CN115737762B - A pharmaceutical composition with memory improving and brain health and cognitive function protecting effects - Google Patents
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Abstract
The invention relates to a preparation composition with the functions of improving memory and protecting brain health and cognition, which consists of cistanche extract, red sage extract, ginkgo leaf extract and alpinia oxyphylla extract, and is prepared by adopting scientific extraction and preparation technology. Memory and cognition disorder belongs to the categories of dementia, amnesia and the like in traditional Chinese medicine, and is caused by deficiency of essence, qi, blood, yin and yang (namely deficiency of kidney essence and deficiency of qi and blood) and excessive stasis, phlegm, qi and internal fire (namely phlegm turbidity blocking orifices, qi stagnation and blood stasis) and is caused by deficiency of pathogenesis and excessive inclusion. The composition is based on the theory of traditional Chinese medicine and the rules of modern pharmacological research on hypomnesis and cognitive dysfunction, and takes cistanche deserticola and ginkgo leaf as monarch drugs to tonify kidney, replenish essence, activate blood and remove meridian obstruction, and lead the drugs to be taken; the Chinese medicinal composition is matched with intelligence-improving medicines as adjuvant medicines, and has the effects of tonifying kidney and securing essence, strengthening the essence and marrow filling, nourishing essence and securing kidney of monarch medicines, warming spleen, helping spleen to rise and clear nutrition head and eyes; radix Salviae Miltiorrhizae is used as a guiding drug to promote blood circulation and remove meridian obstruction, and guiding drugs to enter meridian, and also to clear the pathogenic fire in blood and calm the mind. Four-in-one compatibility is adopted to tonify kidney and replenish essence to treat the root cause, promote blood circulation to remove meridian obstruction to treat both principal and secondary aspect of disease, and can tonify kidney and replenish essence, cool blood and relieve restlessness; scientific compatibility, synergy, treatment of both principal and secondary aspect of disease, combination of deficiency and excess, multiple treatment methods and multi-target effect; modern pharmacological researches of four medicines show that the Chinese medicinal composition has the effects of improving learning and memory capacity, improving memory re-defect, protecting nerves, promoting neuronal injury repair and the like and inhibiting brain function decline. The composition preparation has the functions of improving memory and protecting brain health and cognition, thereby effectively improving symptoms such as poor disease resistance, amnesia, insomnia, difficult thinking, negative, irritability, anxiety, depression, mental abnormality and the like.
Description
Technical Field
The invention relates to a traditional Chinese medicine preparation composition, in particular to a preparation composition with the functions of improving memory and protecting brain health and cognition.
Background
The study of improving memory and cognitive dysfunction by using traditional Chinese medicines is more and more, wherein single medicines such as polygala tenuifolia, ginkgo biloba, grassleaved sweetflag rhizome, ginseng, epimedium herb, gastrodia elata, prepared rehmannia root, red sage root and the like are adopted; the Chinese medicinal compound comprises heart-opening powder, radix Angelicae sinensis and radix Paeoniae powder, heart-clearing and resuscitation-inducing powder, radix Hui decoction, spleen-invigorating decoction, and fructus Alpinae Oxyphyllae and the like. These are both single and compound Chinese medicines, which exhibit a certain improvement in memory and cognitive dysfunction. However, there is still a need in the market for other traditional Chinese medicine preparations with significant efficacy for improving memory and cognitive impairment.
Disclosure of Invention
The invention provides a traditional Chinese medicine preparation for tonifying kidney and replenishing essence to treat the root cause, promoting blood circulation and removing obstruction in collaterals to treat both principal and secondary aspect of disease, tonifying kidney and replenishing essence, cooling blood and relieving restlessness, warming and not drying, and combining deficiency and excess, so that the symptoms such as poor disease resistance, limb weakness, amnesia, insomnia, depression, difficult thinking, memory loss and the like are effectively solved, and the memory and cognitive dysfunction are improved.
The traditional Chinese medicine preparation contains 40-60 parts by weight of cistanche extract, 20-40 parts by weight of ginkgo leaf extract, 50-100 parts by weight of alpinia oxyphylla extract and 150-200 parts by weight of salvia miltiorrhiza extract.
Cistanche deserticola
Also known as cistanche deserticola, dijing, jinzhang, etc., commonly known as Dayun, has the reputation of "desert ginseng". The traditional Chinese herbs are regarded as good drugs for tonifying kidney and prolonging life, and are second only to ginseng in anti-aging and prolonging life prescriptions. Shen nong Ben Cao Jing (Shen nong's herbal), is sweet in flavor and slightly warm. The recipe is characterized by the above-mentioned herbs in terms of treating impairment of five internal organs and seven internal organs, tonifying middle-jiao, nourishing five internal organs, strengthening yin, replenishing vital essence and qi, and reducing weight after long-term administration. The theory of medicine is called Yi Ji, yu Shen, yan Lian, yang-strengthening and Da Yi. It is called kidney-nourishing and essence-blood-replenishing herbs in Ben Cao Jing Shu, and is also indicated for long-term administration because it is fat-invigorating and light-weight, and has the actions of tonifying kidney, liver and essence and blood. Principal drugs for nourishing kidney qi and replenishing essence and blood in Ben Cao Hui Yan (materia Medica and Hui Yan). The recipe is characterized by that it is a tonic for treating the deficiency of cold of the male's danyuan, the chronic sinking of the yang channel, and the disharmony of the thoroughfare and conception vessels of women, and it is a tonic for treating the deficiency of yin-qi, warm but not hot, warm but not dry, slippery but not leak. Cistanche deserticola, its nature, taste and meridian tropism, is sweet, salty and warm in nature recorded in Chinese pharmacopoeia. Enter kidney and large intestine meridians. [ Functions and indications ] tonify kidney yang, replenish essence and blood, moisten intestines and relieve constipation. Can be used for treating kidney yang deficiency, essence and blood deficiency, sexual impotence, infertility, soreness of waist and knees, weakness of tendons and bones, and constipation due to intestinal dryness.
Ginkgo leaf
Ginkgo is a big national treasures of the plant kingdom of China, and only one plant of the family Ginkgo of China exists in the world at present. Ginkgo leaf is recorded in Chinese pharmacopoeia: [ the nature and flavor of qi and meridian tropism ] sweet, bitter, astringent and flat. It enters heart and lung meridians. [ Functions and indications ] activate blood circulation to dissipate blood stasis, dredge collaterals to relieve pain, astringe lung to relieve asthma, dispel turbidity and reduce lipid. Can be used for treating obstruction of collaterals by blood stasis, chest stuffiness and pain, apoplexy, hemiplegia, cough and asthma due to lung deficiency, and hyperlipidemia.
Intelligence-improving
The fructus alpiniae oxyphyllae is a dry mature fruit of the plant alpinia oxyphyllae Alpinia oxyphylla Miq of the family Zingiberaceae, is one of four south-great-herb medicines in China, and is increasingly applied to brain health care along with continuous research in recent years. "Chinese pharmacopoeia" describes developing intelligence: is dried mature fruit of alpinia oxyphyllaq. [ the nature and meridian tropism ] pungent and warm. Enter spleen and kidney meridians. [ Functions and indications ] warming the kidney, securing essence, reducing urination, warming the spleen, relieving diarrhea and taking saliva. Can be used for treating enuresis due to kidney deficiency, frequent urination, spermatorrhea, turbid urine, diarrhea due to spleen cold, abdominal pain, excessive saliva, etc.
Radix Salviae Miltiorrhizae
The root and rhizome of Salvia Miltiorrhiza Salvia miltiorrhiza Bge are dry root and rhizome of Salvia Miltiorrhiza, which is a traditional Chinese bulk traditional medicine, and has effects of clearing heart fire, relieving vexation, removing blood stasis, relieving pain, promoting blood circulation and dredging channels. The Chinese pharmacopoeia records the root of red-rooted salvia: [ the nature and flavor of qi and meridian entered ] bitter, slightly cold, heart and liver meridians entered. [ Functions and indications ] activate blood, remove stasis, promote menstruation, relieve menalgia, clear heart and relieve restlessness, cool blood and cure carbuncles. Can be used for treating chest pain, abdominal pain, hypochondriac pain, abdominal mass, pain due to pyretic arthralgia, vexation, insomnia, menoxenia, dysmenorrhea, amenorrhea, and pyocutaneous disease.
Memory and cognition disorder belongs to the categories of dementia, amnesia and the like in traditional Chinese medicine, and is caused by deficiency of essence, qi, blood, yin and yang (namely deficiency of kidney essence and deficiency of qi and blood) and excessive stasis, phlegm, qi and internal fire (namely phlegm turbidity blocking orifices, qi stagnation and blood stasis) and is caused by deficiency of pathogenesis and excessive inclusion.
The invention takes cistanche deserticola and ginkgo leaf as monarch drugs, and has the effects of tonifying kidney, replenishing essence, promoting blood circulation, removing obstruction in channels and relieving stuffiness; the Chinese medicinal composition is matched with intelligence-improving medicines as adjuvant medicines, and has the effects of tonifying kidney and securing essence, strengthening the essence and marrow filling, nourishing essence and securing kidney of monarch medicines, warming spleen, helping spleen to rise and clear nutrition head and eyes; radix Salviae Miltiorrhizae is used as a guiding drug to promote blood circulation and remove meridian obstruction, and guiding drugs to enter meridian, and also to clear the pathogenic fire in blood and calm the mind. Four-in-one compatibility is adopted to tonify kidney and replenish essence to treat the root cause, promote blood circulation to remove meridian obstruction to treat both principal and secondary aspect of disease, and can tonify kidney and replenish essence, cool blood and relieve restlessness; scientific compatibility, synergy, treatment of both principal and secondary aspect of disease, combination of deficiency and excess, multiple treatment methods and multi-target effect; modern pharmacological researches of four medicines show that the Chinese medicinal composition has the effects of improving learning and memory capacity, improving memory re-defect, protecting nerves, promoting neuronal injury repair and the like and inhibiting brain function decline. The composition preparation has the functions of improving memory and protecting brain health and cognition, thereby effectively improving symptoms such as poor disease resistance, amnesia, insomnia, difficult thinking, negative, irritability, anxiety, depression, mental abnormality and the like.
Detailed Description
The cistanche used in the invention is selected from cistanche tubulosa or cistanche deserticola, and the extraction process is as follows: extracting herba cistanches decoction pieces or large particles with 5-10 times of 60-80% ethanol for 2-3 times (each for 1-2 hr), mixing the extractive solutions, filtering, and recovering ethanol from the filtrate to obtain ethanol extractive solution; extracting the residues with 5-8 times of water for 2-3 times (each for 1-2 hr), mixing the extractive solutions, and filtering to obtain water extractive solution; mixing the ethanol extractive solution and water extractive solution, concentrating under reduced pressure until the specific gravity of the extract is 1.05-1.25, and vacuum drying or spray drying to obtain herba cistanches extract with total glycoside content of phenethyl alcohol not less than 50.0%.
The ginkgo extract obtaining process used in the invention comprises the following steps: reflux extracting folium Ginkgo with 5-8 times of 50-75% ethanol under heating for 1-2 hr each time, mixing extractive solutions, recovering ethanol, concentrating to appropriate amount, eluting with macroporous adsorbent resin ethanol, recovering ethanol, spray drying to obtain folium Ginkgo extract with quality standard meeting the requirements of folium Ginkgo extract item in Chinese pharmacopoeia.
The intelligence-promoting extract obtaining process used in the invention comprises the following steps: pulverizing fructus Alpinae Oxyphyllae, decocting with 6-9 times of water for 2-3 times each for 1-2 hr, filtering, and mixing filtrates; concentrating under reduced pressure until the specific gravity of the extract is 1.05-1.25, vacuum drying or spray drying to obtain extract with yield of more than or equal to 10.0%.
The extraction process of the salvia miltiorrhiza extract is as follows: extracting Saviae Miltiorrhizae radix with 5-10 times of water under heating for 2-3 times (each for 1-2 hr), mixing extractive solutions, concentrating under reduced pressure to obtain extract with specific gravity of 1.10-1.25, adding ethanol content of 50-80%, and standing overnight; recovering ethanol from the supernatant, concentrating under reduced pressure until the specific gravity of the extract is 1.05-1.25, and vacuum drying or spray drying to obtain Saviae Miltiorrhizae radix extract with salvianolic acid B content of more than or equal to 5.0%.
The preparation composition with the functions of improving memory and protecting brain health and cognition can be common oral preparations in the field, such as tablets, granules, soft and hard capsules, oral liquid, suspension and the like, and the preparation can be prepared by adopting a preparation method conventional in the field.
The invention will be further illustrated with reference to specific examples.
Example 1: capsule preparation
Taking 50 parts by weight of cistanche extract, 180 parts by weight of red sage extract, 30 parts by weight of ginkgo leaf extract and 70 parts by weight of alpinia oxyphylla extract, adding an appropriate amount of auxiliary materials such as starch, povidone and magnesium stearate, and preparing the mixture into capsule particles according to a conventional method in the field.
Example 2: evaluation test for improving memory function of human body by aid of capsules
1 materials and methods
1.1 sample: the capsule and the placebo of the invention have the specification of 0.35 g/granule and the recommended dosage of human body of 1.4 g/person/day. The administration method comprises the following steps: orally taken 2 times a day, 2 granules each time.
1.2 principle of selecting subjects
Selecting a voluntary subject from a population in which the influence factors are substantially the same in all aspects in the comparative set; the culture degree is basically consistent; if the corresponding scale belongs to the same age group, correcting the scale if the corresponding scale is not in the same age group; similar testers were not accepted; excluding those taking items related to the function under test for a short period of time, and having an influence on the result.
1.3 test methods
According to the human body test food test procedure of the technical specification of health food inspection and evaluation (2003 edition), the memory quotient of the test subject is measured according to the test requirement by adopting a clinical memory scale.
1.4 test Meter
The "clinical memory scale" revised in the national academy of sciences psychological institute 1996 was adopted.
1.5 test food design and grouping
The health analysis and detection center of Nanjing medical university and the 105 th Hospital of the Chinese people's liberation army jointly carry out human body test food test, and the people with the ages of 18-65 years and good physical health condition are selected to be subjected to volunteer test to ensure matching. Subjects underwent informed consent. Two control designs, self and inter-group, were used. The test feeding group and the control group are randomly divided according to the Memory Quotient (MQ), and main factors such as age, sex and the like affecting the result are considered as much as possible to carry out balance test so as to ensure comparability among the groups. The complete test diet and inclusion statistics were 102, with test diet group 51 and control group 51.
1.6 administration dosage and time
The test group took the test sample and the control group took the placebo. The administration method comprises the following steps: orally taken 2 times a day, 2 granules each time. The test feeding observation time is 30 days.
1.7 Main instruments
Full-automatic biochemical analyzer (a 25 biosystems spain); full-automatic blood analyzer (BC-3000 PLus home-made, michael); urine chemistry analyzer (Uritest-300 Guilin); ultrasonic B machine (RH-3200, shanghai); x-ray fluoroscopy (Imax-1500 z Germany); electrocardiograph (AIKD-B-12 Beijing).
1.8 observations index
1.8.1 safety index
1.8.1.1 general status: mental, sleep, diet, bowel movement, heart rate, blood pressure, etc.
1.8.1.2 blood and urine routine examination: blood routine programs include white blood cells, red blood cells, hemoglobin, and platelets.
1.8.1.3 biochemical blood examination: the examination items include serum total protein, albumin, glutamic pyruvic transaminase, urea, creatinine, cholesterol, triglyceride, and blood sugar.
1.8.1.4 chest radiography, electrocardiogram and abdomen B-ultrasound examination: only once before the start of the test.
1.8.2 efficacy index
Clinical memory scales were used. The method comprises pointing to a memory score, associating the memory score, freely recalling the memory score by images, recongning the memory score by nonsensical images, and associating the memory score by portrait characteristics. Testing the original score with each tested score, adding the score to obtain a total score, and checking the memory quotient with the total score.
1.9 data statistics
The parallel comparison between groups adopts t test of the average value of two samples, the self comparison data adopts paired t test, and when the variance is uneven, data conversion is carried out or t' test, rank sum test are used. The effective rate and the total effective rate are checked by adopting the X2 test. The total number of cases of the four-grid table is smaller than 40, or the total number of cases is equal to or larger than 40, but when the theoretical number is equal to or smaller than 1, the exact probability method is adopted instead.
1.10 result determination
On the premise that two groups of memory quotient are balanced before the test, the memory quotient of the test food group after the test food is higher than that of the control group, the difference is significant, and meanwhile, the memory quotient of the test food group after the test is higher than that of the test food group before the test, the difference is significant, so that the tested sample can be judged to have the function of assisting in improving the memory function.
2 results
2.1 comparison of the equality of the test and control groups
The statistics were included in 102 cases, 51 cases in the test group, 22 cases in men and 29 cases in women, with average age of 44.43 years; the control group consisted of 51 cases, 19 cases for men and 32 cases for women, with an average age of 42.47 years. As can be seen from Table 1, the differences were statistically significant (P > 0.05) in the MQ, age, gender, and cultural level test diet groups compared to the control group. Indicating that the MQ, age, sex, cultural degree have balanced comparability before the two groups are tried. Before the test, the chest radiography, electrocardiogram and abdomen B ultrasonic examination of the two groups of subjects do not have obvious abnormality.
Table 1 comparison of the equality of the two basic data before the test food
Note that: p is the test diet compared to the control. The table below is the same.
2.2 safety index
2.2.1 comparison of the general cases in the test and control groups
The subjects were examined for mental, sleeping, eating, bowel movement, etc., counted at good, general, differential levels, and blood pressure, heart rate were measured. As can be seen from Table 2, the capsules of the present invention had no adverse effects on general conditions such as human spirit, sleep, diet, blood pressure, heart rate, etc. during the test.
Table 2 comparison of general conditions before and after two groups of test foods
Note that: p (P) 1 For self-pairing comparison before and after trial feeding. The table below is the same.
2.2.2 effects of the inventive Capsule on blood and urine routine and blood Biochemical index of human body
As can be seen from Table 3, the blood chemistry and blood biochemistry indexes of the test diet group and the control group are all basically in the normal range. Urine is normal before and after test feeding of the test group and the control group. The capsule of the invention has no adverse effect on the routine and biochemical indexes of human blood and urine.
TABLE 3 influence of the capsules of the invention on the routine and biochemical blood-urine index of human body
2.3 efficacy index
2.3.1 Effect of the capsules of the invention on the pointing memory score of a subject
As can be seen from Table 4, the difference between the index memory scale of the pre-test group compared to the control group was not statistically significant (P > 0.05). The memory score of the test group after test is higher than that of the control group, and the difference is statistically significant (P < 0.05). The matching comparison is carried out before and after the test food, the test food group points to the memory scale, and the test food group is higher than before the test food after the test food is divided, and the difference has statistical significance (P < 0.05); the control group was assigned to the memory scale after test diet and compared to before test diet, the difference was not statistically significant (P > 0.05).
TABLE 4 influence of the inventive capsules on the point memory score
2.3.2 influence of the capsules of the invention on the score of the subject's associative learning
As can be seen from Table 5, the comparative differences between the study scale of the pre-test-feed group and the control group were not statistically significant (P > 0.05). The associative learning scale of the test food group after test food is higher than that of the control group, and the difference has statistical significance (P < 0.05). The matching comparison is carried out before and after the test food, the test food group association learning scale is higher than before the test food after the test food is divided, and the difference has statistical significance (P < 0.05); the control group associative learning scale compares post-test with pre-test, and the difference is not statistically significant (P > 0.05).
TABLE 5 influence of the inventive capsules on associative learning scale
2.3.3 effects of the capsules of the invention on the free memory score of images of subjects
As can be seen from Table 6, the images of the pre-test groups were freely recalled and the differences were statistically significant (P > 0.05) compared to the control group. The images of the test food groups after test food were free recall that the score was higher than that of the control group, and the difference was statistically significant (P < 0.05). The matching comparison before and after the test food, the test food group image free recall scale after the test food is compared with the test food before, the difference has statistical significance (P < 0.05); the control group images were free recall that the differences were statistically significant (P > 0.05) compared after and before the test diet.
TABLE 6 influence of the capsules of the invention on the free memory score of images
2.3.4 Effect of the capsules of the invention on meaningless graphic re-recognition of the score in a subject
As can be seen from Table 7, the meaningless pattern reconfirming amount of the pre-test group was statistically significant (P > 0.05) for the differences compared to the control group. The meaningless pattern of the test group after the test was reconfirmed to a higher score than the control group, and the difference was statistically significant (P < 0.05). The matching comparison is carried out before and after the test food, the nonsensical graph of the test food group is confirmed to be higher than before the test food after the test food is divided, and the difference has statistical significance (P < 0.05); the nonsensical pattern of the control group was reconfirmed to a statistically significant difference (P > 0.05) after the test diet compared to before the test diet.
TABLE 7 Effect of the capsules of the invention on meaningless graphic reconfirmation scores
2.3.5 influence of the inventive Capsule on the associative recall score of the Portrait characteristics of the subject
As can be seen from Table 8, the human image characteristics of the pre-test groups were recalled that the differences were statistically significant (P > 0.05) compared to the control group. The portrait character of the test food group after test food is higher than that of the control group, and the difference has statistical significance (P < 0.05). The matching comparison is carried out before and after the test food, the portrait characteristic of the test food group is higher than before the test food after the test food is divided by the recall scale, and the difference has statistical significance (P < 0.05); the contrast group portrait character is lower than before the test food after the memory scale test food is related, and the difference has statistical significance (P < 0.05).
TABLE 8 influence of the capsules of the invention on the associative recall score of portrait characteristics
2.3.6 Effect of the inventive capsules on memory quotient in subjects
As can be seen from Table 9, the difference was statistically significant (P > 0.05) in the test group memory quotient before the test as compared with the control group. The memory quotient of the test food group after test food is higher than that of the control group, and the difference has statistical significance (P < 0.05). The matching comparison is carried out before and after the test food, the memory quotient of the test food group has higher statistical significance (P < 0.05) after the test food is compared with the memory quotient before the test food; the difference was statistically significant (P > 0.05) after and before test feeding by the memory quotient of the control group.
TABLE 9 influence of the inventive capsules on memory quotient
3 knots
3.1 safety index
All subjects were essentially normal via chest radiography, electrocardiogram and B-mode examination prior to ingestion. The test eater tests the red blood cells, white blood cells, hemoglobin, platelets, serum total protein, albumin, glutamic-pyruvic transaminase, glutamic-oxaloacetic transaminase, creatinine, urea, cholesterol, triglyceride, blood sugar, urine routine and the like before and after the capsule of the invention are basically in the normal range, which indicates that the capsule of the invention has no adverse effect on human body. No adverse reaction is seen in the feeding process.
3.2 efficacy index
3.2.1 group-to-group comparisons: after test feeding, the memory score, the associative learning score, the free memory score, the nonsensical graph recongnition score, the portrait characteristic contact memory score and the memory merchant test feeding group are higher than those of the control group, and the difference has statistical significance (P < 0.05).
3.2.2 self pairing comparison: the test food group points to memory score, associative learning score, image free recall score, nonsensical image reconfirmation score, portrait character contact recall score, after test food of memory quotient is higher than before test food, the difference has statistical significance (P < 0.05). The figure characteristic of the control group is lower than before the test food after the memory scale is used for testing the food, the difference has statistical significance (P < 0.05), and the matched comparison difference of other indexes has no statistical significance (P > 0.05).
3.3 loss rate: the trial starts with 109 groups of people, 54 groups of trial and 55 groups of control. Complete the test diet and incorporate statistics 102, where test diet group 51, control group 51. Test food end test food group lost visit 3, control group lost visit 4, total lost visit rate 6.42%.
According to the result judgment of the human body test food test for assisting in improving the memory function of the health food inspection and evaluation technical Specification (2003 edition), the capsule has the function of assisting in improving the memory.
The foregoing description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the invention, which is defined broadly in the appended claims, and any person skilled in the art to which the invention pertains will readily appreciate that many modifications, including those that fall within the metes and bounds of the claims, or equivalence of such metes and bounds thereof.
Claims (5)
1. A traditional Chinese medicine composition with functions of improving memory and cognition is characterized by being prepared from the following raw materials in parts by weight: 40-60 parts of cistanche extract, 20-40 parts of ginkgo leaf extract, 55-85 parts of alpinia oxyphylla extract and 155-200 parts of red sage root extract.
2. The composition of claim 1, further comprising pharmaceutically acceptable excipients.
3. The traditional Chinese medicine composition according to claim 2, which is further prepared into a traditional Chinese medicine preparation.
4. The Chinese medicinal composition according to claim 3, wherein the Chinese medicinal preparation is selected from one of tablet, granule, soft capsule, hard capsule, oral liquid and suspension.
5. The use of the Chinese medicinal composition according to claim 1 for preparing health care products for assisting in improving memory function.
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