CN1057003C - Application of theaflavine for prepn. of medicine for treating cerebral senilism and dementia - Google Patents
Application of theaflavine for prepn. of medicine for treating cerebral senilism and dementia Download PDFInfo
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- CN1057003C CN1057003C CN97116354A CN97116354A CN1057003C CN 1057003 C CN1057003 C CN 1057003C CN 97116354 A CN97116354 A CN 97116354A CN 97116354 A CN97116354 A CN 97116354A CN 1057003 C CN1057003 C CN 1057003C
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Landscapes
- Medicines Containing Plant Substances (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The present invention discloses a new application of tea pigment, namely a new application of tea pigment for curing the diseases of early encephalasthenia, vascular dementia and psychonosema caused by cardiovascular and cerebrovascular diseases.
Description
The present invention relates to the new medicine use of tea pigment, be specifically related to the application of tea pigment in the medicine of preparation treatment cerebral senilism and dementia, belong to the field of Chinese medicines.
Tea pigment is the natural plant pigment that extracts from Folium Camelliae sinensis, is a kind of active pigment complex that catechin forms through peroxidating in the tea polyphenols.Tea pigment is made up of theaflavin, thearubigins and abrownin.For the existing bibliographical information of the research of tea pigment.CN1074618A discloses tea pigment and production method thereof.This production process is, Folium Camelliae sinensis is to decoct extracting juice, and alkalization concentrates, and acidify adds alcohol reflux, and alcohol reflux liquid alkalizes and obtains tea pigment crystallization product, through vacuum drying, promptly obtains this tea pigment.Theaflavin, thearubigins and abrownin three have constant ratio in the tea pigment that makes with this method, can be used as medicinal.Medical value report for tea pigment may be summarized to be reduction blood viscosity, blood fat reducing, cholesterol reducing, prevention and treatment cardiovascular disease.But up to the present, the relevant tea pigment of Shang Weijian is used for the treatment of the report of cerebral senilism and dementia.
A kind of new pharmaceutical applications that the purpose of this invention is to provide tea pigment, i.e. the application of tea pigment in the medicine of preparation treatment cerebral senilism and dementia.
Cerebral senilism is that multiple physiological pathology factor acts on the change of brain tissue cell recurring structure, metabolic mechanism is not normal and clinical, the subclinical syndrome of brain function decline.Cerebral senilism is more common in the middle age, the psychosis reaction of the existing presenile dementia of part.Dementia is the key subjects that world today's medical circle is faced, and old people's dementia has the main cause of two aspects: alzheimer disease and vascular dementia.Tea pigment is used for the treatment of cerebral senilism and dementia has good curative effect, and cardiovascular and cerebrovascular vessel characteristic of disease mental disorder is had therapeutical effect preferably.
The extracting method of tea pigment of the present invention can extract according to known extraction process, preferably the tea pigment that extracts according to following method:
(1), with Folium Camelliae sinensis by 1: after 15-30 multiple proportions example added water, through once or the decoction extracting juice once, fried liquid is used in the aqueous solution can produce OH
-Ionic chemical compound alkalizes, and regulates PH8-10, at the 1/4-1/10 that heats concentrated this alkaline solution to the original volume amount down less than 70 ℃, gets concentrated solution then; (2) concentrated solution transfers to PH3-6 with acid, and acidifying solution adds ethanol 1-10 volume doubly to be measured, and backflow 0.5-2 hour, gets alcohol reflux liquid; (3) alcohol reflux liquid is used in aqueous solution and can produces OH
-Ionic chemical compound is regulated PH7-10, and post precipitation filters, and gets the tea pigment crystallization, and tea pigment crystallization vacuum drying promptly gets the tea pigment product.
Tea pigment of the present invention is a kind of active constituents of medicine, preparation process according to routine, can be main active constituent with tea pigment, add excipient substances such as conventional excipient, flavoring agent, disintegrating agent, antiseptic, lubricant, wetting agent, binding agent, solvent, thickening agent, solubilizing agent, make any dosage form that is suitable for using clinically, as tablet, capsule, granule, oral liquid, injection etc.
Because the present invention discloses the pharmacologic action of tea pigment treatment cerebral senilism and dementia and cardiovascular and cerebrovascular vessel characteristic of disease mental disorder first; therefore; tea pigment cooperated separately or with other active constituents or adjuvant make medicament; so long as this medicament is used for the treatment of cerebral senilism and dementia and cardiovascular and cerebrovascular vessel characteristic of disease mental disorder, all belong to protection scope of the present invention.
Tea pigment of the present invention all has the effect of treatment cerebral senilism and dementia and cardiovascular and cerebrovascular vessel characteristic of disease mental disorder when making any dosage form.Any medicament; if contain tea pigment in its component or only prepare patent medicine with the tea pigment single component; on signs such as its packing or description or on other any propaganda materials, need only effect dated or that prompting has treatment cerebral senilism and dementia and cardiovascular and cerebrovascular vessel characteristic of disease mental disorder, then fall within protection scope of the present invention.
Tea pigment of the present invention is the natural plants Folium Camelliae sinensis that derives from medicine-food two-purpose.Therefore, also tea pigment can be made health food or health care medicine.Health food or health care medicine with tea pigment is made have the effect for the treatment of cerebral senilism and dementia and cardiovascular and cerebrovascular vessel characteristic of disease mental disorder if indicate or point out on signs such as its packing or description, also fall within protection scope of the present invention.
Embodiment 1
Prescription
Tea pigment 125 grams
Medical starch 875 grams
Above-mentioned component is gone into blender, and fully stirring and evenly mixing is encapsulated with capsule machine, and every filling 1 gram makes 1000 of tea pigment capsules, and every capsules contains 125 milligrams of tea pigments.
Embodiment 2
Tea pigment 250 grams
2000 milliliters of distilled water
Stevioside 1 gram
Tea pigment is dissolved in the distilled water, and fully mixing adds stevioside, and stirring and evenly mixing is once more packed in the vial with can packing machine, and every bottled 10 milliliters, sterilization makes the tea pigment oral liquid.
The clinical research of experimental example 1 tea pigment treatment cerebral senilism 1000 examples
Data and method
1.1 physical data
Collect 46-60 year patient 1150 examples.Man's 856 examples, women 294 examples.54.6 years old mean age.Complete is the city brain worker.The influence of extrinsic factor as society, environment, life style and condition, improper diet, medicine and occupation generally arranged; Intrinsic factor have the direct influence of (42 example) behind hypertension (213 example), hyperlipemia (280 example), diabetes (17 example), coronary heart disease (36 example), TLA (28 example), the cerebral infarction, cerebral arteriosclerosis diseases such as (301 examples).The performance of clinical and sub-clinical state removes the clinical typical disease that protopathy arranged levies, outstanding see that neurosis is inclined to (586 example), vegetative nerve function is understable (697 example) and have slight, can not localized, atypical nervous system soft sign as: benzene hands, nystagmus, anisocoria, diplopia, hemianopsia, the structure sound is ambiguous, coordination is poor, physiological reflex is asymmetric, the one-sided probable positive of pathologic reflex.Press KOLOKOWASKAShi method integration K＞5,486 examples, K＞10,278 examples, K＞15 182 examples, descend 58 examples, hypomnesis 103 examples, personality of thinking sensitivity in distress and tired, that be weary of differentiation take on morbit forms and develop 201 examples, slight depressed 112 examples, psychosis reaction such as fuzzy somatization 312 examples is arranged, head CT exists symmetry low density area 8 examples, Chang Gu river method IQ 44 examples below 85 minutes, 86-95 minute 127 examples around showing brain atrophy 37 examples, tricorn.
1.2 detection method
1.2.1 adopt homemade XD-300B type multifunctional colour microcirculation instrument special messenger operation, routine examination method and quantitative comprehensive statistics field cattle method are carried out observation chou membranous part microcirculation and be as the criterion with the two temples of eyeball, 23 ℃ of room temperatures are amplified 100 times of observations.The ocular fundus arteriosclerosis picture is according to the legal degree of KEIIH-WAGNE.
Detect with homemade FL type hemorheology instrument, WX-3D type platelet adhesion instrument 1.2.2 hemorheology is learned, evaluation is measured by the instrument requirement.
1.2.3 lipid determination is by the special messenger's operation routinely of three hospitals.
1.3 medication
The TP capsule that tea pigment group 1000 examples provide with the green pharmacy in Jiangxi Group Co.,Ltd, lot number is that Jiangxi is defended the accurate word of medicine (1994)-139-1 number.Each 250MG, every day 3 times, after oral 30 days, every day, 125mg vitaminize EI ball was kept 30 days, and finish the course of treatment; Matched group 150 example is made placebo with the Shi Purui capsules that the natural pharmaceutical Co. Ltd in Yunnan provides, and lot number is that Yunnan is defended the accurate word of medicine (1992)-101-2 number, each 2, every day 3 times, after oral 30 days every day 1 vitaminize E1 grain, kept the end course of treatment 30 days.At the period in a medicine course of treatment, stop using without exception hypolipidemic, depressor and anti senile medicine such as cerebrolysin.
1.4 statistical method
Measurement data represents that with X ± S own control is relatively used X with pairing T check between group
2Check, P＜0.05 is meaningful.1.5 efficacy evaluation method
1.5.1 clinical efficacy precentagewise.Produce effects: the main suit reduces more than 80%, and positive sign disappears substantially, soft sign K＜3, and blood fat reducing effective percentage TC, TG, HDL, LDL are respectively 71%, 50%, 74%, 76%; Effectively: the main suit reduces more than 50%, and positive sign partly disappears, soft sign K＜5, blood fat reducing effective percentage TC, TG, HDL, LDL are respectively 50%, 30%, 50%, 50%; Invalid: above no change; Worsen: main suit and positive neurons sign, soft sign increase, and 1-2 item index ANOMALOUS VARIATIONS is arranged in the blood fat reducing.
1.52 the bulbar Conjunctiva Microcirculation obstacle improves the judgement according to the variation weight degree of total mark value, probability that occurs with the qualitative index with great or important physiological pathology meaning and speed and decide.
1.5.3 learning, hemorheology changes according to measurement result rate of change and heave amplitude evaluation.
2, result and analysis
2.1 the incidence rate of cerebral senilism.Find by ten thousand example investigation: adolescence's 80 examples (8 ‰), old 120 examples (1.2%), middle aged 1150 examples (11.5%), annual morbidity height in showing is normal distribution.
2.2 severe was unusual during the bulbar Conjunctiva Microcirculation obstacle was; the total mark value is 18.40 ± 1.12-21.48 ± 1.16; it is outstanding that morphological index is counted minimizing, malformation, ischemic focus 1-3 with microtubule; the fluidised form index up to 84%-94.96%, sees Table 1 with the occurrence rate of blood grain unhurried current, white little bolt, the gathering of erythrocyte moderate etc.With ocular fundus arteriosclerosis as almost parallel, see Table 2.Before and after the tea pigment group treatment relatively, have significant difference (P＜0.05-0.001), with matched group relatively, also significant difference (P＜0.05-0.001), see Table 3 after controlling.The improvement of blood fat shows the rectifiable lipid metabolic disorder of tea pigment.
2.3 the improvement that rheological property of blood is unusual, the rate of change of whole blood viscosity, plasma viscosity, fiber and the white unit after the tea pigment treatment, platelet adhesion rate etc., more all there is significant difference (P＜0.05-0.01), see Table 4 the administration front and back.
2.4 clinical efficacy sees Table 5.As seen tea pigment group total effective rate 97.4%; Shi Purui group total effective rate 40%, invalid and worsen totally 60%.After accepting the tea pigment treatment, mental symptom is improved the somatization that reaches more than 50%, blurs and is taken a turn for the better 65%.
Probability (n.%) appears in the main mutation index of table 1 bulbar Conjunctiva Microcirculation
Annotate: * shows unusual probability＞90%, and Δ shows about 80%.
| Index | Routine number (%) appears |
| * microvessel count reduces | 1048 91.34 |
| * ischemic focus (1-3/visual field) | 1106 96.17 |
| * deformity is managed (capsule, shuttle, tumor) | 1088 94.01 |
| The Δ caliber changes (containing A/V＞1/3) | 996 86.60 |
| * little blood flow grain delays shape | 1122 96.57 |
| * white little inspection (1-3/visual field) | 1092 94.96 |
| Δ erythrocyte moderate is above assembles | 981 85.61 |
| Blood capillary mobility reduces | 876 76.69 |
| The Δ traveling is unusual | 965 84.00 |
| Δ thickness inequality | 974 84.69 |
Table 2 bulbar Conjunctiva Microcirculation obstacle and ocular fundus arteriosclerosis resemble comparison (n)
Unusual 57 00 572 ° 0 680 25 7053 ° 0 150 238 388 of 1 ° of sclerosis that add up to of the unusual severe of optical fundus bulbus arteriosus conjunctiva microcirculation disturbance degree hardenability mile abnormality moderate
Table 3 liang group treatment bulbar Conjunctiva Microcirculation integrated value comparison (X ± S)
Annotate: Δ, Δ Δ Δ P＜0.001, Δ Δ P＜0.05 ▲ ▲, ▲ ▲ ▲ p＜0.05 ▲ p＜0.01
| After group was controlled before sp controlled after group was controlled before tp controlled | Form value 15.42 ± 2.66 5.63 ± 0.72 13.41 ± 2.60 10.28 ± 0.74 | Fluidised form value 5.44 ± 0.71 2.02 ± 0.45 3.40 ± 0.61 2.13 ± 1.42 | Pipe week is worth 1.50 ± 2.76 0.26 ± 0.11 1.57 ± 3.21 0.76 ± 0.25 | Total mark value 21.48 ± 1.16 7.43 ± 1.40 18.40 ± 1.12 12.98 ± 1.03 |
The hemorheology of table 4 tea pigment treatment cerebral senilism is learned and is changed
| X±S(mmol/l) | Rate of change t value p value | ||
| After the preceding administration of administration | |||
| The whole blood height is cut rate | 5.22±1.42 | 4.73±1.16 | 9.38 2.14 0.05 |
| The low rate of cutting of viscosity | 6.82±2.47 | 6.15±1.52 | 10.75 2.25 ＜0.05 |
| Plasma viscosity | 1.81±0.19 | 1.74±0.13 | 5.48 3.34 ＜0.01 |
| The fiber dawn is unit in vain | 3.92±1.12 | 3.20±1.03 | 18.32 3.82 ＜0.01 |
| Platelet adhesion rate | 64.25±17.74 | 28.79±10.8 | 21.31 9.18 ＜0.01 |
Table 5 liang group clinical efficacy comparison (n＞%)
Significantly enabledisable worsens
TP group 392 (39.20) 582 (58.20) 26 (26.0) 0
SP group 18 (12.00) 42 (28.00) 85 (56.67) 5 (3.33)
3, discussion and conclusion
Cerebral senilism is that multiple physiological pathology factor acts on the change of brain tissue cell recurring structure, metabolic mechanism is not normal and clinical, the subclinical syndrome of brain function decline, does not very easily cause serious consequence if do not intervene early.Data shows: cerebral senilism is more common in the middle age, the psychosis reaction of the existing presenile dementia of part, and clinical refreshing essence is that sign and soft sign are seen more; Often be incorporated in the cardiovascular and cerebrovascular vessel ischemic diseases; The regression of chou blood capillary, cirrhosis, distortion, appearance, the Bai Weishuan of ischemic region swim, and blood flow speed grain is slow; That rheological property of blood is is high sticking, blood clotting is unusual.These blood of not only having represented internal and external reasons effect hypencephalon limitation or popularity irritate bad, also are the direct cause of disease and the favourable turns that brain function decline takes place.The heap of free radical, the decline of immune function will inspire and increase the weight of the brain decline, and DT confirms to have the sign of brain atrophy, be all the diagnosis cerebral senilism foundation is provided.Bulbar Conjunctiva Microcirculation obstacle degree and optical fundus tremulous pulseization come from the direct continuity of internal carotid artery together as basically identical system, thus can intuitively reflect brain decline situation, thus observe superior than first folds in a garment position.Use the tea pigment treatment down from two-way index monitoring, data also shows safety, efficient, and especially microcirculatory blood capillary number increases, ischemic focus disappears, white little bolt loses, blood flow is accelerated, the change of caliber; The rate of change of rheological property of blood four-index is also obvious simultaneously, illustrates that two-way index monitoring method is responsive comparable, and the quantification treatment credible result is convenient.The senilism determined curative effect is intervened in tea pigment control, and key is to fully recover from an illness contraction to remove the arteriole high pressure, coordinate the excretory movable material of pipe inner membrance, to reduce cutting property stress and enliven microcirculation by loose smooth muscle; Reduce white first content of fiber dawn and platelet adhesion by adjusting packed cell volume, depolymerization, to improve plasma component sticking to fall blood; Improve the SOD vigor, reduce the MDA effect, remove free radical prolong to prevent lipid peroxidation decline anti-ageing.
The Clinical exploration of experimental example 2 tea pigment treatment of vascular dementias
1, data and method
1.1 case is selected:
40 routine patients are the Patients with Vascular Dementia that October nineteen ninety-five-1997, year April, my institute accepted for medical treatment, male 28 examples, and women 12 examples, 58.2 ± 13.1 years old mean age, all meet following diagnostic criteria: (1) must have dementia symptom clinically; (2) enough evidences (comprising the evidence that medical history, physical examination and irradiation image are learned) of suffering from cerebrovascular must be arranged simultaneously; (3) both must have interrelated; (4) differentiate that through Hachinski the table of integrals and Rortera-Sanchey change scoring method and get rid of the AlzheimerShi dementia.
1.2 medication
Tea pigment is provided by Chinese-foreign joint Jiangxi Greens Ind Ltd..Lot number: medicine standard (1994) 139-1 number defended in Jiangxi, and every capsules contains tea pigment 125mg, every day 3 times, each 2,1 month course of treatment.Inactive other blood fat reducing of viewing duration and brain cell pharmacological activation.
1.3 observational technique
The examinate is at blood sampling forbid taking food evening before that day high lipid food and forbid drinking, adopt ulnar vein blood second day early morning on an empty stomach, treat row blood sampling for the second time after 30 days, carry out every index such as blood fat, hemorheology and nail fold microcirculation and judge, intelligence changes evaluation and is when being admitted to hospital and treated 30 days after Chang Gu river simple intelligent detection table (Hasegawa ' s Dementia Scale) and detect.
1.4 efficacy assessment standard
Intelligence evaluation is dull-witted below 21.5 minutes, efficacy evaluation is divided into be clearly better (intelligence improves more than 10 minutes), (intelligent scoring improves the 5-9.5 branch), slightly better (the more preceding sensitivity of emotion healing crisis take a turn for the better, the defecation may command, intelligence improved less than 5 minutes), no change (intelligence is estimated score value does not have changes), worsen (the more preceding minimizing of intelligence evaluation score value).
1.5 statistical analysis technique
Adopt own control, the situation of change of every indexs such as blood fat, nail fold microcirculation, hemorheology, intelligence evaluation before and after the t check analysis treatment, data are defended STATISTIC45 statistical software of teaching and research room through my institute's public affairs, and microcomputer is handled.P＜0.05 is for there being statistical significance.
1.6 side effect
The back patient that takes medicine does not have bad main suit, hematuria routine, liver, renal function no any variation before and after treatment.
2, result
2.1 the patient of vascular dementia is often with hyperlipidemia, hemorheology, microcirculatory unusual, the variation of input tap footpath, flow velocity, Fibrinogen, whole blood reduced viscosity (height is cut, hanged down and cut), packed cell volume, cholesterol, triglyceride all has significance (P＜0.05) before and after the tea pigment treatment.The result shows that tea pigment has the effect of blood fat reducing, anti-fibrinolytic, minimizing erythrocyte aggregation, microcirculation improvement.
2.2 this group patient detects table through Chang Gu river simple intelligent and measures; Intelligence evaluation is starkly lower than normal value (21.5 minutes) before the treatment; And after the tea pigment treatment; It is normal that the patient does not recover fully; Microcirculation of nail rugae before and after but estimate the score value variation the remarkable difference (P＜0.037) that gets is arranged, the treatment effective percentage reaches 87.5%. table 1 Tea Pigment in Treating; Blood flow becomes; （ X±SD ） （ 30 ） P （ um ） 7.9046±2.0716 8.3154±1.4048 0.141 （ um ） 7.0969±2.4107 9.3923±1.4068 0.1608 856.8±255.28 940.5±121.96 0.0028 35.862±19.565 21.615±11.197 0.0001 （ g／L ） 296.35±77.485 269.65±42.14 0.0001 （ ） 6.1195±1.1446 5.4440±0.7282 0.0001 （ ） 8.1963±2.1936 7.3185±1.0904 0.0001 48.846±4.9725 45.000±2.7613 0.0001K 48.518±19.544 49.498±8.372 0.5742 （ mmol／L ） 5.5915±0.8877 5.0737±0.8518 0.0001 （ mmol／L ） 1.5460±0.7148 1.1703±0.3396 0.0010：*P＜0.05。
Intelligence evaluation score value situation of change before and after the treatment of table 2 tea pigment (X ± SD)
| Index | Treatment back P value before the treatment of example number |
| Estimate score value | 40 9.12±2.25 21.56±3.25 ＜0.037 |
Intelligence changes efficacy evaluation before and after the treatment of table 3 tea pigment
| The slightly better no change deterioration that takes a turn for the better is clearly better | |
| The example number | 11 15 9 4 1 |
3, discuss
Vascular dementia (Vascular dementaia VD) is the elderly dementia's that generally acknowledges common cause, it mainly since cerebrovascular disease cause; A kind of be since repeatedly ischemic brain infarction cause dementia, claim multi-infarct dementia (multi-infarctdementia again, MD), another kind is without the caused dementia of obvious cerebral infarction, to carry out cortex under encephalopathy (Binswanger demantia) as vascular owing to chronic cerebral ischemia.In view of the vascular dementia pathogeny is the repeatedly outbreak of cerebrovascular and chronic ischemic infringement, mainly be putting prevention first therefore to the treatment of this disease, prevention of brain blood vessel palindromia and cause the statural lacunaris of alba chronic ischemia particularly.And cerebral arteriosclerosis, hypertension, high blood viscosity, platelet aggregation, microcirculation disturbance and unusual hemorheology all are the significant risk factors that cause above disease.Tea pigment is water solublity polyhydric phenols and the derivant of extracting from Folium Camelliae sinensis thereof.The data of observing from this group shows that tea pigment is the generation and the recurrence of prevention of brain angiopathy from many aspects, the treatment vascular dementia.
Blood component and blood flow aspect.Tea pigment improves high density lipoprotein (HDL) thereby blood fat reducing by cholesterol reducing (TC), triglyceride (TG), low density lipoprotein, LDL (LDL).Tea pigment improves blood viscosity by reducing Fibrinogen, reduce platelet aggregation, adjust red cell morphology, strengthening its deformability thereby obviously reduce erythrocyte aggregation, and atherosclerosis forms, and improves the blood supply of tissue and supports.
The hematodinamics aspect.Input tap footpath obviously broadening after treating from the visible microcirculation of observed result.Velocity of blood flow also has clear improvement.Tea pigment improves blood capillary, kidney arteriole particularly, and influence the vasotonia system, the spasm of loose smooth muscle increases tissue perfusion, thereby adjusts abnormal blood pressure.
Great mass of data has confirmed that Endothelin is a kind of peptide material, regulates the local vascular tensity from paracrine and autocrine mode, participates in adjust blood pressure.Its level improves with artery thrombosis dependency.Tea pigment can be removed the Endothelin that increases under the ischemic state.Thromboxane A in addition
2(TXA
2) and prostacyclin (PGI
2) dynamic equilibrium imbalance also be the reason that angiopathy forms.PGI
2Synthetic by vascular endothelial cell, be intensive vasodilation and anticoagulant, TXA
2Discharging by platelet microsome is synthetic, is intensive vasoconstriction and platelet aggregating agent.Both are all unstable, can change stable 6-ketone-PGFI-a and TXB rapidly into
2, and tea pigment can reduce TXB
2The ratio of/6-ketone-PGFIa, thereby tea pigment has the effect that cerebrovascular disease takes place, develops and recur that suppresses.
Free radical has substantial connection with generation, the development of dementia.Produce a large amount of free radicals behind the hypoxic-ischemic, attack biomembrane, cause its afunction even destroy fully, make enzyme deactivation, and produce the material that causes microcirculation disturbance in a large number.And superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX) all are important antioxidases, and its vigor can reflect the ability of body removing free radical.And tea pigment can improve the activity of SOD and GSH-PX in the serum, has the ability of removing free radical blood lipid reducing peroxidase (LPO) content, and by forming complex with the low price iron molecule, thereby remove the free radical that causes because of low price ferrum.Tea pigment also can improve trace element such as selenium, germanium, can improve T
3, T
4, T
4/ T
8Ratio is regulated immunity of organisms, promotes cell metabolism.As seen tea pigment has the effect of antioxidation, defying age, human body immunity improving power.
At present, lack a kind of moderate cost clinically, the medicine of treatment dementia evident in efficacy, and tea pigment is drawn materials extensively, is a kind of green medicine of pure natural, oral safety, no side effects has broad application prospect aspect dull-witted treating.
Experimental example 3 tea pigments treatment vascular senile dementia 480 routine curative effect contrast observings
1, data and method:
1.1.1 data: two groups of cases all are our regional center (RC) outpatient service and inpatient in recent years, tea pigment group 480 examples, age 50-80 year (60.6 years old mean age); Male's 360 examples, women's 120 examples; Wherein hyperlipemia 400 examples are suffered from hypertension and its medical history person 50 examples are arranged, coronary heart disease 16 routine cerebral infarction sequela 14 examples.Matched group 80 examples, age 52-76 year (62 years old mean age); Male's 62 examples, women's 18 examples; Hyperlipemia 50 examples wherein, hypertension 11 examples, coronary heart disease 9 examples, cerebral infarction sequela 10 examples.
1.1.2 diagnosis: two groups of cases all have tangible bradykinesia, give an irrelevant answer sometimes, hypomnesis, apathy or emotion is emotional, or the time laugh at when crying, lassitude from head to foot, tiredly all day desire to be disinclined to speech or speech is disorder, thinking is poor, muddle, check that sensation and muscular strength descend, the head CT inspection has in various degree and brain atrophy.Detect through hemorheology and microcirculation, prompting has hemorheology and microcirculation disturbance.
1.2.1 medicine: the lot number that the treatment group uses the green pharmaceutical Co. Ltd in Chinese-foreign joint Jiangxi to produce is defended medicine standard (1994) 139-1 number as Jiangxi, every tea pigment capsule that contains tea pigment 125MG; Matched group uses the troxerutin sheet to add and makes mental new micelle.
1.2.2 Therapeutic Method: two groups of patients are except that conventional therapy that other disease is suited the medicine to the illness, and oral tea pigment capsule 250MG (body constitution weaker player 125MG) every day three times, taking medicine before meal are organized in treatment; The oral troxerutin sheet of matched group 4# makes 1 in mental new micelle, every day three times, taking medicine after meal.All took medicine 30 days for two groups.
1.3 instrument and detection method: extract 4 milliliters in patient's empty stomach venous blood, use homemade XBH-31 type rotary viscosimeter, detect whole blood viscosity (height is cut, hanged down and cut), the length of plasma viscosity, packed cell volume, erythrocyte sedimentation rate and external thrombus, weight in wet base, dry weight, and the detection before and after the treatment.The detection of nail fold microcirculation is used homemade XG-5B1 type microcirculation black-and-white television computer and is measured diagnostic apparatus with reference to national microcirculation detection method and requirement condition, 12 indexs such as the form of the unknown fingernail folds in a garment of detection left hand blood capillary loop, fluidised form before and after the treatment.
2 results
2.1 curative effect: treatment group 8 indexs of hemorheology after treatment are recovered normal (P＜0.01), and 12 indexs of microcirculation are recovered normal (P＜0.01), and patient's symptom is obviously improved.Matched group 8 indexs of hemorheology and 12 indexs of microcirculation and patient's symptom after treatment are not seen obvious improvement the (P＞0.05).See Table 1 and table 2
2.2 toxic and side effects: there is no special untoward reaction after two groups of treatments.
Table 1: hemorheology comparison before and after two groups of treatments (X ± s)
| Observation index | The treatment group | Matched group | |||||
| Before the treatment | After the treatment | The P value | Before the treatment | After the treatment | The P value | ||
| Whole blood viscosity | Height is cut | 5.93±0.3 | 5.31±0.3 | ＜0.05 | 5.63±0.19 | 5.6±0.2 | ＞0.05 |
| Low cutting | 11.9±0.5 | 9.7±0.7 | ＜0.05 | 10.99±0.7 | 8.91±0.5 | ＞0.05 | |
| Plasma viscosity | 2.6±0.4 | 1.74±0.2 | ＜0.01 | 2.00±0.4 | 1.96±0.38 | ＞0.05 | |
| Packed cell volume (%) | 51.36±5.16 | 43.22±4.4 | ＜0.05 | 50.27±4.57 | 49.30±4.10 | ＞0.05 | |
| Erythrocyte sedimentation rate (Mmm/n) | 26.64±13.34 | 21.3±11 | ＜0.01 | 24.56±11.68 | 24.54±11.62 | ＞0.05 | |
| External thrombus long (mm) | 31.78±6.38 | 20.39±3.29 | ＜0.01 | 32.79±7.39 | 32.76±7.35 | ＞0.05 | |
| External thrombus weight in wet base (mg) | 78.46±15.09 | 56.09±11.26 | ＜0.01 | 76.44±13.07 | 76.14±13.02 | ＞0.05 | |
| External thrombus dry weight (mg) | 26.04±7.62 | 16.03±5.22 | ＜0.01 | 25.40±6.68 | 25.36±6.66 | ＞0.05 | |
Table 2: nail fold microcirculation comparison before and after two groups of treatments (X ± S)) n=560
| Observation index | Treatment group (n=500) (n=480) | Matched group (n=80) | ||||
| Before the treatment | After the treatment | The P value | Before the treatment | After the treatment | The P value | |
| Pipe loop fuzzy (number) | 446 | 8 | ＜0.01 | 68 | 64 | ＞0.05 |
| Pipe loop density | 6.70±1.81 | 8.88±1.51 | ＜0.01 | 6.78±1.89 | 6.81±1.91 | ＞0.05 |
| Intersect lopsided number (bar/mm 3) | 4.02±0.73 | 2.36±0.24 | ＜0.01 | 4.14±0.86 | 4.08±0.84 | ＞0.05 |
| Input branch diameter (mm) | 3.13±1.18 | 4.09±1.27 | ＜0.01 | 3.17±1.22 | 3.21±1.26 | ＞0.05 |
| Output branch diameter (mm) | 5.42±1.13 | 6.54±1.23 | ＜0.01 | 5.38±1.09 | 5.40±1.06 | ＞0.05 |
| Loop top diameter (μ m) | 7.54±1.15 | 8.56±1.46 | ＜0.01 | 7.52±1.13 | 7.22±1.08 | ＞0.05 |
| Pipe loop length (μ m) | 147.88±58.66 | 199.42±69.15 | ＜0.01 | 149.52±59.76 | 150.90±60.21 | ＞0.05 |
| Blood flow rate (μ m/s) | 670.01±126.76 | 989.14±158.00 | ＜0.01 | 673.12±129.81 | 674.00±30.69 | ＞0.05 |
| The all states of loop | 0.68±1.80 | 0.41±0.60 | ＜0.01 | 0.70±1.82 | 0.66±1.80 | ＞0.05 |
| The blood flow form | 2.39±0.85 | 0.84±0.46 | ＜0.01 | 2.34±0.80 | 2.30±0.76 | ＞0.05 |
| Pipe loop form | 1.49±0.70 | 0.98±0.33 | ＜0.01 | 1.12±1.33 | 1.10±1.31 | ＞0.05 |
| Erythrocyte slurry collection (n) | Heavy in light | Heavy in light | Heavy in light | Heavy in light | ||
| 26 344 110 | 340 138 2 | 10 54 16 | 12 52 16 | |||
3, discuss
The vascular senile dementia is a kind of PD, pilosity is done in the old people of cerebral atherosclerosis, and hyperlipemia is arteriosclerotic main cause, it also is the main cause that forms hemorheology and microcirculation disturbance, because unnecessary fat is in the precipitation of blood vessel, destroyed vascular endothelial cell, blood vessel wall is become fragile, elasticity reduces, and it is narrow that tube chamber becomes, and makes hemorheology detect the unusual blood of every index and flows in hardened arteries, add microcirculatory obstacle, the then long-term blood supply oxygen supply deficiency of brain tissue cell, so that form brain atrophy, and form the vascular senile dementia.As not improving and controlling this phenomenon, conditions of patients can the aggravation of carrying out property.Clinical through dead point troxerutin, cerebrolysin, propylene glycol alginate sodium sulfate, oral troxerutin, make mental medicine such as new, all be difficult to reverse the tide.And tea pigment capsule has solved this difficult and complicated illness that can't resolve for many years, and this is vast vascular senile dementia patient's a Gospel undoubtedly.
Tea pigment is the very strong material of a class biological activity, the effect that strengthens blood capillary is arranged, anti-matter peroxidation is arranged, the function of blood fat reducing, anticoagulant fibrinolysis enhancing, reduction blood viscosity, microcirculation improvement, atherosclerosis and enhance immunity, especially we find in clinical research, it is crossed aspect the speed reducing plasma viscosity and raising blood flow, and very special tangible curative effect is arranged.Senile dementia card patient through the tea pigment treatment is evident in efficacy, not only hemorheology and microcirculatory detection index have clear improvement after taking medicine, and from head to foot symptom complete obiteration such as lassitude, abepithymia and excited, muddled, limb adynamia or obviously alleviate, the head CT check all takes a turn for the better to some extent, patient and family members are very satisfied.
Experimental example 4 tea pigments are to the treatment research of cardiovascular and cerebrovascular vessel characteristic of disease mental disorder
Material and method
One, patient selection
All cases are the cardiovascular and cerebrovascular disease patient after making a definite diagnosis, coronary heart disease 16 examples (40%) wherein, cerebrovascular 24 examples (60%), 46～67 years old age, average 60.11 ± 9.0 years old, male 25 examples, women 15 examples.
Go into the group standard:
(1) sanity, intelligence normal (Chang Gu river simple intelligent scoring＞24 minutes)
Except because aphasia or be in a bad way and can not cooperate the examiner.
(2) measure through ZungShi self rating depressive scale (SDS), total points＞50 a minute person goes into the depression group, totally 14 examples.
(3) through Zung anxiety self-appraisal scale (SAS) evaluation, total points) 50 fens persons go into the anxiety neurosis group, totally 26 examples.
Two, medication
Oral tea pigment, each 125mg, every day three times.The protopathy treatment continues (as aspirin, sorbitrate, Radix Salviae Miltiorrhizae, 706 plasma substitutes, thrombolytics, cerebrolysin etc.), forbids other antipsychotic drug.
Three, efficacy evaluation
1, before the treatment and treatment back each record of second, four, six weeks once subtracts the branch rate to draw SDS and SAS.
2, clinical efficacy evaluation: by four ranking methods
Recovery from illness: symptom all disappears
Marked improvement: symptom is most of to disappear, and degree obviously alleviates
Progressive: symptom partly disappears, and degree partly alleviates
Invalid: symptom no change or deterioration
Produce effects is above to be obvious effective rate, is effective percentage more than the progress.
Four, statistical procedures: t check
The result
X ± SD is compared in the SDS evaluation before and after the treatment of table 1 depressive neurosis
Six weeks 10 43.8 ± 2.1＜0.01 of 14 48.7 ± 3.1＜0.01 treatment back around preceding 14 57.7 ± 4.6 treatment backs of n SDS P treatment two weeks, 14 52.8 ± 4.1 0.01＜P＜0.05 treatment back
X ± SD is compared in the SAS evaluation before and after the treatment of table 2 anxiety neurosis
Six weeks 20 43.2 ± 2.8＜0.01 of 25 48.4 ± 2.9＜0.01 treatment back around two weeks 26 52.3 ± 3.2＜0.05 treatment back, preceding 26 59.6 ± 4.4 treatment backs of n SDS P treatment
By table 1, table 2 as can be seen, treatment back SDS and SAS total points all obviously reduce, obvious with curative effect after treating for 4 weeks, it respectively is 15.6% and 18.8% that SDS and SAS subtract the branch rate, best results during the 6th week, subtracting the branch rate respectively is 24.1% and 38.0%, learns by statistics and handles, two groups all have significant difference (P＜0.01) before and after the treatment, and the anxiety treatment is better than antidepressant.
The evaluation of table 3 clinical efficacy
Recovery from illness marked improvement progress is invalid
Example number % example number % example number % example number % depressive neurosis 1 (14) 3 (21) 9 (64) 1 (7) anxiety neurosis 2 (7) 6 (26) 17 (65) 1 (7)
As seen tea pigment reaches 93% to depression group effective percentage, and anxiety neurosis group effective percentage 96%, obvious effective rate respectively are 23% and 31%.
Side effect:, do not find side effect with the evaluation of TESS scale.
Discuss
Suffer from after the cardiovascular and cerebrovascular disease, especially after the apoplexy, the influence of this outstanding incident be can't take care of oneself because health is disabled suddenly, and life circle diminishes, and is economical in addition, each side factor effects such as society, make this class patient can the while with various mental maladjustment.Foreign literature reports that its incidence rate is 47%, domestic report post-stroke anxiety/depression incidence 55%, and incidence rate 65.7% after the coronary heart disease, shows as outstanding with anxiety, sleep disordered, emotional lability, irritability.Its mechanism is thought and is unified with sympathetic nervous system that to regulate imbalance relevant for hypothalamus one hypophysis hypothalamic pituitary adrenal axis function, and anxiety/depression can increase the weight of somatization, the function that affects the nerves and cardiac function recover, and the sympathetic tension force of depression/anxiety patient increases, vagal tension reduces, further reduce the ventricular ischemia ventricular fibrillation threshholds, easily trigger malignant arrhythmia, increase cardiac sudden death danger.So should pay attention to the treatment of psychological behavior.Tea pigment is by the living substance of extracting in the Folium Camelliae sinensis, a large amount of studies show that, it can be removed free radical and generate, suppress the cytolipin peroxidating, reduce blood viscosity, microcirculation improvement, the tea pigment that this group result shows can improve patient's various body discomforts, and is especially to emotional lability, sleep disordered, effects such as anxiety, may with tea pigment scalable vegetative nerve function, stablize sympathetic nerve function, it is relevant to stablize sympathetic nervous system one hypothalamus one hypophysis hypothalamic pituitary adrenal axis function, simultaneously also can improve the confession of heart and brain blood, improve the heart, brain function is relevant with it.Know from experience through preliminary study, tea pigment to cardiovascular and cerebrovascular vessel after being ill anxiety neurosis and depressive neurosis certain curative effect is all arranged, and without any side effects.
Claims (4)
1, the application of tea pigment in the medicine of preparation treatment cerebral senilism.
2, the application of tea pigment in the medicine of preparation treatment dementia.
3, the application of tea pigment in the medicine of preparation treatment vascular dementia.
4, the application of tea pigment in the medicine of preparation treatment cardiovascular and cerebrovascular vessel characteristic of disease mental disorder.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97116354A CN1057003C (en) | 1997-08-18 | 1997-08-18 | Application of theaflavine for prepn. of medicine for treating cerebral senilism and dementia |
| AU87973/98A AU8797398A (en) | 1997-08-18 | 1998-08-18 | New uses of tea pigment |
| PCT/CN1998/000167 WO1999008674A1 (en) | 1997-08-18 | 1998-08-18 | New uses of tea pigment |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97116354A CN1057003C (en) | 1997-08-18 | 1997-08-18 | Application of theaflavine for prepn. of medicine for treating cerebral senilism and dementia |
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| CN1057003C true CN1057003C (en) | 2000-10-04 |
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| CN117159628A (en) * | 2023-09-22 | 2023-12-05 | 遵义医科大学附属医院 | Application of theabrownin in preparation of products for preventing and treating iron overload related diseases or reducing iron accumulation of organisms |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1074618A (en) * | 1993-01-01 | 1993-07-28 | 南昌洪婺名茶开发公司 | Tea pigment and production method thereof |
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