CN103705845A - Traditional Chinese medicinal composition preparation for preventing and treating senile dementia and preparation method thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine combination preparation for preventing and treating senile dementia and a preparation method thereof, which belongs to the technical field of traditional Chinese medicine and is prepared from Chinese herbal medicines such as ginseng, angelica, polygala, calamus calamus, turmeric, poria cocos and rhizoma chuanxiong according to a certain proportion. Mixed with pharmaceutically applicable carriers, various preparations prepared according to specific processes. The invention also includes an industrially applicable preparation method. The preparation has the functions of nourishing yin and tonifying kidney, invigorating spleen and replenishing qi, promoting blood circulation and removing blood stasis, and is used for the treatment of senile dementia and spleen and kidney yin deficiency.

Description

Combination preparation of traditional Chinese medicine for preventing and treating senile dementia and preparation method thereof

technical field

The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine combination preparation for preventing and treating senile dementia and a preparation method thereof.

Background technique

Senile dementia has a high disability and mortality rate, which seriously affects people's physical and mental health and quality of life. Traditional Chinese medicine does not have the disease name "senile dementia", and senile dementia is scattered in the categories of "vertigo" and "forgetfulness" in traditional Chinese medicine. The name of dementia was first seen in "Jingyue Quanshu", such as "Jingyue Quanshu Volume Thirty-Four Days Collection of Miscellaneous Syndrome Mo Madness and Dementia Treatment" "Dementia syndrome, usually without phlegm, and either stagnation, or failure, or Worrying, doubt, or fear gradually lead to dementia, speech reversal, erratic behavior, or profuse sweating or melancholy. The symptoms are all kinds of strange and omnipresent. Not often. However, it is observed that his body is strong, his diet is not reduced, and there is no evidence of collapse. However, some of these symptoms can be cured, and some cannot be cured." In Qing Dynasty Chen Shiduo's Dialectical Records Dementia Gate, he specifically pointed out the relationship between dementia and the liver and stomach, such as "However, dementia must have its cause, and its beginning is roughly from the stagnation of liver qi; its end is also Due to the decline of stomach qi, the stagnation of the liver will cause the wood to restrain the earth, and the phlegm will not be dissolved, and the stomach will be weakened, and the earth will make water, and the phlegm will not be eliminated, so the phlegm will accumulate in the chest and occupy the outside of the heart, making the mind unclear and resulting in dullness sick." Combining the theory of traditional Chinese medicine and the views of ancient medical literature, it is now believed that Alzheimer's disease is a disease of deficiency in origin and excess in superficiality, and is related to the five internal organs. Deficiency in origin is mainly due to deficiency of kidney essence and deficiency of qi and blood, while excess in superficiality is mainly due to turbid phlegm obstructing orifices, stagnation of qi and blood stasis. Among the five viscera, the heart, spleen, liver, kidney and other viscera are particularly important, and the "basic" and "standard" can transform and influence each other, forming a vicious circle and making the disease gradually worsen.

There is no specific drug for the treatment of senile dementia in western medicine. The main treatment methods include two categories: one is the drug for improving neurological symptoms, the main purpose is to enhance the function of the remaining neurons and alleviate symptoms such as memory impairment, but it has no slowing effect on the progress of the disease, such as Brain neurotransmission function improvers, including neurotransmitter (Ach) precursors, Ach synthesis accelerators, Ach decomposing enzyme inhibitors, Ach receptor agonists, brain energy metabolism activators, cerebral blood circulation improvers, etc.; Therapeutic drugs to delay the progression of the disease, including neuropeptides, nerve growth factors, antioxidants, anti-inflammatory drugs, estrogens, anti-β-amyloid drugs, etc. However, the above drugs are mostly effective for the first use, and the curative effect is not obvious after long-term use, and the side effects are relatively large, and the price is expensive.

Contents of the invention

The purpose of the present invention is to overcome the defects of the above-mentioned technologies, and provide a traditional Chinese medicine combination preparation for preventing and treating senile dementia and a preparation method thereof, which mainly focuses on tonifying, tonifies the middle and relieves the middle, treats both symptoms and root causes, and resuscitates phlegm. It is mainly used for the treatment of senile dementia caused by deficiency of kidney meridian, deficiency of qi and blood, obstruction of orifices by phlegm turbidity, stagnation of qi and blood stasis; the method can extract active ingredients in traditional Chinese medicine, the preparation process is simple, and the content of active ingredients is high. Its specific technical plan is:

On the basis of summarizing the theory and clinical practice of traditional Chinese medicine for treating senile dementia, combined with the preliminary screening of pharmacodynamic experiments, the present invention develops a medicine for treating senile dementia. Qi leads the blood to run, and ginseng plays a leading and participating role in the running of blood, so that the blood can go up to the brain to meet the needs of the brain, and play a role in calming the nerves and improving intelligence. Angelica nourishes blood and harmonizes blood, promotes blood circulation and regulates menstruation, nourishes blood without hurting blood, and is compatible with ginseng, which not only nourishes qi and blood, but also removes blood stasis and unblocks meridians, which has the effect of relieving diseases without hurting health. Shichangpu can reduce phlegm and resuscitate, refresh the mind and strengthen the brain. Modern research shows that Shichangpu has a two-way regulating effect on the central nervous system (CNS) of excitation and inhibition, and can improve a variety of learning and memory impairment models. Its water extract Both volatile oil and volatile oil have the effect of improving the learning and memory function of memory impairment model mice, and are important medicines for the treatment of brain diseases. Turmeric promotes blood circulation and removes blood stasis, promotes qi and relieves stagnation. It is mainly used to relieve stagnation and resuscitate. Shichangpu is mainly used to eliminate filth and rejuvenate. The combination of turmeric and Shichangpu can refresh the brain and revitalize the body, and the effect of clearing the heart and resuscitating is stronger. Yuanzhi calms the mind, calms the nerves, eliminates phlegm and resuscitates, it can not only strengthen the effect of resolving phlegm and resuscitating, but also combine with Poria cocos to communicate with the heart and kidney to soothe the nerves and improve intelligence. Poria cocos invigorates the spleen and resolves phlegm, calms the mind and calms the nerves, diures water and eliminates dampness. . Angelica is soft and moisturizing in nature, nourishes blood and regulates menstruation, promotes blood circulation and relieves pain, removes stasis and swelling, moistens dryness and smooths intestines; Chuanxiong is pungent and fragrant, promotes qi and blood circulation, dispels wind and relieves pain. The two medicines are used together, mutually restraining their shortness and extending their length, taking into account both qi and blood, nourishing blood and regulating menstruation, promoting qi and blood circulation, dispelling blood stasis and relieving pain, and are commonly used in clinical practice. Salvia miltiorrhiza promotes blood circulation and removes blood stasis, clears heart-fire and relieves troubles, and assists the power of angelica to promote blood circulation and remove blood stasis. Traditional Chinese medicine believes that Astragalus has the effects of invigorating qi and raising yang, strengthening the surface and antiperspirant, detoxifying and discharging pus, diuresis and swelling, and astringing sores and promoting muscle growth. Modern pharmacological studies have shown that Astragalus has the function of enhancing the body's immunity. Rehmannia glutinosa nourishes blood, nourishes yin, nourishes essence and fills marrow, and is an important medicine for nourishing liver and kidney.

A traditional Chinese medicine combination preparation for preventing and treating senile dementia, comprising the following raw materials in parts by weight: 5-20 parts of ginseng, 5-20 parts of angelica, 5-20 parts of Polygala, 5-20 parts of Poria cocos, 5-15 parts of Shichangpu, Curcuma 5-15 parts, Chuanxiong 6-10 parts.

More preferably, the following raw materials are also included in parts by weight: 10-15 parts of Danshen, 5-12 parts of Radix Astragali, and 9-15 parts of Rehmannia glutinosa.

More preferably, it includes the following raw materials by weight: 6-10 parts of ginseng, 10-12 parts of angelica, 10-15 parts of polygala, 12-15 parts of Poria cocos, 6-10 parts of Shichangpu, 6-8 parts of curcuma , 6-10 parts of Chuanxiong, 10-15 parts of Danshen, 5-12 parts of Astragalus, and 9-15 parts of Rehmannia glutinosa.

More preferably, it includes the following raw materials in parts by weight: 6 parts of ginseng, 10 parts of angelica, 10 parts of polygala, 12 parts of Poria cocos, 6 parts of Shichangpu, 6 parts of curcuma, 10 parts of Chuanxiong, 10 parts of salvia miltiorrhiza, and 10 parts of astragalus , Rehmannia glutinosa 10 parts.

More preferably, it includes the following raw materials in parts by weight: 10 parts of ginseng, 12 parts of angelica, 15 parts of polygala, 15 parts of Poria cocos, 10 parts of Shichangbu, 8 parts of curcuma, 10 parts of Chuanxiong, 15 parts of salvia miltiorrhiza, and 10 parts of astragalus , Rehmannia glutinosa 15 parts.

The dosage form of the traditional Chinese medicine combination preparation of the present invention is any one of granules, tablets, powders, pills, capsules, dripping pills, syrups and mixtures.

A preparation method of the traditional Chinese medicine combination preparation for preventing and treating senile dementia of the present invention, comprising the following steps:

(1) Add 8 times the amount of water to the decoction pieces of Shichangpu, Angelica, and Chuanxiong medicinal materials and keep boiling for 8 hours, extract the volatile oil by steam distillation, and prepare the volatile oil, medicinal residues, Shichangpu, and Angelica aqueous solution for later use;

(2) Put the rest of the medicinal materials and dregs in a multifunctional tank, add water and decoct 3 times, the decoction time is 2h, 2h, 1h respectively, combine the three extracts and the aqueous solutions of Shichangpu, Angelica, and Chuanxiong, and decompress Concentrate to a relative density of 1.10-1.15, clear the paste at a temperature of 50°C, and let it cool; take the above concentrate, add ethanol until the alcohol content reaches 60%, let it stand, and filter; the filtrate recovers ethanol under reduced pressure, and concentrates to relative Density is 1.25-1.35, the temperature is 80 ℃ clear paste, decompression drying, pulverization, obtain extract powder I;

(3) Take volatile oil: cyclodextrin is 1:8, add appropriate amount of water to make a saturated aqueous solution, slowly add 1ml of ethanol solution (1:1) of mixed volatile oils of Acorus calamus, Angelica, and Rhizoma Chuanxiong, and bathe in constant temperature water at 50°C for 2 hours After completion of the inclusion complex, let it stand and filter, and the obtained inclusion compound is dried and pulverized into a fine powder at 40°C as a volatile oil inclusion compound for later use;

(4) Extract powder I is mixed with Shichangpu, angelica volatile oil clathrate, add suitable adjuvant, make granule, tablet, powder, pill, capsule, dripping pill, syrup, mixture in conventional process any type.

In order to better obtain the active ingredient of the medicine of the present invention, the raw medicinal material can be pulverized into coarse powder or fine powder during preparation, and then subjected to water extraction, or the raw medicinal material can be soaked, and then subjected to water extraction.

Compared with the prior art, the beneficial effect of the present invention is: the present invention sums up the etiology and pathogenesis of senile dementia, and is prepared by combining modern pharmacological research results. The invention is mainly used for preventing and treating senile dementia caused by deficiency of kidney meridian, deficiency of qi and blood, obstruction of orifices by phlegm turbidity and stagnation of qi and blood stasis. Preparations such as tablets, powders, pills, granules, capsules, and oral liquids prepared by the preparation method provided by the invention can fully extract the active ingredients in Chinese medicinal materials; The volatile oil has improved the utilization rate and stability of the volatile oil of Shichangpu, Angelica, and Rhizoma Chuanxiong. The reasonable formula and reasonable preparation method ensure that the present invention has: eradication of the cause of the disease, alleviation of the disease, shortening the course of treatment, definite curative effect, cheap price, and non-toxic Side effects, suitable for industrial production and other advantages.

Detailed ways

The technical solutions of the present invention will be further described in detail below in conjunction with specific embodiments.

Pharmacodynamics experiment using the combination preparation of traditional Chinese medicine for preventing and treating senile dementia according to the present invention

1 Acute toxicity test

The median lethal dose (LD ₅₀ ) or the maximum dosage is determined by measuring the acute toxicity of the pharmaceutical granules of the present invention, so as to provide a safety basis for clinical medication.

1.1 Materials

1.1.1 Animals

50 Kunming mice, half male and half female, 18-25g, provided by Changchun High-tech Medical Experimental Animal Center, certificate number: 13-0513. 10 per box, separate boxes for male and female, adaptive breeding and observation for one day after purchase.

1.1.2 Experimental drugs

The granules prepared by implementing the method of Example 1 were mixed with distilled water into a suspension with the maximum concentration (as long as the syringe does not block and does not affect normal gavage).

1.1.3 Instruments

T-1000 electronic balance (Changshu Shuangjie Test Instrument Factory); 1ml gavage device; BD-125D electronic balance (Beijing Sartorius Scientific Instrument Co., Ltd.).

1.2 Methods and results

On the basis that the LD ₅₀ was not detected in the preliminary experiment, the maximum dosage experiment was changed. Take 40 healthy Kunming mice, half male and half male, and randomly divide them into 4 groups with 10 mice in each group. The mice are fasted for 12 hours before administration. 130.0, 260.0, and 520.0 crude drug g/Kg (respectively equivalent to 50, 100, and 200 times the clinical dosage) of the blank control group and the drug administration group. Three times a day in the morning, noon, and evening, the test liquid was given by intragastric administration, according to the maximum volume of 0.4ml/10g; the blank control group was given the same dose of normal saline. Then observe the appearance, behavior, activity, mental activity, appetite, urine and stool and its color, fur, breathing, nose, eyes, oral cavity with or without abnormal secretions, body weight changes and death of the mice.

After 7 days of administration, the mice were killed by decapitation after 12 hours of fasting, the abdominal cavity was opened to check the appearance of the main organs, and the changes of the internal organs of the mice were observed with the naked eye. The hearts, livers, spleens, lungs and kidneys were peeled off, weighed precisely with an electronic balance, and the organ coefficients were calculated for statistical comparison between groups.

1.3 Results

After continuous observation for 7 days, the mice moved freely without convulsions, ataxia, salivation, tearing, runny nose, dyspnea, diarrhea, constipation, flatulence and other phenomena. The fur of the animals was shiny, and none of the animals died within 7 days after administration.

As shown in Table 1, there was no significant difference in body weight between groups of mice before administration (P>0.05), which was comparable. After administration, the body weight of mice in the administration group compared with the blank control group showed no significant difference. (P > 0.05).

The dissected organs were observed with the naked eye, and no abnormal changes such as swelling, atrophy, bleeding, abnormal color, adhesion, and hardening were found in the liver, kidney, spleen, and other organ tissues. There was no significant statistical difference in organ coefficient between the treatment group and the control group (P>0.05), as shown in Table 2.

Organ coefficient = (organ weight ÷ body weight) × 100%

Table 1 granules of the present invention are on the impact of acute toxicity experiment mouse body weight (x ± s, n=10)

group Blank control group 50 times dose group 100 times dose group 200 times dose group Dose (g/kg) - 130.0 260.0 520.0 Initial weight (g) 23.13±1.67 24.82±4.32 22.34±1.02 23.05±1.43 1d 23.35±1.46 23.57±2.36 22.18±0.89 22.49±0.96 2d 23.90±2.07 22.38±1.58 23.07±1.61 22.24±0.72 3d 24.80±2.53 21.27±2.13 23.37±2.28 22.25±0.97 4d 25.96±2.69 22.46±3.02 23.45±2.00 24.37±1.14 5th 26.72±3.10 23.15±3.53 24.76±2.41 24.68±1.64 No. 6d 26.24±2.64 25.22±4.71 25.28±2.60 26.15±2.17 7d 27.58±3.80 27.45±3.80 26.89±23.15 26.46±18.88

Table 2 Acute toxicity experiment female mouse organ coefficient (X±S, n=40)

1.3 Conclusion

The results of the acute toxicity test indicated that the preparation had no obvious effect on the body weight of mice, and no obvious pathological damage to important organs. The maximum tolerated dose of the drug granule of the present invention to mice is not less than 520.0 g of crude drug/kg, which shows that the product has good safety and low toxicity. This result ruled out the possibility of drug toxicity for the dosage problem used in subsequent experiments.

2 Effects on scopolamine-induced senile dementia mouse model

2.1 Experimental materials

2.1.1 Drugs

Drugs used in the present invention: Scopolamine Hydrobromide, produced by Shanghai Hefeng Pharmaceutical Co., Ltd., batch number: 090801; donepezil hydrochloride tablets, produced by Eisai (China) Pharmaceutical Co., Ltd., batch number: 100336A.

2.1.2 Animals

Fifty Kunming mice aged 3-4 months, half male and half male, weighing 35-45 g, were provided by Changchun High-tech Medical Experimental Animal Center, certificate number: 13-5113. The animals were kept in a feeding room with constant temperature (21-23° C.), constant humidity (45-65%), and a light-dark cycle of 12 hours each. Five mice of the same sex were reared in the same cage, fed with pellet feed, and drank water freely.

2.1.3 Instruments

Y-shaped water maze device, produced by Beijing Medical University Instrument Factory.

2.1.4 Model and group administration

After 3 days of adaptive feeding, the Y-shaped water maze experiment was carried out. The water temperature in the mouse Y-shaped water maze box was maintained at 25-27° C., and the water depth was about 10 cm. Put the mice in each group into the water labyrinth for training, first place the mice in the starting area, use a glass rod to guide them to the water outlet steps in the end area, rest for 15 seconds after reaching the platform, and then repeat the training. 6 times. After 24 hours, the memory retention was tested, and after 48 hours, the memory consolidation was tested, and the swimming time and the number of correct responses of the mice were recorded respectively from entering the water to reaching the platform. According to the test results, they were randomly divided into 5 groups, namely the normal control group, the model group, the drug treatment group (6.0, 8.0, 10.0 g crude drug amount/Kg), and the positive drug donepezil hydrochloride group (2.0 mg/kg).

Oral administration or equal volume of normal saline once a day. The mice in the model group were subcutaneously injected with 2 mg/kg of scopolamine hydrobromide on the back, the normal control group was injected with the same volume of normal saline, and the two groups were given normal saline; Inject scopolamine hydrobromide 2mg/kg. All of the above were administered continuously for 45 days.

2.2 Behavioral testing methods

The Y-shaped water maze test was carried out on the 21st, 22nd and 44th, 45th days of administration. Training was carried out on the 21st and 44th days, and the training was performed 10 times. On the 22nd and 45th days, the groups were tested, and each was tested 10 times. The calculation was based on reaching the destination within 15 seconds, and the results were recorded respectively, as shown in Table 3.

2.3 Results

Compared with the normal control group, the number of times the mice in the model group correctly reached the destination on day 22 and day 45 was significantly reduced (P<0.01), and the latency period to correctly reach the destination was significantly prolonged (P<0.05). Compared with the model group, the times of correct arrival at the destination in the high, middle and low dose groups were significantly increased (P<0.05), and the latency period for correct arrival at the destination was significantly shortened (P<0.05). It shows that the medicament of the present invention helps to increase the number of correct responses in mice, and shows a protective effect on memory function.

Table 3 Behavioral test results

Note: Compared with the model group, ^* P<0.05, ^** P<0.01; compared with the control group ^# P<0.05, ^## P<0.01.

Example 1

The present invention weighs the medicinal components according to the following weight proportions: 6 ginseng, 10 angelica, 10 polygala, 12 poria, 6 calamus, 6 turmeric and 10 chuanxiong.

Its preparation process is as follows: (1) add 8 times the amount of water to the decoction pieces of Shichangpu, Angelica, and Chuanxiong medicinal materials and keep it slightly boiled for 8 hours, extract the volatile oil by steam distillation, and use the volatile oil, medicinal residues, Shichangpu, and Angelica aqueous solution for later use; and medicinal dregs in a multi-functional tank, add water and decoct 3 times, the three decoction times are 2, 2 and 1 h respectively, combine the three extracts and the aqueous solutions of Shichangpu, Angelica and Chuanxiong, filter with ultrafiltration membrane, and depressurize the filtrate Concentrate to a clear paste with a relative density of 1.25 (80°C), dry under reduced pressure, and pulverize to obtain extract powder I; (3) take volatile oil (ml): cyclodextrin (g) at a ratio of 1:6, add appropriate amount of water to prepare After forming a saturated aqueous solution, slowly add 1ml of ethanol solution (1:1) of mixed volatile oils of Shichangpu, Angelica, and Chuanxiong Rhizoma Rhizoma Chuanxiong, in a constant temperature water bath at 50°C for 1 hour, after the clathrate is completed, let it stand and filter, and the clathrate obtained is dried and crushed Become fine powder and be volatile oil clathrate for subsequent use; (4) extract powder I is mixed with Shichangpu, angelica volatile oil clathrate, add appropriate adjuvant, make granule, tablet, powder, pill, capsule by conventional process Any one of oral preparations such as pills, syrups, and mixtures.

Example 2

The present invention weighs the medicinal components according to the following weight proportions: 10 parts of ginseng, 12 parts of angelica, 15 parts of Polygala, 15 parts of Poria cocos, 10 parts of Shichangpu, 8 parts of curcuma and 10 parts of Chuanxiong.

The preparation process is as follows: (1) adding 8 times the amount of water to the crude powder of Acorus shichangpu, angelica and chuanxiong, keeping it slightly boiled for 5 hours, extracting the volatile oil by steam distillation, and preparing the volatile oil, dregs and aqueous solutions of shichangpu, angelica and chuanxiong for standby; Put the remaining medicinal materials and medicinal residues in a multifunctional tank, add water and decoct 3 times, the decoction time of the three times is 2, 2, and 1 hour respectively, combine the three extracts and the aqueous solutions of Acorus calamus, Angelica, and Rhizoma Chuanxiong, and filter them with an ultrafiltration membrane. The filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.28 (80° C.), dried under reduced pressure, and pulverized to obtain extract powder I; (3) take volatile oil (ml): cyclodextrin (g) at a ratio of 1:8, add water After making a saturated aqueous solution, slowly add 1ml of ethanol solution (1:1) of mixed volatile oils of Shichangpu, Angelica, and Chuanxiong Rhizoma Rhizoma Chuanxiong, in a constant temperature water bath at 50°C for 2 hours, let stand and filter after completion of clathrate, and dry the clathrate obtained Grinding into fine powder is the volatile oil inclusion compound for subsequent use; (4) mixing the extract powder I with the volatile oil inclusion compound of Shichangpu, Angelica, and Rhizoma Chuanxiong, adding appropriate auxiliary materials, and making granules, tablets, powders, and pills according to conventional processes Any one of oral preparations such as capsules, dripping pills, syrups, and mixtures.

Example 3

The present invention weighs the medicinal components according to the following weight ratio: 12 ginseng, 12 angelica, 15 polygala, 14 poria, 8 calamus, 8 turmeric and 10 chuanxiong.

The preparation process is as follows: (1) adding 8 times the amount of water to the fine powder of Shichangpu and Angelica medicinal materials and keeping it slightly boiled for 8 hours, extracting the volatile oil by steam distillation, and using the volatile oil, medicinal residues, Shichangpu and Angelica aqueous solution for later use; Put the dregs in a multifunctional tank, add water and decoct 3 times, the three decoction times are 2, 2 and 1 h respectively, separate the extracts, combine them, and filter; the filtrate is combined with the above aqueous solution, and concentrated under reduced pressure to a relative density 1.10 (50°C) clear paste, let it cool; take the above concentrate, add ethanol until the alcohol content reaches 60%, let it stand, and filter; the filtrate is decompressed to recover ethanol, concentrated to a relative density of about 1.32 (80°C) The clear paste, dry under reduced pressure, pulverize, get extract powder I. (3) Take volatile oil (ml): cyclodextrin (g) at 1:6, add water to make a saturated aqueous solution, slowly add 1ml of ethanol solution (1:1) of mixed volatile oil of Acorus calamus and Angelica sinensis, and keep the temperature at 50°C Bath in water for 1 hour, let stand and filter after completion of clathrate, and dry and pulverize the obtained clathrate into fine powder as volatile oil clathrate for later use; (4) Mix extract powder I with volatile oil clathrate of Shichangpu and Angelica sinensis, add Appropriate excipients are made into any one of oral preparations such as granules, tablets, powders, pills, capsules, dripping pills, syrups, and mixtures according to conventional techniques.

Example 4

The present invention weighs the medicinal components according to the following weight ratio: 6 ginseng, 10 angelica, 10 polygala, 12 poria, 6 calamus, 6 turmeric, 10 chuanxiong, 10 salvia, 10 astragalus, and 10 rehmannia.

The preparation process is as follows: (1) adding 8 times the amount of water to the crude powder of Acorus shichangpu, angelica and chuanxiong, keeping it slightly boiled for 6 hours, extracting the volatile oil by steam distillation, and taking the volatile oil, dregs and the aqueous solution of shichangpu, angelica and chuanxiong for standby; Put the rest of the medicinal materials and dregs in a multifunctional tank, add water and decoct 3 times, the three decoction times are 2, 2 and 1 h respectively, separate the extracts, combine them, and filter them; Concentrate to a clear paste with a relative density of 1.12 (50°C), and let it cool; take the above concentrated solution, add ethanol until the alcohol content reaches 70%, let it stand, and filter; the filtrate recovers ethanol under reduced pressure, and concentrates to a relative density of about 1.30 (80°C) clear paste, dried under reduced pressure, pulverized to obtain extract powder I. (3) Take volatile oil (ml): cyclodextrin (g) is 1:6, add water to make a saturated aqueous solution, slowly add 1ml of ethanol solution (1:1) of mixed volatile oils of Acorus calamus, Angelica, and Rhizoma Chuanxiong, 40 ℃ constant temperature water bath for 3 hours, after completion of inclusion, let it stand and filter, and the obtained inclusion compound is dried and crushed into fine powder as volatile oil inclusion compound for later use; (4) Extraction powder I is included with volatile oil of Shichangpu, Angelica, and Chuanxiong Mix the mixture, add appropriate auxiliary materials, and make any one of oral preparations such as granules, tablets, powders, pills, capsules, dripping pills, syrups, and mixtures according to conventional processes.

Example 5

The present invention weighs the medicinal components according to the following weight ratio: 10 ginseng, 12 angelica, 15 polygala, 10 calamus, 8 curcuma, 15 poria cocos, 15 salvia miltiorrhiza, 10 chuanxiong, 10 astragalus, and 15 rehmannia glutinosa.

The preparation process is as follows: (1) adding 8 times the amount of water to the fine powder of Acorus shichangpu, angelica and chuanxiong, keeping it slightly boiled for 5 hours, extracting the volatile oil by steam distillation, and taking the volatile oil, dregs and the aqueous solution of shichangpu, angelica and chuanxiong for standby; Put the rest of the medicinal materials and dregs in a multifunctional tank, add water and decoct 3 times, the three decoction times are 2, 2 and 1 h respectively, separate the extracts, combine them, and filter them; Concentrate to a clear paste with a relative density of 1.15 (50°C), and let it cool; take the above concentrate, add ethanol until the alcohol content reaches 80%, let it stand, and filter; the filtrate recovers ethanol under reduced pressure, and concentrates to a relative density of about 1.35 (80°C) clear paste, dried under reduced pressure, pulverized to obtain extract powder I. (3) Take volatile oil (ml): cyclodextrin (g) is 1:8, add water to make a saturated aqueous solution, slowly add 1ml of ethanol solution (1:1) of mixed volatile oils of Acorus calamus, Angelica, and Rhizoma Chuanxiong, 60 ℃ constant temperature water bath for 1 hour, after completion of inclusion, let it stand, filter, and the obtained inclusion compound is dried and crushed into fine powder as volatile oil inclusion compound for use; Mix the mixture, add appropriate auxiliary materials, and make any one of oral preparations such as granules, tablets, powders, pills, capsules, dripping pills, syrups, and mixtures according to conventional processes.

The above is only a preferred specific embodiment of the present invention, and the scope of protection of the present invention is not limited thereto. Any person familiar with the technical field within the technical scope disclosed in the present invention can obviously obtain the simplicity of the technical solution. Changes or equivalent replacements all fall within the protection scope of the present invention.

Claims (7)

1. A combination preparation of traditional Chinese medicine for preventing and treating senile dementia, characterized in that, comprises the bulk drug by following parts by weight: 5-20 parts of Radix Ginseng, 5-20 parts of Angelica Sinensis, 5-20 parts of Polygala, 5-20 parts of Poria cocos, Calamus 5-15 parts, Curcuma 5-15 parts, Chuanxiong 6-10 parts. 2. The traditional Chinese medicine combination preparation for preventing and treating senile dementia according to claim 1, further comprising the following raw materials in parts by weight: 10-15 parts of Salvia miltiorrhiza, 5-12 parts of Radix Astragali, and 9-15 parts of Rehmannia glutinosa. 3. The traditional Chinese medicine combination preparation for preventing and treating senile dementia according to claim 2, is characterized in that, comprises the crude drug of following parts by weight: 6-10 parts of ginseng, 10-12 parts of angelica, 10-15 parts of polygala, 12 parts of poria cocos -15 parts, Shichangpu 6-10 parts, Curcuma 6-8 parts, Chuanxiong 6-10 parts, Salvia miltiorrhiza 10-15 parts, Astragalus 5-12 parts, Rehmannia glutinosa 9-15 parts. 4. The traditional Chinese medicine combination preparation for preventing and treating senile dementia according to claim 2, is characterized in that, comprises the crude drug of following parts by weight: 6 parts of ginseng, 10 parts of angelica, 10 parts of Polygala, 12 parts of Poria cocos, 6 parts of Shichangpu , 6 parts of turmeric, 10 parts of Chuanxiong, 10 parts of Danshen, 10 parts of Astragalus, and 10 parts of Rehmannia glutinosa. 5. The traditional Chinese medicine combination preparation for preventing and treating senile dementia according to claim 2, is characterized in that it comprises the following raw materials in parts by weight: 10 parts of ginseng, 12 parts of angelica, 15 parts of Polygala, 15 parts of Poria cocos, 10 parts of Shichangpu , 8 parts of turmeric, 10 parts of Chuanxiong, 15 parts of Danshen, 10 parts of Astragalus, and 15 parts of Rehmannia glutinosa. 6. according to any one of claim 1-5, prevent and treat senile dementia Chinese medicine combination preparation, it is characterized in that: the dosage form of described Chinese medicine combination preparation is granule, tablet, powder, pill, capsule, drop pill, syrup Any of the medicines and mixtures. 7. A preparation method for preventing and treating senile dementia Chinese medicine combination preparation according to any one of claims 1-5, characterized in that, comprising the following steps: (1) Add 8 times the amount of water to the decoction pieces of Shichangpu, Angelica, and Chuanxiong medicinal materials and keep boiling for 8 hours, extract the volatile oil by steam distillation, and prepare the volatile oil, medicinal residues, Shichangpu, and Angelica aqueous solution for later use; (2) Put the rest of the medicinal materials and dregs in a multifunctional tank, add water and decoct 3 times, the decoction time is 2h, 2h, 1h respectively, combine the three extracts and the aqueous solutions of Shichangpu, Angelica, and Chuanxiong, and decompress Concentrate to a relative density of 1.10-1.15, clear the paste at a temperature of 50°C, and let it cool; take the above concentrate, add ethanol until the alcohol content reaches 60%, let it stand, and filter; the filtrate recovers ethanol under reduced pressure, and concentrates to relative Density is 1.25-1.35, the temperature is 80 ℃ clear paste, decompression drying, pulverization, obtain extract powder I; (3) Take volatile oil: cyclodextrin is 1:8, add appropriate amount of water to make a saturated aqueous solution, slowly add 1ml of ethanol solution of mixed volatile oil of Acorus calamus, Angelica, and Rhizoma Chuanxiong, and bathe in constant temperature water at 50°C for 2 hours. After standing and filtering, the obtained clathrate is dried and pulverized into fine powder as volatile oil clathrate for subsequent use; (4) Extract powder I is mixed with Shichangpu, angelica volatile oil clathrate, add suitable adjuvant, make granule, tablet, powder, pill, capsule, dripping pill, syrup, mixture in conventional process any type.