CN101850031B

CN101850031B - Pueraria isoflavone capsule

Info

Publication number: CN101850031B
Application number: CN2010101559274A
Authority: CN
Inventors: 胡庆禧
Original assignee: Individual
Current assignee: Individual
Priority date: 2010-04-23
Filing date: 2010-04-23
Publication date: 2012-06-27
Anticipated expiration: 2030-04-23
Also published as: CN101850031A

Abstract

The invention discloses a pueraria isoflavone capsule (or a Hu's Besser capsule). The capsule is prepared by the following components in parts by weight: 1 part of Panax Notoginsenosides, 1 part of radix salviae miltiorrhizae extract, 1 part of ligustrazine, 1 part of kudzu root extract, 0.5 part of tea polyphenol and 1 part of Grifola frondosa extract. The components are combined together to make the effect of each component to generate a synergistic effect to achieve the effect of lowering blood viscosity, reducing blood fat and preventing cardio-cerebral blood vessels from being stiffened and infarcted. The pueraria isoflavone capsule can be used for treating serious diseases influencing the health of the old and lowering the quality of life of the old, such as Alzheimer diseases, hypophrenia caused by cerebral thrombosis, diabetes mellitus, senile benign hypophrenia and the like. Proved by a large number of clinical effect observation tests, through taking effective dose of pueraria isoflavone capsule, patients with mild-moderate dementia can be recovered with self-care ability after taking the capsule for 3 months, and the serious disease of Parkinson's disease and the like can be cured in 3-4 months.

Description

Pueraria isoflavone capsule

Technical field

The invention belongs to the field of Chinese medicines, relate to a kind of can blood viscosity lowering, blood fat reducing, prevent the medicine of cerebrovascular sclerosis and infraction.

Background technology

Along with the change of the raising of living standards of the people and life style, diet structure, particularly in China's urban population, sickness rate such as hyperlipemia, coronary heart disease, cerebrovascular disease are quite high; According to report on Epidemiological, the morbidity ratio of cerebral infarction is 19 people/100,000 people, and ill ratio is 459 people/100,000 people; Just more as for the hyperlipemia number, so cardiovascular and cerebrovascular disease become first killer who threatens China people, the formation of disease mainly is because blood fat increases; Hemorheology changes, and forms pathologic basis sticking, dense, cohesion, on arteriosclerotic basis; The endarterium damage is broken, or forms ulcer, and cholesterol deposits is in subintima; Cause blood vessel wall fat hyaline degeneration, further fibroplasia, the tremulous pulse hardening is tortuous; Tube wall thickens, and platelet and cellulose etc. has and form to adhere to, assembles, calmly forms thrombosis, even makes arterial occlusion and ischemic diseases takes place.In addition, senile dementia, the optimum hypophrenia of the hypophrenia that causes behind the cerebral embolism, diabetes and old people is the current senior health and fitness of influence, the serious disease that reduces the life of elderly person quality.At present, the medicine of the above-mentioned disease of many treatments, perhaps curative effect can not be satisfactory, and perhaps toxic and side effects is obvious.

Summary of the invention

The technical problem that the present invention will solve provides a kind of ability blood fat reducing, blood glucose, prevents and treats the pueraria isoflavone capsule (having another name called Hu Shi capsule at the age of one hundred years old) of hypertension, reduction thrombosis and safety non-toxic.

For solving the problems of the technologies described above, the present invention adopts following technical scheme:

Pueraria isoflavone capsule of the present invention is the Chinese medicine composition that is formed by Radix Notoginseng total arasaponins, Radix Salviae Miltiorrhizae extract, ligustrazine, Radix Puerariae extract, tea polyphenols, six kinds of combination of components of Grifola frondosa extract.Radix Notoginseng total arasaponins is the extract of the root of panax araliaceae plant Panaxotoginseng (Burk.) F.H.Chen, and the main active effective ingredient for Radix Notoginseng has blood circulation promoting and blood stasis dispelling, a demountable function of promoting blood circulation; Radix Salviae Miltiorrhizae extract is that the dry root and rhizome extraction of labiate Radix Salviae Miltiorrhizae Salvia miltio rrhiza Bge. processes; Be reddish brown toner art; Contain Tanshinone I, Tanshinone I I, dihydrotanshinone I, methylene tanshinquinone, Methyl tanshinoate, cryptotanshinone, protocatechuic acid, protocatechualdehyde etc.; Has stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, the effect of the relieving restlessness that clears away heart-fire; Ligustrazine has the effect of antiplatelet aggregation, expansion small artery, microcirculation improvement and cerebral blood flow; Radix Puerariae extract is the extract of leguminous plant Pueraria lobota (Herba Gelsemii Elegantis) Pueraria lobata (Wild) Ohwi dry root; Contain multiple flavones ingredient; Be rich in isoflavone such as puerarin, daidzin and daidzein etc. have the sclerosis of anticancer, prevention of arterial, improve effect such as osteoporosis; Tea polyphenols is the general name of catechin in the Folium Camelliae sinensis, acetone class, phenolic acids and anthocyan chemical compound, has very strong antioxidation, aging resistance effect; The Grifola frondosa extract has the effect of antitumor, resisting hypertension, blood sugar lowering, obesity, makes each component effect produce synergism these drug regimens, thereby reaches blood fat reducing, blood glucose, prevents and treats hypertension, reduces thrombotic therapeutic effect.More than six kinds of components all can buy through market, also can extract or separate to purify and make according to methods such as the Chinese herbal medicine extracting of routine, purifications.

The component of pueraria isoflavone capsule of the present invention has better curative effect during for following weight parts:

1 part of Radix Notoginseng total arasaponins, 1 part of Radix Salviae Miltiorrhizae extract, 1 part of ligustrazine, 1 part of Radix Puerariae extract, 0.5 part of tea polyphenols, 1 part of Grifola frondosa extract.

Further, each component meets following quality standard: Radix Notoginseng total arasaponins content is more than 80%; The Radix Salviae Miltiorrhizae extract specification is 10: 1, and promptly 10 kilograms of salvia miltiorrhiza raw materials make 1 kilogram of Radix Salviae Miltiorrhizae extract; Ligustrazine content is more than 98%; Radix Puerariae flavone content is more than 62% in the Radix Puerariae extract; Polyphenol content is 78%～82%; The Grifola frondosa polyoses content is more than 35% in the Grifola frondosa extract.

Further, polyphenol content is 80%.

The method for preparing of pueraria isoflavone capsule of the present invention is: after six kinds of components of above-mentioned weight portion were mixed, the snap fit capsule of packing into promptly got pueraria isoflavone capsule of the present invention (Hu Shi capsule at the age of one hundred years old).

Through adding various conventional adjuvants, like filler (like dextrin etc.), disintegrating agent, lubricant, binding agent etc., adopt conventional method of Chinese medicinal, also can be made into the peroral dosage form any commonly used except that capsule, like granule, tablet, pill etc.

Can process the preparation of different size according to actual needs according to above-mentioned method for preparing; For example can take by weighing Radix Notoginseng total arasaponins 10g, Radix Salviae Miltiorrhizae extract 10g, ligustrazine 10g, Radix Puerariae extract 10g, tea polyphenols 5g, Grifola frondosa extract 10g respectively; After fully mixing; Divide the snap fit capsule of packing into, process the capsule that specification is the 500mg/ grain.

The treatment senile dementia; During serious diseases such as the hypophrenia that causes behind the cerebral embolism, diabetes and the optimum hypophrenia of old people, consumption is each 2.5g, every day 2 times; Also can be according to the state of an illness adjustment taking dose of following the doctor's advice; All can obtain better curative effect to above-mentioned serious disease, recover self care ability after mild or moderate dementia patient was taken medicine 3 months, cure Parkinson's diseases etc. in 3～4 months.

The specific embodiment

Below come further to set forth the beneficial effect of medicine according to the invention, these Test Example to be the clinical observation on the therapeutic effect test of the pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) [specification is the 500mg/ grain] that the embodiment of the invention makes through Test Example.

The clinical observation on the therapeutic effect of [Test Example 1] medicine pueraria isoflavone capsule of the present invention (Hu Shi capsule at the age of one hundred years old) treatment hyperlipemia

One, clinical data

1, case is selected

(1) dyslipidemia person.Serum cholesterol (TC)>=6.5mmol/L or serum triglycerides (TG)>=1.54mmol/L, or HDL-C (HDL-C) male≤1.04mmol/L, women＜1.17mmol/L person can make a definite diagnosis.

(2) the unusual person of blood examination, i.e. WBV or plasma viscosity, or packed cell volume, or the Fibrinogen person can make a definite diagnosis.

(3) clinical symptoms.This group is observed case and is hyperlipemia, the common clinically obesity of most patients, and the limb fiber crops are heavy, and malaise is dizzy or nose heave, and cardiopalmus or uncomfortable in chest is forgetful, and tinnitus is indigestion and loss of appetite or nauseating, diarrhoea, tongue is greasy in vain, rolling pulse, or symptom such as stringy and rolling pulse.

2, physical data

(1) accept patient's totally 110 examples for medical treatment, male's 69 examples wherein, women's 41 examples, the man: the woman is 1.6: 1, the oldest 78 years old, minimum 30 years old, average 65 ± 17.4 years old.

(2) sick kind situation: coronary heart disease 51 examples, hypertension 45 examples, diabetes 6 examples, arrhythmia 3 examples, cerebral infarction 5 examples.

3, testing program

Each 5 of oral pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old), every day 2 times, six weeks were a course of treatment, filled out the observation form on request, took medicine on request and checked, at period in a medicine other relevant lipid lowerers and blood circulation promoting living silt medicine of stopping using.

4, observation index

(1) safety is observed

A, hematuria routine

B, liver function (SGPT)

C, renal function (BUN, Cr)

(2) health giving quality is observed

A, symptom curative effect

Subjective symptoms before and after the treatment: obesity, the limb fiber crops are heavy, and malaise is dizzy or nose heave, and cardiopalmus or uncomfortable in chest is forgetful, and tinnitus is indigestion and loss of appetite or nauseating, diarrhoea, tongue is greasy in vain, rolling pulse, or stringy and rolling pulse, symptom is given the integration evaluation by the order of severity:

3 minutes---initiatively state symptom or appearance repeatedly

2 minutes---heavy or be interrupted appearance when light during symptom

1 minute---symptom or accidental the appearance

B, lab index curative effect

Serum lipids: TC, TG, HDL-C, HDL-G2, HDL-G3, LP (a)

Hemorheological property: WBV (high shear rate, low shear rate), plasma viscosity, packed cell volume, erythrocyte sedimentation rate, Fibrinogen

5, efficacy assessment standard

Combine clinical practice according to " new drug (Chinese medicine) clinical research guideline ", formulate following synthetic determination curative effect:

Produce effects---primary symptom all disappears with time disease; Or indivedual primary symptoms have clear improvement; Other primary and secondary diseases all disappear (by the symptom classification by +++or ++ transfer to+or-), blood lipid level reaches following each person: TC and descends >=20%, TG descends >=40%; HDL-G rising >=10mg/dl (0.25mmol), TC-HDL-G/HDL-C descends >=20%.

Effectively---primary symptom has clear improvement with time disease, or primary symptom do not have clear improvement, but inferior disease all disappears; (by the symptom classification, primary symptom by +++or ++ transfer to ++ or+, and inferior disease transfers to-); Blood lipid level reaches following each person: TC and descends 10%～20%; TG descends 20%～40%, and HDL-C raises, and (0.1～0.5mmol/L), TC-HDL-C/HDL-C descends 10%～20% to 4～10mg/dl.

Invalid---primary and secondary disease does not have improvement, and blood lipid level does not reach effective standard person.

Two, clinical test results

1, clinical efficacy

Produce effects 30 examples (27.2%), effective 61 examples (55.4%), total effective rate 82.6%.

2, take pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) back blood fat and improving situation

Table 1 pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) is to hyperlipemic patients blood lipids index influence (X ± S)

Project	The example number	Before the treatment	After the treatment	T value	P
						TC(mmol/L)	89	6.592±1.021	5.032±1.001	1.96	＜0.05
TG(mmol/L)	95	3.945±1.351	1.723±0.641	2.58	＜0.05
						HDL-C(mmol/L)	99	1.081±0.3172	1.470±0.2105	0.68	＜0.05
LP(a)(mg/L)	30	405±102	298±112	2.89	＜0.05
						TC-HDL-C/HDL-C	18	6.748±4.326	4.9509±1.265	1.91	＜0.01

Annotate: pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) is to having significant difference, P＜0.05 before and after cholesterol reducing, triglyceride, lipoprotein (a) treatment.

3, take pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) back hemorheology and improve situation

Table 2 pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) is to the influence of hemorheology index (X ± S)

Annotate: pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) is to hyperlipemia, and WBV, packed cell volume, Fibrinogen are treated all significances of front and back, P＜0.05.

Three, conclusion

Can know that from 110 routine Clinical results pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) has following efficacy result:

1, significantly, through statistical procedures P＜0.05, significance to cholesterol reducing, triglyceride, lipoprotein (a) effect.

2, to reduction hemorheological property WBV, packed cell volume, Fibrinogen significance (P＜0.05), thus microcirculation improvement, and the stasis of blood is turbid in the removing blood, dredges benefite channel and vessel.

3, pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) through clinical observation on the therapeutic effect is: produce effects 30 examples (27.2%), and effective 61 examples (55.4%), total effective rate reaches 82.6%.

And, do not see obvious toxicity through clinical trial.

[Test Example 2] medicine pueraria isoflavone capsule of the present invention (Hu Shi capsule at the age of one hundred years old) is to the clinical observation (30 routine randomized controlled observation) of old cognitive decline improvement effect

One, clinical data

1, case choice criteria: the above educational level of primary school, hypomnesis did not obviously increase the weight of the trend or the person of making slow progress but have more than 3 years.The personality emotion is normal, and the part thing is forgotten, but omnidirectional power and insight obstacle.Wechsler Memory Scale is the optimum hypomnesis of weight degree.

2, case exclusion standard:

(1) merges nerve, mental symptom or sign.

(2) severe cardiac, liver, kidney, abnormal pulmonary function person are arranged.

(3) age is less than 50 years old, greater than 80 years old.

3, sex

Table 3 treatment group and matched group sex distribution table

Annotate: use the T check.

Can find out that from last table treatment group and matched group have comparability in sex.

4, the age

Table 4 treatment group and matched group age distribution table

Annotate: use the T check.

Can find out that from last table treatment group and matched group have comparability in years.

5, schooling

Table 5 treatment group and matched group schooling distribution table

Annotate: use the T check

Can find out that from last table treatment group and matched group have comparability in schooling.

6, the state of an illness weight and the course of disease

Table 6 treatment group and matched group state of an illness weight and course of disease distribution table

Annotate: use the T check

Can find out that from last table treatment group and matched group have comparability at the state of an illness weight and the course of disease.

7, diagnostic criteria

Referring to Wechsler Memory Scale.Be the light optimum hypomnesis person of moderate.

Two, Therapeutic Method

1, clinical application, dosage:

Treatment group: pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old), each 2, every day 2 times.

Matched group: blank capsules (starch), each 2, every day 2 times.

When medication, do not add with various brain nutrient drugs, nootropics, cerebral vasodilators medicine.

2, the course of treatment: one month is a course of treatment.

3, curative effect judging standard

Produce effects: MQ increment >=blank group increment meansigma methods (X)+1/2 blank group value added criterion poor (S), promptly >=(4.4+8.8x1.5=17.6) 18.

Effectively: 9＜MQ＜18 minute.

Invalid: MQ＜9 minute.

Three, therapeutic outcome

1, memory function is improved situation (seeing table 7)

Table 7 memory function is improved situation

Annotate: use the T check.

Visible from last table, pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) improves significantly to memory function.

2, total effects table (seeing the following form 8)

Annotate: use X ²Check

Table 8 prompting Hu Shi capsular curative effect at the age of one hundred years old obviously is superior to matched group.

3, safety indexes (seeing the following form 9)

Four, conclusion

1, find that through above-mentioned observation pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) goes down to improving memory of elderly person power, the treatment group is compared with matched group, and the improvement of each item index is all variant, and except that 100-1, accumulation and picture, the difference of highly significant is arranged all.From effective percentage pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) total effective rate is 76.66%, and the effective percentage of matched group is 36.66%, and there were significant differences between the two.Explain that pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) has good effect to the hypomnesis that improves the old people.

2, make discovery from observation pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) take before and after renal function, liver function, electrocardiogram, routine blood test, routine urinalysis, stool routine all no abnormal, pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) safety non-toxic side reaction is described.

In sum, pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old) comprises neurotrophic factor, can stop the brain cell atrophy, and the patient is improved and improves one's memory, and anti-brain fag has clear and definite effect, and safety non-toxic.

The case report therapeutic scheme of [Test Example 3] medicine pueraria isoflavone capsule of the present invention (Hu Shi capsule at the age of one hundred years old) treatment senile dementia: oral pueraria isoflavone capsule (Hu Shi capsule at the age of one hundred years old), each 5, every day 2 times

Case 1: woman, 75 years old

Concise and to the point medical history---patient because of suffer from hypertension, diabetes, slightly the function and thinking obstacle is admitted to hospital.Be admitted to hospital after observe, the anti-bradykinesia of patient talks incoherently, inarticulateness, and gatism, be unable to leave the bed daytime, and nighttime sleep is relatively poor, and the brain CT examination is a left side temporal lobe malacosis, senile dementia.

After beginning oral Hu Shi capsule at the age of one hundred years old on June 28th, 99, in second week, patient's symptom begins to improve, and defecation basically can automatic control.After one month, defecation can be controlled fully, can every day get up and other old man's chats, and thinking is more clear, can be more complete, state the cause and effect of something.

Case 2: woman, 76 years old

Concise and to the point medical history: the patient is admitted to hospital because of suffering from senile dementia.Be admitted to hospital after treat nursing, the state of an illness is basicly stable.From beginning the year before, function and thinking serious hindrance, obnubilation, emotional instability, gatism was reluctant feed in nearly 3～4 months, can not sit up straight, and was unable to leave the bed, daily life can not be taken care of oneself fully.

On June 28th, 99 began oral Hu Shi capsule at the age of one hundred years old, and after the week, patient's appetite is promoted, and after second week, can stand up to sit up straight, and can answer simple the enquirement.After January, defecation basically can automatic control.After two months, can take food voluntarily, do some simple talk with the nursing staff.

Case 3: man, 83 years old

Concise and to the point medical history: the patient suffers from senile dementia, and the back situation of being admitted to hospital is unstable, and the speech thinking is unclear, can't talk with the people, and daily life can not be taken care of oneself fully.After develop into gradually sagging, sialorrhea, apathetic expression can not be walked.

Behind the oral Hu Shi capsule at the age of one hundred years old, second week rose, and can answer other people and put question to, and can simply talk, and memory makes moderate progress, the next day can state the fact day before yesterday, can square one's shoulders and sit up straight, head is not sagging.Under other people assisting in, can in the corridor, walk.

Case 4: man, 71 years old

Concise and to the point medical history: the patient is because of cerebral infarction, and the right side limbs are stiff, bradykinesia, and the slight obstacle of function and thinking, gatism, after being admitted to hospital, hypomnesis is obvious, the forfeiture digital concept, 20 can't count clearly with interior number.

Behind the oral Hu Shi capsule at the age of one hundred years old, in second week, 50 is denumerable clear with interior number.The 3rd week rose, and 20 can carry out computing with interior addition and subtraction.After January, 50 can carry out computing with interior addition and subtraction, and function and thinking makes moderate progress.The automatic control of defecation ability on daytime can answer the question and be ready to talk with the household.

Case 5: man, 84 years old

Concise and to the point medical history: the patient suffers from senile dementia.Promptly find patient's emotional instability after being admitted to hospital, short-tempered, often be trival matters and other old man's quarrels with the chamber, often take a lift voluntarily and go out, quarrel with the entrance guard.

Behind the oral Hu Shi capsule at the age of one hundred years old, first week rose, and patient's emotion is promptly stable to some extent, and second week rose, and temper takes a turn for the better gradually, can chat with other old men and nursing staff, and language fluency degree and computing capability improve, and after thought is dredged, are willing to partner treatment.

Sum up: through one month treatment, patient's function and thinking obstacle, hypomnesis all be improved significantly, the patient that can not take care of oneself to gatism, daily life especially has better curative effect.

The preparation of [embodiment] pueraria isoflavone capsule of the present invention (Hu Shi capsule at the age of one hundred years old)

Take by weighing Radix Notoginseng total arasaponins 10g, Radix Salviae Miltiorrhizae extract 10g, ligustrazine 10g, Radix Puerariae extract 10g, tea polyphenols 5g, Grifola frondosa extract 10g respectively; After fully mixing; By every for the specification of 500mg is respectively charged into snap fit capsule, promptly get pueraria isoflavone capsule of the present invention (Hu Shi capsule at the age of one hundred years old).

Above-mentioned Radix Notoginseng total arasaponins, Radix Salviae Miltiorrhizae extract, ligustrazine, Radix Puerariae extract, tea polyphenols, Grifola frondosa extract are all buied through market.Each component meets following quality standard: Radix Notoginseng total arasaponins content is 80%; The specification of Radix Salviae Miltiorrhizae extract is 10: 1; Ligustrazine content is 98%; Radix Puerariae flavone content is 62% in the Radix Puerariae extract; Polyphenol content is 80%; The Grifola frondosa polyoses content is 35% in the Grifola frondosa extract.

Above-mentioned description to embodiment is can understand and use the present invention for the ease of the those of ordinary skill of this technical field.The personnel of skilled obviously can easily make various modifications to these embodiment, and needn't pass through performing creative labour being applied in the General Principle of this explanation among other embodiment.Therefore, the invention is not restricted to the embodiment here, those skilled in the art should be within protection scope of the present invention for improvement and modification that the present invention makes according to announcement of the present invention.

Claims

1. pueraria isoflavone capsule; It is characterized in that: the effective ingredient in this capsule softgel shell is combined 1 part of Radix Notoginseng total arasaponins, 1 part of Radix Salviae Miltiorrhizae extract, 1 part of ligustrazine, 1 part of Radix Puerariae extract, 0.5 part of tea polyphenols, 1 part of Grifola frondosa extract by following components in part by weight.

2. pueraria isoflavone capsule according to claim 1 is characterized in that: said each component meets following quality standard, and Radix Notoginseng total arasaponins content is more than 80%; The specification of Radix Salviae Miltiorrhizae extract is 10: 1, and promptly 10 kilograms of salvia miltiorrhiza raw materials make 1 kilogram of Radix Salviae Miltiorrhizae extract; Ligustrazine content is more than 98%; Radix Puerariae flavone content is more than 62% in the Radix Puerariae extract; Polyphenol content is 78%～82%; The Grifola frondosa polyoses content is more than 35% in the Grifola frondosa extract.

3. pueraria isoflavone capsule according to claim 1 and 2 is characterized in that: polyphenol content is 80%.