CN106581335A - Medicine composition for treating Alzheimer's disease and preparing method and application thereof - Google Patents

Abstract

The invention discloses a medicine composition for treating Alzheimer's disease and a preparing method and application thereof. The active constituents of the medicine composition are composed of, by weight, 8-30 parts of total saponins in polygalaceae and 1-5 parts of acorustatatinowii schott naphtha. The medicine composition for treating Alzheimer's disease can effectively treat Alzheimer's disease.

Description

Pharmaceutical composition for treating senile dementia, its preparation method and application

technical field

The invention relates to a pharmaceutical composition, especially a pharmaceutical composition for treating senile dementia, and also relates to a preparation method and application of the composition.

Background technique

Alzheimer's disease, also known as Alzheimer's disease (Alzheimer disease, AD), is a degenerative disease of the central nervous system with an insidious onset and a chronic progressive course. Neuropsychiatric symptoms such as cognitive dysfunction, personality changes, and language barriers seriously affect social, occupational, and life functions. The etiology and pathogenesis of senile dementia have not yet been elucidated, and there is no specific therapy for the treatment. Symptomatic treatment is mainly used, including drug treatment to improve cognitive function and memory impairment, symptomatic treatment to improve mental symptoms, and good nursing to delay the progression of the disease. Among the therapeutic drugs, cholinesterase inhibitors and glutamate receptor antagonists are the most commonly used drugs, which have a certain effect on improving the clinical symptoms of patients, but there are also many adverse reactions. For example, donepezil, a cholinesterase inhibitor, can cause symptoms such as nausea and diarrhea, and even some patients have mental disorders such as irritability and aggressive behavior; the glutamate receptor antagonist "memantine" for the treatment of severe Alzheimer's disease Cause patients with hallucinations, confusion, dizziness, headache and other adverse reactions. These adverse reactions and drug risks limit their clinical use to some extent.

A variety of traditional Chinese medicines and natural medicines have also been used to treat senile dementia, including some traditional Chinese medicine extracts or monomeric components or compositions extracted from traditional Chinese medicines. Chinese patent application CN201210109961.7 discloses a traditional Chinese medicine compound preparation for treating Alzheimer's disease, which is made of angelica, calamus, rehmannia glutinosa, chuanxiong, epimedium, mulberry, and polygala. Chinese patent application CN201410140646.X discloses a traditional Chinese medicine for treating Alzheimer's disease, which is made of the following raw materials by weight: 5-20 parts of Morinda officinalis, 5-20 parts of Shichangpu, and 5-30 parts of Curcuma , 5-30 parts of Astragalus, 1-20 parts of Polygala. Chinese patent application CN201410693128.0 discloses a traditional Chinese medicine monomer compound composition for preventing and treating Alzheimer's disease, including 3 parts of ligustrazine, 2 parts of polygala saponin and 2 parts of stilbene glycoside. These drugs have certain curative effects in the treatment of Alzheimer's disease.

Contents of the invention

The object of the present invention is to provide a pharmaceutical composition for treating senile dementia, which has definite curative effect and low cost.

Another object of the present invention is to provide a preparation method of the pharmaceutical composition.

Another object of the present invention is to provide a preparation for treating senile dementia.

Another object of the present invention is to provide the application of the pharmaceutical composition.

The purpose of the present invention is achieved through the following technical solutions:

The invention provides a pharmaceutical composition for treating senile dementia, the active ingredient of which consists of 8-30 parts by weight of total saponins of polygala and 1-5 parts by weight of volatile oil of calamus acorus.

According to the pharmaceutical composition of the present invention, preferably, the medicinal components of the pharmaceutical composition consist of 8-20 parts by weight of total saponins of polygala and 1-2 parts by weight of volatile oil of Acorus calamus.

According to the pharmaceutical composition of the present invention, preferably, the medicinal components of the pharmaceutical composition are composed of 8-12 parts by weight of total saponins of polygala and 1 part by weight of volatile oil of Acorus calamus.

According to the pharmaceutical composition of the present invention, preferably, the medicinal components of the pharmaceutical composition are composed of 8 parts by weight of total saponins of polygala and 1 part by weight of volatile oil of Shichangpu.

According to the pharmaceutical composition of the present invention, preferably, the medicinal components of the pharmaceutical composition are composed of 10 parts by weight of total saponins of polygala and 1 part by weight of volatile oil of Shichangpu.

According to the pharmaceutical composition of the present invention, preferably, the medicinal components of the pharmaceutical composition are composed of 12 parts by weight of total saponins of polygala and 1 part by weight of volatile oil of Shichangpu.

According to the pharmaceutical composition of the present invention, preferably, the content of polygala saponins in the total polygala saponins is not less than 15 wt%.

In the present invention, described polygala saponins are prepared by the following method:

(1) Carry out supercritical extraction of polygala, remove the supercritical extract, and then use 50-80 vol% ethanol aqueous solution as a solvent for extraction to obtain an extract;

(2) The extract is made into a loading sample, and the loading sample is loaded on a macroporous resin column, and eluted with the first eluent, the second eluent and the third eluent in sequence , obtain the first eluent, the second eluent and the third eluent in sequence, and collect the third eluent; the first eluent is water, and the second eluent is 15-25vol% Ethanol aqueous solution, the third eluent is 55-80vol% ethanol aqueous solution;

(3) Concentrating and drying the third eluate to obtain the total saponins of polygala.

In the present invention, in step (1), firstly, Polygala is subjected to supercritical extraction treatment to remove supercritical extract, thereby removing low-polarity components in Polygala. The inventors found that removing the low-polarity volatile oil components in Polygala first is beneficial to obtain high-purity Polygala total saponins in the subsequent elution procedure.

In the present invention, in the step (1), the polygala is extracted with a solvent after removing the volatile oil components. Preferably, the solvent is 55-75 vol % ethanol aqueous solution, more preferably 65-75 vol % ethanol aqueous solution, even more preferably 70-75 vol % ethanol aqueous solution.

In the present invention, the extraction method of Polygala in step (1) is selected from heating reflux method, ultrasonic method, dipping method or percolation method. Preferably, the extraction method of Polygala is heating reflux method. According to one embodiment of the present invention, in step (1), polygala is extracted 1 to 4 times with 55 to 75 vol% ethanol aqueous solution as a solvent, and the amount of solvent used each time is 5 to 12 times the weight of Polygala, and the extraction time is 1 to 4 hours to obtain the extract. According to a preferred embodiment of the present invention, in step (1), Polygala is extracted 3 times with 70vol% ethanol aqueous solution as a solvent, and the amount of solvent each time is 8 times, 6 times, and 6 times the weight of Polygala, and each time The extraction time was 1 hour to obtain the extract.

In the present invention, preferably, the resin described in step (2) is D101 macroporous resin.

In the present invention, preferably, the method for preparing the sample from the extract in step (2) is as follows: reclaim the ethanol from the extract and then add water to adjust to a weight equivalent to 0.1 per milliliter of Polygala medicinal material. ~1.0g, preferably 0.1~0.5g, more preferably 0.1~0.3g of the solution, as the loading sample.

In the present invention, preferably, in step (2), the second eluent is 15-25 vol % ethanol aqueous solution, more preferably 18-22 vol % ethanol aqueous solution. The third eluent is 55-80vol% ethanol aqueous solution, more preferably 60-75vol% ethanol aqueous solution.

In the present invention, preferably, in step (2), the amount of the first eluent is 2 to 7 times the volume of the column, the amount of the second eluent is 4 to 8 times the volume of the column, and the amount of the third eluent is 4 to 8 times the volume of the column. The amount used is 4 to 8 times the column volume. More preferably, the amount of the first eluent is 4 to 6 times the volume of the column, the amount of the second eluent is 5 to 7 times the volume of the column, and the amount of the third eluent is 5 to 7 times the volume of the column. times.

In the present invention, preferably, in step (2), the elution rates of the first eluent, the second eluent and the third eluent are 0.1-1.0 ml/min, more preferably 0.1-0.5 ml/min. According to a preferred embodiment of the present invention, the elution rates of the first eluent, the second eluent and the third eluent are all 0.25ml/min.

The method for preparing total saponins of Polygala of the present invention firstly carries out supercritical extraction treatment to remove low-polarity components in Polygala, then extracts with ethanol solution, and removes impurities from the extract through the above-mentioned macroporous resin, thereby effectively removing the polygala in Polygala. impurity components, and obtain an eluate enriched in polygala saponins.

According to the pharmaceutical composition of the present invention, preferably, the content of β-asarone in the volatile oil of Shichangpu is not less than 50wt%, and the content of α-asarone is not less than 3wt%.

In the present invention, the volatile oil of Shichangpu is prepared by steam distillation or supercritical extraction of Shichangpu.

According to one embodiment of the present invention, the preparation method of the volatile oil of Acorus acorus is as follows: add 6 to 15 times the amount of water to Acorus acorus, extract by steam distillation for 3 to 8 hours, and collect the volatile oil of Acorus acorus. According to one embodiment of the present invention, the preparation method of the volatile oil of Acorus acorus is as follows: add 12 times the amount of water to Acorus acorus, extract by steam distillation for 5 hours, and collect the volatile oil of Acorus acorus.

According to another embodiment of the present invention, the preparation method of the volatile oil of Shichangpu is as follows: put Shichangpu in a supercritical carbon dioxide extraction apparatus, and the extraction temperature is 45-65° C., preferably 50-60° C., more preferably 55-60° C. °C; the extraction pressure is 20-40 MPa, more preferably 25-35 MPa; the extraction time is 60-120 min, preferably 70-100 min, more preferably 80-95 min; collect the extract. According to one embodiment of the present invention, the preparation method of the volatile oil of Acorus acorus is as follows: placing Acorus acorus in a supercritical carbon dioxide extraction apparatus, the extraction temperature is 59° C., the extraction pressure is 28 MPa, and the extraction time is 90 minutes.

The present invention also provides a preparation method of the pharmaceutical composition, comprising uniformly mixing the total saponins of polygala and the volatile oil of Acorus calamus. Preferably, the volatile oil of Acorus calamus is mixed evenly with the total saponins of polygala after being clathrated with β-cyclodextrin.

According to the preparation method of the pharmaceutical composition of the present invention, preferably, it comprises the following steps:

1) The preparation steps of Polygala saponins:

(1) Carry out supercritical extraction of polygala, remove the supercritical extract, and then use 50-80 vol% ethanol aqueous solution as a solvent for extraction to obtain an extract;

(2) The extract is made into a loading sample, and the loading sample is loaded on a macroporous resin column, and eluted with the first eluent, the second eluent and the third eluent in sequence , obtain the first eluent, the second eluent and the third eluent in sequence, and collect the third eluent; the first eluent is water, and the second eluent is 15-25vol% Ethanol aqueous solution, the third eluent is 55-80vol% ethanol aqueous solution;

(3) Concentrating and drying the third eluate to obtain the total saponins of polygala;

2) The preparation steps of the volatile oil of Shichangpu:

Put Acorus calamus in a supercritical carbon dioxide extraction apparatus, the extraction temperature is 45-65°C, the extraction pressure is 20-40MPa, and the extraction time is 60-120min, to obtain the volatile oil of Acorus calamus;

3) Mixing steps:

The Acorus volatile oil obtained in step 2) is clathrated with β-cyclodextrin, and then mixed evenly with the total saponins of polygala obtained in step 1).

The process parameters in the above steps are as mentioned above, and will not be repeated here.

The present invention also provides a pharmaceutical preparation for treating senile dementia, which comprises the above pharmaceutical composition and pharmaceutically acceptable auxiliary materials. The pharmaceutically acceptable excipients include but are not limited to starch, dextrin, sucrose, microcrystalline cellulose, lactose, polyethylene glycol 4000, polyethylene glycol 6000, vegetable oil, beeswax and the like. The dosage form of the pharmaceutical preparation is selected from soft capsules, hard capsules, dropping pills, tablets, granules and the like.

The present invention also provides the use of the pharmaceutical composition for preparing medicine or health food for treating senile dementia.

The pharmaceutical composition composed of the total saponins of polygala and the volatile oil of calamus acorus in the dosage ratio of the present invention has obvious therapeutic effects on senile dementia (that is, Alzheimer's disease).

detailed description

The present invention will be further described below in conjunction with specific examples, but the protection scope of the present invention is not limited thereto.

In the present invention, the senile dementia is Alzheimer's disease (Alzheimer disease, AD).

In the present invention, the Polygala is the dried root of Polygala tenuifolia Willd. or Polygala sibirica L., a plant of Polygalaceae. The calamus is the dry rhizome of the plant Acorusstatarinowii Schott of the family Araceae.

Preparation Example 1

Preparation of Polygala saponins: take 5 kg of Polygala medicinal material, grind it into 20 mesh coarse particles, carry out supercritical carbon dioxide extraction treatment, remove the supercritical extract, add 70vol% ethanol solution as solvent for extraction 3 times, and the amount of solvent is the weight of Polygala medicinal material in order 8 times, 6 times, and 6 times of the amount, extracted for 1 hour each time, filtered, and the filtrates were combined to obtain the extract; the obtained extract was rotary evaporated to recover ethanol to the remaining 5000ml, refrigerated for 12 hours, the upper layer was separated, discarded, Add water to the lower floor water to adjust to 25L, pass through D101 macroporous resin column (diameter-height ratio is 1:8), use respectively the water (the first eluent) of 5 times of column volume, the 25vol% ethanol aqueous solution of 5 times of column volume ( Second eluent), 5 times column volume of 70vol% ethanol aqueous solution (third eluent) for elution, and collect the eluate obtained by eluting with 70vol% ethanol aqueous solution. The eluate was recovered with ethanol and dried to obtain total saponins of polygala. It is determined that the content of the polygala saponins in the total polygala saponins is 18.6 wt%.

Preparation example 2

Preparation of Polygala saponins: take 10 kg of Polygala medicinal material, grind it into 20 mesh coarse particles, carry out supercritical carbon dioxide extraction treatment, remove the supercritical extract, add 80vol% ethanol as solvent for extraction twice, and the amount of each solvent is 100% of Polygala weight 6 times the amount, extracted for 0.5 hours each time, filtered, combined the filtrates to obtain the extract; the obtained extract was rotary evaporated to recover ethanol to the remaining 8L, refrigerated for 12 hours, separated from the upper layer, discarded, and the lower layer was adjusted to 80L by adding water. D101 macroporous resin column (diameter-to-height ratio is 1:6), respectively use 5 times the water (first eluent) of wet resin volume, 7 times the amount of 20vol% ethanol aqueous solution (second eluent), 6 times column volume of 75 vol% ethanol aqueous solution (the third eluent) for elution, and collect the eluate obtained by elution with 75 vol% ethanol aqueous solution. The eluate was recovered with ethanol and dried to obtain total saponins of polygala. It is determined that the content of the polygala saponins in the total polygala saponins is 16.8 wt%.

Preparation example 3

Preparation of the volatile oil of Acorus acorus: take the medicinal material of Acorus acorus, crush it into coarse particles passing through a 20-mesh sieve, add 12 times the amount of water, extract the volatile oil by steam distillation for 5 hours, collect the volatile oil, and obtain the volatile oil of Acorus acorus. It is determined that the content of β-asarone in the volatile oil of Shichangpu is 55.2wt%, and the content of α-asarone is 4.8wt%.

Preparation Example 4

The preparation of the volatile oil of Acorus calamus: Take the medicinal material of Acorus calamus, crush it into a coarse powder passing through a 40-mesh sieve, put it in the extraction kettle of a supercritical carbon dioxide extraction apparatus, extract the temperature at 59°C, extract the pressure at 28mPa, and extract for 90 minutes. Calamus volatile oil. It is determined that the content of β-asarone in the volatile oil of Shichangpu is 58.1wt%, and that of α-asarone is 5.2wt%.

Example 1

Preparation of the pharmaceutical composition: 100 g of the volatile oil of Acorus calamus prepared by the method in Preparation Example 3 was added to 400 g of β-cyclodextrin for clathrate, and 500 g of clathrate was obtained.

40 g of total saponins of polygala in Preparation Example 1 and 25 g of the clathrate were uniformly mixed to obtain the pharmaceutical composition of this example.

Example 2

Preparation of the pharmaceutical composition: take 100 g of the volatile oil of Acorus calamus prepared by the method of Preparation Example 4, add 1200 g of β-cyclodextrin for clathrate, and obtain 1300 g of clathrate. Put 100 g of total polygala saponins prepared by the method in Preparation Example 2 and 130 g of the clathrate into a multidimensional mixer and mix evenly to obtain the pharmaceutical composition of this embodiment.

Example 3

Preparation of the pharmaceutical composition: evenly spray 10 g of the volatile oil of Acorus calamus prepared by the method of Preparation Example 3 into 100 g of total saponins of polygala prepared by the method of Preparation Example 2 to obtain the pharmaceutical composition of this example.

Example 4

Preparation of the pharmaceutical composition: Spray evenly 20 g of the volatile oil of Acorus calamus prepared by the method of Preparation Example 4 into 180 g of total saponins of polygala prepared by the method of Preparation Example 1 to obtain the pharmaceutical composition of this example.

Example 5

Preparation of pharmaceutical preparations: 100 g of the pharmaceutical composition prepared by the method in Example 1 was added with 100 g of lactose, mixed evenly, and dry-pressed into granules to obtain granules.

Example 6

Preparation of pharmaceutical preparations: Add 100 g of the pharmaceutical composition prepared in Example 2 to 70 g of starch, mix well, use 80vol% ethanol as a wetting agent, granulate, dry below 60°C, granulate, fill into hard capsules, and obtain hard capsules. capsules.

Example 7

Preparation of pharmaceutical preparations: Take 300g of PEG6000, heat and melt, add 120g of polygala total saponins prepared by the method of Preparation Example 2, and 10g of Acorus volatile oil prepared by the method of Preparation Example 3, stir evenly, drop into simethicone oil, take out For dropping pills, wipe off the simethicone oil on the surface to obtain dropping pills.

Experimental example

The therapeutic effect of the pharmaceutical composition of the present invention on senile dementia is verified through a drug efficacy test. The experimental methods and results are as follows:

1. Animals and materials

1.1 Animals: Healthy Wistar rats, SPF grade, body weight 200-220g, temperature 24±0.5°C, humidity maintained at 60±2vol%, indoor light controlled at normal circadian rhythm (lights on at 8 o’clock in the morning), animals free access to food and water.

1.2 Preparation of Alzheimer's disease animal model (AD animal model)

The senile dementia model was established by the following method: D-galactose 50 mg/(kg·d) was subcutaneously injected into the back of the rat's neck for 6 consecutive weeks, and Aβ25-35 (product of Sigma, USA) was injected into the lateral ventricle at the 7th week. Rats were anesthetized with pentobarbital sodium (45 mg/kg), fixed on a stereotaxic instrument, and made a midline incision on the top of the head to expose the bregma. Drill a small hole 1.3mm behind and 2mm aside, drill a small hole with a 5ml injection needle, insert a 10μl micro-injector vertically to a depth of 40mm (reaching the lateral ventricle), and slowly inject 5μl of aggregated Aβ25-35 for 10 minutes, retain the needle for 5 minutes, and inject After the completion, compound sulfamethoxazole powder was sprinkled locally to prevent infection, the scalp was sutured, and 50,000 units of penicillin was injected intramuscularly after the operation for 4 consecutive days to obtain Alzheimer's disease model rats (hereinafter referred to as model rats).

1.3 Grouping and administration of animals

Blank control group: 10 healthy rats were given 5ml/kg of distilled water every day.

Model control group: 11 model rats were given 5ml/kg of distilled water every day.

Positive control group: 11 model rats, pulverized nimodipine tablets, and administered 15 mg/kg from the second day after operation, once a day.

Control group 1: 10 model rats, take 60 g of polygala saponins from Preparation Example 1, dissolve in water to 0.06 g/ml; start from the 2nd day after the operation, give 5 ml/kg orally, once a day.

Control group 2: 10 model rats, take 60 g of the volatile oil of Acorus acorus in Preparation Example 3, add β-cyclodextrin for clathrate to 300 g, and suspend the clathrated cyclodextrin volatile oil with water to contain 0.06 g/ml, orally administered at 5ml/kg from the second day after operation, once a day.

The present invention group: 10 model rats, take 125.45g of the pharmaceutical composition of Example 2, add water to dissolve to 0.125g/ml, start from the second day after the operation, and administer it by gavage at 5ml/kg, once/day.

After the above administration for 6 consecutive weeks, a follow-up experiment was carried out.

2. Experimental method

2.1 Behavioral determination of eight-arm maze

The eight-arm maze training began at the sixth week of gavage. The radial eight-arm (four arms put food) is a classic method for measuring the spatial memory of animals, which can simultaneously detect the animal's reference memory and working memory. The diameter of the central area of the maze is 30 cm, and eight arms extend around at equal angles and equal lengths. Before the training, the rats were first adapted to the maze for 1 day. During the adaptation, 3 to 4 rats were placed in the maze at the same time, free to move and ingest food for 10 minutes. Perform each training session after adaptation. During each training session, only four of the eight arms placed food (arms 1, 3, 6 and 7, respectively), and this order was maintained throughout the experiment. Rats are placed in the central area of the maze. At this time, the central area is closed with doors for 15 seconds and the door is opened. Rats can choose to enter any arm to ingest food. If the rat entered the arm with food and ingested the food, it was a correct choice, otherwise it was a wrong choice. Records the number of times the parameter was chosen incorrectly. Re-entering the food arm was called working memory error (WME), and re-entering the no-food arm was called reference memory error (RME). 5 consecutive training sessions, the 6th official test.

2.2 Detection of superoxide dismutase (SOD) activity and malondialdehyde (MDA) content in rat serum

After the eight-arm maze test, food was fasted for 12 hours, urethane (0.8g/kg) was injected intraperitoneally for anesthesia, the dorsal position was fixed, incision was made along the midline of the abdomen, blood was collected from the inferior vena cava, serum was separated, and serum SOD was determined according to the instructions of the SOD kit; Serum MDA was determined according to the instructions of the MDA kit.

2.3 Detection of acetylcholinesterase (AchE) content in rat serum and brain

Serum was taken according to the method in 2.2, and serum AchE was determined according to the kit instructions. After the blood was taken, the rats were sacrificed, and the brain tissue was taken, and the blood film, olfactory bulb and cerebellum were removed, placed in liquid nitrogen for 5 minutes, and then stored in a refrigerator at ~20°C. Brain tissue protein was determined by the biuret method.

2.4 Statistical analysis

for data t test was used for comparison between groups, and P<0.05 was considered statistically significant.

3. Experimental results

3.1 Eight-arm maze behavior test results

The test results are shown in Table 1. Compared with the blank control group, the reference memory error (RME) of the rats in the model control group increased significantly (P<0.05), and the working memory error (WME) tended to increase, but there was no significant difference. The group of the present invention significantly reduces the reference memory error (RME) of model rats (P<0.05), and has a tendency to reduce the working memory error (WME). The result shows that the invention has obvious improvement effect on learning and memory impairment of model rats, and can improve learning and memory.

Table 1 The results of the eight-arm maze behavior test in rats

Note: △ means compared with the model control group, P<0.05.

3.2 Serum SOD, MDA determination test results

The test results are shown in Table 2. Compared with the blank control group, the serum SOD of rats in the model control group tended to decrease, and the serum MDA content increased (P<0.05). The SOD activity of the serum of the model mice of the present invention group is significantly increased (P<0.01), and the serum MDA content of the model mice is significantly reduced (P<0.01). The results show that the composition of the invention can improve the SOD activity in the serum of model rats, thereby enhancing the ability of the body to scavenge oxygen free radicals and reducing the generation of malondialdehyde.

SOD, MDA determination result in table 2 rat serum

Note: △ means compared with the model control group, P<0.05;

△Δ means compared with the model control group, P<0.01;

^▲▲ indicates that compared with the positive control group, P<0.01.

3.3 AchE assay results in serum and brain tissue

The test results are shown in Table 3. Compared with the blank control group, the AchE in the rat serum and brain tissue of the model control group was significantly increased (P<0.05); the group of the present invention can reduce the AchE activity in the serum of the model rats (P<0.05), and significantly reduce the AchE activity in the brain tissue. Vitality (P<0.01), and compared with the nimodipine group, there was also a significant difference (P<0.05). The results show that the composition of the present invention can significantly reduce the activity of AchE in serum and brain tissue of model rats.

Table 3 rat serum and brain AchE assay results

Note: △ means compared with the model control, P<0.05;

△Δ means compared with the model control group, P<0.01;

■Indicates that compared with the positive control group, P<0.05.

In summary, the traditional Chinese medicine composition of the present invention can improve the activity of SOD in the serum of Alzheimer's disease model mice, reduce the content of MDA in the serum of model mice, and improve the learning and memory impairment of model rats. At the same time, the composition of the present invention can also significantly reduce the activity of AchE in the brain tissue and serum of senile dementia rats, increase the level of acetylcholine, thereby enhancing the function of the cholinergic nervous system and improving the state of learning and memory. The results show that the pharmaceutical composition of the present invention has obvious therapeutic effect on senile dementia, and the effect is better than that of total saponins of polygala and volatile oil of calamus calamus used alone.

The present invention is not limited to the above-mentioned embodiments. Without departing from the essence of the present invention, any deformation, improvement, and replacement conceivable by those skilled in the art fall within the scope of the present invention.

Claims (10)

1. a kind of pharmaceutical composition for treating senile dementia, it is characterised in that the active component in described pharmaceutical composition by 8～30 weight portion of Radix Polygalae total saponins and 1～5 weight portion of Rhizoma Acori Graminei volatile oil composition.

2. pharmaceutical composition according to claim 1, it is characterised in that the Pharmaceutical ingredients of described pharmaceutical composition are by Radix Polygalae 8～20 weight portion of total saponins and 1～2 weight portion of Rhizoma Acori Graminei volatile oil composition.

3. pharmaceutical composition according to claim 1, it is characterised in that the Pharmaceutical ingredients of described pharmaceutical composition are by as follows Into being grouped into：

1 weight portion of 8 weight portion of Radix Polygalae total saponins and Rhizoma Acori Graminei volatile oil；Or

1 weight portion of 10 weight portion of Radix Polygalae total saponins and Rhizoma Acori Graminei volatile oil；Or

1 weight portion of 12 weight portion of Radix Polygalae total saponins and Rhizoma Acori Graminei volatile oil.

4. the pharmaceutical composition according to any one of claims 1 to 3, it is characterised in that thin in described Radix Polygalae total saponins The content of leaf polygalic acid is not less than 15wt%.

5. the pharmaceutical composition according to any one of claims 1 to 3, it is characterised in that described Radix Polygalae total saponins pass through Following method is prepared：

(1) Radix Polygalae is carried out into supercritical extraction, removes supercritical extract, then using the ethanol water work of 50～80vol% Extracted for solvent, obtained extracting solution；

(2) extracting solution is made into loading sample, by macroporous resin column on the loading sample, successively with the first eluant, Second eluant and the 3rd eluting eluant carry out eluting, obtain the first eluent, the second eluent and the 3rd eluent successively, Collect the 3rd eluent；The first described eluant is water, and the second eluant is the ethanol water of 15～25vol%, the 3rd Eluant is the ethanol water of 55～80vol%；

(3) the 3rd eluent is concentrated, is dried, obtains the Radix Polygalae total saponins.

6. the pharmaceutical composition according to any one of claims 1 to 3, it is characterised in that in described Rhizoma Acori Graminei volatile oil The content of beta-Asarone is not less than the content of 50wt%, α-asaricin and is not less than 3wt%.

7. the pharmaceutical composition according to any one of claims 1 to 3, it is characterised in that described Rhizoma Acori Graminei volatile oil Preparation method is：Rhizoma Acori Graminei is placed in supercritical carbon dioxide extraction instrument, extraction temperature is 45～65 DEG C, and extracting pressure is 20 ～40MPa, extraction time are 60～120min, obtain the Rhizoma Acori Graminei volatile oil.

8. the preparation method of the pharmaceutical composition according to any one of claims 1 to 3, it is characterised in that including following step Suddenly：

1) preparation process of Radix Polygalae total saponins：

(1) Radix Polygalae is carried out into supercritical extraction, removes supercritical extract, then using the ethanol water work of 50～80vol% Extracted for solvent, obtained extracting solution；

(2) extracting solution is made into loading sample, by macroporous resin column on the loading sample, successively with the first eluant, Second eluant and the 3rd eluting eluant carry out eluting, obtain the first eluent, the second eluent and the 3rd eluent successively, Collect the 3rd eluent；The first described eluant is water, and the second eluant is the ethanol water of 15～25vol%, the 3rd Eluant is the ethanol water of 55～80vol%；

(3) the 3rd eluent is concentrated, is dried, obtains the Radix Polygalae total saponins；

2) preparation process of Rhizoma Acori Graminei volatile oil：

Rhizoma Acori Graminei is placed in supercritical carbon dioxide extraction instrument, extraction temperature be 45～65 DEG C, extracting pressure be 20～ 40MPa, extraction time are 60～120min, obtain described Rhizoma Acori Graminei volatile oil；

3) blend step：

By step 2) Rhizoma Acori Graminei volatile oil that obtains through beta-cyclodextrin inclusion compound, then with step 1) Radix Polygalae total saponins that obtain mix Uniformly.

9. a kind of pharmaceutical preparation for treating senile dementia, comprising according to any one of claim 1～7 in described pharmaceutical preparation Described pharmaceutical composition.

10. the pharmaceutical composition according to any one of claim 1～7 is used for medicine or the guarantor for preparing treatment senile dementia Purposes in health food.