CN1943749B - A Chinese traditional medicinal composition for treatment of Child's feeblemindedness of and its preparation method - Google Patents
A Chinese traditional medicinal composition for treatment of Child's feeblemindedness of and its preparation method Download PDFInfo
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Abstract
This invention discloses a compound Chinese herb in the domain of Chinese traditional medicine. The said compound is processes according to certain techniques by using a certain ratio of Radix Ginseng, Fructus Alpiniae Oxyphyllae, Pericarpium Citri Reticulatae Viride, Plastrum Testudinis, Fructus Lycii and Herba Menthae. This product has a good curative effect on children mental retardation. This invention also discloses preparation method of the compound at the same time.
Description
Technical field
The present invention relates to a kind of treatment children mental retardation Chinese medicine composition and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Mental retardation or claim mental retardation claims retardedly again, is meant in developmental stage that intelligence is lower than child's level of the same age and with the adaptive behavior defective.Add up according to The World Health Organization (WHO): any country in the world, any nationality, the prevalence of its mental retardation is all 1～3%.Calculate that in view of the above China mental retardation patient is 1,200 ten thousand～3,600 ten thousand.So numerous patients has brought greatest misery not only for patient and family, returns society and has caused heavy pressure, and directly reduced the population quality of China.Therefore, formulate prophylactico-therapeutic measures, reduce its prevalence, enhancement children ' s intelligence development level to greatest extent, have crucial meaning improving China's population quality, promotion society and expanding economy.
The traditional Chinese medical science is thought, causes the cause of disease of children mental retardation mainly to comprise: the natural endowment deficiency: kidney storing essence, comprise congenital essence and acquired essence, and if deficiency of essence endowed from father, a little less than female vim and vigour, then fetus is congenital has thanks to; Or father or mother have its disease to lose in fetus, causes the congenital deficiency of the liver and kindey of children's.The heart controlling mental and emotional activities, liver the chief instigator omit, kidney master intelligence and store essential substances, the smart marrow of giving birth to, fill on the marrow in brain, people's growth promoter, if the vital essence that the growth that comprises brain all needs kidney is hidden is congenital deficiency of the liver and kindey, then brain is not filled, brain do not have support and mental retardation, mostly this type of mentally retarded child is inherent.Acquired disposition: acquired essence that kidney is hidden derives from the vital organs of the human body, if the birth back is weak and sickly, or feeds imbalance, malnutrition or terrified tumbling down damage in brain, or difficult labour etc. when giving birth to, and all can cause the children's's deficiency day after tomorrow, be that kidney is hidden the acquired essence deficiency, be difficult to give birth to marrow and support brain and stare blankly.In addition, more than the acquired disposition with when childbirth maternal infuries and to give birth to the evil poison of back impression relevant.
The advantage and the characteristic of performance treatment by Chinese herbs primary disease, further investigation and exploitation both can improve patient's quality of life to this sick medicine, can produce very high economic benefit again, and the exploitation of this veriety has broad prospects, and will bring glad tidings for extensive patients.
Summary of the invention
One of purpose of the present invention provides a kind of Chinese medicine composition, can treat children mental retardation;
Two of purpose of the present invention provides the preparation method of this Chinese medicine composition.
The Chinese medicine composition that the present invention developed is to be made by the crude drug of following weight part ratio: Radix Ginseng 2-6, Fructus Alpiniae Oxyphyllae 4-12, Pericarpium Citri Reticulatae Viride 1-3, Carapax et Plastrum Testudinis 2-6, Fructus Lycii 2-6, Herba Menthae 0.5-2.
The above-mentioned raw materials optimum ratio is: Radix Ginseng 4, Fructus Alpiniae Oxyphyllae 8, Pericarpium Citri Reticulatae Viride 2, Carapax et Plastrum Testudinis 4, Fructus Lycii 4, Herba Menthae 1.
Aforementioned pharmaceutical compositions of the present invention adds the medicine correctives or/and drug excipient can be prepared into the pharmaceutical preparation that oral liquid, granule, tablet, capsule, soft capsule, pill etc. use clinically according to the Chinese medicine preparation technology of routine.Said medicine correctives is one or more the combination in sucrose, sodium benzoate, stevioside, the protein sugar, so that the medicament of prepared one-tenth has good mouthfeel, overcomes and produces abnormal flavour behind the above Chinese herbal medicine compatibility and be difficult to the drawback that enters the mouth or swallow.Said drug excipient is one or more the combination in dextrin, magnesium stearate, microcrystalline Cellulose, carboxymethyl starch sodium, starch, Pulvis Talci, sodium bicarbonate, Polyethylene Glycol, vegetable oil, propylene glycol, Cera Flava, the citric acid, with the oral formulations that medication preparation of the present invention is become to be convenient to take.
The preparation method of above medicine is as follows:
Get Radix Ginseng and add 30-80% ethanol, reflux, extract, 1-3 time, each 1-3 hour, filter, merging filtrate reclaims ethanol, and is standby; Other gets Fructus Alpiniae Oxyphyllae, Pericarpium Citri Reticulatae Viride, Herba Menthae, adds the water vapor distillation, collects volatile oil, and is standby; Residual liquid and residue add Fructus Lycii and decoct with water 1-3 time, and each 1-3 hour, gradation filtered, merging filtrate, and filtrate concentrates, and puts coldly, under agitation slowly adds ethanol, stirs, leave standstill, filtration, filtrate recycling ethanol, standby; Get Carapax et Plastrum Testudinis again and decoct with water 2-4 time, extracted 1-3 hour at every turn, filter, merging filtrate merges with above-mentioned clear paste and volatile oil, and mixing adds proper auxiliary materials, makes required dosage form.
Through further test, can obtain preferred technology:
Get Radix Ginseng and add 50% ethanol, the reflux, extract, secondary adds 4 times for the first time and measures 50% ethanol, adds 2 times of amounts of alcohol, 50% ethanol for the second time, extracts 2 hours at every turn, and gradation filters, merging filtrate, and recovery ethanol to relative density in the time of 80 ℃ is 1.05 clear paste, and is standby; Other gets Fructus Alpiniae Oxyphyllae, Pericarpium Citri Reticulatae Viride, Herba Menthae, adds the water vapor distillation, collects volatile oil, enclose, and drying, standby; Residual liquid and residue add Fructus Lycii and decoct with water secondary, add 10 times of amounts of water at every turn, decoct 2 hours for the first time, decocted 1.5 hours for the second time, gradation filters, merging filtrate, filtrate is concentrated into that relative density is the clear paste of 1.15-1.20 in the time of 80 ℃, puts coldly, under agitation slowly adds ethanol, make and contain alcohol amount and reach 70%, fully stir, left standstill 12 hours, filter, filtrate recycling ethanol to relative density in the time of 80 ℃ is 1.05 clear paste, and is standby; Get Carapax et Plastrum Testudinis again and add 8 times of water gagings decoctions three times, 2 hours for the first time, second and third time each 1.5 hours, gradation filters, and merging filtrate concentrates, and with above-mentioned clear paste merging, drying adds proper auxiliary materials, makes granule.
In order to estimate the curative effect of Chinese medicine composition of the present invention, it has been carried out pharmacological experiment study, be reported as follows:
Experimental example 1: to the influence experiment of learning and memory of little mouse
Method: with 60 of the qualified mices of diving tower method preliminary election, body weight 20 ± 2g, male entirely, be divided into 5 groups at random, 15 every group.Ig is subjected to reagent respectively, every day 1 time, successive administration 21 days.Ahau is trained every mice respectively 1 time with the diving tower method, begins to test and write down the errors number in (time of jumping off on diving tower) and the 5min of jumping off incubation period of every group of mice behind the 24h.The results are shown in Table 1.
Table 1 Chinese medicine composition to the influence of normal mouse learning and memory capacitation (X ± S, n=15)
Annotate: compare with the blank group:
*P＜0.01,
* *P＜0.001
The result: Chinese medicine composition can obviously strengthen ability of learning and memory in mice.
Experimental example 2: to the pentobarbital sodium influence experiment of the length of one's sleep
Method: 75 of mices, the male and female dual-purpose is divided into 5 groups at random.The high, medium and low dosage group of Chinese medicine composition gives 2.25g/kg respectively, 1.05mg/kg, and 0.45g crude drug/kg, the oral stable 2.5mg/kg of positive group, the NS group gives the co-content normal saline.30min after the administration, every group of mouse peritoneal injection pentobarbital sodium 40mg/kg.The length of one's sleep (with the righting reflex loss is time for falling asleep, is sleep time from righting reflex loss to recovery time) of record mice.The results are shown in Table 2.
Table 2 Chinese medicine composition to the pentobarbital sodium influence of the length of one's sleep (X ± S, n=15)
The result: Chinese medicine composition object height, middle dosage group can obviously prolong mice pentobarbital sodium length of one's sleep, with the NS group significant difference (P＜0.05) are arranged relatively.
Experimental example 3: Chinese medicine composition is to the influence experiment of mice autonomic activities
Method: get 75 of mices, be divided into 5 groups at random, 15/group, be respectively Chinese medicine composition group (0.45,1.05,2.25g crude drug kg-1), diazepam positive controls (4mgkg-1) and the blank group of 3 dosage by body weight.The administration volume is 0.3mL10g-1, the isometric distilled water of blank group ig.Place the free movable instrument of mice to adapt to 2min, autonomic activities number of times in the opening entry 5min mice behind the administration 1h.The results are shown in Table 3.
Table 3 Chinese medicine composition is to the influence of mice autonomic activities (X ± S)
Annotate: the t check:
* *P＜0.05,
* * *Compare with the blank group P＜0.01.
The result shows: Chinese medicine composition 2.25gkg-1 can obviously reduce mice autonomic activities number of times, compare with the blank group, and significant difference (P＜0.05), all the other 2 administration groups have effect trend, but no statistical significance.
Experimental example 4: Chinese medicine composition is to the sleep dosage influence experiment down of pentobarbital sodium threshold
Method: get 75 of mices, the male and female dual-purpose is divided into 5 groups at random.The high, medium and low dosage group of Chinese medicine composition gives 0.45g crude drug/kg respectively, 1.05g crude drug/kg, and 2.25g crude drug/kg, the oral stable 2.5mg/kg of positive group, the NS group gives the co-content normal saline.30min after the administration, each treated animal lumbar injection pentobarbital sodium 30mg/kg, the number of animals (to be index more than the righting reflex loss 1min) that observation is slept to each group generation in the 30min behind the pentobarbital sodium.The results are shown in Table 4.
Table 4 Chinese medicine composition is to the influence of sleep dosage down of mice pentobarbital sodium threshold
Annotate: the t check:
* *P＜0.05,
* * *Compare with the blank group P＜0.01.
The result shows that the Chinese medicine composition high dose group obviously increases the dosage of sleeping under the pentobarbital sodium threshold and causes sleeping number of mice (P＜0.05).
The specific embodiment
Embodiment 1:
Prescription: Radix Ginseng 50g Fructus Alpiniae Oxyphyllae 100g Pericarpium Citri Reticulatae Viride 25g
Carapax et Plastrum Testudinis 50g Fructus Lycii 50g Herba Menthae 12.5g
Method for making: above Six-element, give as one thinks fit cataclasmly, get Radix Ginseng and add 50% ethanol respectively, the reflux, extract, secondary, add for the first time pure 200ml, add pure 100ml for the second time, each extracted 2 hours, and gradation filters, merging filtrate reclaims ethanol to relative density and is the clear paste of 1.05 (80 ℃), and is standby.Other gets Fructus Alpiniae Oxyphyllae, Pericarpium Citri Reticulatae Viride, Herba Menthae, adds the water vapor distillation, collects the Aromatic water 250ml that contains volatile oil, and device is preserved in addition, and is standby.Residual liquid and residue add Fructus Lycii and decoct with water secondary, add 10 times of amounts of water at every turn, decoct 2 hours for the first time, decocted 1.5 hours for the second time, gradation filters, merging filtrate, filtrate is concentrated into the clear paste of relative density 1.15-1.20 (80 ℃), puts coldly, under agitation slowly adds ethanol, make and contain alcohol amount and reach 70%, fully stir, left standstill 12 hours, filter, filtrate recycling ethanol to relative density is the clear paste of 1.05 (80 ℃), and is standby.Get Carapax et Plastrum Testudinis again and add 8 times of water gagings decoctions three times, 2 hours for the first time, second and third time each 1.5 hours, gradation filters, and merging filtrate is concentrated into about 100ml, merge with above-mentioned clear paste and Aromatic water, add molasses plain 5g, sodium benzoate 3g, add water and be adjusted to 1000ml, cold preservation 24 hours, filter, packing, sterilization, promptly.
Embodiment 2:
Prescription: Radix Ginseng 250g Fructus Alpiniae Oxyphyllae 500g Pericarpium Citri Reticulatae Viride 125g
Carapax et Plastrum Testudinis 250g Fructus Lycii 250g Herba Menthae 62.5g
Method for making: above Six-element, give as one thinks fit cataclasmly, get Radix Ginseng and add 50% ethanol respectively, the reflux, extract, secondary, add for the first time pure 200ml, add pure 100ml for the second time, each extracted 2 hours, and gradation filters, merging filtrate reclaims ethanol to relative density and is the clear paste of 1.05 (80 ℃), and is standby.Other gets Fructus Alpiniae Oxyphyllae, Pericarpium Citri Reticulatae Viride, Herba Menthae, adds the water vapor distillation, collect to contain volatile oil, and the betacyclodextrin enclose, drying is pulverized, and is standby.Residual liquid and residue add Fructus Lycii and decoct with water secondary, add 10 times of amounts of water at every turn, decoct 2 hours for the first time, decocted 1.5 hours for the second time, gradation filters, merging filtrate, filtrate is concentrated into the clear paste of relative density 1.15-1.20 (80 ℃), puts coldly, under agitation slowly adds ethanol, make and contain alcohol amount and reach 70%, fully stir, left standstill 12 hours, filter, filtrate recycling ethanol to relative density is the clear paste of 1.05 (80 ℃), and is standby.Get Carapax et Plastrum Testudinis again and add 8 times of water gagings decoctions three times, 2 hours for the first time, second and third time each 1.5 hours, gradation filters, merging filtrate is concentrated into about 100ml, spray drying, spray powder adds above-mentioned volatile oil clathrate compound mixing, add lactose, dextrin, molasses element, mixing, dry-pressing is granulated, make 1000g, promptly.
Embodiment 3:
Prescription: Radix Ginseng 25g Fructus Alpiniae Oxyphyllae 50g Pericarpium Citri Reticulatae Viride 12.5g
Carapax et Plastrum Testudinis 25g Fructus Lycii 25g Herba Menthae 6.25g
Method for making: above Six-element, give as one thinks fit cataclasmly, get Radix Ginseng and add 50% ethanol respectively, the reflux, extract, secondary, add for the first time pure 200ml, add pure 100ml for the second time, each extracted 2 hours, and gradation filters, merging filtrate reclaims ethanol to relative density and is the clear paste of 1.05 (80 ℃), and is standby.Other gets Fructus Alpiniae Oxyphyllae, Pericarpium Citri Reticulatae Viride, Herba Menthae, adds the water vapor distillation, collect to contain volatile oil, and the betacyclodextrin enclose, drying is pulverized, and is standby.Residual liquid and residue add Fructus Lycii and decoct with water secondary, add 10 times of amounts of water at every turn, decoct 2 hours for the first time, decocted 1.5 hours for the second time, gradation filters, merging filtrate, filtrate is concentrated into the clear paste of relative density 1.15-1.20 (80 ℃), puts coldly, under agitation slowly adds ethanol, make and contain alcohol amount and reach 70%, fully stir, left standstill 12 hours, filter, filtrate recycling ethanol to relative density is the clear paste of 1.05 (80 ℃), and is standby.Get Carapax et Plastrum Testudinis again and add 8 times of water gagings decoctions three times, 2 hours for the first time, second and third time each 1.5 hours, gradation filters, and merging filtrate concentrates, drying is pulverized, and adds above-mentioned volatile oil clathrate compound, starch, and mixing is granulated, drying, granulate, filled capsules is made 1000, promptly.
Embodiment 4:
Prescription: Radix Ginseng 25g Fructus Alpiniae Oxyphyllae 50g Pericarpium Citri Reticulatae Viride 12.5g
Carapax et Plastrum Testudinis 25g Fructus Lycii 25g Herba Menthae 6.25g
Method for making: above Six-element, give as one thinks fit cataclasmly, get Radix Ginseng and add 50% ethanol respectively, the reflux, extract, secondary, add for the first time pure 200ml, add pure 100ml for the second time, each extracted 2 hours, and gradation filters, merging filtrate reclaims ethanol to relative density and is the clear paste of 1.05 (80 ℃), and is standby.Other gets Fructus Alpiniae Oxyphyllae, Pericarpium Citri Reticulatae Viride, Herba Menthae, adds the water vapor distillation, collect to contain volatile oil, and the betacyclodextrin enclose, drying is pulverized, and is standby.Residual liquid and residue add Fructus Lycii and decoct with water secondary, add 10 times of amounts of water at every turn, decoct 2 hours for the first time, decocted 1.5 hours for the second time, gradation filters, merging filtrate, filtrate is concentrated into the clear paste of relative density 1.15-1.20 (80 ℃), puts coldly, under agitation slowly adds ethanol, make and contain alcohol amount and reach 70%, fully stir, left standstill 12 hours, filter, filtrate recycling ethanol to relative density is the clear paste of 1.05 (80 ℃), and is standby.Get Carapax et Plastrum Testudinis again and add 8 times of water gagings decoctions three times, 2 hours for the first time, second and third time each 1.5 hours, gradation filters, and merging filtrate concentrates, drying is pulverized, and adds above-mentioned volatile oil clathrate compound, carboxymethylstach sodium, starch, and mixing is granulated, drying, granulate, tabletting is made 1000, promptly.
Embodiment 5:
Prescription: Radix Ginseng 25g Fructus Alpiniae Oxyphyllae 50g Pericarpium Citri Reticulatae Viride 12.5g
Carapax et Plastrum Testudinis 25g Fructus Lycii 25g Herba Menthae 6.25g
Method for making: above Six-element, give as one thinks fit cataclasmly, get Radix Ginseng and add 50% ethanol respectively, the reflux, extract, secondary, add for the first time pure 200ml, add pure 100ml for the second time, each extracted 2 hours, and gradation filters, merging filtrate reclaims ethanol to relative density and is the clear paste of 1.05 (80 ℃), and is standby.Other gets Fructus Alpiniae Oxyphyllae, Pericarpium Citri Reticulatae Viride, Herba Menthae, adds the water vapor distillation, collect to contain volatile oil, and the betacyclodextrin enclose, drying is pulverized, and is standby.Residual liquid and residue add Fructus Lycii and decoct with water secondary, add 10 times of amounts of water at every turn, decoct 2 hours for the first time, decocted 1.5 hours for the second time, gradation filters, merging filtrate, filtrate is concentrated into the clear paste of relative density 1.15-1.20 (80 ℃), puts coldly, under agitation slowly adds ethanol, make and contain alcohol amount and reach 70%, fully stir, left standstill 12 hours, filter, filtrate recycling ethanol to relative density is the clear paste of 1.05 (80 ℃), and is standby.Get Carapax et Plastrum Testudinis again and add 8 times of water gagings decoctions three times, 2 hours for the first time, second and third time each 1.5 hours, gradation filters, and merging filtrate concentrates, drying is pulverized, and adds above-mentioned volatile oil clathrate compound, and mixing sieves, add Cera Flava, vegetable oil, mixing, the compacting soft capsule is made 1000, promptly.
Embodiment 6:
Prescription: Radix Ginseng 500g Fructus Alpiniae Oxyphyllae 1000g Pericarpium Citri Reticulatae Viride 250g
Carapax et Plastrum Testudinis 500g Fructus Lycii 500g Herba Menthae 125g
Method for making: above Six-element, give as one thinks fit cataclasmly, get Radix Ginseng and add 50% ethanol respectively, the reflux, extract, secondary, add for the first time pure 200ml, add pure 100ml for the second time, each extracted 2 hours, and gradation filters, merging filtrate reclaims ethanol to relative density and is the clear paste of 1.05 (80 ℃), and is standby.Other gets Fructus Alpiniae Oxyphyllae, Pericarpium Citri Reticulatae Viride, Herba Menthae, adds the water vapor distillation, collects the Aromatic water 250ml that contains volatile oil, and device is preserved in addition, and is standby.Residual liquid and residue add Fructus Lycii and decoct with water secondary, add 10 times of amounts of water at every turn, decoct 2 hours for the first time, decocted 1.5 hours for the second time, gradation filters, merging filtrate, filtrate is concentrated into the clear paste of relative density 1.15-1.20 (80 ℃), puts coldly, under agitation slowly adds ethanol, make and contain alcohol amount and reach 70%, fully stir, left standstill 12 hours, filter, filtrate recycling ethanol to relative density is the clear paste of 1.05 (80 ℃), and is standby.Get Carapax et Plastrum Testudinis again and add 8 times of water gagings decoctions three times, 2 hours for the first time, second and third time each 1.5 hours, gradation filters, and merging filtrate concentrates, drying, pulverizing adds carboxymethylstach sodium, starch, and mixing is used water pill, makes 1000g, promptly.
Claims (5)
1. Chinese medicine composition is characterized in that said composition is to be made by the crude drug of following weight ratio:
Radix Ginseng 2-6, Fructus Alpiniae Oxyphyllae 4-12, Pericarpium Citri Reticulatae Viride 1-3, Carapax et Plastrum Testudinis 2-6, Fructus Lycii 2-6, Herba Menthae 0.5-2.
2. Chinese medicine composition as claimed in claim 1 is characterized in that the optimum weight ratio of each crude drug is:
Radix Ginseng 4, Fructus Alpiniae Oxyphyllae 8, Pericarpium Citri Reticulatae Viride 2, Carapax et Plastrum Testudinis 4, Fructus Lycii 4, Herba Menthae 1.
3. Chinese medicine composition as claimed in claim 1 or 2 is characterized in that said composition is made into oral liquid, granule, capsule, tablet or pill.
4. the preparation method of Chinese medicine composition as claimed in claim 3 is characterized in that passing through following steps:
Get Radix Ginseng and add 30-80% ethanol, reflux, extract, 1-3 time, each 1-3 hour, filter, relative density is 1.05 clear paste when merging filtrate, recovery ethanol to 80 ℃, and is standby; Other gets Fructus Alpiniae Oxyphyllae, Pericarpium Citri Reticulatae Viride, Herba Menthae, adds the water vapor distillation, collects volatile oil, and is standby; Residual liquid and residue add Fructus Lycii and decoct with water 1-3 time, and each 1-3 hour, gradation filtered, merging filtrate, and filtrate concentrates, and puts coldly, adds ethanol, stirs, leave standstill, filtration, relative density is 1.05 clear paste during filtrate recycling ethanol to 80 ℃, and is standby; Get Carapax et Plastrum Testudinis again and decoct with water 2-4 time, extracted 1-3 hour at every turn, filter, merging filtrate merges with above-mentioned clear paste and volatile oil, and mixing adds proper auxiliary materials, makes required dosage form.
5. Chinese medicine composition as claimed in claim 1 or 2 is used for the treatment of application in the children mental retardation medicine in preparation.
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| CN104547834A (en) * | 2015-02-11 | 2015-04-29 | 郭如英 | Agent capable of improving intelligence level of patients suffering from intellectual disability |
| CN106377717A (en) * | 2016-10-15 | 2017-02-08 | 成都兴倍加生物科技有限责任公司 | Traditional Chinese medicine composition capable of being used for effectively treating child hypophrenia and preparation method thereof |
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