CN100344318C - Medicine for treating apoplectic sequel and prepn. thereof - Google Patents

Abstract

The present invention discloses a medicine for treating sequelae of apoplexy, which is prepared from medicinal raw materials of ginseng, antler glue, tortoise, wolfberry fruits, turtle shells, leech, chuanxiong rhizome, rhubarb, haws, earthworms, scorpions, multibanded kraits, gastrodia tuber, bombyx batryticatus and borneol. The present invention also relates to a method for preparing the medicinal raw materials into capsulated agents.

Description

A kind of medicine for treating stroke sequelae and preparation method thereof

technical field

The invention relates to a medicine for treating stroke sequelae and a preparation method thereof.

Background technique

Stroke is also called cerebrovascular disease, including ischemic stroke and hemorrhagic stroke. One of the characteristics of stroke is its high disability rate. Those patients whose lives are saved by early treatment often leave serious sequelae, the most common being complete and incomplete hemiplegia, hemiplegia, crooked eyes and mouth, slurred speech, spasms of hands and feet, numbness of limbs, edema of feet and knees, and incontinence , Muscle and bone pain, etc. These sequelae greatly endanger the quality of life of patients.

There is no specific drug for the treatment of stroke sequelae in the current medical field. The curative effect of the current clinically used drugs for the treatment of stroke sequelae is far from satisfactory, and it is very necessary to find drugs that are convenient to use and have better curative effects. Traditional Chinese medicine has its own characteristics and advantages in the treatment of stroke sequelae, and some Chinese patent medicines with their own characteristics and certain curative effects have emerged. However, these Chinese patent medicines generally have the disadvantages of low curative effect and slow onset. In many years of medical practice, the inventor has continuously researched and explored the treatment of stroke sequelae with traditional Chinese medicine, and has achieved technical achievements including the present invention.

Contents of the invention

The object of the present invention is to provide a medicine prepared from a traditional Chinese medicine composition, the preparation method of which is simple and economical, and has positive effect on the treatment of stroke sequelae.

The medicine of the present invention is made from the following medicinal effect raw materials in weight ratio:

Ginseng 45～50 Deer horn glue 20～25 Tortoise shell 33～38 Wolfberry 33～38

Turtle shell 33～38 Leech 45～50 Chuanxiong 33～38 Rhubarb 13～18

Hawthorn 25～30 Earthworm 25～30 Scorpion 25～30 Money snake 45～50

Gastrodia elata 33-38, silkworm 20-25, borneol 5-10.

The optimal weight ratio of the above raw materials is,

Ginseng 48 Deer Horn Glue 22 Tortoise Shell 36 Wolfberry 36 Turtle Shell 36 Leech 48

Chuanxiong 36 Rhubarb 15 Hawthorn 28 Earthworm 28 Scorpion 28

Money white snake 48 Gastrodia elata 36 silkworm 22 borneol 8.

The medicine of the present invention can be made into various dosage forms called in pharmacy with the above raw materials, and the most suitable dosage form is capsule. The process of making capsules is as follows:

Boil medlar and hawthorn, filter, and concentrate to form a thick paste; melt the antler gum and add it to the thick paste; crush ginseng, rhubarb, Gastrodia elata, and golden snake into coarse powder, and mix well with the above thick paste. Dry and then pulverize into fine powder; grind the tortoise shell, turtle shell, leech, earthworm, scorpion, stiff silkworm, and Chuanxiong into fine powder respectively; grind borneol into fine powder; mix and grind the fine powder obtained in the above steps, Sieve and divide into capsules.

The present invention aims at the pathogenesis of stroke caused by internal movement of liver wind, the more agitated and uncontrolled, the blood goes against the Qi, rushes upwards to the brain vessels, and blocks the brain orifices, and adopts the treatment principles of nourishing qi and kidney, promoting blood circulation and removing blood stasis, extinguishing wind and dredging collaterals . The formula uses ginseng to nourish the vitality, cultivate the essence and strengthen the foundation, and is used as the monarch medicine; deer antler glue nourishes the liver and kidney, and nourishes the essence and blood; Liver; turtle shell nourishes yin and suppresses yang, softens hard masses and dissipates stagnation. These four, deer antler glue nourishes yang, tortoise shell, medlar, and turtle shell nourish yin, the so-called yang is born from yin, yin is born from yang, yin and yang are supplemented, nourishing yin and helping yang, both are ministerial medicines, and cooperate with monarch medicine to nourish qi and nourish kidney , Peiyuan solidified. Accompanied by leeches to dispel blood stasis; rhubarb attack stagnant laxative, expelling stasis and activating collaterals; mountain peony to eliminate food stagnation, promote blood circulation and disperse stasis; Chuanxiong promote blood circulation and qi, dispel wind and relieve pain; earthworm and scorpion promote blood circulation and collaterals, quench wind and relieve spasm ; The money snake takes its internal organs, penetrates the skin externally, searches the wind through the bones, activates the collaterals and calms convulsions. Above all medicines promoting blood circulation and removing blood stasis, quenching wind and dredging collaterals are all adjuvants. Borneol is fragrant and pungent, resuscitates and refreshes the mind, and leads all medicines directly to the sick place, so it is believed to make. Taking a comprehensive view of the whole prescription, the root is treated by cultivating the essence, nourishing qi and tonifying the kidney, and treating the symptoms by promoting blood circulation to remove blood stasis, quenching wind and dredging collaterals, taking into account both the symptoms and symptoms, and playing the functions of nourishing qi and tonifying kidney, promoting blood circulation to remove blood stasis, quenching wind and dredging collaterals.

The good curative effect of the drug of the present invention in treating stroke sequelae is confirmed in the following experimental examples.

Experimental example Clinical curative effect observation of 100 cases of hemiplegia syndrome treated by the present invention

In order to evaluate the curative effect and safety of the medicament of the present invention in treating stroke sequelae, clinical verification was carried out by Henan Provincial Hospital of Traditional Chinese Medicine, Henan Provincial Academy of Traditional Chinese Medicine, and the First Affiliated Hospital of Henan College of Traditional Chinese Medicine. The summary report is as follows.

Materials and Methods

1. General Information

A total of 130 patients were observed, all of whom were stroke rehabilitation patients. Among them, there were 100 cases in the test group and 30 cases in the control group. Gender: 67 males and 33 females in the test group; 17 males and 13 females in the control group. Age: 62.14±5.94 years old in the test group; 62.81±5.39 years old in the control group. Disease course: the average disease course of the test group was 5.24±2.01 years; the average disease course of the control group was 5.60±1.26 years. After statistical test, the age, course of disease, degree of disease and neurological deficit were comparable between the two groups.

2. Case selection

1. Diagnostic criteria of western medicine: the onset usually occurs in a quiet state; most of them do not have obvious headache and vomiting; the onset can be slow, progress gradually, or progress in stages, mostly related to cerebral atherosclerosis, and can also be seen in arteritis , blood disease, etc.; generally clear consciousness or mild impairment 1 to 2 days after the onset; symptoms and signs of the internal carotid artery system and/or vertebral artery system; lumbar puncture cerebrospinal fluid should generally not contain blood; CT examination revealed the location of cerebral infarction .

2. TCM diagnostic criteria

①Main symptoms: hemiplegia, crooked mouth and tongue, dim look, strong tongue or speechlessness, numbness in one side of the body; ②Acute onset; ③The onset has predisposing factors, and there are aura symptoms before the onset; ④Aged over 40 years old.

With two or more main symptoms, combined with one of the remaining items, the diagnosis can be confirmed.

3. TCM Syndrome Differentiation

Qi deficiency and blood stagnation, kidney deficiency and essence deficiency: hemiplegia, crooked mouth and tongue, dysphasia, numbness of hands and feet, dizziness and tinnitus, soreness of waist and knees, dull tongue, thin white or white greasy coating, deep thready pulse.

Main symptoms: ① hemiplegia; ② soft waist and knees;

Secondary symptoms: ① crooked mouth and tongue; ② poor speech; ③ numbness in hands and feet; ④ dizziness and tinnitus;

Dialectical requirements

I. Those who have the main certificate ①② shall belong to this certificate;

II. Those who have both the main certificate ① and the secondary certificate are eligible for this certificate.

III. Those who have the main certificate ② and the secondary certificate ①② are the certificate.

4. Condition and course of disease: The vital signs and nervous system signs are stable, and the onset is more than 2 weeks.

2. Case criteria

1. Criteria for inclusion of cases: Those who meet the criteria for the diagnosis of stroke and cerebral thrombosis, TCM syndrome differentiation, disease condition and course of disease can be included in the experimental cases.

2. Criteria for exclusion of cases: ①transient ischemic attack; ②brain tumor, traumatic brain injury, brain parasitic disease, metabolic disorder, rheumatic heart disease, coronary heart disease and other heart diseases combined with atrial fibrillation. Those with embolism; ③ over 80 years old, pregnant or breastfeeding women, those who are allergic to this drug; ④ combined with serious primary diseases such as liver, kidney, hematopoietic system and endocrine system, and mental illness; Medication, the curative effect cannot be judged or the data is incomplete, which affects the curative effect or safety judgment.

3. Criteria for eliminating cases: Traditional Chinese medicine syndromes belong to hyperactivity of liver yang, wind-phlegm disturbance syndrome;

4. Group comparison

This experiment is divided into two groups, adopts random design, there is no significant difference in gender, age, condition, constitution, etc. between the two groups of patients, and they are comparable.

5. Drugs and usage

The test group took the capsules made according to Example 1 of the present invention, 4 capsules each time, 3 times a day. The control group took Hemiplegia Recovery Pills produced by Beijing Tongrentang Pharmaceutical Factory, 4 pills each time, 3 times a day. 30 days is a course of treatment, during which the antagonistic or synergistic drugs are stopped.

6. Observation indicators

1. Safety observation: ①General physical examination items; ②Routine blood, urine, and stool tests; ③Heart, liver, and kidney function tests; ④Hemostasis and coagulation function tests, including PT, TT, APTT, and FIB.

2. Observation of curative effect: ① Improvement degree of clinical symptoms and disappearance days. ② Nervous system shape. ③ head CT scan.

7. Efficacy Judgment Criteria

The curative effect was judged according to the changes of symptoms, signs and treatment points. The stroke scoring method, the starting point is no more than 18 points, and the curative effect score evaluation formula is:

Efficacy points [(points before treatment - points after treatment) ÷ points before treatment] × 100%

Recovery: Symptoms and signs disappear, basically able to live independently; or score ≥ 85%.

Significantly effective: symptoms and signs are improved, able to walk with a cane or take care of basic daily life; or score ≥ 50%.

Effective: partial disappearance of symptoms and signs, can stand up with the support of others, unable to take care of oneself; or score ≥ 20%.

Invalid: no change in symptoms and signs; or score <20%.

result

One. medicine of the present invention is to apoplexy cardinal syndrome and Chinese medicine symptom curative effect analysis, and the results are shown in Table 1.

Select 5 syndromes of stroke, including hemiplegia, crooked tongue, dysphasia, dizziness, tinnitus, soreness of waist and knees, etc. for statistical processing. There are significant differences (P<0.01), indicating that the medicine of the present invention has a significant improvement effect on the clinical syndromes of qi deficiency and blood stagnation and kidney deficiency and essence deficiency.

Table 1 Comparison of symptom improvement between the two groups (example) symptom group Number of cases disappear reduce no change Hemiplegia therapy group 94 16* 49* 29 control group 28 3 9 16 crooked tongue therapy group 85 19* 60* 6* control group 26 8 14 4 language disadvantage therapy group 68 14* 48* 6* control group 14 2 9 3 dizziness tinnitus therapy group 91 51* 33* 7* control group 19 8 9 6 Soreness of the waist and knees therapy group 96 80* 10* 6* control group 29 6 20 3

Note: Compared with the control group, *P<0.01.

2. Evaluation of clinical efficacy, the results are shown in Table 2.

Table 2 Comparison of curative effects between the two groups [case (%)] group Number of cases get well markedly effective efficient invalid total effective rate therapy group 100 46(46.00) 26(26.00) 10(10.00) 18(18.00) 82.00 control group 30 10(33.33) 6(20.00) 2(6.67) 12(40.00) 60.00

Note: Compared with the control group, *P<0.01

The recovery rate of patients treated with the medicine of the present invention is 46%, and the total effective rate is 82.0%, which are obviously better than those of the control group.

Three, the influence of medicine of the present invention on cranial CT

In the treatment group, cranial CT was reexamined one month after taking the medicine in 28 cases, and the infarct size shrunk in 6 cases, accounting for 21.43%. The clinical symptoms and signs of these 6 patients also improved significantly, which is consistent with the improvement of cranial CT.

4. Safety Observation

During the test, it was not found that the medicine of the present invention has obvious toxic and side effects. The PT and TT measurements in the treatment group were significantly longer than those in the control group (P<0.05), but both were within the safe range. There was no significant change in APTT and F1B between the two groups, both fluctuated within the normal value.

In a word, the drug of the present invention has a total effective rate of 82.00% and a recovery rate of 46% in the treatment of stroke sequelae. It can significantly improve symptoms such as hemiplegia, crooked mouth and tongue, dysphasia, dizziness, tinnitus, soreness of the waist and knees, etc., and cranial CT shows that it has a certain curative effect. , no toxic side effects were found.

Detailed ways

The present invention will be further described below through embodiment.

Example Weigh 48g of ginseng, 22g of deer horn glue, 36g of tortoise shell, 36g of medlar, 36g of turtle shell, 48g of leech, 36g of Chuanxiong, 15g of rhubarb, 28g of hawthorn, 28g of earthworm, 28g of scorpion, 48g of white snake, 36g of Gastrodia elata, Silkworm 22g, borneol 8g.

Add water to decoct wolfberry and hawthorn three times, decoct for 2 hours for the first time, decoct for 1 hour each for the second and third times, combine the decoction, filter, and condense into a thick paste; decoct the antler gum with an appropriate amount of decoction Mix it into the thick paste; crush ginseng, rhubarb, Gastrodia elata and golden snake into the coarsest powder, mix well with the above thick paste, dry, and then crush into fine powder; the rest of the raw materials are tortoise shell, turtle shell, leech, earthworm , scorpion, silkworm, and chuanxiong are crushed into fine powder, and borneol is ground into fine powder. The above-mentioned fine powders were mixed and ground, sieved, packed into capsules, and made into 1000 capsules. Adult patients take 3-5 capsules orally each time, 2-4 times a day.

Claims (3)

1. A medicine for the treatment of apoplexy sequelae, characterized in that the effective raw materials and weight proportions thereof are: Ginseng 45～50 Deer horn glue 20～25 Tortoise shell 33～38 Wolfberry 33～38 Turtle shell 33～38 Leech 45～50 Chuanxiong 33～38 Rhubarb 13～18 Hawthorn 25～30 Earthworm 25～30 Scorpion 25～30 Money snake 45～50 Gastrodia elata 33-38, silkworm 20-25, borneol 5-10. 2. medicine according to claim 1, is characterized in that, the weight proportion of used medicinal effect raw material is: Ginseng 48 Deer Horn Glue 22 Tortoise Shell 36 Wolfberry 36 Turtle Shell 36 Leech 48 Chuanxiong 36 Rhubarb 15 Hawthorn 28 Earthworm 28 Scorpion 28 Money white snake 48 Gastrodia elata 36 silkworm 22 borneol 8. 3. The preparation method of the described medicine according to claim 1 or 2, characterized in that, after decocting wolfberry fruit and hawthorn, decocting, filtering, and concentrating into a thick paste; melting the antler gum and blending it into the thick paste; mixing ginseng, rhubarb Crush the four medicines of Gastrodia elata, Gastrodia elata and Snake chrysalis into coarse powder, mix well with the above thick paste, dry, and then pulverize into fine powder; grind the seven medicines of tortoise shell, turtle shell, leech, earthworm, scorpion, silkworm, and chuanxiong respectively into a fine powder; the borneol is ground into a fine powder; the fine powder obtained in the above steps is mixed and ground, sieved, and packed into capsules.