CN107213293B - Traditional Chinese medicine composition for treating chronic cerebral circulation insufficiency and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating chronic cerebral circulation insufficiency and preparation method thereof Download PDF

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CN107213293B
CN107213293B CN201710457930.3A CN201710457930A CN107213293B CN 107213293 B CN107213293 B CN 107213293B CN 201710457930 A CN201710457930 A CN 201710457930A CN 107213293 B CN107213293 B CN 107213293B
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traditional chinese
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chinese medicine
cerebral circulation
blood
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臧运华
高向慧
郑志轩
王群
周喜燕
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Qingdao Hospital of Traditional Chinese Medicine
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Traditional Chinese Medical Co
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Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic cerebral circulation insufficiency, belonging to the field of traditional Chinese medicines. The traditional Chinese medicine composition for treating chronic cerebral circulation insufficiency is prepared from the following components in parts by mass: 9-30 g of radix rehmanniae recen, 9-15 g of herba epimedii, 9-15 g of cistanche, 9-15 g of peach kernel, 9-15 g of angelica sinensis, 6-30 g of rhizoma acori graminei and 6-30 g of ligusticum wallichii; preferably, the composition is prepared from the following components in mass: 30g of radix rehmanniae recen, 15g of epimedium herb, 15g of cistanche deserticola, 12g of peach kernel, 12g of angelica, 15g of rhizoma acori graminei and 9g of ligusticum wallichii. The traditional Chinese medicine composition can increase the generation of serum ghrelin of patients with chronic cerebral circulation insufficiency; can improve cognitive function of CCCI patients; shortening the stool interval time of CCCI patients; the effect is better than that of blood-nourishing and brain-refreshing granules; and the application is safe.

Description

Traditional Chinese medicine composition for treating chronic cerebral circulation insufficiency and preparation method thereof
Technical Field
The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating chronic cerebral circulation insufficiency and a preparation method thereof.
Background
Chronic Cerebral Circulation Insufficiency (CCCI) is a state of reduced blood supply (less than 40-60mL/100g brain tissue/min) at the level of the whole brain, rather than focal cerebral ischemia. The disease is mainly classified into vertigo, headache, insomnia and the like in the traditional Chinese medicine. According to statistics, 80% of people over 80 years old have different degrees of chronic cerebral circulation insufficiency; of the population over the age of 60, about 2/3 have chronic cerebral insufficiency. If the disease is not treated in time, the disturbance of cerebral circulation can be gradually aggravated, and acute cerebrovascular disease and dementia are easy to form. Great attention should be paid to the patients, because the research finds that chronic cerebral circulation insufficiency is an important link in the occurrence and development processes of various diseases such as ischemic stroke, Alzheimer disease, vascular dementia, Binswanger disease and the like.
The traditional Chinese medicine has no name of chronic cerebral circulation insufficiency, but is recorded and discussed in the categories of dizziness, insomnia, blood impediment and the like, is not researched as a disease, and lacks the traditional Chinese medicine diagnosis and treatment standard of the disease. If the disease is not treated in time, the cerebral circulation disorder can be gradually aggravated, and even serious acute ischemic cerebrovascular diseases such as transient ischemic attack, cerebral infarction and the like can be generated. Thus, CCCI is often considered to be one of the bases for the pathogenesis of acute ischemic stroke.
Typing of chronic cerebral circulation insufficiency: type I: simple chronic cerebral circulation insufficiency; type II: chronic cerebral insufficiency + change in brain parenchyma (MRI or CT found lacunar infarction); type III: parenchymal changes in the brain (cerebral and lacunar infarctions) + chronic cerebral insufficiency.
At present, the western medicine treatment of CCCI mainly removes risk factors such as hypertension, diabetes, lipid metabolism disorder, obesity and the like, and is applied with anti-platelet aggregation medicines, and more optional methods and medicines are lacked. Modern medicine generally holds that chronic cerebral circulation insufficiency is closely related to four organs of liver, heart, spleen and kidney; however, the relationship between chronic cerebral circulation insufficiency and large intestine has not been studied. Therefore, the traditional Chinese medicine researches are mostly conducted by the theory of tonifying the kidney and invigorating the blood circulation, and the researches conducted by the method of tonifying the kidney, invigorating the blood circulation and clearing the hollow viscera are not published yet.
The effective rate is 90% by treating and observing 90 cases of chronic cerebral circulation insufficiency patients by the Jianjun and the like, and the blood-nourishing and brain-refreshing granules prove that the blood-nourishing and brain-refreshing granules can improve the hemodynamic index of the patients, increase the cerebral circulation, improve symptoms such as dizziness and headache and the like. Royal eine and the like randomly divide 120 cases of CCCI patients into a combination group (combining nimodipine with blood-nourishing and brain-refreshing granules) and a nimodipine group, and observe Fibrinogen (Fibrinogen, FG) and basal arterial blood flow velocity before and after treatment respectively, so that the FG in the combination group is obviously reduced, the basal arterial blood flow velocity is obviously increased, and the combination group has obvious statistical significance compared with the nimodipine group, and shows that the combination of the blood-nourishing and brain-refreshing granules and the nimodipine can obviously improve the symptoms of the CCCI patients.
Disclosure of Invention
In order to solve the problems in the prior art, the technical scheme of the invention is as follows:
a traditional Chinese medicine composition for treating chronic cerebral circulation insufficiency is prepared from the following components in parts by mass: 9-30 g of radix rehmanniae recen, 9-15 g of herba epimedii, 9-15 g of cistanche, 9-15 g of peach kernel, 9-15 g of angelica sinensis, 6-30 g of rhizoma acori graminei and 6-30 g of ligusticum wallichii.
On the basis of the scheme, the traditional Chinese medicine composition for treating chronic cerebral circulation insufficiency is prepared from the following components in parts by mass: 30g of radix rehmanniae recen, 15g of epimedium herb, 15g of cistanche deserticola, 12g of peach kernel, 12g of angelica, 15g of rhizoma acori graminei and 9g of ligusticum wallichii.
On the basis of the scheme, the traditional Chinese medicine composition for treating chronic cerebral circulation inefficiency is used for preparing a medicine for treating chronic cerebral circulation inefficiency.
A medicament for treating chronic cerebral circulation inefficiency is in the form of decoction, paste or granules.
A method for preparing a decoction for treating chronic cerebral circulation insufficiency comprises the following steps:
decocting radix rehmanniae 30g, herba Epimedii 15g, Cistanchis herba 15g, semen Persicae 12g, radix Angelicae sinensis 12g, rhizoma Acori Graminei 15g, and rhizoma Ligustici Chuanxiong 9g with water twice, adding water 10000mL for the first time and 8000mL for the second time, each for 2 hr, mixing decoctions to obtain 5000mL, and filtering to obtain decoction.
A preparation method of an ointment for treating chronic cerebral circulation insufficiency comprises the following steps:
1) decocting radix rehmanniae 30g, herba Epimedii 15g, Cistanchis herba 15g, semen Persicae 12g, radix Angelicae sinensis 12g, rhizoma Acori Graminei 15g, and rhizoma Ligustici Chuanxiong 9g with water twice, adding water 10000mL for the first time and 8000mL for the second time, each for 2 hr, mixing decoctions to 5000mL, and filtering;
2) concentrating 4500mL of the filtrate until the relative density is 1.05-1.10 to obtain 1400mL of concentrated solution;
3) adding 95% ethanol into the concentrated solution to enable the ethanol content to reach 65%, refrigerating overnight, filtering, taking supernate, recovering ethanol, and concentrating the supernate to obtain clear paste with the relative density of 1.30-1.35 at 50 ℃; and (5) obtaining the product.
A preparation method of granules for treating chronic cerebral circulation insufficiency comprises the following steps:
1) soaking radix rehmanniae 30g, herba Epimedii 15g, Cistanchis herba 15g, semen Persicae 12g, and radix Angelicae sinensis 12g in 8000mL water for 4 hr, extracting volatile oil by steam distillation for 6 hr, and collecting volatile oil 4 mL; 1800ml of distilled aqueous solution is collected in another container;
2) taking 40g of beta-cyclodextrin, adding 200g of water to prepare supersaturated solution of the beta-cyclodextrin,
3) dripping volatile oil into supersaturated solution of beta-cyclodextrin, stirring for 1 hr, standing at low temperature, filtering, and oven drying at low temperature to obtain beta-cyclodextrin clathrate of volatile oil 40 g;
4) decocting the residue of the distillation of radix rehmanniae, herba Epimedii, Cistanchis herba, semen Persicae, and radix Angelicae sinensis, 15g rhizoma Acori Graminei and 9g rhizoma Ligustici Chuanxiong in water twice, adding 10000mL water for the first time and 8000mL water for the second time, each time for 2 hr, mixing decoctions to 5000mL, and filtering;
5) mixing 4500mL of the filtrate with the distilled water solution, and concentrating until the relative density is 1.05-1.10 to obtain 1400mL of concentrated solution;
6) adding 95% ethanol into the concentrated solution to enable the ethanol content to reach 65%, refrigerating overnight, filtering, taking supernate, recovering ethanol, and concentrating the supernate to obtain clear paste with the relative density of 1.30-1.35 at 50 ℃;
7) adding equivalent amount of beta-cyclodextrin into the fluid extract, mixing, drying, adding stevioside and beta-cyclodextrin clathrate of volatile oil, mixing, granulating, and drying.
The invention relates to a traditional Chinese medicine composition for treating chronic cerebral circulation insufficiency, which comprises the following components:
dried rehmannia root: clear heat, promote the production of body fluid, nourish yin, nourish blood.
[ PROPERTIES AND FLAVOUR ] sweet and cold.
[ GUIJING ] GUIJING is responsible for the heart, liver and kidney meridians.
[ FUNCTIONS ] can clear heat and cool blood, nourish yin, promote the production of body fluid, and tonify kidney. It can be used for treating bone-steaming, internal heat, diabetes, speckle, and erythra. It is indicated for fever due to yin deficiency, diabetes, hematemesis, epistaxis, metrorrhagia, irregular menstruation, threatened abortion, constipation due to yin deficiency.
(I) Ben Jing: "sweet taste; is cold. "
② Biyu (miscellaneous records) bitter and nontoxic. "
③ Ben Cao Tang Ye (herbal decoction): "enter the Taiyang channel and Shaoyin channel. "
Fourthly, the explanation of the properties of processed Lei Gong medicine: enter heart, liver, spleen and lung meridians. "
Herba epimedii: invigorating kidney, supporting yang, dispelling pathogenic wind, and removing dampness;
[ PROPERTIES AND FLAVOUR ] pungent, sweet and warm.
[ GUIJING ] enters liver and kidney meridians.
[ FUNCTIONS ] can tonify kidney yang, strengthen tendons and bones, and dispel wind-damp. Can be used for treating sexual impotence, spermatorrhea, tendons and bones flaccidity, rheumatalgia, numbness and contracture; climacteric hypertension.
(I) Ben Jing: "governing impotence and exhaustion of yin and pain in the stem". Induce diuresis, supplement qi and strengthen mind. "
② Biyu (miscellaneous records): to strengthen the muscles and bones. Eliminating scrofula, red carbuncle; sores on the lower part, washing and getting insects. "
③ Rihuazi Ben Cao: "treat all cold wind too much qi, tonify waist and knees, strengthen heart force, husband's yang deficits failing to rise, women's yin deficits failing to rise, muscles and bones are contracture and urgent, limbs are not any, the aged patient is patient's leg cancer, amnesia of middle aged. "
Fourthly, medical entry: to tonify kidney deficiency and strengthen yang. It is indicated for hemiplegia and skin disorders of limbs due to wind bias. "
Cistanche deserticola: tonifying kidney and yang, moistening intestine and relaxing bowels;
[ PROPERTIES AND FLAVOUR ] sweet, salty and warm.
[ GUIJING ] enters kidney and large intestine meridians.
[ FUNCTIONS ] can tonify kidney yang, replenish essence and blood, moisten intestines and relieve constipation. Can be used for treating sexual impotence, infertility, soreness of waist and knees, weakness of tendons and bones, constipation due to intestinal dryness.
(I) Ben Jing: the Chinese medicine composition can be used for treating overstrain, seven-limb injuries, strengthening the middle-jiao, removing cold and heat pain in stems, nourishing five internal organs, strengthening yin, benefiting vital essence and qi and treating gynecological abdominal mass. "
② Biyu (miscellaneous records): to relieve bladder pathogenic qi, lumbago and dysentery. "
③ treatise on herb Property: "Yisui, Yue Cao, Yan Nian, for metrorrhagia in women, Yang-strengthening, tonifying and treating leukorrhagia. "
Fourthly, Rihuazi materia Medica: it is used to treat male impotence, female infertility, five internal organs moistening, muscle growing, waist and knee warming, male spermatorrhea, hematuria, enuresis, leukorrhagia, and vaginal pain. "
Fifth, Ben Cao Jing Shu (fundamental and sparse of materia Medica): the old people can be treated by boiling the white spirit and eating the white spirit for dryness and stagnation of the excrement and urine. "
Peach kernel: promoting blood circulation, removing blood stasis, loosening bowel to relieve constipation, relieving cough and asthma;
[ PROPERTIES AND FLAVOUR ] bitter, sweet and neutral.
[ GUIJING ] GUIJING is responsible for the heart, liver and large intestine meridians.
(I) Ben Jing: "governing blood stasis, blood block, pathogenic qi and killing parasites". "
② Biyu (miscellaneous records): relieving cough, reversing the flow of qi, eliminating heart-fire, removing blood stroke, breaking the symptoms, dredging collaterals and relieving pain. "
③ Meng: "kill three worms and stop heart pain". "
Fourthly, medical inspiration: "treat hematochezia. "
Li Gao: it is indicated for blood stagnation in abdomen, skin dryness and itching due to heat entering blood chamber, and skin coagulation. "
Sixthly, Yunnan Ben Cao: "treat blood phlegm". "
Seventh, the compendium: it is used to treat wind arthralgia due to blood stagnation, bone steaming, liver malaria, cold and heat, and puerperal blood disease. "
Chinese angelica: enriching blood, regulating menstruation, promoting blood circulation, relieving pain, and loosening bowel to relieve constipation;
[ PROPERTIES AND FLAVOUR ] sweet, pungent and warm.
[ GUIJING ] enters liver, heart and spleen meridians.
(I) Ben Jing: it is mainly used for cough, dyspnea and upper qi, warm malaria, cold, warm and hot washing in skin, women leakage, peerless, various malignant sores and ulcers, and boil drinking. "
② Biyu (miscellaneous records): warming the middle energizer to relieve pain, removing obstruction in the blood, relieving spasm of the middle energizer, failing to perspire, damp arthralgia, aversion to qi, deficiency cold, nourishing five reservoirs, and growing muscle. "
③ treatise on herb Property: to relieve vomiting, cold and heat due to consumptive disease, and old blood, manifested as metrorrhagia, diarrhea, abdominal pain. The decoction is decocted alone to treat warm malaria, lumbago due to blood drop of the woman, and toothache. It is used for treating deficiency cold of patients. "
Fourthly, Rihuazi materia Medica: for wind-cutting, blood-nourishing, fatigue-breaking, blood-stasis-breaking, blood-nourishing and mass-eliminating. "
Grassleaf sweelflag rhizome: from 1, the atlas of this materia Medica. Inducing resuscitation and refreshing mind, eliminating dampness and regulating stomach, calming mind and nourishing mind;
[ PROPERTIES AND WESTERN ] is pungent, bitter and warm.
[ GUIJING ] returning to the heart and stomach meridians.
(I) Ben Jing: it can be used for treating arthralgia due to wind-cold-dampness, cough, adverse rising of qi, opening heart-qi, tonifying five internal organs, dredging nine orifices, improving eyesight and hearing, and producing voice. "
② Biyu (miscellaneous records): "mainly deafness, carbuncle and sore, warming intestines and stomach, stopping small and convenient, damp arthralgia of limbs, no flexing and stretching, warm malaria in children, no decomposition of heat in body, can be used as bath soup. Improve hearing and eyes, and benefit heart and intelligence. "
③ treatise on herb Property: for stubborn arthralgia due to wind-damp, tinnitus, wind-head and dribbles, killing parasites, and treating sore, scabies and pruritus. "
Ligusticum wallichii: it is from Ben Cao (herbal decoction). Promote blood circulation and move qi, dispel wind and alleviate pain. [ PROPERTIES AND FLAVOUR ] pungent and warm. [ GUIJING ] enters liver, gallbladder and pericardium.
(I) Ben Jing: "it is mainly indicated for apoplexy manifested as headache, arthralgia due to cold, spasm of muscles, spasm of tendons, pain and trauma, blood block and anuria of women. "
② Biyu (miscellaneous records): remove cold in brain, wind on face, eye tears, nasal mucus, sudden and sudden such as intoxication, cold qi, heart and abdomen stiffness and pain, aversion to heart, sudden swelling and pain, hypochondriac pain, warm middle-jiao and cold interior. Ceramic carry scene: for bleeding in tooth root, it is usually treated. Treatise on herb Property: it is indicated for weak waist and legs, hemiplegia, and cold pain in abdomen.
③ Rihuazi Ben Cao: for treating wind, qi, strain, blood, internal fatigue, strengthening bones and muscles, dredging channels, breaking symptoms, nourishing blood, promoting granulation, relieving rhinorrhea, hematemesis, hematuria, hemorrhoid, fistula, cerebral carbuncle, back pain, scrofula, wart, scabies, pus discharge and blood stasis.
The monarch, minister, assistant and guide relationship of the formula is as follows:
in the formula, the radix rehmanniae is classified into liver and kidney meridians, is used for concentrating the main organs with chronic cerebral circulation insufficiency, replenishing blood and nourishing yin, and replenishing essence and benefiting marrow, and is a monarch drug; peach kernel, Chinese angelica root and rhizome of Sichuan lovage can all activate blood, and are supplemented with the monarch drug, radix rehmanniae, to play the roles of nourishing blood and activating blood; the grassleaf sweelflag rhizome has the effects of inducing resuscitation and refreshing mind, improving hearing and eyes, benefiting heart and intelligence, and assisting the effects of dried rehmannia root in tonifying kidney and replenishing essence; the epimedium herbs tonify kidney and strengthen yang, the cistanche deserticola tonifies kidney yang, replenishes essence and blood, assists the dried rehmannia roots to tonify kidney, and achieves the effect of tonifying yin and yang; in the formula, the cistanche, the peach kernel and the angelica have the effects of relaxing bowel, clearing hollow viscera without damaging yin, and are more suitable for treating the constipation of the old, and are taken as guiding medicaments. The medicines are combined, and the effects of tonifying and invigorating the kidney, promoting blood circulation and clearing hollow viscera are achieved.
The book Su Wen, Yin Yang Ben Bing Lun says: "Kidney-growing bone marrow. Sufficient kidney essence, nourishment of marrow sea and healthy and complete brain development, quick thinking and vigorous energy; constipation, senile yang-yin deficiency, and stagnation of fu-qi, which can promote aging or diseases, are also common in chronic cerebral circulation insufficiency patients. Therefore, in treatment, when the dried rehmannia root is used for replenishing blood and nourishing yin, and replenishing essence and benefiting marrow, the peach kernel, the Chinese angelica and the szechuan lovage rhizome are used for replenishing blood and activating blood, the calamus is used for inducing resuscitation and refreshing mind, the epimedium and the desertliving cistanche are used for tonifying kidney and strengthening yang, in addition, the desertliving cistanche, the peach kernel and the Chinese angelica in the formula have the effects of relaxing bowel and relieving constipation, the functions of clearing hollow viscera but not damaging yin are realized, the medicines are combined, and the effects of tonifying kidney, activating blood and clearing hollow viscera are realized together.
The invention has the beneficial effects that: the traditional Chinese medicine composition can increase the generation of serum ghrelin of patients with chronic cerebral circulation insufficiency; can improve cognitive function of CCCI patients; shortening the stool interval time of CCCI patients; has better effect than blood-nourishing and brain-refreshing granules. In addition, the application of the traditional Chinese medicine composition is safe, no serious adverse event occurs, and the blood system and the liver and kidney functions of a patient are not influenced.
Detailed Description
Terms used in the present invention have generally meanings as commonly understood by one of ordinary skill in the art, unless otherwise specified.
The present invention will be described in further detail with reference to the following data in conjunction with specific examples. The following examples are intended to illustrate the invention and are not intended to limit the scope of the invention in any way.
Examples
A traditional Chinese medicine composition for treating chronic cerebral circulation insufficiency is prepared from the following components in parts by mass: 30g of radix rehmanniae recen, 15g of epimedium herb, 15g of cistanche deserticola, 12g of peach kernel, 12g of angelica, 15g of rhizoma acori graminei and 9g of ligusticum wallichii.
A method for preparing a decoction for treating chronic cerebral circulation insufficiency comprises the following steps:
decocting radix rehmanniae 30g, herba Epimedii 15g, Cistanchis herba 15g, semen Persicae 12g, radix Angelicae sinensis 12g, rhizoma Acori Graminei 15g, and rhizoma Ligustici Chuanxiong 9g with water twice, adding water 10000mL for the first time and 8000mL for the second time, each for 2 hr, mixing decoctions to obtain 5000mL, and filtering to obtain decoction.
A preparation method of an ointment for treating chronic cerebral circulation insufficiency comprises the following steps:
1) decocting radix rehmanniae 30g, herba Epimedii 15g, Cistanchis herba 15g, semen Persicae 12g, radix Angelicae sinensis 12g, rhizoma Acori Graminei 15g, and rhizoma Ligustici Chuanxiong 9g with water twice, adding water 10000mL for the first time and 8000mL for the second time, each for 2 hr, mixing decoctions to 5000mL, and filtering;
2) concentrating 4500mL of the filtrate until the relative density is 1.05-1.10 to obtain 1400mL of concentrated solution;
3) adding 95% ethanol into the concentrated solution to enable the ethanol content to reach 65%, refrigerating overnight, filtering, taking supernate, recovering ethanol, and concentrating the supernate to obtain clear paste with the relative density of 1.30-1.35 at 50 ℃; and (5) obtaining the product.
A preparation method of granules for treating chronic cerebral circulation insufficiency comprises the following steps:
1) soaking radix rehmanniae 30g, herba Epimedii 15g, Cistanchis herba 15g, semen Persicae 12g, and radix Angelicae sinensis 12g in 8000mL water for 4 hr, extracting volatile oil by steam distillation for 6 hr, and collecting volatile oil 4 mL; 1800ml of distilled aqueous solution is collected in another container;
2) taking 40g of beta-cyclodextrin, and adding 200g of water to prepare supersaturated solution of the beta-cyclodextrin;
3) dripping volatile oil into supersaturated solution of beta-cyclodextrin, stirring for 1 hr, standing at low temperature, filtering, and oven drying at low temperature to obtain beta-cyclodextrin clathrate of volatile oil 40 g;
4) decocting the residue of the distillation of radix rehmanniae, herba Epimedii, Cistanchis herba, semen Persicae, and radix Angelicae sinensis, 15g rhizoma Acori Graminei and 9g rhizoma Ligustici Chuanxiong in water twice, adding 10000mL water for the first time and 8000mL water for the second time, each time for 2 hr, mixing decoctions to 5000mL, and filtering;
5) mixing 4500mL of the filtrate with the distilled water solution, and concentrating until the relative density is 1.05-1.10 to obtain 1400mL of concentrated solution;
6) adding 95% ethanol into the concentrated solution to enable the ethanol content to reach 65%, refrigerating overnight, filtering, taking supernate, recovering ethanol, and concentrating the supernate to 700g of clear paste with the relative density of 1.30-1.35 at 50 ℃;
7) adding 700g of beta-cyclodextrin into 700g of clear paste, mixing and drying, adding 15g of stevioside and 40g of beta-cyclodextrin inclusion complex of volatile oil, mixing uniformly, preparing into granules, and drying to obtain 1000g of granules.
1. Subject and method of administration
1.1 inclusion criteria
1. Meets the diagnosis standard of chronic cerebral circulation insufficiency (prepared according to the Huji source research). The course of disease is longer than 1 month.
2. The age is more than 45 years and less than 80 years.
3. The distance from the previous patient with the history of cerebral infarction and cerebral hemorrhage is more than 6 months.
4. Meets the diagnosis standard of blood stasis syndrome (made according to the clinical research guiding principle of new traditional Chinese medicine).
1.2 exclusion criteria
1. Transient ischemic attack, acute cerebral infarction, cerebral hemorrhage; meniere's disease, labyrinthitis, inner ear drug intoxication, vestibular neuronitis, aural vertigo.
2. Intracranial infectious diseases and intracranial demyelinating diseases, moderate and severe anemia, acute febrile diseases, paroxysmal tachycardia, atrioventricular block and dizziness caused by head trauma.
3. Intracranial aneurysm, arteriovenous malformation, brain tumor, brain trauma, and cerebral parasitosis.
4. There are severe diseases of the center of gravity, liver, kidney, hematopoietic system and endocrine system.
5. Patients with psychosis, severe cognitive impairment, and dementia.
Under age 6.45, and above age 80.
7. Pregnant and lactating women.
1.3 criteria for diagnosis of chronic cerebral circulation insufficiency (according to the Huji-source study):
1. the clinical manifestations include the subjective symptoms of heaviness of the head, dizziness, and abnormal numbness.
2. There are findings that support cerebral arteriosclerosis: first, hypertension, changes in the retinal arteriosclerosis, etc. are accompanied, and vascular noise of cerebral perfusion arteries is heard in some cases.
3. Focal neurological signs of the brain were not seen.
4. CT or/and MRI examination confirms the absence of neovascular organic brain lesions.
5. The above-mentioned subjective symptoms due to other diseases were excluded.
6. The age is in principle greater than 60 years.
7. Cerebral circulation examination confirmed low cerebral blood flow.
8. Cerebral perfusion artery occlusion and stenosis are determined by cerebrovascular angiography, neck TCD and the like.
All the above items are necessary for diagnosing chronic cerebral circulation insufficiency, especially 1-5 items.
1.4 diagnosis standard of blood stasis syndrome (according to clinical research guiding principle of new traditional Chinese medicine):
1. and (3) master certificate: stabbing pain, localized pain, tenderness, blood stasis in the vessels, ecchymosis, mass, blood stasis, dark purple tongue or with ecchymosis and petechia, thick and tense tongue vessels, unsmooth, deep and wiry pulse.
2. Secondary verification: the symptoms of the diseases include skin nail error, numbness or hemiplegia of limbs, dementia epilepsy, mania, amnesia, local paresthesia, trauma history, operation history and artificial abortion history.
The blood stasis syndrome can be diagnosed in 2 terms of the principal syndrome, or 1 term of the principal syndrome and 2 terms of the secondary syndrome.
TABLE 1 hierarchical quantitative score chart of blood stasis syndrome (according to the clinical research guiding principle of new Chinese medicine)
Figure BDA0001324077340000081
1.5 drug toxicity
After 4 patients take the traditional Chinese medicine composition for 2 times/day, mild epigastric discomfort appears, symptoms disappear quickly after the patients take the traditional Chinese medicine composition after meals, and the patients who lose due to the attack of cardiovascular and cerebrovascular diseases during taking the traditional Chinese medicine composition do not appear.
1.6 methods of administration
The inclusion criteria were met, the conditions involved in the exclusion criteria were not eliminated, and a total of 100 patients with chronic cerebral circulation insufficiency and renal deficiency syndrome signed with informed consent. The medicine or health care product has no gastrointestinal tract diseases in 1 month, no antibiotics and medicines or health care products with the function of regulating intestinal flora, and no medicines for improving brain circulation and tonifying kidney are taken within 2 months of research. The treatment group is divided into a control group and a treatment group randomly, wherein each group comprises 50 cases, and the number of the cases is not limited. On the basis that 100mg of enteric aspirin (manufactured by Bayer medicine health promotion Limited company, approved code: J20130078, batch number: BJ22059) is administered to two groups, the preparation of the invention is administered to the treatment group, the granule dosage form is 1 bag per time, and the oral liquid is taken after being infused with water for 2 times per day; the control group was orally administered with blood-nourishing and brain-refreshing granules (approved by Tianjin Tianshili pharmaceutical Co., Ltd., approved article No. Z10960082, lot No. 140826) 1 bag/time and 2 times/day. The treatment course is 28 days. If angina pectoris, myocardial infarction, cerebral hemorrhage, severe diarrhea, hematochezia, etc. are existed, the treatment can be stopped at any time.
1.7 Ghrelin assay:
the patient draws 2mL of venous blood, all specimens are coagulated at room temperature for 30 minutes, centrifuged for 20 minutes (1000 rpm), and plasma is frozen in a refrigerator at-70 ℃ for later use. The content of Ghrelin in plasma was determined by enzyme-linked immunosorbent assay (ELISA). The measurement was carried out using an ELISA kit for Ghrelin (YJ20160301, available from Beijing Noyajie Biotech Co., Ltd.) according to the protocol of the kit, as follows:
(1) the number of wells of the enzyme-labeled plate coated with the antibody required for detection is determined, and 1 well is added as a TMB blank chromogenic well. Total number +9 of samples.
(2) 10000pg/mL, 5000pg/mL, 2500pg/mL, 1250pg/mL, 625pg/mL, 312pg/mL, 156pg/mL of standard substance are added to a row of 7 wells in sequence, 0.1mL each, and 1 well is added with a dilution of the substance as a zero well. 100 μ L of serum sample (1:2) diluted with sample diluent was added.
(3) The microplate was covered and reacted at 37 ℃ for 90 minutes.
(4) After reaction, the liquid in the enzyme label plate is thrown off, and the plate is patted down against absorbent paper without washing.
(5) The prepared biotin antihuman Ghrelin antibody working solution is added into each well in turn according to 100 mu L, and TMB blank chromogenic wells are not added. The reaction was carried out at 37 ℃ for 60 minutes.
(6)0.01M PBS wash 3 times, each soaking for 1 minutes.
(7) The prepared ABC working solution is added into each hole in a 100-mu L sequence, and the TMB blank color developing hole is not added. The reaction was carried out at 37 ℃ for 30 minutes.
(8)0.01M PBS wash 5 times, each soaking for 2 minutes.
(9) The TMB color developing solution equilibrated at 37 ℃ for 30 minutes was added in the order of 90. mu.L per well, and the reaction was carried out at 37 ℃ for 12 minutes in the absence of light.
(10) TMB stop solution was added to 100. mu.L of each well in sequence, whereupon the blue color immediately turned yellow.
(11) OD was measured at 450nm with a microplate reader. TMB blank color wells were set as controls. After subtracting the absorbance of the TMB blank color development well from the absorbance of all the standards and samples, the concentration of each sample was calculated using "Curve insert 1.3" software, and the Ghrelin content of each sample was calculated.
1.8 evaluation of curative effect: the curative effect is divided into cure, obvious effect, effective and ineffective.
TABLE 2 evaluation of therapeutic effects
Figure BDA0001324077340000101
And (3) healing: dizziness and headache symptoms completely disappear; the remaining symptoms essentially disappeared.
The effect is shown: vertigo and headache symptoms basically disappear or occasionally recur, and the people can normally live and work without self and scenery sense of rotation and shaking; the rest symptoms are obviously relieved.
The method has the following advantages: dizziness, headache or vertigo are relieved obviously, and people can insist on working, but life and work are affected.
And (4) invalidation: the symptoms such as dizziness, headache, and the like are not improved or aggravated.
1.9 stool flora analysis, blood fat, hypersensitive C reactive protein, homocysteine, blood routine, urine routine, stool routine, liver and kidney function detection: is prepared by the Haike medical group in Qingdao city and the clinical laboratory of Chinese medical hospitals in Jiaonang city. Electrocardiographic examination is performed by an observer.
2. Results and analysis
Processing with PEMS3.2, measuring data by t-test, measuring value
Figure BDA0001324077340000102
(mean. + -. standard deviation). Counting data are subjected to statistics of a four-grid table exact probability method and Ridit analysis. The index correlation is obtained by means of multivariate linear correlation, stepwise regression, etc.
A random comparison table is generated according to PEMS3.2 statistical software, 100 patients are randomly divided into two groups, namely a treatment group and a comparison group, and each group comprises 50 patients.
2.1 sex: the gender distribution is shown in table 3.
TABLE 3 two groups of case sex distribution comparison (number of cases and%)
Figure BDA0001324077340000111
Note: warp X2Inspection, P>0.05, suggesting no significant difference in gender distribution between the two groups of cases.
2.2 age: the mean age distribution is shown in table 4.
TABLE 4 mean age distribution comparison of two groups of cases
Figure BDA0001324077340000112
Figure BDA0001324077340000113
Note: the T test shows that P is more than 0.05, which indicates that the average age distribution of two groups of cases has no significant difference.
2.3 past history scoring: the past history is shown in Table 5.
TABLE 5 comparison of history
Figure BDA0001324077340000114
Figure BDA0001324077340000115
Note: and through t test, P is less than 0.05, which indicates that the prior history score of the control group is higher than that of the treatment group.
2.4MMSE integration comparison: the MMSE integration comparison is shown in table 6:
there were 4 losses in the follow-up visit for the treatment group and 7 losses in the follow-up visit for the control group.
TABLE 6 two sets of MMSE integral comparisons
Figure BDA0001324077340000121
Figure BDA0001324077340000122
As seen from table 6: prior to dosing, the MMSE scores of the treatment and control groups were comparable; the MMSE score of the treatment group is improved after treatment, and the difference between the treatment group and the treatment group is significant (P < 0.05). The control group had no significant change in MMSE score before and after treatment. After treatment, the MMSE score of the treated group appeared to be improved compared to the control group, but there was no statistical difference (P > 0.05).
2.5 two groups of stool flora change comparison: the changes of the two groups of fecal flora are shown in tables 7-10:
because our observations require that stool be retained the next day of inclusion, some patients fail to leave stool as expected, resulting in fewer cases observed and different numbers of cases before and after treatment.
TABLE 7 comparison of two groups of gram-negative cocci
Figure BDA0001324077340000123
Figure BDA0001324077340000124
As seen from table 7: the gram-negative cocci of the treated group and the control group did not change significantly before and after treatment (P > 0.05).
TABLE 8 comparison of two groups of gram-positive cocci
Figure BDA0001324077340000131
Figure BDA0001324077340000132
As seen from table 8: the gram-positive cocci of the treatment group and the control group have no obvious change before and after the treatment (P > 0.05).
TABLE 9 comparison of two groups of gram-negative bacilli
Figure BDA0001324077340000133
Figure BDA0001324077340000134
As seen from table 9: the gram-negative bacilli of the treated group and the control group have no obvious change before and after treatment (P > 0.05).
TABLE 10 comparison of two groups of gram-positive bacilli
Figure BDA0001324077340000141
Figure BDA0001324077340000142
As seen from table 10: the gram positive bacilli of the treated group and the control group have no obvious change before and after treatment (P > 0.05).
2.6 two stool interval comparisons: two stool interval comparisons are shown in table 11:
because our observations require that stool be retained the next day of inclusion, some patients fail to leave stool as expected, resulting in fewer cases observed and different numbers of cases before and after treatment.
TABLE 11 stool space comparison of two groups
Figure BDA0001324077340000143
Figure BDA0001324077340000144
As seen from table 11: the treatment group had a reduction in the number of days between stools after treatment compared to before treatment, with differences of significance (P < 0.05). The control group had no significant change in the number of days between stools before and after treatment (P > 0.05). After treatment, the days between stools in the treatment group are less than those in the control group, and the difference is very significant (P < 0.01).
2.7 integral comparison of two groups of blood stasis syndromes: the two groups of blood stasis syndrome integral comparison is shown in table 12:
there were 4 losses in the follow-up visit for the treatment group and 7 losses in the follow-up visit for the control group.
TABLE 12 two-group integral comparison of blood stasis syndromes
Figure BDA0001324077340000151
Figure BDA0001324077340000152
Shown by table 12: the degree of blood stasis syndrome of the cases of the treatment group and the control group before treatment has no significant difference (P is more than 0.05); the degree of blood stasis syndrome of the treated group and the control group is very obviously different (P is less than 0.01); after treatment, the integral of blood stasis syndrome is reduced compared with that before treatment in the treatment group, and the difference is very obvious (P is less than 0.01); the integral of blood stasis syndrome after the treatment of the control group is also reduced compared with that before the treatment, and the difference is very obvious (P < 0.01).
2.8 comparison of serum Ghrelin expression before and after two groups of treatments: a comparison of serum Ghrelin expression before and after treatment in both groups is shown in table 13:
some patients failed to detect Ghrelin, and the actual number of cases included is shown in the table below.
TABLE 13 serum Ghrelin (ng/mL) expression before and after two groups of treatment
Figure BDA0001324077340000153
Figure BDA0001324077340000154
As can be seen from table 13: the serum Ghrelin levels of the treatment group and the control group before treatment are equivalent (P > 0.05); the difference of the serum Ghrelin level of the treatment group and the control group after treatment is not significant (P > 0.05); the difference of the serum Ghrelin levels before and after treatment of the treatment groups is significant (P < 0.05); there was no significant difference in Ghrelin levels before and after treatment in the control group (P > 0.05).
2.9 changes in blood lipids before and after treatment: the changes in blood lipids before and after treatment are shown in tables 14 and 15:
there were 4 losses in the follow-up visit for the treatment group and 7 losses in the follow-up visit for the control group.
TABLE 14 comparison of Triglyceride (TG) changes before and after two groups of drug treatment (mmoL/L)
Figure BDA0001324077340000161
)
Figure BDA0001324077340000162
As can be seen from table 14: no significant difference in triglyceride levels between cases in the pre-treatment group and the control group (P > 0.05); there was no significant difference in triglyceride levels between the treated and control cases after treatment (P > 0.05); no significant difference in triglyceride levels before and after treatment in the treatment group (P > 0.05); there was also no significant difference in triglyceride levels before and after treatment with the control group (P > 0.05).
TABLE 15 Total Cholesterol (TC) changes before and after treatment with two groups of drugsChemical comparison (mmoL/L)
Figure BDA0001324077340000163
)
Figure BDA0001324077340000164
As can be seen from table 15: the total cholesterol level of the cases of the treatment group and the control group before treatment is not obviously different (P is more than 0.05); the total cholesterol level of the treatment group and the control group has no significant difference after treatment (P is more than 0.05); the total cholesterol level before and after treatment of the treatment group has no significant difference (P is more than 0.05); there was also no significant difference in total cholesterol levels before and after control treatment (P > 0.05).
2.10 change in CRP before and after treatment: changes in CRP before and after treatment are shown in table 16:
4 patients lost in the follow-up visit and 1 patient finally had no CRP found; there were 7 losses in the control follow-up and 1 final unchecked CRP.
TABLE 16 CRP comparison (g/L) between two groups before and after treatment
Figure BDA0001324077340000171
)
Figure BDA0001324077340000172
As can be seen from table 16: cases of pre-treatment and control had no significant difference in CRP levels (P > 0.05); there was no significant difference in CRP levels between treatment and control cases after treatment (P > 0.05); there was no significant difference in CRP levels before and after treatment in the treatment groups (P > 0.05); there was also no significant difference in CRP levels before and after control treatment (P > 0.05).
2.11 homocysteine changes before and after treatment: changes in homocysteine before and after treatment are shown in table 17:
the patients had loss and some patients rejected to check for homocysteine, and the actual number of cases is indicated below.
TABLE 17 homocysteine comparison (g/L) before and after treatment in two groups
Figure BDA0001324077340000173
)
Figure BDA0001324077340000174
As can be seen from table 17: and (5) prompting through t test: the homocysteine level of the cases of the treatment group and the control group has no significant difference (P is more than 0.05); the homocysteine level of the treatment group and the control group has no significant difference after treatment (P is more than 0.05); the homocysteine level has no significant difference before and after the treatment of the treatment group (P is more than 0.05); there was also no significant difference in homocysteine levels before and after treatment in the control group (P > 0.05).
2.12 clinical efficacy: clinical efficacy is shown in table 18:
there were 4 losses in the follow-up visit for the treatment group and 7 losses in the follow-up visit for the control group.
TABLE 18 clinical curative effect comparison of two groups of patients with chronic cerebral circulation inefficiency (case number)
Figure BDA0001324077340000181
As can be seen from table 18: by chi-square test, X20.0496 and 0.8238. The treatment group treatment can be considered equivalent to the control group (P)>0.05)。
2.13 safety observations No obvious abnormal changes were observed before and after treatment with blood, urine, routine stool, liver and kidney functions and electrocardiographic examination.
2.14 adverse reactions
The treatment group takes the prescription for tonifying the kidney, activating the blood and clearing the hollow viscera for 4 patients, mild epigastric discomfort appears after 2 times/day, and symptoms disappear quickly after the patients take the prescription after meals; in the control group, 3 patients showed abdominal distension and nausea, and after symptomatic treatment such as oral administration of morpholine, the symptoms disappeared rapidly, and both groups had those who discontinued treatment due to adverse reactions. The patients with loss caused by the attack of cardiovascular and cerebrovascular diseases do not appear.

Claims (2)

1. A traditional Chinese medicine granule for treating chronic cerebral circulation insufficiency is characterized in that: the composition is prepared from the following components in parts by mass: rehmannia root 30g, epimedium 15g, broomrape 15g, peach kernel 12g, Chinese angelica root 12g, grassleaved sweetflag 15g, Ligusticum wallichii 9 g;
the preparation method of the traditional Chinese medicine granule comprises the following specific steps:
(1) soaking rehmanniae radix 30g, herba Epimedii 15g, Cistanchis herba 15g, semen Persicae 12g, and radix Angelicae sinensis 12g in 8000mL water for 4 hr, extracting volatile oil by steam distillation for 6 hr, and collecting volatile oil 4 mL; collecting 1800mL of distilled water solution in another container;
(2) taking 40g of beta-cyclodextrin, and adding 200g of water to prepare supersaturated solution of the beta-cyclodextrin;
(3) dripping the volatile oil prepared in the step (1) into a supersaturated solution of beta-cyclodextrin, stirring for 1 hour, standing at a low temperature, filtering, and drying at a low temperature to obtain 40g of beta-cyclodextrin inclusion complex of the volatile oil for later use;
(4) decocting the residue of distilled rehmanniae radix, herba Epimedii, Cistanchis herba, semen Persicae, and radix Angelicae sinensis, 15g rhizoma Acori Graminei and 9g rhizoma Ligustici Chuanxiong with water twice, adding 10000mL water for the first time and 8000mL water for the second time, each for 2 hr, mixing decoctions to 5000mL, and filtering;
(5) mixing 4500mL of the filtrate with the distilled water solution, and concentrating until the relative density is 1.05-1.10 to obtain 1400mL of concentrated solution;
(6) adding 95% ethanol into the concentrated solution to enable the ethanol content to reach 65%, refrigerating overnight, filtering, taking supernate, recovering ethanol, and concentrating the supernate to obtain clear paste with the relative density of 1.30-1.35 at 50 ℃;
(7) adding equivalent amount of beta-cyclodextrin into the fluid extract, mixing, drying, adding stevioside and beta-cyclodextrin clathrate of volatile oil, mixing, granulating, and drying.
2. The use of the traditional Chinese medicine granules for treating chronic cerebral circulation insufficiency as claimed in claim 1, is characterized in that: can be used for preparing medicine for treating chronic cerebral circulation inefficiency.
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Publication number Priority date Publication date Assignee Title
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