WO2020233459A1 - Composition for improving memory and preparation method therefor - Google Patents

Composition for improving memory and preparation method therefor Download PDF

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Publication number
WO2020233459A1
WO2020233459A1 PCT/CN2020/089920 CN2020089920W WO2020233459A1 WO 2020233459 A1 WO2020233459 A1 WO 2020233459A1 CN 2020089920 W CN2020089920 W CN 2020089920W WO 2020233459 A1 WO2020233459 A1 WO 2020233459A1
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Prior art keywords
parts
composition
yizhiren
ginseng
schisandra
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PCT/CN2020/089920
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French (fr)
Chinese (zh)
Inventor
吴以岭
吴相君
吴瑞
贾振华
孙亚琴
张闪闪
王光路
李晓燕
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石家庄以岭药业股份有限公司
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Publication of WO2020233459A1 publication Critical patent/WO2020233459A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/254—Acanthopanax or Eleutherococcus
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/57—Magnoliaceae (Magnolia family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/79—Schisandraceae (Schisandra family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9062—Alpinia, e.g. red ginger or galangal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Definitions

  • the invention relates to a memory-improving composition and a preparation method thereof.
  • the components contained in the composition are all listed in the list of articles that can be used in health foods, and belong to the related field of medicines and health products.
  • Memory is the human brain's recurrence of past experiences and events, including the process of remembering, keeping, recalling and cognizing (reappearing). In this process, things are classified, summarized, compared, and connected. Therefore, memory is the processing of the human brain's past experience, so there is partial or complete distortion or error.
  • recall time In clinical work, memory can be divided into the following three types according to the length of recall time: 1 Immediate memory: refers to the memory of things that can only be kept for less than 1 minute, and it is generally easy to forget. Give the examinee a string of numbers and ask them to recite or recite them. The subjects must have normal attention and the amount of information they can process is limited, only about 7 digits. 2Recent memory: the memory of things within a few minutes to a few days, 3remote memory: the memory of things from months to many years ago.
  • hypomnesia hypomnesia
  • the overall function of the memory process is most common in patients with organic brain disorders such as dementia, and can also be seen in normal elderly people.
  • Paramnesia a kind of memory error, when the patient recalls the events that he experienced personally, he has errors or confusion in the memory of the place, especially the time, such as recollecting what happened in this time period as another time occurring.
  • Confabulation is also a kind of memory error.
  • the patient forgets a certain personal experience, and fills in and replaces it with a completely fictitious story, and then firmly believes that most of what some patients talk about is the remnants of past memories , Linked together under the inducement of the questioner, are rich and vivid and seem unrealistic, but they are forgotten in a flash. It is clinically called hypostatic disorder, which is more common in brain organic mental disorders such as dementia patients and chronic alcoholic psychosis.
  • Latent memory also known as distorted memory, in which the patient recalls the experiences of others and what he has seen and heard as his own personal experience, or recalls his real experience as the experience of others that he saw and heard .
  • memory disorders such as various degenerative diseases of the brain (such as Alzheimer's disease), brain trauma and boxer dementia; subcortical arteriosclerotic encephalopathy, lacunar infarction, cerebral infarction, cerebral hemorrhage and other cerebrovascular diseases After illness; after encephalitis; after brain hypoxia such as carbon monoxide poisoning; nutritional deficiency encephalopathy (such as Wernicke encephalopathy); alcoholism and biochemical metabolic dysfunction encephalopathy can be caused, memory impairment is a complex pathological process, any of the above The cause involves the frontal lobe, temporal lobe, hippocampal gyrus, thalamus, cingulate gyrus, diencephalon and midbrain reticular structure, etc., all have memory impairment. Mental patients also have memory impairment.
  • Li Shizhen calls the brain "the palace of the primordial spirit", and the human memory exists in the brain. Lin Peiqin believed that "the brain is the home of the soul, the sea of quintessence, and the true memory depends on” in “Like Syndrome Treatment ⁇ Forgetfulness”. Wang Qingren also clearly stated in “Medical Lin Correction”: "Brain”, it can be seen that the brain is the source of the magic machine, the master of the whole body, participates in the activities of nerves, consciousness, and thinking, and controls the sense, perception and memory. “Medical Lin Correction” puts forward that "children with no memory are not full of brains; for seniors with no memory, their brains are gradually empty”. It shows that the material basis of the brain is the brain.
  • Vitamin B1 deficiency causes Wernicke encephalopathy. Early treatment with vitamin B1 will restore memory. Memory impairment caused by chronic organic diseases is generally difficult to recover. The psychogenic forgetting of pseudodementia can be improved by psychotherapy.
  • the inventor believes that dysfunction of the brain is the key pathogenesis of forgetfulness. Based on the above-mentioned understanding of pathogenesis, with the main therapeutic principles of replenishing qi, nourishing body fluid, nourishing the kidney, replenishing essence, and nourishing the brain, the inventor provides a health food that can improve memory impairment, using ginseng to nourish vital energy, soothe the nerves and nourish the mind.
  • the ginseng the emperor of the prescription, is sweet, slightly bitter, calming, and is returned to the spleen, lung and heart meridian. It has the effects of invigorating vitality, restoring the pulse, replenishing the spleen and lungs, soothing the nerves and improving the mind. It was first seen in the "Shen Nong's Materia Medica” as the top grade, saying that it: “mainly replenishes the five internal organs, calms the spirit, relieves panic, eliminates evil, improves eyesight, happy and nourishment.” The ancient name was “the first medicine for the treatment of fatigue and internal injury.” "On” also records ginseng: “Mainly the five internal organs are inadequate, five labors and seven injuries, weakness and weakness...
  • ginseng plays a significant role in improving immunity, anti-tumor, improving cardiovascular, anti-oxidation, anti-aging, and anti-senile dementia.
  • Jiufu is "a person who is very clever, with lost teeth, whiter and blacker, and lighter body”.
  • “Kidney Qi”, “Materia Medica Supplements” contains it: “Yiqi, soothe the nerves, replenish deficiencies, benefit the three energies, adjust all qi", Wang Haogu called it: “benefit the spleen and stomach, regulate vitality, invigorate kidney deficiency", and store the source , It is effective for those who are weak in intelligence caused by insufficient kidney essence, slow thinking, forgetful things, and lazy thinking. It can be used in combination with the monarch medicine to strengthen the essence and nourish the essence and strengthen the kidney. Modern research has shown that Yizhiren mainly contains terpenes, flavonoids, diphenylheptanes, sterols, phenols, etc. It can significantly inhibit the activity of neuronal acetylcholinesterase, increase the content of protein in the brain of model rats, and promote the recovery of memory impairment.
  • the adjuvant schisandra is sour, sweet and warm in taste. Return to the lung, heart and kidney channels. It has the effects of astringent, astringent, nourishing qi, nourishing body fluid, nourishing the kidney and calming the heart.
  • Jin's "Baopuzi” records that "regular clothes can rejuvenate the old and rejuvenate, prolong life.” Li Gao said. It: “Producing body fluid to quench thirst.
  • Schisandra contains schisandrin A, schisandrin, schisandrin A, schisandrin A, schisandrin B and other main components, which can improve memory, protect nerve cells, calm and soothe the nerves. And so on.
  • a health food that can be taken daily and has low side effects for improving memory is to provide a health food with the function of improving memory and health care. Since the medicinal materials used in the food are of the same origin, it can be used for daily consumption.
  • composition consists of the following parts by weight of Chinese medicinal materials:
  • composition is made of the following parts by weight of Chinese medicinal materials:
  • composition can also be made from the following parts by weight of Chinese medicinal materials:
  • composition can also be made from the following parts by weight of Chinese medicinal materials:
  • composition is also made of the following parts by weight of Chinese medicinal materials:
  • the preparation of the active component of the composition includes the following steps:
  • Raw material processing take Acanthopanax Senticosus, Yizhiren, and Schisandra slices, wash and set aside; ginseng, crush, pass through 80 mesh sieve;
  • composition of the present invention can be prepared into medicines or health foods, and its preparation forms are capsules, tablets, pills, powders or ointments.
  • the capsule preparation method is:
  • Raw material treatment Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
  • Vacuum drying drying in a vacuum oven at a temperature of 55 ⁇ 70°C and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55 ⁇ 70°C, and a vacuum degree of 0.04 ⁇ 0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
  • Dry paste crushing crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
  • the preferred preparation method of capsules is:
  • Raw material treatment Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
  • Vacuum drying drying in a vacuum oven at a temperature of 55 ⁇ 70°C and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55 ⁇ 70°C, and a vacuum degree of 0.04 ⁇ 0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
  • Dry paste crushing crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
  • composition of the present invention the Latin name of the active ingredient and the processing method of the crude drug come from the "Chinese Medicine Dictionary” (July 1977, first edition, Shanghai Science and Technology Press) and “Chinese Pharmacopoeia” (2005 edition) , Chemical Industry Press).
  • the health food of the present invention can be prepared into any conventional pharmacologically acceptable dosage form, such as capsules, according to the conventional preparation process, for example, the preparation process described in Fan Biting's "Chinese Medicine Pharmacy” (Shanghai Science Press, December 1997, 1st edition) Medicine, tablet, pill, powder, soft capsule or ointment, etc.
  • the health food is one of capsules, tablets, pills, powders, soft capsules or ointments.
  • pharmaceutically acceptable Excipients such as fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, etc.
  • Fillers include: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; disintegrants include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, Cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, croscarmellose sodium, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silicon dioxide, etc.; suspending agent Including: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include starch slurry, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.; sweeteners include: Saccharin sodium, aspartame, sucrose, cyclamate, glycyrrhetinic acid, etc.; correctives include:
  • the prescription uses ginseng as the emperor medicine to invigorate vitality, nourish the kidney and essence, soothe the nerves and nourish the mind. It is matched with Acanthopanax Senticosus to help the emperor to nourish the foundation of the acquired, cultivate the innate essence, and supplement the essence and marrow of the elixir and benevolence. It warms the kidney and invigorates the essence, and at the same time uses Schisandra chinensis to nourish qi and promote fluid.
  • the Hygienic Analysis and Testing Center of Nanjing Medical University was entrusted to conduct the following clinical trials with the capsule prepared according to the method of Example 1 (hereinafter referred to as the composition of the present invention).
  • the associative learning scale in the control group was lower than that before the test, and the difference was statistically significant (P ⁇ 0.05). There was no significant difference in the self-paired comparison of other indicators in the control group (P>0.05).
  • composition of the present invention can assist in improving memory function.
  • Samples The composition of the present invention and placebo, specifications: 0.4g/capsule x 36 capsules/bottle, production batch number: 150501. Provided by Shijiazhuang Yiling Pharmaceutical Co., Ltd., the recommended dose for humans is 3.6g/person/day. The method of administration is oral, 3 times a day, 3 capsules each time.
  • MQ memory quotient
  • the test group took the test sample, and the control group took a placebo.
  • the method of administration is oral, 3 times a day, 3 capsules each time, and the observation time is 30 days.
  • the start date for the tasting is August 30, 2016.
  • Fully automatic biochemical analyzer Keratua Zhuoyue 400
  • Fully automatic blood analyzer BC-3000PLus domestically produced, Mindray
  • Urine chemistry analyzer Urine chemistry analyzer (Unitech 300)
  • B-ultrasound machine GE C5
  • X-ray fluoroscopy machine Aerospace ZTE LDR-O lB-5KW
  • ECG machine Neippon Optoelectronics 9130p.
  • Routine blood and urine examination routine blood items include white blood cells, red blood cells, hemoglobin, and platelets.
  • the inspection items include total serum protein, albumin, alanine aminotransferase, aspartate aminotransferase, urea, muscle, cholesterol, triglyceride, and blood sugar.
  • the memory quotient of the test group after the test is higher than that of the control group, and the difference is significant.
  • the memory quotient of the test group after the test is higher than the memory quotient before the test.
  • the difference is significant, it can be determined that the test sample has the effect of assisting in improving memory function. 2 results
  • 101 cases were included in the statistics, including 51 cases in the test group, 20 males and 31 females, with an average age of 46.49 years; 50 cases in the control group, with 26 males and 24 females, with an average age of 45.3 6 years. It can be seen from Table 1 that there was no statistically significant difference between the MQ, age, gender, and educational level test group and the control group (P>0.05). It shows that the MQ, age, gender, and education level of the two groups before the test are balanced and comparable. Before the test, there were no obvious abnormalities in chest X-ray, ECG, and abdominal B-ultrasound.
  • composition of the present invention on human blood, urine routine and blood biochemical indexes can be seen from Table 3.
  • the blood and blood biochemical indexes of the test group and control group before and after the test are basically in the normal range.
  • the urine routine of the test group and the control group was basically normal before and after the test. It shows that the composition of the present invention has no adverse effects on human blood, urine routine and blood biochemical indicators.
  • Table 8 The influence of the pharmaceutical composition of the present invention on the scores of the portrait characteristic association recall scale
  • red blood cells, white blood cells, hemoglobin, platelets, total serum protein, albumin, alanine aminotransferase, aspartate aminotransferase, muscle research, urea, cholesterol, triglyceride, blood sugar, urine routine, etc. were all basic In the normal range, it indicates that the composition of the present invention has no adverse effects on the human body. There were no adverse reactions during the food test.
  • test group points to the memory scale, the associative learning scale, the image free recall scale, the meaningless graphic recognition scale, the portrait characteristic connection recall scale, the memory test food After the test, the difference was statistically significant (P ⁇ 0.05).
  • the associative learning scale in the control group was lower after the sub-testing than before the test, and the difference was statistically significant (P ⁇ 0.05). There was no statistically significant difference in the paired comparison of other indicators (P>0.05).
  • Raw material treatment Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
  • Vacuum drying drying in a vacuum oven at a temperature of 55 ⁇ 70°C and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55 ⁇ 70°C, and a vacuum degree of 0.04 ⁇ 0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
  • Dry paste crushing crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
  • Raw material treatment Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
  • Vacuum drying drying in a vacuum oven at a temperature of 55 ⁇ 70°C and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55 ⁇ 70°C, and a vacuum degree of 0.04 ⁇ 0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
  • Dry paste crushing crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
  • Raw material treatment Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
  • Vacuum drying drying in a vacuum oven at a temperature of 55 ⁇ 70°C and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55 ⁇ 70°C, and a vacuum degree of 0.04 ⁇ 0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
  • Dry paste crushing crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
  • Raw material treatment Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
  • Vacuum drying drying in a vacuum oven at a temperature of 55 ⁇ 70°C and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55 ⁇ 70°C, and a vacuum degree of 0.04 ⁇ 0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
  • Dry paste crushing crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;

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Abstract

A composition for assisting in improving memory is prepared from particular parts by weight of raw materials: Eleutherococcus senticosus, ginseng, fructus alpiniae oxyphyllae, and Schisandra chinensis. The combination of these medicines can reinforce deficiency, invigorate the kidney, secure essence and enrich marrow to cure roots, nourish qi to generate fluid, promote blood circulation to remove meridian obstruction, and address both symptoms and root causes. The composition can effectively improve and enhance learning and memory abilities.

Description

一种改善记忆的组合物及其制备方法Composition for improving memory and preparation method thereof
本申请要求于2019年05月17日提交中国专利局、申请号为201910412174.1、发明名称为“一种改善记忆的组合物及其制备方法”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。This application claims the priority of a Chinese patent application filed with the Chinese Patent Office on May 17, 2019, the application number is 201910412174.1, and the invention title is "a memory-improving composition and its preparation method", the entire content of which is incorporated by reference In this application.
技术领域Technical field
本发明涉及一种改善记忆的组合物及其制备方法，该组合物中所含成分都为可用于保健食品的物品名单中所列品种，属于药品保健品相关领域。The invention relates to a memory-improving composition and a preparation method thereof. The components contained in the composition are all listed in the list of articles that can be used in health foods, and belong to the related field of medicines and health products.
背景技术Background technique
记忆是人脑对过去经历和发生过的事物的重现，包括铭记、保持、回忆与认知(再现)的过程，在这个过程中对事物进行分类、概括、对比，联系等加工。因此，回忆是人脑对以往经历事物经加工后的再现，故有部分或完全性失真或错误。临床工作中可按回忆时间的长短将记忆分为以下3种：①即刻记忆(immediate memory)：指对事物仅能保持不到1分钟的记忆，一般易遗忘。给被检查者一串数字后请其背出或倒背出。受试者必须注意力正常，能处理的信息容量有限，仅7位数左右。②近事记忆(recent memory)：对几分钟至几天内事物的记忆，③远事记忆(remote memory)：对几个月至多年前事物的记忆。Memory is the human brain's recurrence of past experiences and events, including the process of remembering, keeping, recalling and cognizing (reappearing). In this process, things are classified, summarized, compared, and connected. Therefore, memory is the processing of the human brain's past experience, so there is partial or complete distortion or error. In clinical work, memory can be divided into the following three types according to the length of recall time: ① Immediate memory: refers to the memory of things that can only be kept for less than 1 minute, and it is generally easy to forget. Give the examinee a string of numbers and ask them to recite or recite them. The subjects must have normal attention and the amount of information they can process is limited, only about 7 digits. ②Recent memory: the memory of things within a few minutes to a few days, ③remote memory: the memory of things from months to many years ago.
常见的记忆障碍表现为：Common memory impairment manifested as:
1.记忆增强(hypermnesia)，临床常见轻躁狂患者联想加速，“过目不忘”，而且对平时不能回忆的往事细节也能回忆起来，抑郁障碍患者也存在类似情况，主要表现为对既往细小过错的记忆犹新，病情缓解后以上现象消失。1. Memory enhancement (hypermnesia), clinically common hypomanic patients’ associations are accelerated, "not forgetting", and they can recall details of past events that can’t be recalled at ordinary times. A similar situation exists in patients with depressive disorder, which is mainly manifested in the smallness of the past. The memory of the fault is still fresh, and the above phenomenon disappears after the condition is relieved.
2.记忆减弱(hypomnesia)，记忆过程全面的功能减退，最常见于脑器质性精神障碍如痴呆患者，也可见于正常老年人。2. Hypomnesia (hypomnesia), the overall function of the memory process, is most common in patients with organic brain disorders such as dementia, and can also be seen in normal elderly people.
3.遗忘(amnesia)，对某一事件或某段经历不能回忆，称为回忆空 白，可保留再认功能，分为顺行性遗忘，逆行性遗忘，进行性遗忘，心因性遗忘，前两类多见于脑损伤，进行性遗忘主要见于痴呆，心因性遗忘具有选择性遗忘的特点，即所遗忘的事情选择性地限于痛苦经历或可能引起心理痛苦的事情，多在重大心理应激后发生，常见于分离性障碍，急性应激障碍(acute stress disorder)等。3. Forgetting (amnesia), the inability to recall a certain event or a certain period of experience, called the memory blank, can retain the recognition function, divided into antegrade forgetting, retrograde forgetting, progressive forgetting, psychogenic forgetting, former Two types are more common in brain injury. Progressive forgetting is mainly seen in dementia. Psychogenic forgetting has the characteristics of selective forgetting, that is, what is forgotten is selectively limited to painful experiences or things that may cause psychological pain, and most of them are major psychological stress. Occurs later, often in dissociative disorder, acute stress disorder, etc.
4.错构(paramnesia)，一种记忆错误，患者在回忆自己亲身经历的事件时，对地点尤其是时间的记忆出现错误或混淆，如将此时间段内发生的事情回忆成在另外时间里发生的。4. Paramnesia (paramnesia), a kind of memory error, when the patient recalls the events that he experienced personally, he has errors or confusion in the memory of the place, especially the time, such as recollecting what happened in this time period as another time occurring.
5.虚构(confabulation)，也是一种记忆错误，患者对某段亲身经历发生遗忘，而用完全虚构的故事来填补和代替之，随之坚信，有些患者所谈内容大部分为既往记忆的残余，在提问者的诱导下串联在一起，丰富生动又显得荒诞不经，但转瞬即忘，临床上称为虚谈症，多见于脑器质性精神障碍如痴呆患者和慢性酒中毒性精神病。5. Confabulation is also a kind of memory error. The patient forgets a certain personal experience, and fills in and replaces it with a completely fictitious story, and then firmly believes that most of what some patients talk about is the remnants of past memories , Linked together under the inducement of the questioner, are rich and vivid and seem absurd, but they are forgotten in a flash. It is clinically called hypostatic disorder, which is more common in brain organic mental disorders such as dementia patients and chronic alcoholic psychosis.
6.潜隐记忆(kryptomnsia)，又称歪曲记忆，患者将别人的经历以及自己曾经的所见所闻回忆成自己的亲身经历，或者将本人的真实经历回忆成自己所见所闻的别人经历。6. Latent memory (kryptomnsia), also known as distorted memory, in which the patient recalls the experiences of others and what he has seen and heard as his own personal experience, or recalls his real experience as the experience of others that he saw and heard .
造成记忆障碍(memory disorders)的疾病很多，脑部各种变性病(如Alzheimer病)，脑外伤和拳击手痴呆；皮质下动脉硬化性脑病，腔隙性梗塞，脑梗塞和脑出血等脑血管病后；脑炎后；一氧化碳中毒等脑缺氧后；营养缺乏性脑病(如Wernicke脑病)；酒精中毒和生化代谢障碍性脑病等均可引起，记忆障碍是一个复杂的病理过程，上述任何一原因累及额叶，颞叶，海马回，丘脑，扣带回，间脑和中脑网状结构等均可有记忆障碍，精神病患者也有记忆障碍。There are many diseases that cause memory disorders, such as various degenerative diseases of the brain (such as Alzheimer's disease), brain trauma and boxer dementia; subcortical arteriosclerotic encephalopathy, lacunar infarction, cerebral infarction, cerebral hemorrhage and other cerebrovascular diseases After illness; after encephalitis; after brain hypoxia such as carbon monoxide poisoning; nutritional deficiency encephalopathy (such as Wernicke encephalopathy); alcoholism and biochemical metabolic dysfunction encephalopathy can be caused, memory impairment is a complex pathological process, any of the above The cause involves the frontal lobe, temporal lobe, hippocampal gyrus, thalamus, cingulate gyrus, diencephalon and midbrain reticular structure, etc., all have memory impairment. Mental patients also have memory impairment.
学习、记忆障碍属于中医“健忘”范畴，春秋战国时期《素问·五常政大论》将其称之为“善忘”、“喜忘”，隋代巢元方《诸病源候论》称其为“多忘”，唐代孙思邈《千金要方》曰其“好忘”，至宋《太平圣惠方》以“忘”命名沿用至今。中医学认为，肾藏精生髓而上通于脑。脑居颅内，由髓汇聚而成，李时珍将脑称为“元神之府”，人之记忆存在于脑中。林佩琴于《类证治裁·健忘》就认为“脑为元神之府，精髓之海，实记性所 凭也”，王清任在《医林改错》也明确提出：“灵机记性不在心，在脑”，可见脑为神机之源，一身之主，参与神经、意识、思维活动，司感觉、知觉和记忆。《医林改错》提出“小儿无记性者，脑髓未满；高年无记性者，脑髓渐空”。说明脑主神的物质基础是脑髓。只有脑髓充足，脑神得养，脑的听、嗅、视觉及精神活动才能正常发挥作用，反之就会出现障碍。《类证治裁》亦指出：“夫人之神，宅于心，心之精依于肾，而脑为元神之府，精髓之海，实记性所凭也。”唐容川在《中西汇通医经精义》中也说：“事物之所以不忘，赖此记性，记在何处，则在肾精。益肾生精，化为髓，而藏之于脑中”。因此可见“健忘”病位在脑，与脑髓、肾精的充盛密切相关。Learning and memory disorders belong to the category of "forgetfulness" in traditional Chinese medicine. During the Spring and Autumn and Warring States Period, "Suwen·Wuchang Zhengda Lun" called them "forgetfulness" and "happy forgetting", and Chaoyuan Fang in the Sui Dynasty called them "The Origin of Diseases" To "forget more", Sun Simiao of the Tang Dynasty called it "good forgotten" in "A Thousand Jin Yaofang", until the Song "Tai Ping Sheng Hui Fang" named "forget." Traditional Chinese medicine believes that the kidney stores the essence and produces the marrow and goes up to the brain. The brain resides in the skull and is formed by the convergence of marrow. Li Shizhen calls the brain "the palace of the primordial spirit", and the human memory exists in the brain. Lin Peiqin believed that "the brain is the home of the soul, the sea of quintessence, and the true memory depends on" in "Like Syndrome Treatment · Forgetfulness". Wang Qingren also clearly stated in "Medical Lin Correction": "Brain", it can be seen that the brain is the source of the magic machine, the master of the whole body, participates in the activities of nerves, consciousness, and thinking, and controls the sense, perception and memory. "Medical Lin Correction" puts forward that "children with no memory are not full of brains; for seniors with no memory, their brains are gradually empty". It shows that the material basis of the brain is the brain. Only when the brain is sufficient and the brain is nourished, can the brain's hearing, smell, vision and mental activities function normally, otherwise there will be obstacles. "Leizhengzhicai" also pointed out: "The god of the lady lives in the heart, the essence of the heart rests on the kidneys, and the brain is the home of the soul, the sea of quintessence, and the true memory depends on it." It also says in "Jing Jing Yi": "The reason why things are not forgotten depends on this memory. Wherever they are recorded, they are in the kidney essence. The kidney produces essence, which turns into marrow, and it is hidden in the brain." Therefore, it can be seen that "forgetfulness" is located in the brain and is closely related to the abundance of brain marrow and kidney essence.
由于先天禀赋不足，精血亏损，脑髓失养，则心无所虑，神无所依，神机失控而使理智活动能力下降，记忆减退。正如《见闻录》指出“人之记性，皆在脑中。小儿善忘者，脑未满也，老人健忘者，脑渐空也。”或因后天失养、七情内伤、久病耗损、年老神衰，或久服某种药物导致气、血、痰、瘀等病邪为患，导致精血不足，髓海失聪。《黄帝内经》中记载“上气不足”，“邪轻心火”，“肾盛怒不止则伤志，志伤则喜忘所言”，“血并于下，气并于上，乱而善忘”，不难看出古代医家已认识到“健忘”与精、气、血、阴的亏虚有重要关系。Due to the lack of congenital endowment, the loss of essence and blood, and the loss of brain marrow, the heart has nothing to worry about, the god has nowhere to rely, and the spiritual mechanism is out of control, which reduces the ability of intellectual activity and memory. Just as the "Knowledge Records" pointed out that "people's memory is in the brain. Children who are forgetful, the brain is not full, and the elderly who are forgetful, the brain becomes empty." Or due to acquired loss of support, internal injuries of seven emotions, chronic illness and depletion, Old age, mental decay, or prolonged use of certain drugs may cause illnesses such as qi, blood, phlegm, and stasis, resulting in insufficient blood essence and deafness. The "Huang Di Nei Jing" records "the lack of upper qi", "the evil is light on the heart and the fire", "the kidney is more than anger, it will hurt the mind, and the will will be happy to forget what is said." "Blood and Qi are both above, chaos but good "Forget", it is not difficult to see that ancient physicians have realized that "forgetfulness" has an important relationship with the deficiency of essence, qi, blood, and yin.
目前尚无有效的方法治疗记忆障碍。含卵磷脂食品、神经递质的前体、利他林、双氢麦角碱类的扩血管药等疗效难定。记忆功能的训练有一定帮助。记忆恢复决定于病变性质、部位、严重和广泛程度。急性疾病如脑外伤和分脑炎，治疗后记忆功能一般在6～12月恢复。There is currently no effective method to treat memory disorders. The curative effect of lecithin-containing foods, neurotransmitter precursors, Ritalin, dihydroergot alkaloids and other vasodilators is difficult to determine. Training of memory function can help. Memory recovery depends on the nature, location, severity and extent of the lesion. For acute diseases such as traumatic brain injury and encephalitis, memory function generally recovers in 6 to 12 months after treatment.
一年后恢复机会很少。维生素B1缺乏造成Wernicke脑病，早期用维生素B1治疗记忆会恢复。慢性器质性疾病造成的记忆障碍一般恢复很困难。假性痴呆的精神源性遗忘可通过精神治疗获得好转。There is little chance of recovery after one year. Vitamin B1 deficiency causes Wernicke encephalopathy. Early treatment with vitamin B1 will restore memory. Memory impairment caused by chronic organic diseases is generally difficult to recover. The psychogenic forgetting of pseudodementia can be improved by psychotherapy.
经检索发现，临床上应用刺五加、人参、益智仁等原料相互配伍制成的药物在治疗智力障碍方面均获得一些疗效。但多用于治疗老年期血管性痴呆。如何通过合理的配伍选用合适的计量达到治疗和预防学习、记忆障碍，目前还没有好的治疗方法。After searching, it was found that the clinical application of acanthopanax senticosus, ginseng, yizhiren and other raw materials made from the compatibility of drugs have achieved some curative effects in the treatment of mental retardation. But it is mostly used to treat senile vascular dementia. How to treat and prevent learning and memory disorders through reasonable compatibility and selection of appropriate measurements, there is currently no good treatment method.
发明内容Summary of the invention
根据学习、记忆障碍中医病因病机分析论治，发明人认为，脑神失养为健忘之关键病机，本虚标实，虚实夹杂。基于上述病机认识，以益气生津、补肾填精、健脑益智为主要治疗原则，发明人提供了一种可以改善记忆障碍的保健食品，采用人参大补元气、安神益智，刺五加、益智仁益气养神、补肾固精，五味子益气生津、滋肾健脑，诸药合用，共达标本兼治，以达到恢复正气，改善学习、记忆的治疗目的。According to the analysis and treatment of the etiology and pathogenesis of learning and memory disorders in traditional Chinese medicine, the inventor believes that dysfunction of the brain is the key pathogenesis of forgetfulness. Based on the above-mentioned understanding of pathogenesis, with the main therapeutic principles of replenishing qi, nourishing body fluid, nourishing the kidney, replenishing essence, and nourishing the brain, the inventor provides a health food that can improve memory impairment, using ginseng to nourish vital energy, soothe the nerves and nourish the mind. Adding, Yizhiren, nourishing qi, nourishing the mind, nourishing the kidney and strengthening essence, schisandra schisandra, nourishing qi, nourishing the body fluid, nourishing the kidney and strengthening the brain, all drugs are combined to achieve both symptoms and root causes, so as to achieve the therapeutic purpose of restoring qi and improving learning and memory.
方中君药人参，味甘、微苦、平，归脾、肺、心经。具有大补元气，复脉固脱，补脾益肺，安神益智的功效。最早见于《神农本草经》列为上品，谓其：“主补五脏，安精神，止惊悸，除邪气，明目，开心益智。”古称“为治虚劳内伤第一要药”《药性论》亦记载了人参：“主五脏气不足，五劳七伤，虚损瘦弱……补五脏六腑，保中守神”。《滇南本草》曰其：“治阴阳不足，肺气虚弱”。现代研究表明人参的主要生理活性成分是人参皂苷，人参皂苷对中枢神经系统的调节作用主要表现在对兴奋神经的促进与抑制作用，使之趋于平衡，可提高人体记忆力，抗老年痴呆，减轻人体疲劳。此外，人参在提升免疫力、抗肿瘤、改善心血管、抗氧化、抗衰老、抗老年痴呆等多个方面发挥显著作用。The ginseng, the emperor of the prescription, is sweet, slightly bitter, calming, and is returned to the spleen, lung and heart meridian. It has the effects of invigorating vitality, restoring the pulse, replenishing the spleen and lungs, soothing the nerves and improving the mind. It was first seen in the "Shen Nong's Materia Medica" as the top grade, saying that it: "mainly replenishes the five internal organs, calms the spirit, relieves panic, eliminates evil, improves eyesight, happy and nourishment." The ancient name was "the first medicine for the treatment of fatigue and internal injury." "On" also records ginseng: "Mainly the five internal organs are inadequate, five labors and seven injuries, weakness and weakness... to replenish the five internal organs, to protect the middle and guard the spirit." "Southern Yunnan Materia Medica" said: "Insufficient treatment of Yin and Yang, weak lung Qi". Modern studies have shown that the main physiologically active component of ginseng is ginsenosides. The regulation of ginsenosides on the central nervous system is mainly manifested in the promotion and inhibition of excitatory nerves, which tends to balance, can improve human memory, resist Alzheimer’s, and relieve Human body fatigue. In addition, ginseng plays a significant role in improving immunity, anti-tumor, improving cardiovascular, anti-oxidation, anti-aging, and anti-senile dementia.
臣药刺五加，辛、微苦，温，入脾、肾、心经。具有益气健脾、补肾安神、活血通络的功效。《神农本草经》将其列为上品，谓其“补中益精，坚筋骨，强志意，久服轻身耐老”。《太清经》记载久服“令人耳目聪明，齿落更生，发白更黑，身体轻健”。《本草纲目》谓其：“添精补髓，久服延年益老”，且可“健气力、不忘事”，同时益气健脾，与君药人参配伍，加强补益后天之本，培护先天之精的作用，兼以活血通络，针对痰瘀等病理产物阻滞络脉，发挥络脉通畅，精气血上濡脑髓，精神充沛，记忆恢复的作用。现在研究结果显示刺五加含有刺五加甙、胡萝卜甙、丁香甙等，具有改善空间学习能力，提高记忆力的作用。Sen medicine Acanthopanax senticosus, pungent, slightly bitter, warm, enters the spleen, kidney and heart meridian. It has the effects of replenishing qi, invigorating the spleen, invigorating the kidney and calming the nerves, promoting blood circulation and dredging collaterals. "Shen Nong's Materia Medica" listed it as the top grade, saying that it "replenishes the middle and nourish the essence, strengthens the muscles and bones, strengthens the will, and wears it for a long time." "Taiqing Jing" records that Jiufu is "a person who is very clever, with lost teeth, whiter and blacker, and lighter body". "Compendium of Materia Medica" says it: "Add essence and nourish the marrow, long-term use to prolong the old age", and can "build vitality, not forget things", and at the same time replenish qi and invigorate the spleen. It is compatible with the emperor's medicine ginseng to strengthen the foundation of nourishing the acquired. The function of cultivating the innate essence, activating the blood and dredging the collaterals, blocking the collaterals for pathological products such as phlegm and blood stasis, exerting the functions of smoothing the collaterals, energizing the brain, energetic and memory recovery. The current research results show that Acanthopanax senticosus contains Eleutheroside, carotin, syringin, etc., which can improve spatial learning ability and improve memory.
臣药益智仁，辛，温，入脾，肾经。补肾固精，行阳退阴补肾精不足，暖肾固精，《本草经疏》谓其：“益智子仁，以其敛摄，故治肾气不固之证也……敛摄脾肾之气”，《本草拾遗》载其：“益气安神，补不足，利三焦， 调诸气”，王好古则谓其：“益脾胃，理元气，补肾虚”，藏纳归源，对于肾精不足所致智能减退，思维迟钝、遇事多忘，懈惰思卧者均有显效，与君药合用加强填精益髓，养精固肾的功效。现代研究显示益智仁中主要含有萜类、黄酮类、二苯庚烷类、甾醇类、酚类等。可以明显抑制神经元乙酰胆碱酯酶的活性，提高模型大鼠脑部蛋白质的含量，促进记忆障碍功能恢复。Chen Yao Yizhiren, pungent, warm, into the spleen, kidney meridian. To invigorate the kidney and consolidate essence, promote yang, retreat yin and nourish the essence of the kidney, warm the kidney and consolidate the essence, the "Materia Medica Shu" states: "Yizhiziren is taken by its astringent, so the syndrome of curing the kidney qi is not solid... "Kidney Qi", "Materia Medica Supplements" contains it: "Yiqi, soothe the nerves, replenish deficiencies, benefit the three energies, adjust all qi", Wang Haogu called it: "benefit the spleen and stomach, regulate vitality, invigorate kidney deficiency", and store the source , It is effective for those who are weak in intelligence caused by insufficient kidney essence, slow thinking, forgetful things, and lazy thinking. It can be used in combination with the monarch medicine to strengthen the essence and nourish the essence and strengthen the kidney. Modern research has shown that Yizhiren mainly contains terpenes, flavonoids, diphenylheptanes, sterols, phenols, etc. It can significantly inhibit the activity of neuronal acetylcholinesterase, increase the content of protein in the brain of model rats, and promote the recovery of memory impairment.
佐药五味子性酸、甘，味温。归肺、心、肾经。具有收敛固涩，益气生津，补肾宁心的功效。《神农本草经》：“主益气，咳逆上气，劳伤羸度，补不足，强阴，益男子精。”晋《抱朴子》记载“常服能返老还童、延年益寿。”李杲谓其：“生津止渴。治泻痢，补元气不足，收耗散之气。”《名医别录》：“养五脏，除热，生阴中肌。”明《本草纲目》记载：“补虚劳，令人身体悦泽、明目。”现代研究表明五味子含有五味子甲素、五味子酚、五味子酯戊、五味子醇甲、五味子醇乙等主要成分，具有改善记忆、保护神经细胞、镇静安神等作用。The adjuvant schisandra is sour, sweet and warm in taste. Return to the lung, heart and kidney channels. It has the effects of astringent, astringent, nourishing qi, nourishing body fluid, nourishing the kidney and calming the heart. "Shen Nong's Materia Medica": "Mainly replenishing qi, coughing up the qi, replenishing the insufficiency, strengthening the yin, and benefiting men's essence." Jin's "Baopuzi" records that "regular clothes can rejuvenate the old and rejuvenate, prolong life." Li Gao said. It: "Producing body fluid to quench thirst. Treating diarrhea, replenishing insufficient vitality, and collecting dissipated qi." "Famous Doctor's Record": "Nourish the five internal organs, remove heat, and generate yin muscles." Ming "Compendium of Materia Medica" records: "Replenishment Deficiency makes the body pleasing and improving eyesight." Modern research shows that Schisandra contains schisandrin A, schisandrin, schisandrin A, schisandrin A, schisandrin B and other main components, which can improve memory, protect nerve cells, calm and soothe the nerves. And so on.
现代社会生活压力大，生活节奏快导致大量的年轻人出现记忆功能障碍；学业繁重，学习压力过大导致的学生出现的记忆功能障碍；脑器质性精神障碍多发的老年患者，大量的患者急需一种可以日常服用的，副作用小的保健食品用于改善记忆。本发明目的是提供一种具有改善记忆保健功能的药食同源的保健食品，由于其采用的药材都属于药食同源，因此可以用于日常服用。In modern society, the pressure of life and the fast pace of life have caused a large number of young people to have memory dysfunction; students with heavy academic work and excessive learning pressure have caused memory dysfunction; elderly patients with frequent brain organic mental disorders, and a large number of patients are in urgent need A health food that can be taken daily and has low side effects for improving memory. The purpose of the present invention is to provide a health food with the function of improving memory and health care. Since the medicinal materials used in the food are of the same origin, it can be used for daily consumption.
该组合物由以下重量份的中药材组成：The composition consists of the following parts by weight of Chinese medicinal materials:
刺五加640-960份；人参214-320份；益智仁214-320份；五味子142-214份。Acanthopanax 640-960 parts; Ginseng 214-320 parts; Yizhiren 214-320 parts; Schisandra 142-214 parts.
优选的，该组合物由如下重量份的中药材制成：Preferably, the composition is made of the following parts by weight of Chinese medicinal materials:
刺五加640份；人参320份；益智仁214份；五味子214份。Acanthopanax senticosus 640 parts; Ginseng 320 parts; Yizhiren 214 parts; Schisandra 214 parts.
优选的，该组合物还可以由如下重量份的中药材制成：Preferably, the composition can also be made from the following parts by weight of Chinese medicinal materials:
刺五加960份；人参214份；益智仁320份；五味子142份。Acanthopanax senticosus 960 parts; Ginseng 214 parts; Yizhiren 320 parts; Schisandra 142 parts.
优选的，该组合物也可以由如下重量份的中药材制成：Preferably, the composition can also be made from the following parts by weight of Chinese medicinal materials:
刺五加800份；人参267份；益智仁267份；五味子178份。Acanthopanax senticosus 800 parts; Ginseng 267 parts; Yizhiren 267 parts; Schisandra 178 parts.
优选的，该组合物也由如下重量份的中药材制成：Preferably, the composition is also made of the following parts by weight of Chinese medicinal materials:
刺五加700份；人参250份；益智仁280份；五味子200份。700 parts of Acanthopanax senticosus; 250 parts of ginseng; 280 parts of Yizhiren; 200 parts of Schisandra.
该组合物活性组分制备包括以下步骤：The preparation of the active component of the composition includes the following steps:
(1)原料处理：取刺五加、益智仁、五味子饮片，洗净备用；人参，粉碎，过80目筛；(1) Raw material processing: take Acanthopanax Senticosus, Yizhiren, and Schisandra slices, wash and set aside; ginseng, crush, pass through 80 mesh sieve;
(2)称量：按配方比例称取刺五加、益智仁、五味子及人参粉，备用；(2) Weighing: Weigh Acanthopanax Senticosus, Yizhiren, Schisandra and Ginseng powder according to the formula ratio, and set aside;
(3)提取：将称取的的刺五加、益智仁、五味子加水提取，提取液备用；(3) Extraction: add water to extract the weighed Acanthopanax senticosus, Yizhiren, and Schisandra chinensis, and the extract is ready for use;
(4)浓缩：提取液浓缩成稠膏；(4) Concentration: the extract is concentrated into a thick paste;
(5)干燥：稠膏干燥，所得干膏备用；(5) Drying: The thick paste is dried, and the resulting dry paste is ready for use;
(6)粉碎：干膏进行粉碎,得干膏粉；(6) Crushing: the dry paste is crushed to obtain dry paste powder;
干膏粉和人参粉共同构成了本发明活性组分。Dry paste powder and ginseng powder together constitute the active component of the present invention.
本发明组合物可制备成药品或保健食品，其制剂剂型为胶囊剂、片剂、丸剂、散剂或膏剂。The composition of the present invention can be prepared into medicines or health foods, and its preparation forms are capsules, tablets, pills, powders or ointments.
胶囊剂制备方法为：The capsule preparation method is:
(1)原料处理：取刺五加、益智仁、五味子饮片，洗净备用；人参粉碎，过80目筛， 60Co辐照灭菌，辐照剂量3kGy，备用； (1) Raw material treatment: Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
(2)称量：按配方比例称取刺五加、益智仁、五味子及人参粉，备用；(2) Weighing: Weigh Acanthopanax Senticosus, Yizhiren, Schisandra and Ginseng powder according to the formula ratio, and set aside;
(3)提取：将称量好的刺五加、益智仁、五味子，加水提取3次，每次1小时，第一次加9倍水，第二、三次分别加8倍水，提取液滤过，合并，备用；(3) Extraction: Add water to extract the weighed Acanthopanax Senticosus, Yizhiren, and Schisandra three times, each for 1 hour, add 9 times water for the first time, add 8 times water for the second and third times, respectively. Filter, merge, and reserve;
(4)浓缩：提取液减压浓缩，浓缩温度60～80℃，真空度为0.04～0.08MPa，浓缩至至60℃热测相对密度1.05～1.10的清膏；(4) Concentration: The extract is concentrated under reduced pressure, the concentration temperature is 60-80℃, the vacuum degree is 0.04～0.08MPa, and it is concentrated to 60℃, and the relative density is 1.05～1.10.
(5)真空干燥：采用真空烘箱干燥，温度55～70℃，真空度为0Mpa，先烘干2小时，然后打开真空阀门进行真空干燥，温度55～70℃，真空度为0.04～0.08Mpa，收集干膏，水分应控制在4％以内，备用；(5) Vacuum drying: drying in a vacuum oven at a temperature of 55～70℃ and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55～70℃, and a vacuum degree of 0.04～0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
(6)干膏粉碎：将干膏粉碎，过80目筛网，收集细粉，备用；(6) Dry paste crushing: crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
(7)将干膏粉、人参灭菌粉混合，加入辅料制粒、整粒、总混后，填充胶囊即得。(7) Mix the dry paste powder and the sterilized ginseng powder, add auxiliary materials for granulation, granulation, and total mixing, and then fill the capsule to obtain it.
胶囊剂优选制备方法为：The preferred preparation method of capsules is:
(1)原料处理：取刺五加、益智仁、五味子饮片，洗净备用；人参粉碎，过80目筛， 60Co辐照灭菌，辐照剂量3kGy，备用； (1) Raw material treatment: Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
(2)称量：按配方比例称取刺五加、益智仁、五味子及人参粉，备用；(2) Weighing: Weigh Acanthopanax Senticosus, Yizhiren, Schisandra and Ginseng powder according to the formula ratio, and set aside;
(3)提取：将称量好的刺五加、益智仁、五味子，加水提取3次，每次1小时，第一次加9倍水，第二、三次分别加8倍水，提取液滤过，合并，备用；(3) Extraction: Add water to extract the weighed Acanthopanax Senticosus, Yizhiren, and Schisandra three times, each for 1 hour, add 9 times water for the first time, add 8 times water for the second and third times, respectively. Filter, merge, and reserve;
(4)浓缩：提取液减压浓缩，浓缩温度60～80℃，真空度为0.04～0.08MPa，浓缩至至60℃热测相对密度1.05～1.10的清膏；(4) Concentration: The extract is concentrated under reduced pressure, the concentration temperature is 60-80℃, the vacuum degree is 0.04～0.08MPa, and it is concentrated to 60℃, and the relative density is 1.05～1.10.
(5)真空干燥：采用真空烘箱干燥，温度55～70℃，真空度为0Mpa，先烘干2小时，然后打开真空阀门进行真空干燥，温度55～70℃，真空度为0.04～0.08Mpa，收集干膏，水分应控制在4％以内，备用；(5) Vacuum drying: drying in a vacuum oven at a temperature of 55～70℃ and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55～70℃, and a vacuum degree of 0.04～0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
(6)干膏粉碎：将干膏粉碎，过80目筛网，收集细粉，备用；(6) Dry paste crushing: crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
(7)将干膏粉、人参灭菌粉混合均匀，加入玉米淀粉干法制粒，整粒、总混后，填充胶囊即得。(7) Mix the dry paste powder and the sterilized ginseng powder uniformly, add corn starch to dry granulation, whole and mix, and then fill the capsule.
本发明所述的药品或保健食品在制备辅助改善记忆组合物中的应用。The application of the medicine or health food of the present invention in the preparation of an auxiliary memory improvement composition.
本发明组合物中，作为活性组分的原料药的拉丁名及其加工方法来自《中药大辞典》(1977年7月，第一版，上海科学技术出版社)和《中国药典》(2005年版，化学工业出版社)。In the composition of the present invention, the Latin name of the active ingredient and the processing method of the crude drug come from the "Chinese Medicine Dictionary" (July 1977, first edition, Shanghai Science and Technology Press) and "Chinese Pharmacopoeia" (2005 edition) , Chemical Industry Press).
本发明保健食品可以按常规的制剂工艺，例如，范碧亭《中药药剂学》(上海科学出版社1997年12月第1版)记载的制备工艺，制成药剂学可接受的任意常规剂型，例如胶囊剂、片剂、丸剂、散剂、软胶囊剂或膏剂等。The health food of the present invention can be prepared into any conventional pharmacologically acceptable dosage form, such as capsules, according to the conventional preparation process, for example, the preparation process described in Fan Biting's "Chinese Medicine Pharmacy" (Shanghai Science Press, December 1997, 1st edition) Medicine, tablet, pill, powder, soft capsule or ointment, etc.
本发明的应用中，所述保健食品为胶囊剂、片剂、丸剂、散剂、软胶囊剂或膏剂制剂中的一种，为使上述剂型能够实现，需在制备这些剂型时加入药学可接受的辅料，例如：填充剂、崩解剂、润滑剂、助悬剂、粘合 剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等；润滑剂包括：硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括，淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等；甜味剂包括：糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等；矫味剂包括：甜味剂及各种香精；防腐剂包括：尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等；基质包括：PEG6000，PEG4000，虫蜡等。为使上述剂型能够实现中药药剂学，需在制备这些剂型时加入药学可接受的其它辅料(范碧亭《中药药剂学》，上海科学出版社1997年12月第1版中各剂型记载的辅料)。In the application of the present invention, the health food is one of capsules, tablets, pills, powders, soft capsules or ointments. In order to realize the above dosage forms, it is necessary to add pharmaceutically acceptable Excipients, such as fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, etc. Fillers include: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; disintegrants include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, Cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, croscarmellose sodium, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silicon dioxide, etc.; suspending agent Including: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include starch slurry, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.; sweeteners include: Saccharin sodium, aspartame, sucrose, cyclamate, glycyrrhetinic acid, etc.; correctives include: sweeteners and various flavors; preservatives include: parabens, benzoic acid, sodium benzoate, sorbic acid and other Salts, benzalkonium bromide, chloroethyl acetate, eucalyptus oil, etc.; bases include: PEG6000, PEG4000, insect wax, etc. In order for the above dosage forms to realize the pharmacy of Chinese medicine, other pharmaceutically acceptable excipients need to be added when preparing these dosage forms (Fan Biting "Chinese Medicine Pharmaceutics", the excipients recorded in each dosage form in the first edition of Shanghai Science Press, December 1997).
该方以人参为君药，大补元气、补肾益精、安神益智，配以刺五加助君药补益后天之本，培护先天之精，配以益智仁助君药填精益髓、温肾固精，同时以五味子益气生津，既有增强人参、刺五加、益智仁补肾固涩之功效，又能防治补益太过，滋腻于肾，益气生津。诸药合用补虚益肾、固精增髓以治其本，益气生津、活血通络标本兼治，以达改善、提高学习、记忆能力之效,临床应用取得了很好的疗效。The prescription uses ginseng as the emperor medicine to invigorate vitality, nourish the kidney and essence, soothe the nerves and nourish the mind. It is matched with Acanthopanax Senticosus to help the emperor to nourish the foundation of the acquired, cultivate the innate essence, and supplement the essence and marrow of the elixir and benevolence. It warms the kidney and invigorates the essence, and at the same time uses Schisandra chinensis to nourish qi and promote fluid. It not only enhances the effects of ginseng, Acanthopanax senticosus and Yizhiren to nourish the kidney and astringent, but also can prevent and invigorate too much, nourish the kidneys, nourish qi and promote fluids. The combined use of various drugs to invigorate the kidney, strengthen the essence and increase the marrow to cure its roots, to replenish qi, promote fluids, promote blood circulation and clear the collaterals to improve and improve learning and memory abilities. The clinical application has achieved good results.
为证实本发明组合物改善记忆的作用，委托南京医科大学卫生分析检测中心用按实施例1方法制得的胶囊剂(以下称本发明组合物)进行了下列临床试验。In order to verify the memory improvement effect of the composition of the present invention, the Hygienic Analysis and Testing Center of Nanjing Medical University was entrusted to conduct the following clinical trials with the capsule prepared according to the method of Example 1 (hereinafter referred to as the composition of the present invention).
采用双盲对照随机法，将101例受试者按记忆商随机分为2组，其中51例服用本发明组合物为试食组，另50例服用安慰剂为对照组，服用方法为口服，每日3次，每次3粒。连续观察30天。试食前受试者胸透、B超、心电图检查基本在正常范围，试食前后受试者的血、尿常规及血生化指标基本在正常范围。试食期间保持平日的生活和饮食习惯，试食过程中未见不良反应。试食前两组指向记忆量表分、联想学习量表分、图象自由回忆量表分、无意义图形再认量表分、人像特点联系回忆量表分和记忆商相比较，差异均无统计学意义(P>0.05)。组间比较、试食组试食后指 向记忆量表分、联想学习量表分、图象自由回忆量表分、无意义图形再认量表分、人像特点联系回忆量表分及记忆商均高于对照组，差异有统计学意义(P<0.05)。自身配对比较，试食组指向记忆量表分、联想学习量表分、图象自由回忆量表分、无意义图形再认量表分、人像特点联系回忆量表分及记忆商试食后均高于试食前，差异有统计学意义P<0.05)。Using the double-blind controlled randomization method, 101 subjects were randomly divided into 2 groups according to the memory quotient, 51 of which took the composition of the present invention as the test group, and the other 50 took the placebo as the control group, and the administration method was oral. 3 times a day, 3 capsules each time. Observe for 30 days. Before the test, the subjects' chest X-ray, B-ultrasound, and electrocardiogram were basically in the normal range, and the subjects' blood, urine routine and blood biochemical indexes before and after the test were basically in the normal range. During the test, the daily life and eating habits were maintained, and no adverse reactions were seen during the test. Before the test, there was no statistical difference between the two groups' points of pointing memory scale, associative learning scale, image free recall scale, meaningless graphic recognition scale, portrait characteristics linked recall scale and memory quotient. Academic significance (P>0.05). Comparison between groups, points of the test group after the test, points to the memory scale, associative learning scale, image free recall scale, meaningless graphic recognition scale, portrait characteristics link recall scale and memory quotient Higher than the control group, the difference was statistically significant (P<0.05). Self-pairing comparison, the test group points to the memory scale, the association learning scale, the image free recall scale, the meaningless graphic recognition scale, the portrait characteristic connection recall scale, and the memory test after eating. Higher than before the test, the difference was statistically significant (P<0.05).
对照组联想学习量表分试食后低于试食前，差异有统计学意义(P<0.05)，其它指标对照组自身配对比较差异均无统计学意义(P>0.05)。The associative learning scale in the control group was lower than that before the test, and the difference was statistically significant (P<0.05). There was no significant difference in the self-paired comparison of other indicators in the control group (P>0.05).
根据《保健食品检验与评价技术规范))(2003年版)辅助改善记忆功能人体试食试验的结果判定，本发明组合物具有辅助改善记忆功能。According to the results of the "Health Food Inspection and Evaluation Technical Specification) (2003 Edition) assisted in improving memory function, it is judged that the composition of the present invention can assist in improving memory function.
1材料和方法1 Materials and methods
1.1样品:本发明组合物及安慰剂，规格:0.4g/粒x 36粒/瓶，生产批号:150501.由石家庄以岭药业股份有限公司提供，人体推荐剂量3.6g/人/天。服用方法为口服，每日3次，每次3粒。1.1 Samples: The composition of the present invention and placebo, specifications: 0.4g/capsule x 36 capsules/bottle, production batch number: 150501. Provided by Shijiazhuang Yiling Pharmaceutical Co., Ltd., the recommended dose for humans is 3.6g/person/day. The method of administration is oral, 3 times a day, 3 capsules each time.
1.2选择受试者的原则1.2 Principles for selecting subjects
从比较集中、各方面影响因素大致相同的群体中挑选自愿受试者；文化程度基本一致；属同一年龄组，如不在同一年龄组，则应对量表分进行校正；未接受过类似测试者；排除短期内服用与受试功能有关的物品，对结果有影响者。Select voluntary subjects from groups with relatively concentrated and roughly the same influencing factors; basically the same educational level; belong to the same age group, if not in the same age group, the scale should be adjusted; those who have not received similar tests; Exclude those who take things related to the tested function in the short term, which will affect the results.
1.3试验方法1.3 Test method
按照《保健食品检验与评价技术规范))(2003年版)中辅助改善记忆功能的人体试食试验规程进行，采用临床记忆量表按测试要求测定受试者的记忆商。According to the "Technical Specification for Health Food Inspection and Evaluation) (2003 Edition), the test procedure of human food test to assist in improving memory function was carried out, and the memory quotient of the subjects was measured according to the test requirements using the clinical memory scale.
1.4测试量表1.4 Test scale
采用中国科学院心理研究所1996年修订的"临床记忆量表"。Using the "Clinical Memory Scale" revised in 1996 by the Institute of Psychology, Chinese Academy of Sciences.
1.5试食设计与分组1.5 Tasting design and grouping
南京医科大学卫生分析检测中心与安徽武警总院共同进行人体试食试验，选择年龄在18-65岁，身体健康状况良好，志愿受试保证配合的人群。受试对象实施知情同意。采用自身和组间两种对照设计。根据记忆商数(MQ)随机分为试食组和对照组，尽可能考虑影响结果的主要因素如 年龄、性别等，进行均衡性检验，以保证组间的可比性。完成试食并纳入统计者为101人，其中试食组51人，对照50人。The Health Analysis and Testing Center of Nanjing Medical University and the Anhui Armed Police General Hospital jointly conducted a human food test, selecting people aged 18-65 years old, in good health, and volunteering to ensure cooperation. Subjects implement informed consent. Two control designs of self and between groups are used. According to the memory quotient (MQ), they were randomly divided into a test group and a control group. The main factors affecting the results such as age and gender were considered as much as possible, and the balance test was performed to ensure the comparability between the groups. 101 people completed the food test and included in the statistics, including 51 people in the food test group and 50 people in the control group.
1.6服用剂量及时间1.6 Dosage and time
试食组服用受试样品，对照组服用安慰剂。服用方法为口服，每日3次，每次3粒，试食观察时间30天。试食开始日期为2016年8月30曰。The test group took the test sample, and the control group took a placebo. The method of administration is oral, 3 times a day, 3 capsules each time, and the observation time is 30 days. The start date for the tasting is August 30, 2016.
1.7主要仪器1.7 Main instruments
全自动生化分析仪(科华卓越400)；全自动血液分析仪(BC-3000PLus国产，迈瑞)；尿液化学分析仪(优利特300)；B超机(GE C5)；X线透视机(航天中兴LDR-O lB-5KW)；心电图机(日本光电9130p)。Fully automatic biochemical analyzer (Kehua Zhuoyue 400); Fully automatic blood analyzer (BC-3000PLus domestically produced, Mindray); Urine chemistry analyzer (Unitech 300); B-ultrasound machine (GE C5); X-ray fluoroscopy machine (Aerospace ZTE LDR-O lB-5KW); ECG machine (Nippon Optoelectronics 9130p).
1.8观察指标1.8 Observation indicators
1.8.1安全性指标1.8.1 Safety indicators
1.8.1.1一般状况:精神、睡眠、饮食、大小便、心率、血压等。1.8.1.1 General conditions: mentality, sleep, diet, urine, heart rate, blood pressure, etc.
1.8.1.2血、尿常规检查:血常规项目包括白细胞、红细胞、血红蛋白、血小板。1.8.1.2 Routine blood and urine examination: routine blood items include white blood cells, red blood cells, hemoglobin, and platelets.
1.8.1.3血生化检查:检查项目包括血清总蛋白、白蛋白、谷丙转氨酶、谷草转氨酶、尿素、肌由于、胆固醇、甘油三醋、血糖。1.8.1.3 Blood biochemical inspection: The inspection items include total serum protein, albumin, alanine aminotransferase, aspartate aminotransferase, urea, muscle, cholesterol, triglyceride, and blood sugar.
1.8.1.4胸透、心电图、腹部B超检查:仅在试验开始前检查一次。1.8.1.4 Chest X-ray, ECG, and abdominal B-ultrasound examination: only check once before the start of the test.
1.8.2功效性指标1.8.2 Efficacy Index
使用临床记忆量表。包括指向记忆量表分，联想学习量表分，图象自由回忆量表分，无意义图形再认量表分，人像特点联系回忆量表分。用测试后的各分测验原始分查量表分，各分测验量表分相加得总量表分，用总量表分查记忆商。Use the clinical memory scale. Including pointing memory scale points, associative learning scale points, image free recall scale points, meaningless graphics recognition scale points, and portrait characteristics linked recall scale points. Use the original scores of each subtest after the test to check the scores, add the scores of the subtests to get the total score, and use the total score to check the memory quotient.
1.9数据统计1.9 Statistics
组间平行比较采用两样本均数的t检验，自身对照数据采用配对t检验，方差不齐时进行数据转换或用t'检验、秩和检验。有效率及总有效率采用χ2检验进行检验。四格表总例数小于40，或总例数等于或大于40，但出现理论数等于或小于1时，改用确切概率法。Parallel comparisons between groups were performed using the t test of the mean of the two samples, and the paired t test was used for the self-control data. When the variances were not uniform, data conversion or t'test and rank sum test were used. The effective rate and total effective rate were tested by χ2 test. When the total number of cases in the four-grid table is less than 40, or the total number of cases is equal to or greater than 40, but the theoretical number is equal to or less than 1, use the exact probability method.
1.10结果判定1.10 Results judgment
在试验前两组记忆商均衡的前提下，试食后试食组的记忆商高于对照组，且差异有显著性，同时试食组试验后的记忆商高于其试验前的记忆商，且差异有显著性，可以判定该受试样品具有辅助改善记忆功能的作用。2结果On the premise that the memory quotient of the two groups is balanced before the test, the memory quotient of the test group after the test is higher than that of the control group, and the difference is significant. At the same time, the memory quotient of the test group after the test is higher than the memory quotient before the test. And the difference is significant, it can be determined that the test sample has the effect of assisting in improving memory function. 2 results
2.1试食组与对照组均衡性比较2.1 Comparison of balance between the test group and the control group
纳入统计者101例，其中试食组51例，男性20例、女性31例，平均年龄46.49岁；对照组50例，男性26例、女性24例，平均年龄45.3 6岁。由表1可见，MQ、年龄、性别、文化程度试食组与对照组比较，差异无统计学意义(P>0.05)。表明两组试食前MQ、年龄、性别、文化程度具有均衡可比性。试食前两组受试者胸透、心电图、腹部B超检查，均未见明显异常。101 cases were included in the statistics, including 51 cases in the test group, 20 males and 31 females, with an average age of 46.49 years; 50 cases in the control group, with 26 males and 24 females, with an average age of 45.3 6 years. It can be seen from Table 1 that there was no statistically significant difference between the MQ, age, gender, and educational level test group and the control group (P>0.05). It shows that the MQ, age, gender, and education level of the two groups before the test are balanced and comparable. Before the test, there were no obvious abnormalities in chest X-ray, ECG, and abdominal B-ultrasound.
表1试食前两组基本资料的均衡性比较
Figure PCTCN2020089920-appb-000001
Table 1 Comparison of the balance of the two basic data before the test
Figure PCTCN2020089920-appb-000001
Figure PCTCN2020089920-appb-000002
Figure PCTCN2020089920-appb-000002
注：P为试食组与对照组比较。下表同。Note: P is the comparison between the test group and the control group. The following table is the same.
2.2安全性指标2.2 Safety indicators
2.2.1试食组与对照组一般情况比较2.2.1 Comparison of general conditions between the test group and the control group
对受试者精神、睡眠、饮食、大小便等情况进行了问诊调查，按好、一般、差分级统计，并测定血压、心率。由表2可见，试食期间本发明组合物对人体精神、睡眠、饮食、血压、心率等一般情况无不良影响。The mentality, sleep, diet, urination and defecation of the subjects were surveyed and counted according to the good, normal, and differential levels, and blood pressure and heart rate were measured. It can be seen from Table 2 that the composition of the present invention has no adverse effects on general conditions such as human spirit, sleep, diet, blood pressure, and heart rate during the trial period.
表2两组试食前后一般情况比较
Figure PCTCN2020089920-appb-000003
Table 2 Comparison of general conditions before and after the two groups
Figure PCTCN2020089920-appb-000003
Figure PCTCN2020089920-appb-000004
Figure PCTCN2020089920-appb-000004
Figure PCTCN2020089920-appb-000005
Figure PCTCN2020089920-appb-000005
注：P 1为试食前后自身配对比较。下表同。 Note: P 1 is self-paired comparison before and after the test. The following table is the same.
2.2.2本发明组合物对人体血、尿常规及血生化指标的影响由表3可见，试食组、对照组试食前后各项血液学及血生化指标均基本在正常范围。试食组与对照组试食前后尿常规均基本正常。表明本发明组合物对人体血、尿常规和血生化指标无不良影响。2.2.2 The effect of the composition of the present invention on human blood, urine routine and blood biochemical indexes can be seen from Table 3. The blood and blood biochemical indexes of the test group and control group before and after the test are basically in the normal range. The urine routine of the test group and the control group was basically normal before and after the test. It shows that the composition of the present invention has no adverse effects on human blood, urine routine and blood biochemical indicators.
表3本发明组合物对人体血尿常规及血生化指标的影响
Figure PCTCN2020089920-appb-000006
Table 3 Effect of the composition of the present invention on human blood and urine routine and blood biochemical indexes
Figure PCTCN2020089920-appb-000006
Figure PCTCN2020089920-appb-000007
Figure PCTCN2020089920-appb-000007
2.3功效指标2.3 Efficacy indicators
2.3.1本发明组合物对受试者指向记忆量表分的影响2.3.1 Effect of the composition of the present invention on the scores of the subject's pointing memory scale
由表4可见，试食前试食组指向记忆量表分与对照组比较差异无统计学意义(P>0.05)。试食后试食组指向记忆量表分高于对照组，差异有统计学意义(P<0.05)。试食前后自身配对比较，试食组指向记忆量表分试食后高于试食前，差异有统计学意义(P<0.05)；对照组指向记忆量表分试食后与试食前比较，差异无统计学意义(P>0.05)。It can be seen from Table 4 that there was no statistically significant difference between the pointing memory scale scores of the test group before the test and the control group (P>0.05). After the food test, the points of the test group were higher than the control group, and the difference was statistically significant (P<0.05). Self-paired comparison before and after the food test, the test group pointing to the memory scale after the sub-testing was higher than before the test, the difference was statistically significant (P<0.05); the control group pointing to the memory scale after the sub-testing and before the test, the difference No statistical significance (P>0.05).
表4本发明药物组合物对指向记忆量表分的影响
Figure PCTCN2020089920-appb-000008
Table 4 The effect of the pharmaceutical composition of the present invention on the score of the pointing memory scale
Figure PCTCN2020089920-appb-000008
Figure PCTCN2020089920-appb-000009
Figure PCTCN2020089920-appb-000009
2.3.2本发明组合物对受试者联想学习量表分的影响2.3.2 Effect of the composition of the present invention on the scores of the subjects' associative learning scale
由表5可见，试食前试食组联想学习量表分与对照组比较差异无统计学意义(P>0.05)。试食后试食组联想学习量表分高于对照组，差异有统计学意义(P<0.05)。试食前后自身配对比较，试食组联想学习量表分试食后高于试食前，差异有统计学意义(P<0.05)；对照组联想学习量表分试食后低于试食前，差异有统计学意义(P<0.05)。It can be seen from Table 5 that the associative learning scale scores of the test group before the test were not statistically different from the control group (P>0.05). After the test, the scores of the associative learning scale of the test group were higher than those of the control group, and the difference was statistically significant (P<0.05). Before and after the test, the association learning scale of the test group was higher than before the test, and the difference was statistically significant (P<0.05); the control group was lower than before the test after the test. There is statistical significance (P<0.05).
表5本发明药物组合物对联想学习量表分的影响
Figure PCTCN2020089920-appb-000010
Table 5 The influence of the pharmaceutical composition of the present invention on the scores of the associative learning scale
Figure PCTCN2020089920-appb-000010
Figure PCTCN2020089920-appb-000011
Figure PCTCN2020089920-appb-000011
2.3.3本发明组合物对受试者图象自由回忆量表分的影响2.3.3 The effect of the composition of the present invention on the scores of the subjects' image free recall scale
由表6可见，试食前试食组图象自由回忆量表分与对照组比较，差异无统计学意义(P>0.05)。试食后试食组图象自由回忆量表分高于对照组，差异有统计学意义(P<0.05)。试食前后自身配对比较，试食组图象自由回忆量表分试食后高于试食前，差异有统计学意义(P<0.05)；对照组图象自由回忆量表分试食后与试食前比较，差异无统计学意义(P>0.05)。It can be seen from Table 6 that there was no statistically significant difference between the image free recall scale scores of the test group before the test and the control group (P>0.05). After the test, the image free recall scale score of the test group was higher than that of the control group, and the difference was statistically significant (P<0.05). Self-paired comparison before and after the test, the image free recall scale of the test group was higher than before the test, the difference was statistically significant (P<0.05); Before eating, the difference was not statistically significant (P>0.05).
表6本发明药物组合物对图像自由回忆量表分的影响
Figure PCTCN2020089920-appb-000012
Table 6 The effect of the pharmaceutical composition of the present invention on the scores of the Image Free Recall Scale
Figure PCTCN2020089920-appb-000012
Figure PCTCN2020089920-appb-000013
Figure PCTCN2020089920-appb-000013
Figure PCTCN2020089920-appb-000014
Figure PCTCN2020089920-appb-000014
2.3.4本发明组合物对受试者无意义图形再认量表分的影响2.3.4 Effect of the composition of the present invention on the scores of the testers’ meaningless graph recognition scale
由表7可见，试食前试食组无意义图形再认量表分与对照组比较，差异无统计学意义(P>0.05)。试食后试食组无意义图形再认量表分高于对照组，差异有统计学意义(P<0.05)。试食前后自身配对比较，试食组无意义图形再认量表分试食后高于试食前，差异有统计学意义(P<0.05)；对照组无意义图形再认量表分试食后与试食前比较，差异无统计学意义(P>0.05)。It can be seen from Table 7 that there was no significant difference between the non-significant graphical recognition scale scores of the test group before the test and the control group (P>0.05). After the test, the score of the nonsignificant graphical recognition scale in the test group was higher than that in the control group, and the difference was statistically significant (P<0.05). Self-paired comparison before and after the test, the non-significant graphic recognition scale of the test group was higher than before the test, and the difference was statistically significant (P<0.05); the control group had the non-significant graphic recognition scale after the sub-test Compared with before the test, the difference was not statistically significant (P>0.05).
表7本发明药物组合物对无意义图形再认量表分的影响
Figure PCTCN2020089920-appb-000015
Table 7 The effect of the pharmaceutical composition of the present invention on the scores of the meaningless graph recognition scale
Figure PCTCN2020089920-appb-000015
Figure PCTCN2020089920-appb-000016
Figure PCTCN2020089920-appb-000016
2.3.5本发明组合物对受试者人像特点联系回忆量表分的影响2.3.5 The effect of the composition of the present invention on the scores of the subject's portrait characteristic contact recall scale
由表8可见，试食前试食组人像特点联系回忆量表分与对照组比较，差异无统计学意义(P>0.05)。试食后试食组人像特点联系回忆量表分高于对照组，差异有统计学意义(P<0.05)。试食前后自身配对比较，试食组人像特点联系回忆量表分试食后高于试食前，差异有统计学意义(P<0.05)；对照组人像特点联系回忆量表分试食后与试食前比较，差异无统计学意义(P>0.05)。It can be seen from Table 8 that there was no statistically significant difference between the portrait characteristics and recall scale scores of the test group before the test and the control group (P>0.05). After the test, the scores of the Portrait Characteristics Linking Recall Scale of the test group were higher than those of the control group, and the difference was statistically significant (P<0.05). Self-matching comparisons before and after the test, the portrait characteristics of the test group linked to the recall scale after the test were higher than before the test, the difference was statistically significant (P<0.05); the portrait characteristics linked to the recall scale of the control group was compared with the test after the test Before eating, the difference was not statistically significant (P>0.05).
表8本发明药物组合物对人像特点联系回忆量表分的影响
Figure PCTCN2020089920-appb-000017
Table 8 The influence of the pharmaceutical composition of the present invention on the scores of the portrait characteristic association recall scale
Figure PCTCN2020089920-appb-000017
Figure PCTCN2020089920-appb-000018
Figure PCTCN2020089920-appb-000018
2.3.6本发明组合物对受试者记忆商的影响2.3.6 Effect of the composition of the present invention on the memory quotient of subjects
由表9可见，试食前试食组记忆商与对照组比较，差异无统计学意义(P>0.05)。试食后试食组记忆商高于对照组，差异有统计学意义(P<0.05)。试食前后自身配对比较，试食组记忆商试食后高于试食前，差异有统计学意义(P<0.05)；对照组记忆商试食后与试食前比较，差异无统 计学意义(P>0.05)。It can be seen from Table 9 that there was no statistically significant difference in memory quotient between the test group and the control group before the test (P>0.05). After the test, the memory quotient of the test group was higher than that of the control group, and the difference was statistically significant (P<0.05). Self-paired comparison before and after the test, the memory of the test group after the test was higher than before the test, the difference was statistically significant (P<0.05); the comparison between the memory of the test group after the test and before the test, the difference was not statistically significant (P >0.05).
表9本发明药物组合物对记忆商的影响
Figure PCTCN2020089920-appb-000019
Table 9 The effect of the pharmaceutical composition of the present invention on memory quotient
Figure PCTCN2020089920-appb-000019
Figure PCTCN2020089920-appb-000020
Figure PCTCN2020089920-appb-000020
3小结3 summary
3.1安全性指标3.1 Safety indicators
试食前全部受试者经胸透、心电图、B超检查基本正常。试食者试食本发明组合物前后红细胞、白细胞、血红蛋白、血小板、血清总蛋白、白蛋白、谷丙转氨酶、谷草转氨酶、肌所、尿素、胆固醇、甘油三醋、血糖、尿常规等均基本在正常范围，说明本发明组合物对人体无不良影响。试食过程未见有不良反应。Before the food test, all subjects undergoing chest X-ray, ECG, and B-ultrasound examinations were basically normal. Before and after the tester tried the composition of the present invention, red blood cells, white blood cells, hemoglobin, platelets, total serum protein, albumin, alanine aminotransferase, aspartate aminotransferase, muscle research, urea, cholesterol, triglyceride, blood sugar, urine routine, etc. were all basic In the normal range, it indicates that the composition of the present invention has no adverse effects on the human body. There were no adverse reactions during the food test.
3.2功效性指标3.2 Efficacy index
3.2.1组间比较:试食后指向记忆量表分、联想学习量表分、图像自由回忆量表分、无意义图形再认量表分、人像特点联系回忆量表分、记忆商试食组均高于对照组，差异有统计学意义(P<0.05)。3.2.1 Comparison between groups: Pointing memory scale score, associative learning scale score, image free recall scale score, meaningless graphic recognition scale score, portrait characteristics contact recall scale score, memory test eating The group was higher than the control group, the difference was statistically significant (P<0.05).
3.2.2自身配对比较:试食组指向记忆量表分、联想学习量表分、图像自由回忆量表分、无意义图形再认量表分、人像特点联系回忆量表分、记忆商试食后均高于试食前，差异有统计学意义(P<0.05)。对照组联想学习量表分试食后低于试食前，差异有统计学意义(P<0.05)，其它指标自身配对比较差异均无统计学意义(P>0.05)。3.2.2 Self-matching comparison: the test group points to the memory scale, the associative learning scale, the image free recall scale, the meaningless graphic recognition scale, the portrait characteristic connection recall scale, the memory test food After the test, the difference was statistically significant (P<0.05). The associative learning scale in the control group was lower after the sub-testing than before the test, and the difference was statistically significant (P<0.05). There was no statistically significant difference in the paired comparison of other indicators (P>0.05).
3.3脱失率:试食开始选择人群107例，试食组54例，对照组53例。完成试食并纳入统计者共101，其中试食组51，对照组50。试食结束试食组失访3例，对照组失访3例，总失访率5.61％。根据《保健食品检验与评价技术规范))(2003年版)辅助改善记忆功能人体试食试验的结果判定，本发明组合物具有辅助改善记忆的功能。3.3 Loss rate: 107 cases were selected at the beginning of the test, 54 cases in the test group, and 53 cases in the control group. A total of 101 people who completed the food test were included in the statistics, including 51 in the test group and 50 in the control group. At the end of the food test, 3 cases were lost to follow-up in the food test group and 3 cases in the control group were lost to follow-up. According to the "Technical Specification for Health Food Inspection and Evaluation) (2003 Edition), it is determined that the composition of the present invention has the function of assisting in improving memory.
具体实施方式Detailed ways
实施例1：Example 1:
刺五加800g；人参267g；益智仁267g；五味子178gAcanthopanax 800g; Ginseng 267g; Yizhiren 267g; Schisandra 178g
(1)原料处理：取刺五加、益智仁、五味子饮片，洗净备用；人参粉碎，过80目筛， 60Co辐照灭菌，辐照剂量3kGy，备用； (1) Raw material treatment: Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
(2)称量：按配方比例称取刺五加、益智仁、五味子及人参粉，备用；(2) Weighing: Weigh Acanthopanax Senticosus, Yizhiren, Schisandra and Ginseng powder according to the formula ratio, and set aside;
(3)提取：将称量好的刺五加、益智仁、五味子，加水提取3次，每次1小时，第一次加9倍水，第二、三次分别加8倍水，提取液滤过，合并，备用；(3) Extraction: Add water to extract the weighed Acanthopanax Senticosus, Yizhiren, and Schisandra three times, each for 1 hour, add 9 times water for the first time, add 8 times water for the second and third times, respectively. Filter, merge, and reserve;
(4)浓缩：提取液减压浓缩，浓缩温度60～80℃，真空度为0.04～0.08MPa，浓缩至至60℃热测相对密度1.05～1.10的清膏；(4) Concentration: The extract is concentrated under reduced pressure, the concentration temperature is 60-80℃, the vacuum degree is 0.04～0.08MPa, and it is concentrated to 60℃, and the relative density is 1.05～1.10.
(5)真空干燥：采用真空烘箱干燥，温度55～70℃，真空度为0Mpa，先烘干2小时，然后打开真空阀门进行真空干燥，温度55～70℃，真空度为0.04～0.08Mpa，收集干膏，水分应控制在4％以内，备用；(5) Vacuum drying: drying in a vacuum oven at a temperature of 55～70℃ and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55～70℃, and a vacuum degree of 0.04～0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
(6)干膏粉碎：将干膏粉碎，过80目筛网，收集细粉，备用；(6) Dry paste crushing: crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
(7)将干膏粉、人参灭菌粉混合均匀，加入玉米淀粉13g干法制粒，整粒、总混后，填充胶囊即得。(7) Mix the dry paste powder and the sterilized ginseng powder evenly, add 13 g of corn starch to dry granulation, and fill the capsules after the whole granulation and total mixing.
实施例2：Example 2:
刺五加960g；人参214g；益智仁320g；五味子142gAcanthopanax 960g; Ginseng 214g; Yizhiren 320g; Schisandra 142g
(1)原料处理：取刺五加、益智仁、五味子饮片，洗净备用；人参粉碎，过80目筛， 60Co辐照灭菌，辐照剂量3kGy，备用； (1) Raw material treatment: Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
(2)称量：按配方比例称取刺五加、益智仁、五味子及人参粉，备用；(2) Weighing: Weigh Acanthopanax Senticosus, Yizhiren, Schisandra and Ginseng powder according to the formula ratio, and set aside;
(3)提取：将称量好的刺五加、益智仁、五味子，加水提取3次，每次1小时，第一次加9倍水，第二、三次分别加8倍水，提取液滤过，合并，备用；(3) Extraction: Add water to extract the weighed Acanthopanax Senticosus, Yizhiren, and Schisandra three times, each for 1 hour, add 9 times water for the first time, add 8 times water for the second and third times, respectively. Filter, merge, and reserve;
(4)浓缩：提取液减压浓缩，浓缩温度60～80℃，真空度为0.04～0.08MPa，浓缩至至60℃热测相对密度1.05～1.10的清膏；(4) Concentration: The extract is concentrated under reduced pressure, the concentration temperature is 60-80℃, the vacuum degree is 0.04～0.08MPa, and it is concentrated to 60℃, and the relative density is 1.05～1.10.
(5)真空干燥：采用真空烘箱干燥，温度55～70℃，真空度为0Mpa，先烘干2小时，然后打开真空阀门进行真空干燥，温度55～70℃，真空 度为0.04～0.08Mpa，收集干膏，水分应控制在4％以内，备用；(5) Vacuum drying: drying in a vacuum oven at a temperature of 55～70℃ and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55～70℃, and a vacuum degree of 0.04～0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
(6)干膏粉碎：将干膏粉碎，过80目筛网，收集细粉，备用；(6) Dry paste crushing: crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
(7)将干膏粉、人参灭菌粉混合均匀，加入玉米淀粉干法制粒，整粒、总混后，压片即得。(7) Mix the dry paste powder and the sterilized ginseng powder uniformly, add corn starch to dry granulation, whole and mix, and then press the tablet.
实施例3：Example 3:
刺五加640g；人参320g；益智仁214g；五味子214gAcanthopanax 640g; Ginseng 320g; Yizhiren 214g; Schisandra 214g
(1)原料处理：取刺五加、益智仁、五味子饮片，洗净备用；人参粉碎，过80目筛， 60Co辐照灭菌，辐照剂量3kGy，备用； (1) Raw material treatment: Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
(2)称量：按配方比例称取刺五加、益智仁、五味子及人参粉，备用；(2) Weighing: Weigh Acanthopanax Senticosus, Yizhiren, Schisandra and Ginseng powder according to the formula ratio, and set aside;
(3)提取：将称量好的刺五加、益智仁、五味子，加水提取3次，每次1小时，第一次加9倍水，第二、三次分别加8倍水，提取液滤过，合并，备用；(3) Extraction: Add water to extract the weighed Acanthopanax Senticosus, Yizhiren, and Schisandra three times, each for 1 hour, add 9 times water for the first time, add 8 times water for the second and third times, respectively. Filter, merge, and reserve;
(4)浓缩：提取液减压浓缩，浓缩温度60～80℃，真空度为0.04～0.08MPa，浓缩至至60℃热测相对密度1.05～1.10的清膏；(4) Concentration: The extract is concentrated under reduced pressure, the concentration temperature is 60-80℃, the vacuum degree is 0.04～0.08MPa, and it is concentrated to 60℃, and the relative density is 1.05～1.10.
(5)真空干燥：采用真空烘箱干燥，温度55～70℃，真空度为0Mpa，先烘干2小时，然后打开真空阀门进行真空干燥，温度55～70℃，真空度为0.04～0.08Mpa，收集干膏，水分应控制在4％以内，备用；(5) Vacuum drying: drying in a vacuum oven at a temperature of 55～70℃ and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55～70℃, and a vacuum degree of 0.04～0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
(6)干膏粉碎：将干膏粉碎，过80目筛网，收集细粉，备用；(6) Dry paste crushing: crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
(7)将干膏粉、人参灭菌粉混合均匀，加入玉米淀粉干法制粒，整粒即得颗粒剂。(7) Mix the dry paste powder and the sterilized ginseng powder uniformly, add corn starch to dry granulation, and make the granules whole.
实施例4：Example 4:
刺五加700g；人参250g；益智仁280g；五味子200gEleutherococcus senticosus 700g; Ginseng 250g; Yizhiren 280g; Schisandra 200g
(1)原料处理：取刺五加、益智仁、五味子饮片，洗净备用；人参粉碎，过80目筛， 60Co辐照灭菌，辐照剂量3kGy，备用； (1) Raw material treatment: Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
(2)称量：按配方比例称取刺五加、益智仁、五味子及人参粉，备用；(2) Weighing: Weigh Acanthopanax Senticosus, Yizhiren, Schisandra and Ginseng powder according to the formula ratio, and set aside;
(3)提取：将称量好的刺五加、益智仁、五味子，加水提取3次，每次1小时，第一次加9倍水，第二、三次分别加8倍水，提取液滤过，合 并，备用；(3) Extraction: Add water to extract the weighed Acanthopanax Senticosus, Yizhiren, and Schisandra three times, each for 1 hour, add 9 times water for the first time, add 8 times water for the second and third times, respectively. Filter, merge, and reserve;
(4)浓缩：提取液减压浓缩，浓缩温度60～80℃，真空度为0.04～0.08MPa，浓缩至至60℃热测相对密度1.05～1.10的清膏；(4) Concentration: The extract is concentrated under reduced pressure, the concentration temperature is 60-80℃, the vacuum degree is 0.04～0.08MPa, and it is concentrated to 60℃, and the relative density is 1.05～1.10.
(5)真空干燥：采用真空烘箱干燥，温度55～70℃，真空度为0Mpa，先烘干2小时，然后打开真空阀门进行真空干燥，温度55～70℃，真空度为0.04～0.08Mpa，收集干膏，水分应控制在4％以内，备用；(5) Vacuum drying: drying in a vacuum oven at a temperature of 55～70℃ and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55～70℃, and a vacuum degree of 0.04～0.08Mpa. Collect the dry paste, the moisture should be controlled within 4%, and set aside;
(6)干膏粉碎：将干膏粉碎，过80目筛网，收集细粉，备用；(6) Dry paste crushing: crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
(7)将干膏粉、人参灭菌粉混合均匀，加入玉米淀粉干法制粒，整粒、总混后，按常规方法搓丸即得丸剂。(7) Mix the dry paste powder and the sterilized ginseng powder evenly, add corn starch to dry granulation, whole and mix, and then rub the pill according to the conventional method to obtain the pill.

Claims (10)

  1. 一种辅助改善记忆的组合物，其特征在于该组合物由如下重量份的原料药制成：A composition for assisting memory improvement, characterized in that the composition is made of the following raw materials by weight:
    刺五加640-960份；人参214-320份；益智仁214-320份；五味子142-214份。Acanthopanax 640-960 parts; Ginseng 214-320 parts; Yizhiren 214-320 parts; Schisandra 142-214 parts.
  2. 如权利要求1所述的组合物，其特征在于该组合物由如下重量份的原料药制成：The composition according to claim 1, characterized in that the composition is made of the following parts by weight of raw materials:
    刺五加640份；人参320份；益智仁214份；五味子214份。Acanthopanax senticosus 640 parts; Ginseng 320 parts; Yizhiren 214 parts; Schisandra 214 parts.
  3. 如权利要求1所述的组合物，其特征在于该组合物由如下重量份的原料药制成：The composition according to claim 1, characterized in that the composition is made of the following parts by weight of raw materials:
    刺五加960份；人参214份；益智仁320份；五味子142份。Acanthopanax senticosus 960 parts; Ginseng 214 parts; Yizhiren 320 parts; Schisandra 142 parts.
  4. 如权利要求1所述的组合物，其特征在于该组合物由如下重量份的原料药制成：The composition according to claim 1, characterized in that the composition is made of the following parts by weight of raw materials:
    刺五加800份；人参267份；益智仁267份；五味子178份。Acanthopanax senticosus 800 parts; Ginseng 267 parts; Yizhiren 267 parts; Schisandra 178 parts.
  5. 如权利要求1所述的组合物，其特征在于该组合物由如下重量份的原料药制成：The composition according to claim 1, characterized in that the composition is made of the following parts by weight of raw materials:
    刺五加700份；人参250份；益智仁280份；五味子200份。700 parts of Acanthopanax senticosus; 250 parts of ginseng; 280 parts of Yizhiren; 200 parts of Schisandra.
  6. 如权利要求1-5中任一项所述的组合物，其特征在于其活性组分制备包括以下步骤：The composition according to any one of claims 1-5, characterized in that the preparation of its active ingredient comprises the following steps:
    (1)原料处理：取刺五加、益智仁、五味子饮片，洗净备用；人参，粉碎，过80目筛；(1) Raw material processing: take Acanthopanax Senticosus, Yizhiren, and Schisandra slices, wash and set aside; ginseng, crush, pass through 80 mesh sieve;
    (2)称量：按配方比例称取刺五加、益智仁、五味子及人参粉，备用；(2) Weighing: Weigh Acanthopanax Senticosus, Yizhiren, Schisandra and Ginseng powder according to the formula ratio, and set aside;
    (3)提取：将称取的的刺五加、益智仁、五味子加水提取，提取液备用；(3) Extraction: add water to extract the weighed Acanthopanax senticosus, Yizhiren, and Schisandra chinensis, and the extract is ready for use;
    (4)浓缩：提取液浓缩成稠膏；(4) Concentration: the extract is concentrated into a thick paste;
    (5)干燥：稠膏干燥，所得干膏备用；(5) Drying: The thick paste is dried, and the resulting dry paste is ready for use;
    (6)粉碎：干膏进行粉碎,得干膏粉；(6) Crushing: the dry paste is crushed to obtain dry paste powder;
    干膏粉和人参粉共同构成了本发明活性组分。Dry paste powder and ginseng powder together constitute the active component of the present invention.
  7. 如权利要求1-5中任一项所述的组合物，其特征在于该组合物可制备成药品或保健食品。The composition according to any one of claims 1 to 5, wherein the composition can be prepared into medicines or health foods.
  8. 如权利要求7所述的组合物，其特征在于所述药品或保健食品的制剂剂型为胶囊剂、片剂、丸剂、散剂或膏剂。The composition according to claim 7, wherein the preparation form of the medicine or health food is capsule, tablet, pill, powder or ointment.
  9. 如权利要求8所述的组合物，其特征在于所述胶囊剂制备方法为：The composition according to claim 8, wherein the method for preparing the capsule is:
    (1)原料处理：取刺五加、益智仁、五味子饮片，洗净备用；人参粉碎，过80目筛， 60Co辐照灭菌，辐照剂量3kGy，备用； (1) Raw material treatment: Take Acanthopanax Senticosus, Yizhiren, and Schisandra Chinensis pieces, wash them for later use; crush ginseng, pass through an 80 mesh sieve, and sterilize by 60 Co irradiation, with an irradiation dose of 3kGy, for later use;
    (2)称量：按配方比例称取刺五加、益智仁、五味子及人参粉，备用；(2) Weighing: Weigh Acanthopanax Senticosus, Yizhiren, Schisandra and Ginseng powder according to the formula ratio, and set aside;
    (3)提取：将称量好的刺五加、益智仁、五味子，加水提取3次，每次1小时，第一次加9倍水，第二、三次分别加8倍水，提取液滤过，合并，备用；(3) Extraction: Add water to extract the weighed Acanthopanax Senticosus, Yizhiren, and Schisandra three times, each for 1 hour, add 9 times water for the first time, add 8 times water for the second and third times, respectively. Filter, merge, and reserve;
    (4)浓缩：提取液减压浓缩，浓缩温度60～80℃，真空度为0.04～0.08MPa，浓缩至60℃热测相对密度1.05～1.10的清膏；(4) Concentration: the extract is concentrated under reduced pressure, the concentration temperature is 60-80℃, the vacuum degree is 0.04-0.08MPa, and it is concentrated to 60℃, and the relative density is 1.05～1.10.
    (5)真空干燥：采用真空烘箱干燥，温度55～70℃，真空度为0Mpa，先烘干2小时，然后打开真空阀门进行真空干燥，温度55～70℃，真空度为0.04～0.08Mpa，收集干膏，水分控制在4％以内，备用；(5) Vacuum drying: drying in a vacuum oven at a temperature of 55～70℃ and a vacuum degree of 0Mpa. Dry for 2 hours first, then open the vacuum valve for vacuum drying, at a temperature of 55～70℃, and a vacuum degree of 0.04～0.08Mpa. Collect the dry paste, keep the moisture content within 4%, and set aside;
    (6)干膏粉碎：将干膏粉碎，过80目筛网，收集细粉，备用；(6) Dry paste crushing: crush the dry paste, pass through an 80-mesh screen, collect fine powder, and set aside;
    (7)将干膏粉、人参灭菌粉混合均匀，加入玉米淀粉干法制粒，整粒、总混后，填充胶囊即得。(7) Mix the dry paste powder and the sterilized ginseng powder uniformly, add corn starch to dry granulation, whole and mix, and then fill the capsule.
  10. 如权利要求7所述的药品或保健食品在制备辅助改善记忆的组合物中的应用。The use of the medicine or health food according to claim 7 in the preparation of a composition assisting in improving memory.
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