CN103191216B - A kind of pharmaceutical composition of the treatment apoplexy containing Radix Ginseng and preparation thereof - Google Patents

Abstract

The invention discloses a kind of pharmaceutical composition and preparation thereof for the treatment of apoplexy.Pharmaceutical composition of the present invention is the pure Chinese medicinal preparation be made up of Radix Ginseng, Flos Carthami, Semen Persicae, Radix Paeoniae Rubra, Pheretima, proves that this pharmaceutical composition has benefiting QI for activating blood circulation, eliminating blood stasis and smoothing collaterals effect, be applicable to the paralytic of apoplexy particularly Qi deficiency blood stasis type by test.

Description

A kind of pharmaceutical composition of the treatment apoplexy containing Radix Ginseng and preparation thereof

Technical field

The present invention relates to pharmaceutical composition and the preparation thereof of the treatment apoplexy containing Radix Ginseng, belong to technical field of medicine.

Background technology

The understanding of motherland's medical science to apoplexy has a long history, the aspects such as the cause of disease, pathogenesis, diagnosis, treatment of ancient Chinese medicine doctor to apoplexy has abundant record, and many theories and square medicine, so far still in wide clinical application, are that clinical accumulation is enriched, treatment means is various, determined curative effect.But because of book a lot of, and each doctor's viewpoint is not the same, and apoplexy relates to multiple internal organs in addition, and syndrome performance and change are also rather complicated, and pathogenesis is also different, treats rather thorny.Therefore how to utilize modern scientific research means, high level, expeditiously correlational study is carried out to apoplexy and naturally receive much attention.

Before Tang and Song Dynasty, based on " exogenous wind " theory, how to set forth one's views from " interior exogenous pathogen ", think that apoplexy is true QI-insufficiency, venation is hollow, and ailment said due to cold or exposure is taken advantage of a weak point in opponent's defence caused by invasion and attack.After Tang and Song Dynasty, set forth one's views with " endogenous wind ", the apoplexy etiology and pathogenesis progressively forming " wind " " fire " " expectorant " " gas " " stasis of blood " " void " is seen, and wherein, " wind " comprises the climate change factors such as exogenous wind and Nei Sheng liver-wind two aspects; " fire " comprises liver-fire, heart-fire, stagnated QI transforming into fire etc.; " gas " comprises the seven emotions such as the stagnation of QI, dysphagia related to QI disorder emotional factors; " expectorant " comprises raw in phlegm-damp and fertile people's excessive phlegm etc.; " stasis of blood " comprises blood stasis and blood circulating out of vessels stasis blocking in brain etc.; " void " comprises the deficiency of vital energy and the hepatic and renal YIN deficiency.Perfect apoplexy morbidity theory is because learning a qualitative leap of understanding to apoplexy.

Modern Chinese medicine think apoplexy many due to or worn with age, or overstrain internal injury, or prolonged illness deficiency of qi and blood, or hobby greasy and surfeit flavour and tobacco and wine, make visceral dysfunction.If the body of the hepatic and renal YIN deficiency, then the moon sun not processed, YANG overacting in the uppper part, YIN-deficiency in the lower part, meets inducement and touches, as climate change, overaction of the five emotions etc., liver-yang is opened cruelly, interior pneumatic more, or alter meridians in wind-fire folder expectorant; Or QI and blood is disorderly inverse, upper criminal's brain arteries and veins, clear key obturation is sent out as apoplexy.If the body of deficiency of qi and blood, or deficiency of vital energy fortune blood is unable, and the blood vessels stasis of blood is stagnant, numbness resistance brain arteries and veins; Or deficiency of qi and blood, brain arteries and veins loses supports, and thrombosis is sent out as apoplexy.If the body accumulate in phlegm-damp, or the turbid interior life of expectorant, stop in blood stasis, because expectorant causes the stasis of blood, phlegm and blood stasis, upper heap soil or fertilizer over and around the roots brain arteries and veins, interior stagnant passages through which vital energy circulates, numbness choke blood; Or raw in phlegm-damp, when liver-wind stirring up internally, phlegm-damp borrows the gesture of wind sun superinverse, inaccessible clear key; Or phlegm-damp accumulates heat-transformation of a specified duration, combination of phlegm and heat, the clear key of folder wind-yang and up-boring, numbness hinders brain arteries and veins and sends out as apoplexy.

In a word, primary disease belongs to the time of deficiency in origin and excess in superficiality, visceral dysfunction, the hepatic and renal YIN deficiency, deficiency of qi and blood for cause a disease this, wind, fire, expectorant, the stasis of blood are the mark of morbidity, and both can reciprocal causation, mutually transforms.Its change of pathogenesis, is decided by the prosperity and decline of the pathogenic factor such as wind, fire, expectorant, the stasis of blood and human righteousness, acute stage pathogen sparrow hawk open, brain BI-syndrome involved the blood vessels hinders, if healthy energy does not wane, heat is clear, wind puts out, expectorant, the stasis of blood are dispelled to borrow the machine for the treatment of to make, then sb.'s illness took a favorable turn and become to healing; If healthy energy first declines, pathogen crosses Sheng, and key closes not open, and function is disorderly, and QI and blood consumption wound, vigour loses de-, then the state of an illness is critical.Convalescent period, though pathogenic factor subtracts greatly, healthy energy is hindered, the people especially old, brain is hollow, and deficiency of both QI and blood is multiple, wind, fire, expectorant, the stasis of blood still retention in the meridians and collaterals, and often see that hemiplegia, dispute Wai are oblique, the not smoothgoing card such as puckery, dull-witted of speech.

The Therapeutic Principle of apoplexy should under organic conception and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs instruct, and in conjunction with the course of disease stage, the factors such as morbidity season, giving treatment in accordance with seasonal conditions, giving treatment in accordance with the patient’s individuality, namely emphasizes integration and individualized treatment.So-called integration treatment, requiring that we are when being familiar with apoplexy, should be conceived to entirety, regulate whole body, note influencing each other of complication, and not solely for brain lesions, man and nature circle being also unified entirety, so also want giving treatment in accordance with seasonal conditions simultaneously.In addition, because everyone physical factors is different, incidence is also each heavy to some extent, so want determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, varies with each individual, i.e. individualized treatment.See there is liver-wind stirring up internally as clinical, have again meridian stasis concurrently stagnant, work as symptomatic treatment in acute condition, first based on suppressing the hyperactive liver to relieve the wind syndrome, treat that endogenous wind is flat and put out, continue with dredging the meridian, receive merit with the method for liver and kidney tonifying eventually.And for example existing deficiency of both QI and YIN, qi depression to blood stasis of holding concurrently again, the real expectorant heat of internal organs, control the method when urgently needed eliminating phlegm by purgation in the bowels, make internal organs gas clear and coherent, turbid pathogen must fall, then with tonification, blood stasis dispelling is mutually double controls it.

Summary of the invention

The object of the invention is to provide a kind of pharmaceutical composition for the treatment of apoplexy, and described pharmaceutical composition is made up of the crude drug of following weight portion:

Radix Ginseng 634-962, Flos Carthami 797-1200, Semen Persicae 799-1202, Radix Paeoniae Rubra 635-965, Pheretima 531-804.

Be preferably:

Radix Ginseng 634, Flos Carthami 1200, Semen Persicae 799, Radix Paeoniae Rubra 965, Pheretima 531.

Or:

Radix Ginseng 962, Flos Carthami 797, Semen Persicae 1202, Radix Paeoniae Rubra 635, Pheretima 804.

Or:

Radix Ginseng 800, Flos Carthami 1000, Semen Persicae 1000, Radix Paeoniae Rubra 800, Pheretima 667.

Or:

Radix Ginseng 893, Flos Carthami 854, Semen Persicae 999, Radix Paeoniae Rubra 793, Pheretima 732.

Or:

Radix Ginseng 674, Flos Carthami 1006, Semen Persicae 950, Radix Paeoniae Rubra 960, Pheretima 580.

Or:

Radix Ginseng 808, Flos Carthami 1005, Semen Persicae 1099, Radix Paeoniae Rubra 677, Pheretima 658.

Or:

Radix Ginseng 807, Flos Carthami 1170, Semen Persicae 821, Radix Paeoniae Rubra 797, Pheretima 661.

Experiment proved invention pharmaceutical composition all has significant curative effect for all pattern of syndrome of apoplexy, but especially good for Qi deficiency blood stasis type apoplexy curative effect, therefore the pattern of syndrome of the apoplexy of being treated is preferably blood stasis due to qi deficiency pattern of syndrome.

Another object of the present invention is to provide the pharmaceutical dosage form of this pharmaceutical composition, pharmaceutical composition of the present invention can according to preparation conventional method in theory, such as, the preparation technology that Fan Biting " pharmacy of Chinese materia medica " (Shanghai Science Press 1997 December the 1st edition) records, make any dosage form, be preferably as decoction, capsule, tablet, granule, powder or pill according to its applicable object and indication.

For enabling above-mentioned dosage form realize, the acceptable adjuvant of pharmacy need be added when preparing these dosage forms, such as: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, acetic acid chloroethene are fixed, Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods; Substrate comprises: PEG6000, PEG4000, insect wax etc.

The consumption of pharmaceutical composition of the present invention, is converted to the weight of raw medicinal material, is 50-80 gram every day, divides and takes for 2-4 time, is preferably every day 64 grams, divides and takes for 2 times.

For the curative effect of proved invention pharmaceutical composition, carry out following clinical trial:

1 data and method

1.1 case selections Hebei Yi Ling hospital outpatient and be diagnosed as apoplexy in hospital patient as the object of observation.

1.1.1 blood stasis due to qi deficiency pattern of syndrome apoplexy diagnostic criteria

1.1.2 with reference to the diagnostic criteria of " tcm internal medicine commonly encountered diseases practice guidelines Chinese medical disease part " blood stasis due to qi deficiency pattern of syndrome apoplexy of China Association of Traditional Chinese Medicine's promulgation, as follows:

1. meet apoplexy diagnostic criteria: clinical manifestation is mind unconsciousness, hemiplegia, crooked mouth and tongue, the stuttering puckery or language of speech is not expressed one's ideas, even in silence, and hemianesthesia; Or there is headache, dizzy, pupil god change, drinking-water is sent out and is choked, order not wink partially, gait difficulty etc.

2. blood stasis due to qi deficiency pattern of syndrome diagnostic criteria: pathogenesis is positive QI-insufficiency, hematogenous blockage, the stagnant brain arteries and veins of the stasis of blood, retardance meridians; Syndrome shows as hemiplegia, crooked mouth and tongue, and speech is stuttering puckery or in silence, hemianesthesia, and face color Koushi is white, and shortness of breath and fatigue, from sweating, cardiopalmus loose stool, brothers' swelling, dimly pale tongue, has indentation, white and greasy fur, deep-thready pulse.

1.1.3 case inclusion criteria

Meet apoplexy diagnostic criteria, and possess following condition person, be classified as study subject.

1. the age (men and women does not limit) between 18 ~ 70 years old; 2. Informed choice letter of consent is filled in voluntarily, the person and the experimental check that can accept to treat, treatment is relevant also can not answered a question strictly according to the facts.

1.1.4 case exclusion standard

1. to have a blood test AntiHIV1 RT activity positive clearly;

2. other diseases has a strong impact on its quality of life person, if any the serious heart, brain, kidney, pulmonary dysfunction and severe diabetes, because ascites occurred hepatopathy, hepatic encephalopathy, Esophageal fundus gastricus variceal bleeding, hypersplenism, spontaneous peritonitis, hepatorenal syndrome, liver lung syndrome, wound, chronic gastritis etc.

4. illiteracy or spiritedness disease, gestation and age of sucking patient and compliance difference can not coordinate this researcher;

1.1.5 case rejects standard

Not by regulation medication and observation, or non-drug factor and therapy discontinued, curative effect cannot be judged, or because of data complete, affect the treatment and safety judgement person.

1.2 dosage regimen

To patient 216 example of inclusion criteria be met, be divided into each 72 examples of matched group, curing apoplexy group, Qi deficiency blood stasis type treatment group at random.The Experience of Combined Treatment of Internal Medicines such as three groups of patient's nutrition cranial nerve, reduction cerebral edemas.Curing apoplexy group, the Qi deficiency blood stasis type treatment group decoction (Shijiazhuang Yiling Pharmaceutical Co., Ltd's decoction room provides) 2 bags made of the oral prescription according to embodiment 1 and method respectively on treatment of control group basis, 2 times/day, the course for the treatment of is 6 months.Follow up a case by regular visits to.

1.3 observation index

This test MAIN OUTCOME MEASURES be apoplexy score and TCM syndrome score [Zheng Xiao cornel. new Chinese medicine guideline of clinical investigations [M]. Beijing: China Medical Science Press; 2002:99-104.], secondary observation index is the indexs such as various symptom, sign, hemorheology; Safety indexes is glutamate pyruvate transaminase, creatinine, blood urea nitrogen, routine blood test, routine urinalysis, stool routine, electrocardiogram.

2 curative effect judging standards

2.1 apoplexy score criterions

2.1.1 fully recover: apoplexy score deduction rate >=90%, disability degree 0 grade.

2.1.2 effective: apoplexy score deduction rate 46% ~ 89%, disability degree 1 ~ 3 grade;

2.1.3 effective: apoplexy score deduction rate 18% ~ 45%.

2.1.4 invalid: within apoplexy score deduction rate ± 18%.

2.1.5 worsen: apoplexy is scored increase by more than 18%.

2.2 TCM syndrome criterions

2.2.1 fully recover: TCM syndrome integration deduction rate >=95%.

2.2.2 effective: TCM syndrome integration deduction rate >=70%.

2.2.3 effective: TCM syndrome integration deduction rate >=30%.

2.2.4 invalid: TCM syndrome integration deduction rate <30%.

3 statistical methods

This test will adopt optimal efficiency analysis, and all statistical test all adopt two-sided test, by using P≤0.05 as judging that difference has the standard of statistical significance.

4 interpretation of result apoplexy blood stasis due to qi deficiency pattern of syndrome new recipes are to treatment apoplexy determined curative effect.

4.1 apoplexy score comparitive study are in table 1.

Rear each treatment group treated by table 1 and the score of matched group apoplexy is compared

Group	Number of cases	Recovery from illness/example/%	Effective/example/%	Effectively/example/%	Invalid/example/%	Effective percentage/example/%
							Matched group	72	0(0)	21(29.2)	5(6.9)	24(33.3)	48(66.7)
Curing apoplexy group	72	2(2.8)	32(44.4)	22(30.6)	16(22.2)	56(77.8)
							Qi deficiency blood stasis type treatment group	72	3(4.2)	37(51.4)	25(34.7)	7(9.7)	65(90.3)

Note: between group, effective percentage compares: P<0.05, compares with matched group and has statistical significance, and each treatment group curative effect is all better than matched group.P<0.05, compares with curing apoplexy group and has statistical significance, and Qi deficiency blood stasis type treatment group curative effect is better than curing apoplexy group.

4.2 TCM syndrome comparitive study are in table 2.

After table 2 is treated, each treatment group and matched group TCM syndrome comparitive study

Group	Number of cases	Recovery from illness/example/%	Effective/example/%	Effectively/example/%	Invalid/example/%	Effective percentage/example/%
							Matched group	72	0(0)	24(3.3)	30(41.7)	18(25)	54(75)
Curing apoplexy group	72	1(1.4)	32(44.4)	29(40.3)	10(13.9)	62(86.1)
							Qi deficiency blood stasis type treatment group	72	1(1.4)	33(45.8)	34(47.2)	4(5.6)	68(94.4)

Note: between group, effective percentage compares: P<0.05, compares with matched group and has statistical significance, and each treatment group curative effect is all better than matched group.P<0.05, compares with curing apoplexy group and has statistical significance, and Qi deficiency blood stasis type treatment group curative effect is better than curing apoplexy group.

5 conclusions

Pharmaceutical composition of the present invention excavates the new drug preparation drawn under Traditional Chinese medical theory instructs, and has benefiting QI for activating blood circulation, eliminating blood stasis and smoothing collaterals effect, be applicable to apoplexy, be specially adapted to the blood stasis due to qi deficiency pattern of syndrome of apoplexy.Pharmacodynamics result of study confirms, this pharmaceutical composition has and improves cerebral ischemia, inhibition thrombosis, increase cerebral blood flow, reduces platelet aggregation, increases fibrinolytic, improves microcirculation, improves the effects such as hemorheology.Toxicological experiment does not find obvious toxicity.Comprehensive above situation susceptible of proof medicine composite for curing apoplexy of the present invention, especially Qi deficiency blood stasis type apoplexy determined curative effect, use safety.

Detailed description of the invention

Embodiment 1:

A) crude drug formula is:

Radix Ginseng 800g, Flos Carthami 1000g, Semen Persicae 1000g, Radix Paeoniae Rubra 800g, Pheretima 667g;

B) preparation process:

Take to dry according to formula and select clean medical material, add water to and no medical material, soaks 30 minutes, heated and boiled 40 minutes, inclines and medicinal liquid, then adds water to and do not have medical material, heated and boiled 1 hour, filtration, and merging medicinal liquid, is distributed into 67 bags, stored refrigerated.

Embodiment 2:

A) crude drug formula is:

Radix Ginseng 634g, Flos Carthami 1200g, Semen Persicae 799g, Radix Paeoniae Rubra 965g, Pheretima 531g;

B) preparation process:

Take to dry according to formula and select clean medical material, be jointly crushed to completely by 100 mesh sieves, be distributed into 133 bags.

Embodiment 3:

A) crude drug formula is:

Radix Ginseng 962g, Flos Carthami 797g, Semen Persicae 1202g, Radix Paeoniae Rubra 635g, Pheretima 804g;

B) preparation process:

Take to dry according to formula and select clean medical material, be jointly crushed to completely by 100 mesh sieves, making pellets by mixing medical powder with honey, make 500 balls.

Embodiment 4:

A) crude drug formula is:

Radix Ginseng 893g, Flos Carthami 854g, Semen Persicae 999g, Radix Paeoniae Rubra 793g, Pheretima 732g;

B) preparation process: take to dry according to formula and select clean medical material, Radix Ginseng, Flos Carthami, Semen Persicae, Radix Paeoniae Rubra are added 6 times of soak by water 2 times, each 1 hour, merge extractum, concentrated, dry, dry cream and Pheretima are pulverized jointly, granulate, incapsulate, make 1000 capsules.

Embodiment 5:

A) crude drug formula is:

Radix Ginseng 674g, Flos Carthami 1006g, Semen Persicae 950g, Radix Paeoniae Rubra 960g, Pheretima 580g;

B) preparation process:

Take to dry according to formula and select clean medical material, Radix Ginseng, Flos Carthami, Semen Persicae, Radix Paeoniae Rubra are added 8 times of soak by water 3 times, each 1.5 hours, merge extractum, concentrated, dry, dry cream and Pheretima are pulverized jointly, and granulate, tabletting, makes 1000 tablets of tablets.

Embodiment 6:

A) crude drug formula is:

Radix Ginseng 808g, Flos Carthami 1005g, Semen Persicae 1099g, Radix Paeoniae Rubra 677g, Pheretima 658g;

B) preparation process:

Take to dry according to formula and select clean medical material, Radix Ginseng, Flos Carthami, Semen Persicae, Radix Paeoniae Rubra, Pheretima are added 10 times of soak by water 3 times, each 2 hours, merge extractum, concentrated, dry, pulverize, granulate, be distributed into 200 bags, obtain granule.

Embodiment 7:

A) crude drug formula is:

Radix Ginseng 807g, Flos Carthami 1170g, Semen Persicae 821g, Radix Paeoniae Rubra 797g, Pheretima 661g;

B) preparation process:

Take to dry according to formula and select clean medical material, Radix Ginseng, Flos Carthami, Semen Persicae, Radix Paeoniae Rubra are added 12 times of soak by water 2 times, each 1.5 hours, merge extractum, concentrated, dry, dry cream and Pheretima are pulverized jointly, granulate, incapsulate, make 1000 capsules.

Claims (3)

1. treat a pharmaceutical composition for apoplexy, it is characterized in that this pharmaceutical composition is made by the following method:

A) crude drug formula is:

Radix Ginseng 800g, Flos Carthami 1000g, Semen Persicae 1000g, Radix Paeoniae Rubra 800g, Pheretima 667g;

B) preparation process:

Take to dry according to formula and select clean medical material, add water to and no medical material, soaks 30 minutes, heated and boiled 40 minutes, inclines and medicinal liquid, then adds water to and do not have medical material, heated and boiled 1 hour, filtration, and merging medicinal liquid, is distributed into 67 bags, stored refrigerated.

2. pharmaceutical composition as claimed in claim 1, is characterized in that the pattern of syndrome of described apoplexy is blood stasis due to qi deficiency pattern of syndrome.

3. pharmaceutical composition as claimed in claim 1, is characterized in that described pharmaceutical dosage form is decoction, capsule, tablet, granule, powder or pill.