CN109999155B

CN109999155B - Traditional Chinese medicine composition for treating Alzheimer disease and preparation method thereof

Info

Publication number: CN109999155B
Application number: CN201910371018.5A
Authority: CN
Inventors: 孟胜喜; 彭学丰
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-05-06
Filing date: 2019-05-06
Publication date: 2021-07-30
Anticipated expiration: 2039-05-06
Also published as: CN109999155A

Abstract

The invention relates to a traditional Chinese medicine composition for treating Alzheimer disease and a preparation method thereof, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-30 parts of sharpleaf galangal fruit, 10-20 parts of astragalus membranaceus, 10-20 parts of semen cuscutae, 5-15 parts of ligusticum wallichii, 10-20 parts of prepared rehmannia root, 10-20 parts of parasitic loranthus, 10-20 parts of calcined concha haliotidis, 10-20 parts of eucommia ulmoides, 5-15 parts of lumbricus, 1-3 parts of leech, 5-15 parts of gastrodia elata and 5-15 parts of uncaria. Based on the principle of combining disease differentiation and syndrome differentiation of traditional Chinese medicine, the invention screens out natural medicines with the functions of tonifying the kidney, promoting blood circulation and reducing phlegm, and the traditional Chinese medicine composition is prepared according to a certain weight proportion, and has obvious curative effect and low cost.

Description

Traditional Chinese medicine composition for treating Alzheimer disease and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating Alzheimer disease and a preparation method thereof.

Background

Alzheimer's Disease (AD) is a degenerative disease of the central nervous system with occult onset, gradually developing and progressive worsening of symptoms, marked impairment of memory and cognitive functions, etc., and poor prognosis. In 2015, there were a total of 2980 million people with AD, with 4-5% of patients in prodromal phase of AD, which can lead to approximately 190 million deaths per year. By 2050, the number of people diagnosed with AD will be over 1.3 billion worldwide. It is expected that by 2020, China will cost approximately 700 billion dollars for AD patients. At present, no therapeutic drug aiming at the etiology exists. The traditional Chinese medicine compound has the advantages of multiple ways, multiple links and multiple target points, and plays an increasingly large role in preventing and treating AD. Therefore, the development of effective medicaments for preventing and treating AD by the compatibility of the traditional Chinese medicine decoction pieces has very important significance.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating Alzheimer disease and a preparation method thereof.

In order to achieve the purpose, the technical scheme of the invention is as follows:

a traditional Chinese medicine composition for treating Alzheimer disease is prepared from the following raw materials in parts by weight: 20-30 parts of sharpleaf galangal fruit, 10-20 parts of astragalus membranaceus, 10-20 parts of semen cuscutae, 5-15 parts of ligusticum wallichii, 10-20 parts of prepared rehmannia root, 10-20 parts of parasitic loranthus, 10-20 parts of calcined concha haliotidis, 10-20 parts of eucommia ulmoides, 5-15 parts of lumbricus, 1-3 parts of leech, 5-15 parts of gastrodia elata and 5-15 parts of uncaria.

As a preferable scheme, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of sharpleaf galangal fruit, 15 parts of astragalus, 10 parts of south dodder seed, 10 parts of szechuan lovage rhizome, 15 parts of prepared rehmannia root, 10 parts of parasitic loranthus, 10 parts of calcined abalone shell, 10 parts of eucommia bark, 10 parts of earthworm, 2 parts of leech, 10 parts of tall gastrodia tuber and 10 parts of uncaria.

As a preferable scheme, the traditional Chinese medicine composition also comprises 10-15 parts of codonopsis pilosula and 10-15 parts of bighead atractylodes rhizome, and is used for treating patients with symptoms of qi deficiency.

As a preferable scheme, the traditional Chinese medicine composition also comprises 5-10 parts of dried orange peel and 5-10 parts of fructus aurantii, and is used for treating patients with qi stagnation symptom.

The second objective of the present invention is to provide a preparation method of the above traditional Chinese medicine composition for treating alzheimer's disease, the preparation method comprising the following steps:

the method comprises the following steps: weighing the raw materials in corresponding parts by weight.

Step two: placing the raw materials except Lumbricus and Hirudo into a pot, adding appropriate amount of water, and soaking for 10-30 min.

Step three: decocting with strong fire for 10-25 min; turning to slow fire, and continuing decocting for 10-25 minutes.

Step four: extinguishing fire, filtering to remove residue and obtain filtrate.

Step five: grinding the baked earthworm and the leech into powder, adding the powder into the filtrate obtained in the step four together, and uniformly stirring to obtain the traditional Chinese medicine composition for treating the Alzheimer disease.

As a preferable scheme, in the second step, the total weight ratio of the added water to the traditional Chinese medicine raw materials is 4:1-10: 1.

The third purpose of the invention is to provide the application of the traditional Chinese medicine composition in treating the Alzheimer disease.

The pharmacology of the main components of the traditional Chinese medicine composition is as follows:

fructus alpiniae oxyphyllae, pungent and warm in flavor, enters spleen and kidney channels, warms spleen and kidney, reduces urination and fixes essence; astragalus root, radix astragali, sweet and slightly warm, enters liver, spleen, lung and kidney meridians, invigorates qi and strengthens exterior, induces diuresis and expels pus, heals wound and promotes tissue regeneration, and both are monarch drugs. Dodder seed, pungent and sweet in flavor and neutral in nature, enters liver, kidney and spleen channels, tonifies liver and kidney, and controls nocturnal emission and reduces urination; the rhizoma ligustici wallichii, being pungent and warm, enters liver and gallbladder channels, activates blood and qi, and dispels wind and relieves pain; prepared rehmannia root, radix rehmanniae Praeparata enters liver and kidney channels, enriches blood, nourishes yin, replenishes essence and fills marrow; loranthus parasiticus, bitter and sweet, neutral, entering liver and kidney channels, tonifying liver and kidney, strengthening bones and muscles, removing rheumatism and dredging channels and collaterals; concha Haliotidis, slightly salty and cold, enters liver and lung channels, calms liver, clears heat, improves eyesight and removes nebula; eucommia bark, cortex eucommiae, which is sweet, slightly pungent and warm, tonifies liver and kidney, and strengthens tendons and bones, is used as a ministerial drug. Earthworm, being salty and cold, enters liver, spleen and bladder meridians, clears heat and relieves endogenous wind, and clears collaterals and promotes urination; leeches, salty and bitter and neutral, have the effects of breaking blood and removing stasis; gastrodia elata, sweet and neutral, entering liver meridian, extinguishing wind and arresting convulsion; uncaria rhynchophylla, sweet and cool, enters liver and heart meridians, stops endogenous wind and calms convulsion, clears heat and pacifies liver, and is used as an adjuvant drug together. The twelve medicines jointly play the roles of tonifying kidney, reducing phlegm and activating blood circulation, tonifying kidney essence, reducing phlegm and removing turbidity, activating blood circulation to dissipate blood stasis, nourishing marrow and sea and recovering intelligence, thereby treating the disease.

Modern pharmacological studies have demonstrated that ethanol extracts of alpinia oxyphylla can inhibit phosphorylation of tau protein in nerve cells. The radix astragali extract can improve dysmnesia and learning ability. The semen cuscutae water extract can obviously improve the rat memory disorder caused by cerebral ischemia. The main effective component of the ligusticum wallichii, namely ligustrazine, can obviously improve the learning and memory ability of dementia model mice. The prepared rehmannia root can enhance the learning and memory ability of experimental mice and improve the gene expression of hippocampal nerve growth factor and c-fos. The aqueous extracts of herba Taxilli, Concha Haliotidis and Eucommiae cortex have neuroprotective effect on mice with Abeta (25-35) induced learning and memory disorder. The main effective components of earthworm, namely lumbrokinase and nimodipine can improve the cognitive function and the daily life self-care ability of AD patients. Hirudo has effects of inhibiting platelet aggregation, resisting oxidation, and resisting tumor. The rhizoma Gastrodiae extract can improve learning and memory ability of mouse. The active ingredient isorhynchophylline of uncaria can obviously improve the spatial learning and memory disorder of a model mouse caused by D-galactose.

Research results show that the traditional Chinese medicine composition has a synergistic effect in combination with donepezil hydrochloride for treating Alzheimer disease, can remarkably reduce Hcy, D-D and FIB levels, increase Apo AI and HDL-C levels, reduce Apo B, TC and LDL-C levels, and effectively improve clinical symptoms of AD patients.

The invention has the following advantages:

based on the principle of combining disease differentiation and syndrome differentiation of traditional Chinese medicine, the invention screens out natural medicines with the functions of tonifying the kidney, promoting blood circulation and reducing phlegm, and the traditional Chinese medicine composition is prepared according to a certain weight proportion, and has obvious curative effect and low cost.

The traditional Chinese medicine composition provided by the invention can obviously improve MMSE, ADAS-cog, ADL, social function score and horde behavior score of patients with Alzheimer's disease, has a curative effect obviously superior to that of western medicines, and has no obvious toxic or side effect.

The preparation method of the traditional Chinese medicine composition disclosed by the invention is simple and easy to implement, is easy to produce and prepare, and can extract the effective components of the medicinal components to the maximum extent.

The traditional Chinese medicine composition mainly comprises the following traditional Chinese medicines: fructus Alpinae Oxyphyllae, radix astragali, semen Cuscutae, rhizoma Ligustici Chuanxiong, radix rehmanniae Preparata, herba Taxilli, Concha Haliotidis preparata, Eucommiae cortex, Lumbricus, Hirudo, rhizoma Gastrodiae, and ramulus Uncariae cum uncis. The traditional Chinese medicine has reasonable compatibility, can tonify the kidney to remove blood stasis, treats both principal and secondary aspects of diseases, has good treatment effect on the Alzheimer disease, has scientific and effective preparation method, and can fully play the role of each traditional Chinese medicine.

Detailed Description

The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.

Example 1

The embodiment provides a traditional Chinese medicine composition for treating alzheimer disease, which is prepared from the following raw materials in parts by weight: 30g of sharpleaf galangal fruit, 15g of astragalus root, 10g of south dodder seed, 10g of Szechuan lovage rhizome, 15g of prepared rehmannia root, 10g of Chinese taxillus twig, 10g of calcined abalone shell, 10g of eucommia bark, 10g of earthworm, 2g of leech, 10g of tall gastrodia tuber and 10g of uncaria.

The preparation method of the traditional Chinese medicine composition comprises the following steps:

the method comprises the following steps: weighing the raw materials in corresponding weight grams.

Step two: placing the raw materials except Lumbricus and Hirudo into a pot, adding appropriate amount of water, and soaking for 20 min.

Step three: decocting for 22 minutes with strong fire; turning to soft fire, and continuing to decoct for 22 minutes.

Step four: extinguishing fire, filtering to remove residue and obtain filtrate.

Step five: grinding the baked earthworm and the leech into powder, adding the powder into the filtrate obtained in the step four, and uniformly stirring the mixture to obtain the traditional Chinese medicine composition for treating the Alzheimer disease.

In the second step, the total weight ratio of the added water to the traditional Chinese medicine raw materials is 7: 1.

Example 2

The embodiment provides a traditional Chinese medicine composition for treating alzheimer disease, which is prepared from the following raw materials in parts by weight: 20 g of sharpleaf galangal fruit, 10g of astragalus root, 10g of south dodder seed, 15g of Szechuan lovage rhizome, 10g of prepared rehmannia root, 10g of Chinese taxillus twig, 10g of calcined abalone shell, 10g of eucommia bark, 15g of earthworm, 1 g of leech, 5g of tall gastrodia tuber and 5g of uncaria.

Step two: placing the raw materials except Lumbricus and Hirudo into a pot, adding appropriate amount of water, and soaking for 10 min.

Step three: decocting for 10 minutes with strong fire; turning to soft fire, and continuing decocting for 10 minutes.

Step four: extinguishing fire, filtering to remove residue and obtain filtrate.

In the second step, the total weight ratio of the added water to the traditional Chinese medicine raw materials is 4: 1.

Example 3

The embodiment provides a traditional Chinese medicine composition for treating alzheimer disease, which is prepared from the following raw materials in parts by weight: 30g of sharpleaf galangal fruit, 10g of astragalus root, 15g of south dodder seed, 10g of Szechuan lovage rhizome, 15g of prepared rehmannia root, 15g of Chinese taxillus twig, 10g of calcined abalone shell, 15g of eucommia bark, 10g of earthworm, 2g of leech, 5g of tall gastrodia tuber and 5g of uncaria.

Step two: placing the raw materials except Lumbricus and Hirudo into a pot, adding appropriate amount of water, and soaking for 30 min.

Step three: decocting for 25 minutes with strong fire; turning to soft fire, and continuing to decoct for 25 minutes.

Step four: extinguishing fire, filtering to remove residue and obtain filtrate.

In the second step, the total weight ratio of the added water to the traditional Chinese medicine raw materials is 10: 1.

Example 4

The embodiment provides a traditional Chinese medicine composition for treating alzheimer disease, which is prepared from the following raw materials in parts by weight: 20 g of sharpleaf galangal fruit, 15g of astragalus root, 10g of south dodder seed, 5g of Szechuan lovage rhizome, 10g of prepared rehmannia root, 10g of Chinese taxillus twig, 10g of calcined abalone shell, 10g of eucommia bark, 5g of earthworm, 3 g of leech, 10g of tall gastrodia tuber and 10g of uncaria.

The traditional Chinese medicine composition also comprises 15g of codonopsis pilosula and 15g of bighead atractylodes rhizome.

The preparation method is the same as that of example 1.

Example 5

The embodiment provides a traditional Chinese medicine composition for treating alzheimer disease, which is prepared from the following raw materials in parts by weight: 20 g of sharpleaf galangal fruit, 10g of astragalus root, 10g of south dodder seed, 5g of Szechuan lovage rhizome, 10g of prepared rehmannia root, 10g of Chinese taxillus twig, 15g of calcined abalone shell, 10g of eucommia bark, 10g of earthworm, 2g of leech, 15g of tall gastrodia tuber and 15g of gambir plant.

The traditional Chinese medicine composition also comprises 10g of codonopsis pilosula and 10g of bighead atractylodes rhizome.

The preparation method is the same as that of example 1.

Example 6

The embodiment provides a traditional Chinese medicine composition for treating alzheimer disease, which is prepared from the following raw materials in parts by weight: 25 g of sharpleaf galangal fruit, 10g of astragalus root, 10g of south dodder seed, 10g of Szechuan lovage rhizome, 10g of prepared rehmannia root, 10g of Chinese taxillus twig, 10g of calcined abalone shell, 10g of eucommia bark, 5g of earthworm, 1 g of leech, 15g of tall gastrodia tuber and 15g of gambir plant.

The traditional Chinese medicine composition also comprises 5g of dried orange peel and 7 g of bitter orange.

The preparation method is the same as that of example 1.

Example 7

The embodiment provides a traditional Chinese medicine composition for treating alzheimer disease, which is prepared from the following raw materials in parts by weight: 30g of sharpleaf galangal fruit, 20 g of astragalus root, 10g of south dodder seed, 5g of Szechuan lovage rhizome, 15g of prepared rehmannia root, 15g of Chinese taxillus twig, 15g of calcined abalone shell, 10g of eucommia bark, 10g of earthworm, 1 g of leech, 5g of tall gastrodia tuber and 5g of uncaria.

The traditional Chinese medicine composition also comprises 7 g of dried orange peel and 5g of bitter orange.

The preparation method is the same as that of example 1.

Effect test one:

the traditional Chinese medicine composition described in example 1 achieves satisfactory efficacy in treating alzheimer's disease, as follows.

1 data and method

1.1 general data

112 AD patients in the sixth national hospital of Shanghai were selected as study subjects in 2016-2018 in 12 months. Male and female are not limited.

The standard for diagnosis of AD is in accordance with the American handbook of diagnosis and statistics of mental disorders, 4 th edition (DSM-IV).

Inclusion criteria were: the Chinese medicinal composition has obvious mental symptoms and symptoms of decline of cognitive function, behavior disorder and limited daily life capacity; (ii) meets the diagnosis standard for AD in Chinese mental disorder classification and diagnosis Standard-3 rd edition (CCMD-3); ③ more than or equal to 60 years old and less than or equal to 80 years old; fourthly, serious liver, kidney, lung and other tissue diseases are not combined, and the cardiovascular and cerebrovascular indexes are checked to be normal; the subject voluntarily signs an informed consent with the subject or legal guardian.

Exclusion criteria: (ii) patients with a history of psychosis not caused by AD; ② patients with stroke or history of stroke; (iii) serious hematological, immune or other system malignancies; fourthly, the drugs involved in the study are allergic.

Patients in the group are randomly divided into a control group and a treatment group according to a random number table method. Control 55 cases, of which 31 cases were male and 24 cases were female; the age is 59-79 years, and the average (68.22 +/-8.13) years; the disease course is 1 to 12 years, the average (5.87 +/-3.25) years, the Body Mass Index (BMI) average (22.85 +/-2.71) ((BMI = weight (kg)/height 2 (m)), 26 cases of hypertension, 8 cases of type 2 diabetes, 19 cases of hyperlipidemia, 11 cases of smoking, 17 cases of drinking, 57 cases of treatment groups, 32 cases of male and 25 cases of female, the age is 60 to 79, the average (69.32 +/-8.72) years, the disease course is 6 to 13 years, the average (5.91 +/-3.32) years, the BMI average (23.12 +/-2.46), 28 cases of hypertension, 11 cases of type 2 diabetes, 16 cases of hyperlipidemia, 10 cases of smoking and 19 cases of drinking wine, and the comparison of general data such as gender, age, BMI, basic disease conditions, bad life style and the like of two groups has no statistical significance (P is more than 0.05), and the disease course has comparability, and is shown in Table 1.

TABLE 1 comparison of two general data sets (

±s）

1.2 methods

Donepezil hydrochloride tablets (trade name: aricept, wei material (china) pharmaceutical co., ltd., national drug standard H20050978; lot number: 1705080, specification: 5 mg/tablet) were administered to the control group at an initial dose of 5mg/d, orally taken immediately before sleep at night, and increased to a maximum dose of 10mg/d after 4 weeks.

The treatment group is given with the traditional Chinese medicine composition combined with donepezil hydrochloride for treatment, and the traditional Chinese medicine composition comprises: 30g of sharpleaf galangal fruit, 15g of astragalus root, 10g of south dodder seed, 10g of szechuan lovage rhizome, 15g of prepared rehmannia root, 10g of Chinese taxillus twig, 10g of calcined abalone shell, 10g of eucommia bark, 10g of earthworm, 2g of leech, 10g of tall gastrodia tuber and 10g of uncaria. Provided by a traditional Chinese medicine room in the sixth people hospital in Shanghai city, the traditional Chinese medicine is decocted with water for oral administration, and is taken in the morning and evening, 1 dose per day; the method for treating donepezil hydrochloride is the same as that of the control group.

The treatment course is 3 months.

1.3 Observation index

1.3.1 mental states before and after 1 month and 3 months of treatment, respectively, the mental states of the patients are evaluated by adopting a simple mental state assessment (MMSE) which comprises 5 parts of orientation force, memory force, recall force, language ability, attention and calculation force, and the like, wherein the assessment has 30 questions in total, the scoring range is 0-30 minutes, and the higher the score is, the better the mental state is. Each answer was scored 1 correctly and 0 incorrectly or unknown. Discomfort totaled 9 points, answers were rejected or not comprehended 8 points. When the total score is added, the score of 8 and the score of 9 are calculated as 0. The maximum is 30 points.

1.3.2 cognitive function before and 1 month, 3 months after treatment, adopt AD cognitive function rating scale (ADAS-cog) to assess patient's cognitive function, this scale includes 12 entries totally, the score range is 0-75 points, the higher the score is, indicate that cognitive impairment is more serious.

1.3.3 the ability to live is 1 month, 3 months before treating and after treating respectively, adopt the ability to live scale of daily life (ADL) to appraise patient's ability to live, totally 20 entries, the score range is 14-64 points, the higher the score is, the worse the ability to live of daily life is.

1.3.4 social Performance Scale (PSP) and horror (CMAI) scores were performed before and 1 month, 3 months after treatment, respectively. Personal and social Performance Scale (PSP): when the score is 71-100 minutes, only slight difficulty is reflected, and when the score is 31-70 minutes, different degrees of capacity defects are reflected; the score is 0-30 minutes, which reflects that the patient needs active support or close monitoring due to low function. The horde behavioral scale short-scale (CMAI) includes: (1) no leaping behavior 1 point; (2) the surging behavior occurs for 2 minutes less than 1 time/week; (3) the occurrence of the behavior of more than or equal to 1 time/week shock is 3 minutes; (4) the surging behavior occurs for 1-2 times/d, 4 minutes; (5) 5 minutes of behavior over several times a day; (6) several agitation behaviors can occur per hour, 6 minutes.

1.3.5 Biochemical tests before and after 1 month and 3 months respectively, and two groups of patients fasting for 12 h, 8ml of elbow median venous blood was extracted in the next morning. Separating serum, and measuring Hcy, FIB, ApoAI, ApoB, LDL-C, HDL-C and TC levels by using Hitachi 7600 full-automatic biochemical analyzer; plasma D-D, Fibrinogen (FIB) levels were measured by immunoturbidimetry using Shsmexican CS 5100.

1.3.6 adverse reaction statistics of the adverse reaction incidence rate in the two groups of medication periods.

1.4 statistical methods

The data analysis adopts SPSS 20.0 statistical software, and the measured data are averaged by +/-standard deviation (

S), comparisons are by analysis of variance with repeated measures, pairwise comparisons between groups are by LSD-t test, count data are expressed as composition ratio (%), comparisons are by X²The test shows that the difference is statistically significant when P is less than 0.05.

2 results

2.1 MMSE, ADAS-cog and ADL scores

Compared with the treatment group, the MMSE scores of the treatment group and the control group are increased at 1 month and 3 months after the treatment (P is less than 0.05), and the ADAS-cog and the ADL scores are decreased (P is less than 0.05). The MMSE and ADAS-cog scores of the treatment groups at 3 months after treatment are obviously different from those of the same groups at 1 month after treatment (P is less than 0.05). The MMSE and ADAS-cog scores of the control group at 3 months after treatment are obviously different from those of the control group before treatment (P is less than 0.05). The scores of MMSE, ADAS-cog and ADL of the treatment group at 3 months after treatment are all obviously different from the scores of the control group at the same period (P is all less than 0.05). See table 2.

TABLE 2 two sets of MMSE, ADAS-cog and ADL score comparisons (

±s）

Note: comparing with the same group before treatment, wherein P is less than 0.05; ② compared with the same group after 1 month of treatment, P is less than 0.05; and thirdly, compared with the control group, P is less than 0.05.

2.2 comparison of the Pre-and post-treatment PSP score and CMAI score in two groups

Compared with the treatment group, the PSP score of the treatment group is increased (P is less than 0.05) and the CMAI score is decreased (P is less than 0.05) at 1 month and 3 months after the treatment. The PSP and CMAI scores of 3 months after treatment of the treatment group are obviously different from the scores of 1 month after treatment of the same group (P is less than 0.05). The PSP score and CMAI score of the control group at 3 months after treatment were significantly different (P was < 0.05) from those of the same group before treatment. The PSP and CMAI scores of the treated group at 3 months after treatment are obviously different from the scores of the control group at the same period (P is less than 0.05). See table 3.

Table 3 comparison of PSP scores and CMAI scores before and after treatment in two groups: (

±s）

2.3 serum Hcy levels

Hcy levels were reduced at 3 months post-treatment (P < 0.05) in both the treated and control groups compared to the same group before treatment. Compared with the control group, the Hcy water level of the treatment group at 3 months after treatment is obviously reduced compared with the control group at the same period (P is less than 0.05). See table 4.

Table 4 two groups of serum Hcy levels were compared (mmol/L,

±s）

note: comparing with the same group before treatment, wherein P is less than 0.05; and thirdly, compared with the control group, P is less than 0.05.

2.3 serum D-D and FIB levels

D-D, FIB levels were reduced in both the treatment group at 1 month post-treatment and at 3 months post-treatment (P both < 0.05) compared to the treatment group before treatment. D-D and FIB levels were reduced in the treatment group at 3 months post-treatment compared to 1 month post-treatment (P both < 0.05). D-D and FIB levels were significantly different at 3 months after treatment in the control group compared to those before the same period of treatment (P was < 0.05). D-D and FIB levels 3 months after treatment were significantly different (P is less than 0.05) from the control group at the same time. See table 5.

Table 5 two groups of serum D-D and FIB levels were compared (mg/L, g/L,

±s）

2.4 comparison of blood lipid levels before and after treatment in two groups:

compared with the treatment group before treatment, the treatment group has increased Apo AI level (P < 0.05) and decreased Apo B level (P < 0.05) at 1 month and 3 months after treatment. Compared with the treatment group at 1 month, the Apo AI and Apo B water level of the treatment group at 3 months after the treatment group is obviously different from that of the treatment group at 1 month after the treatment group (P is less than 0.05). Compared with the control group, the Apo AI and Apo B water levels of the treatment group at 3 months after the treatment are obviously different from the control group at the same period (P is less than 0.05). See table 6.

TABLE 6 comparison of Apo AI, Apo B levels before and after two groups of treatments: (

±s）

Compared with the treatment group before treatment, the treatment group has reduced TC and LDL-C levels (P is less than 0.05) at 1 month after the treatment, and has reduced TC and LDL-C levels (P is less than 0.05) and increased HDL-C levels (P is less than 0.05) at 3 months after the treatment. The mean levels of TC, LDL-C and HDL-C in the treatment group at 3 months after treatment are obviously different from that in the same group at 1 month after treatment (P is less than 0.05). Compared with the control group, the TC, LDL-C and HDL-C levels of the treatment group are all obviously different after 3 months of treatment (P is all less than 0.05). See table 7.

TABLE 7 comparison of TC, LDL-C and HDL-C levels before and after two groups of treatments: (

±s）

2.5 adverse reactions

During treatment, the control group has 2 cases of dizziness, 1 case of headache and 1 case of nausea, and the total adverse reaction incidence rate is 9.09%; the treatment group showed 1 case of dizziness and 1 case of nausea, and the total adverse reaction incidence rate was 3.51%. Comparing the incidence rate of adverse reaction between the treatment group and the control group by adopting Chi²The differences were statistically significant (P < 0.05) as tested, see Table 8.

TABLE 8 adverse drug reactions comparison of two groups of patients (%)

The research result shows that: the Hcy, D-D and FIB levels of the two groups of patients after treatment are obviously reduced compared with those of the same group before treatment, and the combination of the traditional Chinese medicine composition and the donepezil hydrochloride treatment group is more obviously reduced compared with the donepezil hydrochloride treatment group. Compared with a control group (donepezil hydrochloride alone), the Apo AI and HDL-C levels of the treatment group (the traditional Chinese medicine composition is combined with the donepezil hydrochloride) are all increased (P is all less than 0.05), and the Apo B, TC and LDL-C levels are all decreased (P is all less than 0.05). Compared with the control group (which is singly treated by donepezil hydrochloride), the Apo AI, HDL-C, Apo B, TC, LDL-C and HDL-C levels of the control group (which is singly treated by donepezil hydrochloride) at 1 month and 3 months have no obvious difference (P is more than 0.05), which indicates that the traditional Chinese medicine composition has good effect of improving the blood lipid metabolism of AD patients. The adverse reaction rate of the treatment group (the traditional Chinese medicine composition combined with the donepezil hydrochloride) is obviously lower than that of the control group (the donepezil hydrochloride alone) (P is less than 0.05), and the traditional Chinese medicine composition is suggested to reduce the adverse reaction rate of the donepezil hydrochloride. The traditional Chinese medicine composition has better safety in combination with donepezil hydrochloride.

Effect test two:

in Zhouji, men, 83 years old, and 18 months 4 and 2018, the physician needs to see the disease for "progressive hypomnesis and slow response for 2 years". The patients have memory decline, frequent insomnia, little speech, slow action and skull-checking nuclear magnetic resonance which show that the white matter of cerebral hemispheres at two sides has an ischemic focus and mild brain atrophy since 2016, and the medicines such as salvia tablets and the like are not obviously improved. Diagnosis: memory deterioration, reaction retardation, difficulty in concentration, dizziness, tinnitus, mild hearing loss, insomnia in the daytime, dull expression, little speech, insomnia, dark tongue, little coating, and deep and thready pulse. Traditional Chinese medicine diagnosis: dementia (kidney deficiency and blood stasis), western diagnosis: alzheimer's disease. Therapeutic method: tonify kidney, replenish essence, promote blood circulation and remove obstruction in channels. Prescription: 15g of sharpleaf galangal fruit, 15g of astragalus root, 10g of south dodder seed, 5g of Szechuan lovage rhizome, 10g of prepared rehmannia root, 10g of Chinese taxillus twig, 10g of calcined abalone shell, 10g of eucommia bark, 5g of earthworm, 3 g of leech, 10g of tall gastrodia tuber and 10g of uncaria, and 14 doses are decocted with water for oral administration. After the re-diagnosis in 5 months and 7 days, the patients have better spirit, dark tongue, thin and white fur and deep and thready pulse, 15g of codonopsis pilosula, 15g of atractylodes macrocephala and 14 doses are added for decoction and taken. The patients in the three diagnostic methods have slow response, clear speech expression, improved dizziness symptoms, pale red tongue, thin and white fur, deep and thready pulse, and no new-born symptoms after taking for 3 months.

Although the invention has been described in detail above with reference to a general description and specific examples, it will be apparent to one skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims

1. The traditional Chinese medicine composition for treating the Alzheimer disease is characterized by being prepared from the following raw materials in parts by weight: 20-30 parts of sharpleaf galangal fruit, 10-20 parts of astragalus membranaceus, 10-20 parts of semen cuscutae, 5-15 parts of ligusticum wallichii, 10-20 parts of prepared rehmannia root, 10-20 parts of parasitic loranthus, 10-20 parts of calcined concha haliotidis, 10-20 parts of eucommia ulmoides, 5-15 parts of lumbricus, 1-3 parts of leech, 5-15 parts of gastrodia elata and 5-15 parts of uncaria.

2. The traditional Chinese medicine composition for treating alzheimer's disease according to claim 1, which is prepared from the following raw materials in parts by weight: 30 parts of sharpleaf galangal fruit, 15 parts of astragalus, 10 parts of south dodder seed, 10 parts of szechuan lovage rhizome, 15 parts of prepared rehmannia root, 10 parts of parasitic loranthus, 10 parts of calcined abalone shell, 10 parts of eucommia bark, 10 parts of earthworm, 2 parts of leech, 10 parts of tall gastrodia tuber and 10 parts of uncaria.

3. The traditional Chinese medicine composition for treating alzheimer's disease according to claim 1, which further comprises 10-15 parts of codonopsis pilosula and 10-15 parts of bighead atractylodes rhizome.

4. The traditional Chinese medicine composition for treating alzheimer's disease according to claim 1, wherein the traditional Chinese medicine composition further comprises 5-10 parts of dried orange peel and 5-10 parts of bitter orange.

5. The preparation method of the traditional Chinese medicine composition for treating the Alzheimer disease according to any one of claims 1 to 4, which is characterized by comprising the following steps:

the method comprises the following steps: weighing the raw materials in corresponding parts by weight;

step two: placing the raw materials except Lumbricus and Hirudo in a pot, adding appropriate amount of water, and soaking for 10-30 min;

step three: decocting with strong fire for 10-25 min; turning to soft fire, and continuing decocting for 10-25 minutes;

step four: extinguishing the fire, filtering and removing slag to obtain filtrate;

6. The traditional Chinese medicine composition for treating alzheimer's disease according to claim 5, wherein in the second step, the total weight ratio of the added water to the traditional Chinese medicine raw materials is 4:1-10: 1.