer to measure the blood pressure of a rat, continuously measuring for 4 times and taking the average value as the systolic pressure. Blood pressure was measured for each group prior to dosing. Blood pressure was measured once a week. The blood pressure requirement is measured while the animal is awake.
The data from this experiment were processed with EXCEL software and the results were examined between groups using a t-test analysis.
2.1 Effect on the systolic pressure in renal hypertensive rats
As shown in Table 3, the systolic pressure of the rats in the model group is stable in the whole experimental observation period and is significantly higher than that in the sham operation group, and the difference has statistical significance (P is less than 0.01), which indicates that the modeling is successful.
Compared with the model group, the positive drug (nifedipine tablets) group has obviously reduced systolic pressure after administration for 1-6 weeks, and the difference has statistical significance (P is less than 0.01); the systolic blood pressure of the composition C group is obviously reduced relative to the model group after being administrated for 1-6 weeks (P is less than 0.05 or P is less than 0.01), the systolic blood pressure of the composition B group is obviously reduced after being administrated for 1-4 weeks (P is less than 0.05 or P is less than 0.01), the systolic blood pressure of the composition A group after being administrated for 1-6 weeks is not obviously reduced, and the difference has no statistical significance (P is more than 0.05). The compositions B and C are shown to have the effect of remarkably reducing the systolic blood pressure of the renal hypertensive rats, while the composition A has no remarkable blood pressure reducing effect.
The systolic blood pressure level of rats in the composition C group and the composition B group is not significantly different (P is more than 0.05) 1-4 weeks after administration, and the systolic blood pressure of rats in the composition C group is significantly lower than that in the composition B group (P is less than 0.01) 5-6 weeks after administration. Composition group C, when measured 2-6 weeks after dosing, the rat systolic blood pressure levels were significantly lower than in composition group a (P < 0.01); the systolic blood pressure of rats in the group B of the composition is lower than that in the group A of the composition at 1-6 weeks of administration, and the rats have significant difference (P <0.05 or P <0.01) compared with the group A of the composition at 2-4 weeks after administration. The composition B is better than the composition A in reducing the systolic pressure of the renal hypertensive rat, and the composition C is remarkably better than the compositions A and B in reducing the systolic pressure of the renal hypertensive rat.
From the duration of the hypotensive effect, the composition group C showed a significant SBP-lowering effect (P <0.01) with respect to the model group at 1-6 weeks after administration, whereas the composition group B showed a significant SBP-lowering effect (P <0.01) with respect to the model group only at 1-4 weeks after administration, and the composition B showed a reduced intensity of the effect of lowering the systolic blood pressure in the renal hypertensive rats at 5-6 weeks after administration. It is suggested that composition C has a superior long-lasting hypotensive effect than composition B.
TABLE 3 Effect of the present invention on the systolic tail artery pressure of renal hypertensive rat after 6 weeks of continuous administration: (
n＝10))
Note: p <0.05 and P <0.01 in comparison with sham group, P <0.05 and P <0.01 in comparison with model group, P <0.05 and P <0.01 in comparison with composition C, P <0.05 and P <0.01 in comparison with composition A; comparison with composition a: it is <0.05, it is < 0.01.
2.2 Effect on diastolic blood pressure in renal hypertensive rats
As shown in Table 4, the diastolic pressure of the rats in the model group is stable in the whole experimental observation period, and is significantly higher than that in the sham operation group, and the difference has statistical significance (P is less than 0.01), which indicates that the model is successfully made.
Compared with the model group, the positive nifedipine group and the composition C group of the invention have the mean remarkably reduced diastolic water pressure after 1-6 weeks of administration (P is less than 0.01). The diastolic blood pressure of rats in the group B of the composition of the invention is remarkably reduced at 1-4 weeks after administration, and has statistical significance relative to the difference of the model group ((P <0.05), the effect of reducing the diastolic blood pressure is not remarkable after 5-6 weeks after administration, the diastolic blood pressure of rats in the group A of the composition is not remarkably reduced (P >0.05) relative to the model group, the results are shown in a table 4, the composition B and the composition C have the effect of remarkably reducing the diastolic blood pressure of the rats with renal hypertension, and the composition A has no remarkable antihypertensive effect.
1-4 weeks after administration, there was no significant difference in diastolic blood pressure levels between composition C and composition B (P > 0.05); the diastolic blood pressure levels in rats in composition C were significantly lower than those in composition B (P <0.01) 5-6 weeks after administration. The diastolic blood pressure level of rats in the composition C group was significantly lower than that in the composition A group (P <0.01) at 1-6 weeks of administration, and the diastolic blood pressure level of rats in the composition B group was lower than that in the composition A group, wherein the difference was significant (P <0.05 or P <0.01) at 1-4 weeks after administration. It is suggested that composition B has better effect on reducing diastolic pressure of renal hypertensive rats than composition A, and composition C has better effect on reducing diastolic pressure of renal hypertensive rats than compositions A and B.
From the duration of the hypotensive effect, the composition group C showed a significant diastolic blood pressure lowering effect (P <0.01) compared to the model group at 1-6 weeks after administration, whereas the composition group B showed a significant DBP lowering effect (P <0.05) compared to the model group at only 1-4 weeks after administration, and the composition group B showed a reduced diastolic blood pressure lowering effect at 5-6 weeks with no significant difference compared to the model group. It is suggested that composition C has a superior long-lasting hypotensive effect than composition B.
Table 4 effect of continuous administration of the present invention on the tail artery diastolic pressure of renal hypertensive rats for 6 weeks n-10, mmHg)
Note: p <0.05, P <0.01 compared to sham group; comparing with model group, # P <0.05, # P < 0.01; comparing with composition C, wherein P is less than 0.05, P is less than 0.01; comparison with composition a: it is <0.05, it is < 0.01.
3. Conclusion
Pharmacological test results show that the compositions B and C have the effect of obviously reducing systolic pressure and diastolic pressure of spontaneous hypertension rats and renal hypertension rats, but the blood pressure reducing effect of the composition A is not obvious, which shows that the blood pressure reducing effect of the gastrodia elata and the uncaria is obviously enhanced by the compatibility of the rauwolfia, the ligusticum wallichii and the rhizoma pinellinae praeparata. The effect of the composition C is obviously superior to that of the compositions A and B, and the composition C is further compatible with the wild chrysanthemum flower, the tuckahoe and the dried orange peel, so that the overall efficacy is further improved.
EXAMPLE 9 Observation of the clinical efficacy of the compositions of the present invention in treating hypertensive patients
The purpose of this experiment was to observe the therapeutic effect of the compound Chinese medicine of the present invention on patients with hypertension.
Composition A: 3 parts of gastrodia elata and 2 parts of uncaria.
Composition B: 3 parts of gastrodia elata, 2 parts of uncaria, 5 parts of rauwolfia, 3 parts of ligusticum wallichii and 2 parts of rhizoma pinellinae praeparata.
Composition C: 3 parts of gastrodia elata, 2 parts of uncaria, 5 parts of rauwolfia, 3 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum flower, 2 parts of poria cocos,
And 2 parts of dried orange peel.
The preparation method of the composition is the same, and specifically comprises the following steps: decocting in water for 2 times, soaking in 8 times of water for 30 min for 2 hr, decocting in 6 times of water for 1.5 hr, filtering, mixing filtrates, concentrating, drying, pulverizing, adding appropriate amount of adjuvant, mixing, granulating, further tabletting, and drying to obtain tablet. The tablet contains 2 g of crude drug per tablet.
1 data and method
1.1 clinical data
1.1.1 Western medicine diagnosis standard refers to hypertension diagnosis standard of '2010 Chinese hypertension prevention and treatment guideline' formulated by the revised Committee of Chinese hypertension guideline: under the condition of not taking antihypertensive drugs, the Systolic Blood Pressure (SBP) is more than or equal to 140mmHg and/or the Diastolic Blood Pressure (DBP) is more than or equal to 90 mmHg; or patients with definite history of hypertension who are taking medicine and have normal blood pressure.
1.1.2 the diagnosis standard of syndrome of traditional Chinese medicine is made according to the guiding principle of clinical research of new Chinese medicine, namely the syndrome differentiation standard. Hyperactivity of liver fire with internal accumulation of phlegm-heat: (1) the main symptoms are: firstly, dizziness; ② headache; thirdly, the patient is anxious and irritative; fourthly, the head is as heavy as the wrapper; chest oppression. (2) The secondary symptoms are as follows: firstly, palpitation; ② insomnia; ③ Red face and red eyes; fourthly, the mouth is dry and the mouth is bitter; excessive phlegm; sixthly, the limbs are tired; seventhly, constipation is dark yellow. Tongue pulse condition: red tongue with yellow and greasy coating and wiry and rapid or soft and rapid pulse. When syndrome diagnosis is performed, vertigo and headache are one of the main symptoms, other main symptoms and secondary symptoms have 2 items or more, and tongue pulse condition is supported, so that diagnosis can be performed.
1.1.3 case inclusion criteria (1) meets 1 and 2 grades of essential hypertension, and the risk stratification belongs to low-risk, medium-risk and high-risk patients; (2) the traditional Chinese medicine syndrome diagnosis conforms to the syndrome of liver-fire hyperactivity and phlegm-heat internal accumulation; (3) between 18 and 70 years of age, signed an informed consent: (4) patients with coronary heart disease stable angina pectoris, diabetes, and cerebrovascular diseases are complicated, and the condition of the disease is stable; (5) and the blood pressure is not controlled well after the blood pressure reducing medicine is not taken or the blood pressure is not controlled well after the blood pressure reducing medicine is taken.
1.1.4 case exclusion criteria (1) age below 18 years or above 70 years; (2) various secondary hypertension and hypertension of grade 3 or dangerous layering belong to high risks; (3) is not consistent with the differentiation of the traditional Chinese medicine, and is a patient with liver fire hyperactivity and phlegm-heat accumulation; (4) white overcoat hypertension: the blood pressure is normal when the dynamic blood pressure is measured, and the blood pressure is high when the dynamic blood pressure is measured; (5) serious target organ damage, or serious primary diseases such as heart, brain, liver, kidney and hematopoietic system; (6) pregnant or lactating women; (7) patients with mental disease.
1.2 methods
1.2.1 treatment methods a randomized, control design was used. All observation cases were divided into composition A group, composition B group, composition C group and positive control group D group by a random number table method. Composition A, B, C composition A, B, C tablets were administered separately, and the administration was 4 tablets each time, 3 times daily. The positive control group D was given telmisartan tablets orally 1 tablet at a time, 1 time per day. Each group was treated for 1 treatment period of 4 weeks.
1.2.2 Observation indicators and methods Each indicator was recorded at weeks 0, 1, 2, 3, 4 of the experimental group. (1) Hypertension symptoms of hyperactivity of liver fire and phlegm-heat accumulation were scored: chief complaints (vertigo, headache, irritability, heaviness of the head as well as fullness in the chest): none (score 0), mild (score 2), moderate (score 4), and severe (score 6); secondary symptoms (palpitation, insomnia, flushed face, conjunctival congestion, dry mouth, bitter taste, profuse sputum, heavy limbs, constipation and dark urine): none (score 0), mild (score 1), moderate (score 2), and severe (score 3); (2) changes in blood pressure before and after treatment.
1.2.3 antihypertensive effect judgment standard (1) is effective: firstly, DBP is reduced by 10mmHg or more and reaches a normal range; ② DBP has not dropped to the normal range, but has dropped 20mmHg or more. (2) The method has the following advantages: firstly, DBP is reduced by less than 10mmHg and reaches a normal range; the DBP is reduced by 10-19 mmHg compared with that before treatment but does not reach the normal range; ③ the SBP is reduced by 30mmHg or more than before the treatment. (3) And (4) invalidation: the above standard is not met.
1.2.4 the traditional Chinese medicine syndrome curative effect standard (1) has obvious effect: the clinical symptoms are obviously improved, and the total integral of the symptoms is reduced by more than or equal to 70 percent compared with that before treatment. (2) The method has the following advantages: the clinical symptoms are relieved, and the total integral of the symptoms is reduced by more than or equal to 30 percent compared with that before treatment. (3) And (4) invalidation: the clinical symptoms are not obviously improved or aggravated, and the total integral of the symptoms is reduced by less than 30 percent compared with that before treatment.
1.2.5 statistical method data adopts SPSS17.0 statistical analysis software, level data adopts Ridit analysis, Fisher accurate probability method; the match t test is used for comparison before and after treatment in the measurement data group, and the F test is used for comparison between groups; p <0.05 is statistically significant for the differences.
2 results
2.1 general case comparison
The four groups of patients had no difference in sex, age, blood pressure level before treatment and score of Chinese medicine (P > 0.05).
2.2 comparison of three groups of antihypertensive effects
2.2.1 Effect on blood pressure composition A, B, C group compared with positive control D group before treatment SBP, DBP, the difference was not statistically significant (P >0.05), and was comparable.
As shown in table 5, group D showed significant SBP, DBP lowering effects at the time points measured 1-4 weeks after dosing. After 1 week of treatment, composition A, B, C showed no significant decrease in SBP, DBP (P >0.05) compared to the group before treatment. At 2 weeks of treatment, composition C group showed significant decrease in SBP, DBP (P <0.05) relative to pre-dose, and at 3-4 weeks of administration, SBP, DBP levels were further decreased, with overall effect levels similar to positive drugs. Composition group B showed significant hypotensive effect 3 weeks after administration (P <0.05) and SBP, DBP levels were comparable 3-4 weeks after administration. Composition group a reduced SBP, DBP in the patients less strongly, only SBP levels were significantly reduced after 4 weeks of administration compared to pre-administration (P < 0.05).
Compared with composition A, B, C, the SBP and DBP levels of composition C group are lower than those of composition A, B group within 1-4 weeks of administration, and are significantly different from those of composition B group within 3-4 weeks of administration (P <0.05), and are significantly different from those of composition A group within 2-4 weeks of administration (P <0.05 or P < 0.01). The patients in the group of composition B had slightly lower SBP, DBP levels than composition A after 1-4 weeks of administration, but no significant difference was observed. The strength of the SBP and DBP reducing effect of the composition C is obviously better than that of the composition A, B.
The composition C group has obvious effects of reducing SBP and DBP compared with the prior administration at 2 weeks, while the composition B group has obvious effects of reducing SBP and DBP compared with the prior administration at 3 weeks, and the composition A has obvious effects of reducing SBP only at 4 weeks, which indicates that the antihypertensive effect of the composition C takes effect more quickly.
TABLE 5 variation of SBP/DBP (n-30, mmHg)
Note: compared with the group before treatment, the Delta P is less than 0.05, and the tangle-solidup-P is less than 0.01; and comparing with group C at the same time, star P <0.05, star P <0.01, comparing with group D at the same time, star P <0.05, star P < 0.01.
2.2.2 comparison of antihypertensive effects for 4 weeks, the total effective rates of the antihypertensive effects of A, B, C group and D group of positive control were 43.33%, 60.00%, 83.33%, and 93.33%, respectively. It can be seen that the blood pressure lowering effect of composition B is better than that of composition A, and the blood pressure lowering effect of composition C is significantly better than that of compositions A and B (P <0.01 or P < 0.05). The results are shown in Table 6.
TABLE 6 antihypertensive effect comparison (example (%))
Note: compared with C, D group, Δ P <0.05, a P < 0.01.
2.3 comparison of the therapeutic effects of the syndromes of traditional Chinese medicine
As shown in table 7, the total effective rate of composition B in improving the traditional Chinese medicine syndrome score of patients was significantly better than that of composition a after 4 weeks of treatment (P < 0.05). The total effective rate of the traditional Chinese medicine syndrome curative effect of the composition C group is obviously superior to that of the composition A and B groups (P <0.05 or P <0.01), and the curative effect of the composition C group is superior to that of the positive control D group (P < 0.01).
TABLE 7 comparison of the treatment effects of the syndrome integrals of TCM (examples (%))
Note: compared with group A, delta P is less than 0.05, and a-P is less than 0.01; compared with group C, it is P <0.05 and P <0.01
2.4 adverse reactions
After 4 weeks of treatment, 1 of the group A showed dizziness, 1 of the group B showed nausea during the treatment, 1 of the group C showed mild diarrhea, and 1 of the group D showed nausea and vomiting. Four groups of patients have light adverse reaction and can tolerate the disease without influence on treatment.
3 conclusion
The composition C can effectively improve various traditional Chinese medicine symptoms of patients with hypertension with liver fire hyperactivity and phlegm-heat internal accumulation, effectively reduces the blood pressure of the patients, has better curative effect than the compositions B and A, and has no obvious adverse drug reactions in an observation period.
In conclusion, pharmacodynamic research results show that the medicine has the effect of obviously reducing systolic pressure and diastolic pressure of spontaneous hypertensive rats and renal hypertensive rats. The invention is prompted to have obvious and lasting antihypertensive effect. Clinical curative effect research results show that the traditional Chinese medicine composition has the effects of calming the liver, stopping endogenous wind, clearing heat and eliminating phlegm, can effectively improve various traditional Chinese medicine symptoms of patients with hypertension with liver-fire hyperactivity and phlegm-heat internal accumulation, effectively reduces the blood pressure of the patients, and has no obvious adverse drug reactions.
Claims (11)
1. A compound traditional Chinese medicine for treating hypertension liver fire hyperactivity and phlegm-heat internal accumulation syndrome is characterized in that: is prepared from the following Chinese medicinal raw materials in part by weight: 2-4 parts of gastrodia elata, 1-3 parts of uncaria, 4-6 parts of rauwolfia, 2-4 parts of ligusticum wallichii, 1-3 parts of rhizoma pinellinae praeparata, 2-5 parts of wild chrysanthemum, 1-3 parts of poria cocos and 0.8-3 parts of dried orange peel.
2. The compound traditional Chinese medicine for treating hypertension liver-fire hyperactivity and phlegm-heat internal accumulation according to claim 1, is characterized in that: the traditional Chinese medicine comprises the following raw materials in parts by weight: 3 parts of gastrodia elata, 2 parts of uncaria, 5 parts of rauwolfia, 3 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum, 2 parts of poria cocos and 2 parts of pericarpium citri reticulatae.
3. The compound traditional Chinese medicine for treating hypertension liver-fire hyperactivity and phlegm-heat internal accumulation according to any one of claims 1-2, which is characterized in that: making into clinically acceptable dosage forms.
4. The compound traditional Chinese medicine for treating hypertension liver-fire hyperactivity and phlegm-heat internal accumulation according to claim 3, is characterized in that: making into tablet, capsule, granule, pill, or oral liquid.
5. The compound traditional Chinese medicine for treating hypertension liver-fire hyperactivity and phlegm-heat internal accumulation according to claim 4, is characterized in that: making into soft capsule, dispersible tablet, orally disintegrating tablet, and dripping pill.
6. The preparation method of the compound traditional Chinese medicine for treating hypertension liver-fire hyperactivity with phlegm-heat internal accumulation according to any one of claims 1-2, characterized in that the preparation method comprises the following steps: adding 0-70% ethanol water solution into the Chinese medicinal materials, extracting for 2-3 times, and adding 4-12 times of ethanol solvent each time; extracting for 1-2 hr each time, mixing extractive solutions, filtering, collecting filtrate, recovering solvent, and concentrating.
7. The method of claim 6, wherein: extracting with water for 2 times, and adding 4-10 times of solvent each time; extracting for 1-2 hr each time, filtering the extractive solution, recovering solvent, and concentrating.
8. The method of claim 6, wherein: adding 30-70% ethanol water solution, extracting for 2 times, adding 6-10 times of solvent for the first time, extracting for 2 hr, adding 4-8 times of solvent for the second time, and extracting for 1 hr; filtering the extractive solution, recovering solvent, and concentrating.
9. The method of claim 8, wherein: extracting with 70% ethanol water solution.
10. The use of the compound traditional Chinese medicine of any one of claims 1-2 and 4-5 or the compound traditional Chinese medicine prepared by the preparation method of any one of claims 6-9 in the preparation of a medicament for treating hypertension liver-fire hyperactivity with phlegm-heat retention.
11. The use of the compound traditional Chinese medicine of claim 3 in the preparation of a medicament for treating hypertension liver-fire hyperactivity and phlegm-heat internal accumulation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711081193.8A CN107648479B (en) | 2017-11-06 | 2017-11-06 | Traditional Chinese medicine formula for treating hypertension and product thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711081193.8A CN107648479B (en) | 2017-11-06 | 2017-11-06 | Traditional Chinese medicine formula for treating hypertension and product thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN107648479A CN107648479A (en) | 2018-02-02 |
| CN107648479B true CN107648479B (en) | 2021-01-19 |
Family
ID=61120673
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711081193.8A Active CN107648479B (en) | 2017-11-06 | 2017-11-06 | Traditional Chinese medicine formula for treating hypertension and product thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN107648479B (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110327427A (en) * | 2019-07-22 | 2019-10-15 | 中南大学湘雅医院 | It is a kind of to treat morning, the Chinese medicine composition of mid-term high blood pressure and preparation method |
| CN113509465A (en) * | 2021-07-09 | 2021-10-19 | 江苏省中医院 | Composition with antihypertensive effect and application thereof |
| CN115054661A (en) * | 2022-07-26 | 2022-09-16 | 刘俊杰 | Traditional Chinese medicine composition for reducing blood pressure and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105213822A (en) * | 2015-11-16 | 2016-01-06 | 上海市闸北区中医医院 | A kind of Chinese medicine composition and application thereof for the treatment of phlegm-damp heap soil or fertilizer over and around the roots Sheng type essential hypertension |
-
2017
- 2017-11-06 CN CN201711081193.8A patent/CN107648479B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105213822A (en) * | 2015-11-16 | 2016-01-06 | 上海市闸北区中医医院 | A kind of Chinese medicine composition and application thereof for the treatment of phlegm-damp heap soil or fertilizer over and around the roots Sheng type essential hypertension |
Also Published As
| Publication number | Publication date |
|---|---|
| CN107648479A (en) | 2018-02-02 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN100366280C (en) | Medicinal composition for treating hypertension, its preparation method and use | |
| WO2012027882A1 (en) | Pharmaceutical composition for treating insomnia and preparation method thereof | |
| CN107648479B (en) | Traditional Chinese medicine formula for treating hypertension and product thereof | |
| CN105287812B (en) | A kind of medical composition and its use for treating irritable bowel syndrome | |
| CN100473394C (en) | Compound preparation of baikal skullcap root | |
| CN1558768A (en) | A pharmaceutical composition made from Chinese traditional medicine and preparation method thereof | |
| CN102258742A (en) | Chinese medicinal medicine composition for treating depression and preparation method thereof | |
| CN102641357B (en) | Medicament for treating hypertension and preparation method thereof | |
| CN103223149B (en) | Chinese herb medicine composition for treating lung cancer | |
| CN112716998B (en) | Traditional Chinese medicine preparation for treating pulmonary hypertension | |
| CN108465061A (en) | It is a kind of to be used to treat pharmaceutical composition of Facial Recurrent Dermatitis and its preparation method and application | |
| CN105213822B (en) | A kind of Chinese medicine composition and its application treated phlegm wet and stop up Sheng type essential hypertension | |
| CN104083478A (en) | Compound traditional Chinese medicine for treating hypertension | |
| CN105833043A (en) | Application of traditional Chinese medicine composition in preparation of medicine for treating primary hypertension | |
| CN107137553B (en) | Lemai capsule and preparation method thereof | |
| CN101947299B (en) | Medicinal composition for treating coronary heart disease | |
| CN108143875B (en) | Traditional Chinese medicine composition for treating diabetic gastroparesis and preparation method thereof | |
| CN110680900B (en) | Medicine for treating recurrent oral ulcer and preparation method thereof | |
| CN102552481A (en) | Traditional Chinese medicinal composition with effects of smoothing collaterals and lowering blood pressure and preparation method thereof | |
| CN108186821A (en) | A kind of Chinese medicine composition for treating nervous headache and its preparation method and application | |
| CN113476526B (en) | A Chinese medicinal composition for treating atrial fibrillation, and its preparation method | |
| CN107753551B (en) | Composition with function of reducing blood pressure and preparation method thereof | |
| CN102784192B (en) | Medicinal composition for preventing and treating coronary disease and preparation method thereof | |
| CN110898170B (en) | Traditional Chinese medicine composition for treating metabolic syndrome and preparation thereof | |
| CN101244127B (en) | Medicament for treating vascular dementia |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |