WO2021103776A1 - Compound preparation having auxiliary effect of preventing and treating psychological depression in children and adolescents - Google Patents
Compound preparation having auxiliary effect of preventing and treating psychological depression in children and adolescents Download PDFInfo
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- WO2021103776A1 WO2021103776A1 PCT/CN2020/116447 CN2020116447W WO2021103776A1 WO 2021103776 A1 WO2021103776 A1 WO 2021103776A1 CN 2020116447 W CN2020116447 W CN 2020116447W WO 2021103776 A1 WO2021103776 A1 WO 2021103776A1
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- vitamin
- bacteria
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- bifidobacterium
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Definitions
- the invention relates to a compound preparation with the function of assisting in preventing and treating psychological depression in children and adolescents.
- Juvenile depression is a mental illness that occurs in teenagers. It is mostly caused by personal character factors, heavier academic pressure and family environment, etc. The patients manifested as mental retardation, slow thinking, emotional disturbance, etc. About 2% of adolescents suffer from depression. The disease affects children and adolescents. The study, life, and physical and mental health of her have a great negative impact. Suicides occur in severe cases, which can cause great harm to individuals and families. The pathogenesis of the disease is not yet clear, and may be related to genetic factors, immune system abnormalities, neuroendocrine and neurotransmitter dysfunction, psychological factors, social environmental factors, etc.
- the intestinal flora has an important impact on the human body’s immunity, neurodevelopment, endocrine, etc.
- Some people have proposed that the intestine- The theory of brain axis shows that intestinal microbes have an important impact on human health, including emotions.
- children and adolescents have refined diets and poor spleen and stomach eaters.
- the composition of intestinal flora is unreasonable and there are few dominant flora, which is harmful to children and adolescents.
- the physical development and nervous system development of adolescents have adverse effects.
- natural medicine has the characteristics of multiple components, multiple action links, and multiple targets. It can act through multiple targets and produce synergistic benefits. It has a good effect on anti-depression.
- the objective of the present invention is to solve the deficiencies of the prior art and provide a functional compound preparation with scientific and reasonable proportions, good treatment of depression and mental illness, safety, reliability, and low adverse reactions.
- the probiotic mineral powder provided by the present invention can not only improve the dominant intestinal flora, improve the intestinal microenvironment, and achieve the effect of improving emotional depression.
- mineral powder is used to supplement trace elements and strengthen the reproduction of intestinal probiotics, and the combination of the two can achieve the purpose of synergy.
- the medicinal materials of the present invention are compatible with both medicine and food, which can effectively improve the symptoms of depression in children and promote recovery; it is then compounded with multiple vitamins for children and adolescents' body bone and nerve development to enhance the therapeutic effect; each component of the present invention is compatible in an advantageous proportion Later, they complement each other, play a synergistic effect, and achieve the effect of clinical treatment of depression in children and adolescents.
- a compound preparation with the effect of assisting in preventing and treating children and adolescents' psychological depression which includes
- Probiotic components Lactobacillus.rhamnosus Lr-32 bacteria, Lactobacillus.rhamnosus HN001 bacteria, Lactobacillus.reuteri 1E1 bacteria, Lactobacillus.gasseriLg-36 bacteria, Bifidobacterium.M-16V bacteria, Bifidobacterium.infantis M-63 bacteria, Bifidobacterium bifidum BB-G90, Bifidobacterium.animalis.ssp.lactis HN019, Bifidobacterium.longum BB536, Akkermansia Muciniphila, Agromonas CS30, Actinomycetes ICM34, Ferment aminococcus;
- Vitamin components vitamin B1, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, folic acid, taurine.
- the above-mentioned compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents includes:
- Mineral and terpenoid components bluestone 5-15g, gypsum 5-25g, stamenite 5-10g, oyster 5-15g, borneol 2-6g;
- Vitamin components vitamin B1 0.5 ⁇ 1.5 mg, vitamin B6 0.5 ⁇ 2 mg, vitamin B12 5 ⁇ 25 micrograms, vitamin C 5 ⁇ 20 mg, vitamin D 0.02 ⁇ 0.15 mg, vitamin E 5 ⁇ 10 mg, folic acid 0.4 to 0.6 mg, taurine 1 to 4 grams.
- the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents is characterized in that it comprises:
- Mineral and terpenoid components 10 grams of bluestone, 15 grams of gypsum, 10 grams of stamenite, 5 grams of oysters, 1 gram of borneol;
- Vitamin components vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, taurine 1 g.
- the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents the dosage ratio of mineral and terpenoid components, medicinal and food components, probiotic components, and vitamin components is 10 ⁇ 100:10 ⁇ 30:0.01 ⁇ 1:0.01 ⁇ 0.05.
- the dosage ratio of the mineral and terpenoid components, the medicinal and edible components, the probiotic components, and the vitamin components is 50:10:0.02:0.01.
- the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents, bluestone, gypsum, stamen and oyster are obtained by crushing with a crusher.
- the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents, the medicinal and food dual-use components are prepared by the following method:
- the compound preparation with the effect of assisting in preventing and treating children and adolescents' psychological depression is to prepare the probiotic mineral powder and the food carrier into capsules or tablets or to make candy with glucose.
- the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents is used in preparing nutritious meals, health products or functional drinks for preventing and treating psychological depression in children and adolescents.
- the compound preparation provided by the present invention which has the function of assisting in preventing and treating psychological depression in children and adolescents, has the following advantages:
- the compound preparation provided by the present invention with the effect of assisting in preventing and treating psychological depression in children and adolescents uses a combination of minerals and probiotics, and at the same time compounded medicinal materials for improving emotions, medicine and food, and vitamins for human growth and development.
- bluestone, gypsum, stamen, and oyster can provide the necessary Ca, Mn, Fe, Zn, Mg, Pb, Sr, Ba, Co, Si, Al, Na, Ba, Cu, Mn necessary for the physical development of children and adolescents.
- Ti, Sr and other trace elements, and mineral powder provides the necessary element requirements for probiotics to multiply, thereby providing a stable dominant flora in the intestines of children and adolescents.
- borneol is also called borneol.
- borneol is specially added to the mineral powder to stimulate resuscitation and promote mental recovery.
- the combined use of mineral elements complements each other and can achieve unexpected technical effects.
- Modern medical research has shown that the intestinal flora of the body is a very complex microenvironment. There are as many as 300 species of bacteria in the intestine, which are closely related to various diseases. The present invention is screened through a large number of experiments, and a variety of specific probiotics are preferred.
- Exogenous supplementation makes it form a microbial flora in the intestines of depressed children or adolescents that is conducive to the healing of depression, promotes the production of various groups of metabolites in children and adolescents, improves neurodevelopment and improves the synthesis of biological factors that improve emotions.
- the experimental results show that it can greatly promote the mental recovery, emotional improvement and activity ability of depressed children, and has achieved very good unexpected technical effects.
- the present invention has undergone a large number of experimental screenings, and screens safe and effective raw materials for medicine and food according to the characteristics of depression in children and adolescents.
- the combination of Gardenia and Yizhiren which can improve emotions, is low in emotions for children's depression. Inability to express and fear of the outside world have a good effect on improving symptoms.
- selective addition of spleen kudzu root, gorgon, coix seed, and jujube promote gastrointestinal digestion, Gallus gallus domesticus and wheat; and add it to help Ebony plum for improvement of intestinal inflammatory diseases; the compatibility of all raw materials together plays a role of nourishing intelligence, improving depression, strengthening the spleen, promoting development, promoting exercise, and improving body function.
- the compound preparation of the present invention can effectively reduce the HAMD scores of depression in children and adolescents.
- the present invention shows through the pharmacological test of depression model mice that the improved compound preparation of the present invention significantly shortens the immobility time of the tail suspension and the forced swimming immobility time of the mice, and shows a good antidepressant effect.
- the comparative test results show that the compound preparation provided by the present invention is significantly better than a single probiotic component or a mineral component and its medicinal and edible components. It shows that each component is complementary, synergistic, and multi-target exerts therapeutic effect. It is safe and effective, without toxic side effects.
- the following microbial strains of the present invention were purchased from Beijing Biotech Biotechnology Co., Ltd. and Beijing Beina Chuanglian Biotechnology Research Institute.
- a compound preparation with the effect of assisting in the prevention and treatment of psychological depression in children and adolescents is composed of mineral and terpenoid components with a weight ratio of 50:10:0.02:0.01, and dual-purpose components for medicine and food: probiotic components and vitamins.
- the mineral and terpenoid components are: bluestone 10g, gypsum 15g, stamenite 10g, oyster 5g, and borneol 1g;
- Vitamin components are: vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, and taurine 1 g.
- the preparation method of the medicinal and food dual-use component is as follows:
- a compound preparation with the effect of assisting in the prevention and treatment of psychological depression in children and adolescents is composed of mineral and terpenoid components with a weight ratio of 50:10:0.02:0.01, and dual-purpose components for medicine and food: probiotic components and vitamins.
- BB-G90 600Million Bifidobacterium.animalis.ssp.lactis HN019 400Million, Bifidobacterium.longum BB536 400Million, Akkermansia Muciniphila 200Million, Agromonas CS30 200Million, Actinomycetes ICM34 200Million, Fermented aminococcus 400Million;
- Vitamin components vitamin B1 1.5 mg, vitamin B6 2 mg, vitamin B12 25 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, taurine 2 g.
- a compound preparation with the effect of assisting in the prevention and treatment of psychological depression in children and adolescents It consists of mineral and terpenoid components with a weight ratio of 10:10:0.01:0.05, and dual-purpose components for medicine and food: probiotic components and vitamins.
- a mixture of components; sealed in a bag, 5 grams per bag; the composition of the mineral and terpenoid components, and the medicinal and edible components: the probiotic component and the vitamin component is the same as in Example 1.
- a compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents It is a mixture of medicinal and food components at a weight ratio of 10:0.02:0.01: probiotics and vitamins, and packed in sealed bags , 5 grams per bag;
- the medicinal and food components are: Gardenia 5g, Gallus gallus domesticus 5g, Yizhiren 10g, Pueraria lobata 20g, Ebony 20g, Gorgon 10g, Coix seed 10g, Jujube 20g, 10 grams of wheat;
- Vitamin components are: vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, and taurine 1 g.
- the preparation method of the medicinal and food dual-use component is as follows:
- a compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents It is a mixture of minerals and terpenoids, probiotics and vitamins in a weight ratio of 50:0.02:0.01, sealed in a bag Packing, 5 grams per bag;
- the mineral and terpenoid components are: bluestone 10g, gypsum 15g, stamenite 10g, oyster 5g, and borneol 1g;
- Vitamin components are: vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, and taurine 1 g.
- a compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents It is a mixture of mineral and terpenoid components, medicinal and food components and vitamin components in a weight ratio of 50:10:0.01. Packed in sealed bags, 5 grams per bag;
- the mineral and terpenoid components are: bluestone 10g, gypsum 15g, stamenite 10g, oyster 5g, and borneol 1g;
- Vitamin components are: vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, and taurine 1 g.
- the preparation method of the medicinal and food dual-use component is as follows:
- Administration method The compound preparation prepared by oral administration in the embodiment 1, group 3, and control group of the present invention (ready to eat after opening the bag), 2 times a day, 10 grams each time, can be mixed with food Take it together. The treatment effect was evaluated after 3 months of medication.
- a reduction rate of ⁇ 75% means recovery, ⁇ 50% means significant improvement, ⁇ 25% means improvement, ⁇ 25% is invalid.
- the overall efficacy evaluation is completed by the doctor in charge and the patient in accordance with the efficacy standards drawn up by the Chinese Neuropsychiatric Association. All scale evaluations are completed by the attending physicians who have undergone scale evaluation training.
- HAMD evaluation results The HAMD scores of the groups of Example 1 and Example 3 of the present invention decreased significantly after 2, 4, 8, and 12 weeks after treatment and before treatment, and there were very significant differences (P ⁇ 0.01).
- the curative effect of Examples 1 to 3 of the control group was significantly reduced due to lack of mineral trace elements, traditional Chinese medicine components or probiotics.
- the results showed that compared with the control group, the total HAMD scores of the treatment groups of Example 1 and 2 were significantly reduced with the prolongation of the treatment course, and the reduction rate of HAMD scores increased significantly.
- Example 1 has better efficacy than Example 3, and examples
- the curative effect of 1 and 3 is better than that of the control group Examples 1 to 3; it shows that the mineral and terpenoid components of the present invention, the medicinal and edible components: the probiotic component and the vitamin component are proportioned according to the dosage of Example 1.
- Optimum When minerals and terpenoids, medicinal and edible components, or probiotics are missing, the efficacy is significantly reduced, indicating that the scientific ratio of the components can play a synergistic effect.
- Minerals can Increase the reproduction of probiotics, improve the dominant intestinal flora, and the intestinal microenvironment plays the role of improving emotions.
- the vitamins grown by teenagers improve immunity.
- mice SPF grade ICR mice, male and female, weighing 18-22g, free drinking and eating, animals and feed are purchased from Nanjing Qinglongshan Animal Farm.
- Test drug Example 1 group, Example 3 group of the present invention, Example 1 to 3 of the control group, diluted to 0.5 g/ml before use.
- the SPF ICR mice were randomly divided into groups, half male and half male, 10 mice in each group, which were respectively the model group, the example 1 group, the example 3 group, and the control group examples 1 to 3. Each group was administered 0.1ml/10g by gavage (ig).
- the tail of the mouse was fixed with a clip about 1 cm from the end, and the mouse was hung upside down on a crossbar about 15 cm from the ground.
- the animal struggled to overcome the abnormal posture, but after a period of activity, Intermittent immobility appeared, showing disappointment, and the total immobility time of each group within 6 minutes.
- the experimental data are all expressed by Mean ⁇ SEM, and the comparison between groups is by t test.
- Example 1 and Example 3 In the classic mouse tail suspension depression model, a single administration of the corresponding drugs, the compound preparations of Example 1 and Example 3 provided by the present invention can significantly shorten the immobility time of mouse tail suspension (P ⁇ 0.05 or P ⁇ 0.01). ), and the effect is better than the control group of Examples 1 to 3.
- the specific experimental results are shown in Table 3.
- the floating immobile state of the mice in the forced swimming model reflects the desperate behavior of the animals.
- the compound preparations of Example 1 and Example 3 provided by the present invention can significantly shorten the forced swimming immobility time of the mice (P ⁇ 0.06), It shows that the compound preparation provided by the present invention has an antidepressant effect on this model, and the effect is better than that of the control group Examples 1 to 3, and the specific experimental results are shown in Table 4.
Abstract
Disclosed is a compound preparation having an auxiliary effect of preventing and treating psychological depression in children and adolescents. The compound preparation comprises mineral and terpene components, a medicinal and edible component, a probiotic component, and a vitamin component. Clinical contrast tests show that the compound preparation can greatly reduce the HAM-D depression score of children and adolescents. Pharmacological tests on depression model mice show that the compound preparation obviously shortens the immobility time of tail suspension in mice and the immobility time during forced swim tests in mice, suggesting a very good anti-depression effect. The compound preparation is obviously superior to a single probiotic component or mineral component or medicinal and edible component. All the components supplement each other and have a synergistic effect, and the treatment effect is achieved at multiple target points. The compound preparation is safe, effective and free from toxicity and side effects.
Description
本发明涉及一种具有辅助防治儿童、青少年心理抑郁的作用的复合制剂。The invention relates to a compound preparation with the function of assisting in preventing and treating psychological depression in children and adolescents.
青少年抑郁症是一种发生在青少年身上的心里病症。多是个人性格因素及较重的学业压力和家庭环境等引起的，患者表现为精神迟缓、思维缓慢、情绪障碍等等，青少年中约有2％人群患有抑郁情绪，该病给儿童、青少年的学习、生活和身心健康带来极大的不良影响，严重时出现自杀情况，给个人和家庭危害极大。该病的发病机理目前尚未明确，可能与遗传因素、免疫系统异常、神经内分泌和神经递质功能失调、心里因素、社会环境因素等相关。Juvenile depression is a mental illness that occurs in teenagers. It is mostly caused by personal character factors, heavier academic pressure and family environment, etc. The patients manifested as mental retardation, slow thinking, emotional disturbance, etc. About 2% of adolescents suffer from depression. The disease affects children and adolescents. The study, life, and physical and mental health of her have a great negative impact. Suicides occur in severe cases, which can cause great harm to individuals and families. The pathogenesis of the disease is not yet clear, and may be related to genetic factors, immune system abnormalities, neuroendocrine and neurotransmitter dysfunction, psychological factors, social environmental factors, etc.
然而目前尚没有一种有效的治疗方法能够在疗效、不良反应及预防复发方面取得突破，世界卫生组织(WHO)预测到2020年抑郁症将成为第二大致残疾病。因此，抗抑郁药物的研究越来越受到人们的重视。However, there is currently no effective treatment that can achieve breakthroughs in efficacy, adverse reactions, and prevention of recurrence. The World Health Organization (WHO) predicts that depression will become the second most disabling disease by 2020. Therefore, the research of antidepressants has attracted more and more attention.
目前，抑郁症的临床治疗主要依靠化学合成药物。由于长期服用此类药物会出现严重的毒副作用，尤其给儿童青少年身体发育造成较大的不良影响。At present, the clinical treatment of depression mainly relies on chemically synthesized drugs. As long-term use of these drugs will have serious side effects, especially the physical development of children and adolescents will cause greater adverse effects.
随着人类对肠道微生物菌群的研究，逐渐发现肠道是一个非常复杂的微环境，肠道菌群对人体的免疫力，神经发育、内分泌等等都具有重要的影响，有人提出肠-脑轴学说，说明肠道微生物对人体的健康，包括情志具有重要的影响，而儿童、青少年精细化饮食和脾胃差挑食，肠道菌群构成不合理，出现优势菌群少，对儿童、青少年的身体发育和神经系统发育都具有不良影响。With human research on the intestinal microbiota, it is gradually discovered that the intestine is a very complex microenvironment. The intestinal flora has an important impact on the human body’s immunity, neurodevelopment, endocrine, etc. Some people have proposed that the intestine- The theory of brain axis shows that intestinal microbes have an important impact on human health, including emotions. However, children and adolescents have refined diets and poor spleen and stomach eaters. The composition of intestinal flora is unreasonable and there are few dominant flora, which is harmful to children and adolescents. The physical development and nervous system development of adolescents have adverse effects.
另外天然药物具有成分多、作用环节多、靶点多的特点，可通过多靶点起作用，产生协同效益，在抗抑郁方面具有较好的作用。In addition, natural medicine has the characteristics of multiple components, multiple action links, and multiple targets. It can act through multiple targets and produce synergistic benefits. It has a good effect on anti-depression.
因此，很有必要在现有技术的基础上研究开发出适用于儿童青少年抑郁病症改善，疗效可靠，安全毒副作用小的新防治制剂。Therefore, it is necessary to research and develop new prevention and treatment preparations suitable for improving children and adolescents' depression, with reliable curative effects, and safe and low toxicity and side effects on the basis of the existing technology.
发明内容Summary of the invention
发明目的：本发明的目的是为了解决现有技术的不足，提供一种配比科学合理，具有很好的治疗抑郁心里病症作用，并且安全可靠，不良反应低的功能性复合制剂。Objective of the invention: The objective of the present invention is to solve the deficiencies of the prior art and provide a functional compound preparation with scientific and reasonable proportions, good treatment of depression and mental illness, safety, reliability, and low adverse reactions.
本发明提供的益生菌矿物粉不但可以改善肠道优势菌群，改善肠道微环境，达到改善情志抑郁的作用。并且通过矿物粉起到补充微量元素和加强肠道益生菌繁殖的目的，二者配伍 可起到协同增效的目的。另外本发明配伍药食两用的药材，可有效改善抑郁心里儿童症状，促进康复；再复配儿童青少年身体骨骼、神经发育的多种维生素，加强治疗效果；本发明各组份按优势比例配伍后，相辅相成，起到协同增效，达到临床治疗儿童青少年抑郁心里的功效。The probiotic mineral powder provided by the present invention can not only improve the dominant intestinal flora, improve the intestinal microenvironment, and achieve the effect of improving emotional depression. In addition, mineral powder is used to supplement trace elements and strengthen the reproduction of intestinal probiotics, and the combination of the two can achieve the purpose of synergy. In addition, the medicinal materials of the present invention are compatible with both medicine and food, which can effectively improve the symptoms of depression in children and promote recovery; it is then compounded with multiple vitamins for children and adolescents' body bone and nerve development to enhance the therapeutic effect; each component of the present invention is compatible in an advantageous proportion Later, they complement each other, play a synergistic effect, and achieve the effect of clinical treatment of depression in children and adolescents.
技术方案：为了实现以上目的，本发明采取的技术方案为：Technical solution: In order to achieve the above objectives, the technical solution adopted by the present invention is:
一种具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，它包括A compound preparation with the effect of assisting in preventing and treating children and adolescents' psychological depression, which includes
(1)矿物类和萜类组份：青礞石、石膏、花蕊石、牡蛎，冰片；(1) Mineral and terpenoid components: bluestone, gypsum, stamen, oyster, borneol;
(2)药食两用组份：栀子、鸡内金、益智仁、葛根、乌梅、芡实、薏苡仁、大枣、小麦；(2) Medicine and food components: Gardenia, Gallus gallus domesticus, Yizhiren, Pueraria lobata, Ebony plum, Gorgon, Coix seed, Jujube, wheat;
(3)益生菌组份：Lactobacillus.rhamnosus Lr-32菌、Lactobacillus.rhamnosus HN001菌、Lactobacillus.reuteri 1E1菌、Lactobacillus.gasseriLg-36菌、Bifidobacterium.M-16V菌、Bifidobacterium.infantis M-63菌、Bifidobacterium bifidum BB-G90、Bifidobacterium.animalis.ssp.lactis HN019菌、Bifidobacterium.longum BB536菌、Akkermansia Muciniphila菌、土壤单胞菌CS30、放线菌ICM34、发酵氨基酸球菌；(3) Probiotic components: Lactobacillus.rhamnosus Lr-32 bacteria, Lactobacillus.rhamnosus HN001 bacteria, Lactobacillus.reuteri 1E1 bacteria, Lactobacillus.gasseriLg-36 bacteria, Bifidobacterium.M-16V bacteria, Bifidobacterium.infantis M-63 bacteria, Bifidobacterium bifidum BB-G90, Bifidobacterium.animalis.ssp.lactis HN019, Bifidobacterium.longum BB536, Akkermansia Muciniphila, Agromonas CS30, Actinomycetes ICM34, Ferment aminococcus;
(4)维生素组份：维生素B1、维生素B6、维生素B12、维生素C、维生素D、维生素E、叶酸、牛磺酸。(4) Vitamin components: vitamin B1, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, folic acid, taurine.
作为优选方案，以上所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，它包括：As a preferred solution, the above-mentioned compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents includes:
(1)矿物类和萜类组份：青礞石5～15克、石膏5～25克、花蕊石5～10克、牡蛎5～15克，冰片2～6克；(1) Mineral and terpenoid components: bluestone 5-15g, gypsum 5-25g, stamenite 5-10g, oyster 5-15g, borneol 2-6g;
(2)药食两用组份：栀子2～6克、鸡内金5～15克、益智仁5～15克、葛根5～25克、芡实5～25克、乌梅5～25克、薏苡仁5～15克、大枣5～25克、小麦5～15克；(2) Medicine and food components: Gardenia 2～6g, Gallus gallus domesticus 5～15g, Yizhiren 5～15g, Pueraria lobata 5～25g, Gorgon 5～25g, Ebony 5～25g , Coix seed 5-15 grams, jujube 5-25 grams, wheat 5-15 grams;
(3)益生菌组份：(3) Probiotic components:
Lactobacillus.rhamnosus Lr-32菌1～2Billion、Lactobacillus.rhamnosus HN001菌1～2Billion、Lactobacillus.reuteri 1E1菌500～800Million、Lactobacillus.gasseriLg-36 200～400Million菌、Bifidobacterium.M-16V菌300～600Million、Bifidobacterium.infantis M-63菌100～300Million、Bifidobacterium bifidum BB-G90 300～600Million、Bifidobacterium.animalis.ssp.lactis HN019菌200～400Million、Bifidobacterium.longum BB536菌200～400Million、Akkermansia Muciniphila菌100～200Million、土壤单胞菌CS30 100～200Million、放线菌ICM34 100～200Million、发酵氨基酸球菌100～400Million；Lactobacillus.rhamnosus Lr-32 bacteria 1～2Billion, Lactobacillus.rhamnosus HN001 bacteria 1～2Billion, Lactobacillus.reuteri 1E1 bacteria 500～800Million, Lactobacillus.gasseriLg-36 200～400Million bacteria, Bifidobacterium.Million bacteria 300～600 .infantis M-63 bacteria 100～300Million, Bifidobacterium bifidum BB-G90 300～600Million, Bifidobacterium.animalis.ssp.lactis HN019 bacteria 200～400Million, Bifidobacterium.longum BB536 bacteria 200～400Million, Akkermansia Muciniphila bacteria 100～200Million, soil Cellular bacteria CS30 100～200Million, Actinomycetes ICM34 100～200Million, Ferment aminococcus 100～400Million;
(4)维生素组份：维生素B1 0.5～1.5毫克、维生素B6 0.5～2毫克、维生素B12 5～25 微克、维生素C 5～20毫克、维生素D 0.02～0.15毫克、维生素E 5～10毫克、叶酸0.4～0.6毫克、牛磺酸1～4克。(4) Vitamin components: vitamin B1 0.5～1.5 mg, vitamin B6 0.5～2 mg, vitamin B12 5～25 micrograms, vitamin C 5～20 mg, vitamin D 0.02～0.15 mg, vitamin E 5～10 mg, folic acid 0.4 to 0.6 mg, taurine 1 to 4 grams.
作为优选方案，所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，其特征在于，它包括：As a preferred solution, the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents is characterized in that it comprises:
(1)矿物类和萜类组份：青礞石10克、石膏15克、花蕊石10克、牡蛎5克，冰片1克；(1) Mineral and terpenoid components: 10 grams of bluestone, 15 grams of gypsum, 10 grams of stamenite, 5 grams of oysters, 1 gram of borneol;
(2)药食两用组份：栀子5克、鸡内金5克、益智仁10克、葛根20克、乌梅20克、芡实10克、薏苡仁10克、大枣20克、小麦10克；(2) Medicine and food ingredients: Gardenia 5g, Gallus gallus domesticus 5g, Yizhiren 10g, Pueraria lobata 20g, Ebony 20g, Gorgon 10g, Coix seed 10g, Jujube 20g, Wheat 10gram;
(3)益生菌组份：(3) Probiotic components:
Lactobacillus.rhamnosus Lr-32菌1Billion、Lactobacillus.rhamnosus HN001菌1Billion、Lactobacillus.reuteri 1E1菌500Million、Lactobacillus.gasseriLg-36 200Million菌、Bifidobacterium.M-16V菌300Million、Bifidobacterium.infantis M-63菌100Million、Bifidobacterium bifidum BB-G90 300Million、Bifidobacterium.animalis.ssp.lactis HN019菌200Million、Bifidobacterium.longum BB536菌200Million、Akkermansia Muciniphila菌100Million、土壤单胞菌CS30 100Million、放线菌ICM34 100Million、发酵氨基酸球菌100Million；Lactobacillus.rhamnosus Lr-32 Bacteria 1Billion, Lactobacillus.rhamnosus HN001 Bacteria 1Billion, Lactobacillus.reuteri 1E1 Bacteria 500Million, Lactobacillus.gasseriLg-36 200Million Bacteria, Bifidobacterium.M-16V Bacteria 300Million Bifidobacterium, Million Bacterium Bifidobacterium 63Billion Bacteria BB-G90 300Million, Bifidobacterium.animalis.ssp.lactis HN019 200Million, Bifidobacterium.longum BB536 200Million, Akkermansia Muciniphila 100Million, Agromonas CS30 100Million, Actinomycetes ICM34 100Million, Fermented aminococcus 100Million;
(4)维生素组份：维生素B1 1.5毫克、维生素B6 1.5毫克、维生素B12 10微克、维生素C 20毫克、维生素D 0.15毫克、维生素E 10毫克、叶酸0.6毫克、牛磺酸1克。(4) Vitamin components: vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, taurine 1 g.
作为优选方案，所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，矿物类和萜类组份、药食两用组份、益生菌组份、维生素组份的用量比为：10～100∶10～30∶0.01～1∶0.01～0.05。作为更优选方案，矿物类和萜类组份、药食两用组份、益生菌组份、维生素组份的用量比为：50∶10∶0.02∶0.01。As a preferred solution, the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents, the dosage ratio of mineral and terpenoid components, medicinal and food components, probiotic components, and vitamin components is 10 ～100:10～30:0.01～1:0.01～0.05. As a more preferred solution, the dosage ratio of the mineral and terpenoid components, the medicinal and edible components, the probiotic components, and the vitamin components is 50:10:0.02:0.01.
作为优选方案，所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，青礞石、石膏、花蕊石和牡蛎通过粉碎机粉碎得到。As a preferred solution, the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents, bluestone, gypsum, stamen and oyster are obtained by crushing with a crusher.
作为优选方案，所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，药食两用组份通过以下方法制备得到：As a preferred solution, the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents, the medicinal and food dual-use components are prepared by the following method:
取栀子、鸡内金、益智仁、葛根、乌梅、芡实、薏苡仁、大枣和小麦，加入原料5～10倍体积量的水提取2～3次.，每次0.5～2小时，减压浓缩得到提取物。Take gardenia, Gallus gallus domesticus, Yizhiren, Pueraria lobata, ebony, ginseng, coix seed, jujube and wheat, add 5-10 times the volume of the raw materials to extract 2 to 3 times. Each time 0.5 to 2 hours, Concentrate under reduced pressure to obtain an extract.
作为优选方案，所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，将益生菌矿物粉与食品载体制备成胶囊、片剂或与葡萄糖制成糖果。As a preferred solution, the compound preparation with the effect of assisting in preventing and treating children and adolescents' psychological depression is to prepare the probiotic mineral powder and the food carrier into capsules or tablets or to make candy with glucose.
作为优选方案，所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂在制备防治儿童青少年心里抑郁的营养餐、保健品或功能饮料中的应用。As a preferred solution, the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents is used in preparing nutritious meals, health products or functional drinks for preventing and treating psychological depression in children and adolescents.
有益效果：本发明提供的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂和现有技术相比具有以下优点：Beneficial effects: Compared with the prior art, the compound preparation provided by the present invention, which has the function of assisting in preventing and treating psychological depression in children and adolescents, has the following advantages:
1、本发明提供的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，采用矿物和益生菌组合，同时复配改善情志药食两用药材和添加人体生长发育的维生素。其中青礞石、石膏、花蕊石、牡蛎能够提供儿童青少年身体发育所需的必须Ca、Mn、Fe、Zn、Mg、Pb、Sr、Ba、Co、Si、Al、Na、Ba、Cu、Mn、Ti、Sr等等微量元素，并且矿物粉为益生菌繁殖提供必须的元素需求，从而在儿童、青少年肠道内提供稳定的优势菌群。另外冰片又称龙脑，本发明在矿物粉中特意添加冰片可以起到开窍促精神恢复的作用，与矿物元素合用相辅相成，可取得预料不到的技术效果。现代医学研究表明，身体肠道菌群是一个非常复杂的微环境，肠道内菌种多达300多种，与多种疾病密切相关，本发明通过大量实验筛选，优选多种特定的益生菌作为外源性补充，使其在抑郁心里儿童或青少年肠道内形成有利于抑郁心里治愈的微生物菌群，促进儿童、青少年各组代谢物的生成，提高神经发育和改善情志的生物因子的合成。实验结果表明可大幅促进抑郁心里儿童精神恢复、情志改善和活动能力，取得了非常好的预料不到的技术效果。1. The compound preparation provided by the present invention with the effect of assisting in preventing and treating psychological depression in children and adolescents uses a combination of minerals and probiotics, and at the same time compounded medicinal materials for improving emotions, medicine and food, and vitamins for human growth and development. Among them, bluestone, gypsum, stamen, and oyster can provide the necessary Ca, Mn, Fe, Zn, Mg, Pb, Sr, Ba, Co, Si, Al, Na, Ba, Cu, Mn necessary for the physical development of children and adolescents. , Ti, Sr and other trace elements, and mineral powder provides the necessary element requirements for probiotics to multiply, thereby providing a stable dominant flora in the intestines of children and adolescents. In addition, borneol is also called borneol. In the present invention, borneol is specially added to the mineral powder to stimulate resuscitation and promote mental recovery. The combined use of mineral elements complements each other and can achieve unexpected technical effects. Modern medical research has shown that the intestinal flora of the body is a very complex microenvironment. There are as many as 300 species of bacteria in the intestine, which are closely related to various diseases. The present invention is screened through a large number of experiments, and a variety of specific probiotics are preferred. Exogenous supplementation makes it form a microbial flora in the intestines of depressed children or adolescents that is conducive to the healing of depression, promotes the production of various groups of metabolites in children and adolescents, improves neurodevelopment and improves the synthesis of biological factors that improve emotions. The experimental results show that it can greatly promote the mental recovery, emotional improvement and activity ability of depressed children, and has achieved very good unexpected technical effects.
并且本发明经过大量实验筛选，根据儿童青少年抑郁心里发病特征，筛选安全有效的药食两用的原料，特别是采用改善情志的栀子和益智仁配伍，对儿童抑郁心里情志低落，不爱表达和对外界的恐惧等症状具有很好的改善作用，另外选择性添加健脾葛根、芡实、薏苡仁、大枣；促胃肠道消化的鸡内金、小麦；并且添加有助于肠道炎症疾病改善的乌梅；诸原料配伍共同起到益智、改善情绪低落、健脾助发育，促运动、提高机体机能的作用。In addition, the present invention has undergone a large number of experimental screenings, and screens safe and effective raw materials for medicine and food according to the characteristics of depression in children and adolescents. In particular, the combination of Gardenia and Yizhiren, which can improve emotions, is low in emotions for children's depression. Inability to express and fear of the outside world have a good effect on improving symptoms. In addition, selective addition of spleen kudzu root, gorgon, coix seed, and jujube; promote gastrointestinal digestion, Gallus gallus domesticus and wheat; and add it to help Ebony plum for improvement of intestinal inflammatory diseases; the compatibility of all raw materials together plays a role of nourishing intelligence, improving depression, strengthening the spleen, promoting development, promoting exercise, and improving body function.
2、经临床对比试验发现，采用本发明的复合制剂，具有很好的降低儿童、青少年抑郁HAMD评分。并且本发明通过抑郁模型小鼠药理试验表明，本发明提高的复方制剂明显缩短小鼠悬尾不动时间和明显缩短小鼠强迫游泳不动时间，显示出很好的抗抑郁功效。2. According to clinical comparative tests, it is found that the compound preparation of the present invention can effectively reduce the HAMD scores of depression in children and adolescents. In addition, the present invention shows through the pharmacological test of depression model mice that the improved compound preparation of the present invention significantly shortens the immobility time of the tail suspension and the forced swimming immobility time of the mice, and shows a good antidepressant effect.
3、并且通过对比试验结果表明，本发明提供的复方制剂显著优于单个的益生菌组份或矿物组份及其药食两用组份。表明各组份相辅相成，协同增效，多靶点发挥治疗功效。且安全有效，无毒副作用。3. The comparative test results show that the compound preparation provided by the present invention is significantly better than a single probiotic component or a mineral component and its medicinal and edible components. It shows that each component is complementary, synergistic, and multi-target exerts therapeutic effect. It is safe and effective, without toxic side effects.
根据下述实施例，可以更好地理解本发明。然而，本领域的技术人员容易理解，实施例所描述的具体的物料配比、工艺条件及其结果仅用于说明本发明，而不应当也不会限制权利要求书中所详细描述的本发明。According to the following examples, the present invention can be better understood. However, those skilled in the art can easily understand that the specific material ratios, process conditions and results described in the examples are only used to illustrate the present invention, and should not and will not limit the present invention described in detail in the claims. .
本发明以下微生物菌种购于北京百欧博伟生物技术有限公司和北京北纳创联生物技术研究院。The following microbial strains of the present invention were purchased from Beijing Biotech Biotechnology Co., Ltd. and Beijing Beina Chuanglian Biotechnology Research Institute.
实施例1Example 1
一种具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，它由重量比为50∶10∶0.02∶0.01的矿物类和萜类组份、药食两用组份：益生菌组份和维生素组份制成的混合物，密封袋装，每袋5克；A compound preparation with the effect of assisting in the prevention and treatment of psychological depression in children and adolescents. It is composed of mineral and terpenoid components with a weight ratio of 50:10:0.02:0.01, and dual-purpose components for medicine and food: probiotic components and vitamins. The mixture made of the components, sealed in a bag, 5 grams per bag;
其中：among them:
(1)矿物类和萜类组份为：青礞石10克、石膏15克、花蕊石10克、牡蛎5克，冰片1克；(1) The mineral and terpenoid components are: bluestone 10g, gypsum 15g, stamenite 10g, oyster 5g, and borneol 1g;
(2)药食两用组份为：栀子5克、鸡内金5克、益智仁10克、葛根20克、乌梅20克、芡实10克、薏苡仁10克、大枣20克、小麦10克；(2) Medicine and food components are: Gardenia 5g, Gallus gallus domesticus 5g, Yizhiren 10g, Pueraria lobata 20g, Ebony 20g, Gorgon 10g, Coix seed 10g, Jujube 20g, 10 grams of wheat;
(3)益生菌组份为：(3) The probiotic components are:
Lactobacillus.rhamnosus Lr-32菌1Billion、Lactobacillus.rhamnosus HN001菌1Billion、Lactobacillus.reuteri 1E1菌500Million、Lactobacillus.gasseriLg-36 200Million菌、Bifidobacterium.M-16V菌300Million、Bifidobacterium.infantis M-63菌100Million、Bifidobacterium bifidum BB-G90 300Million、Bifidobacterium.animalis.ssp.lactis HN019菌200Million、Bifidobacterium.longum BB536菌200Million、Akkermansia Muciniphila菌100Million、土壤单胞菌CS30 100Million、放线菌ICM34 100Million、发酵氨基酸球菌100Million；Lactobacillus.rhamnosus Lr-32 Bacteria 1Billion, Lactobacillus.rhamnosus HN001 Bacteria 1Billion, Lactobacillus.reuteri 1E1 Bacteria 500Million, Lactobacillus.gasseriLg-36 200Million Bacteria, Bifidobacterium.M-16V Bacteria 300Million Bifidobacterium, Million Bacterium Bifidobacterium 63Billion Bacteria BB-G90 300Million, Bifidobacterium.animalis.ssp.lactis HN019 200Million, Bifidobacterium.longum BB536 200Million, Akkermansia Muciniphila 100Million, Agromonas CS30 100Million, Actinomycetes ICM34 100Million, Fermented aminococcus 100Million;
(4)维生素组份为：维生素B1 1.5毫克、维生素B6 1.5毫克、维生素B12 10微克、维生素C 20毫克、维生素D 0.15毫克、维生素E 10毫克、叶酸0.6毫克、牛磺酸1克。(4) Vitamin components are: vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, and taurine 1 g.
其中青礞石、石膏、花蕊石和牡蛎通过粉碎机粉碎得到(200目)；Among them, bluestone, gypsum, stamen and oyster are crushed by a crusher (200 mesh);
其中所述的药食两用组份的制备方法为：The preparation method of the medicinal and food dual-use component is as follows:
取栀子5克、鸡内金5克、益智仁10克、葛根20克、乌梅20克、芡实10克、薏苡仁10克、 大枣20克、小麦10克，加入原料8倍体积量的水提取2次.，每次1小时，减压浓缩得到提取物。Take 5 grams of Gardenia, 5 grams of Gallus gallus domesticus, 10 grams of Yizhiren, 20 grams of Pueraria, 20 grams of ebony, 10 grams of ginseng, 10 grams of coix seed, 20 grams of jujube, 10 grams of wheat, add 8 times the volume of raw materials The water was extracted twice, 1 hour each time, and concentrated under reduced pressure to obtain an extract.
实施例2Example 2
一种具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，它由重量比为50∶10∶0.02∶0.01的矿物类和萜类组份、药食两用组份：益生菌组份和维生素组份制成的混合物，密封袋装，每袋5克；A compound preparation with the effect of assisting in the prevention and treatment of psychological depression in children and adolescents. It is composed of mineral and terpenoid components with a weight ratio of 50:10:0.02:0.01, and dual-purpose components for medicine and food: probiotic components and vitamins. The mixture made of the components, sealed in a bag, 5 grams per bag;
其中among them
(1)矿物类和萜类组份：青礞石15克、石膏25克、花蕊石10克、牡蛎15克，冰片6克；(1) Mineral and terpenoid components: 15 grams of bluestone, 25 grams of gypsum, 10 grams of stamen, 15 grams of oysters, 6 grams of borneol;
(2)药食两用组份：栀子6克、鸡内金15克、益智仁15克、葛根25克、芡实25克、乌梅25克、薏苡仁15克、大枣25克、小麦15克；(2) Medicine and food ingredients: 6 grams of gardenia, 15 grams of Gallus gallus domesticus, 15 grams of Yizhiren, 25 grams of Pueraria lobata, 25 grams of ginseng, 25 grams of ebony, 15 grams of coix seed, 25 grams of jujube, and wheat 15 grams;
(3)益生菌组份：(3) Probiotic components:
Lactobacillus.rhamnosus Lr-32菌2Billion、Lactobacillus.rhamnosus HN001菌2Billion、Lactobacillus.reuteri 1E1菌800Million、Lactobacillus.gasseriLg-36 400Million菌、Bifidobacterium.M-16V菌600Million、Bifidobacterium.infantis M-63菌300Million、Bifidobacterium bifidum BB-G90 600Million、Bifidobacterium.animalis.ssp.lactis HN019菌400Million、Bifidobacterium.longum BB536菌400Million、Akkermansia Muciniphila菌200Million、土壤单胞菌CS30 200Million、放线菌ICM34 200Million、发酵氨基酸球菌400Million；Lactobacillus.rhamnosus Lr-32 Bacteria 2Billion, Lactobacillus.rhamnosus HN001 Bacteria 2Billion, Lactobacillus.reuteri 1E1 Bacteria 800Million, Lactobacillus.gasseriLg-36 400Million Bacteria, Bifidobacterium.M-16V Bacteria 600Million, Bifidobacterium. BB-G90 600Million, Bifidobacterium.animalis.ssp.lactis HN019 400Million, Bifidobacterium.longum BB536 400Million, Akkermansia Muciniphila 200Million, Agromonas CS30 200Million, Actinomycetes ICM34 200Million, Fermented aminococcus 400Million;
(4)维生素组份：维生素B1 1.5毫克、维生素B6 2毫克、维生素B12 25微克、维生素C 20毫克、维生素D 0.15毫克、维生素E 10毫克、叶酸0.6毫克、牛磺酸2克。(4) Vitamin components: vitamin B1 1.5 mg, vitamin B6 2 mg, vitamin B12 25 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, taurine 2 g.
实施例3Example 3
一种具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，它由重量比为10∶10∶0.01∶0.05的矿物类和萜类组份、药食两用组份：益生菌组份和维生素组份制成的混合物；密封袋装，每袋5克；其中矿物类和萜类组份、药食两用组份：益生菌组份和维生素组份的组成同实施例1。A compound preparation with the effect of assisting in the prevention and treatment of psychological depression in children and adolescents. It consists of mineral and terpenoid components with a weight ratio of 10:10:0.01:0.05, and dual-purpose components for medicine and food: probiotic components and vitamins. A mixture of components; sealed in a bag, 5 grams per bag; the composition of the mineral and terpenoid components, and the medicinal and edible components: the probiotic component and the vitamin component is the same as in Example 1.
对照组实施例1Control Example 1
一种具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，它由重量比为10∶0.02∶0.01的药食两用组份：益生菌组份和维生素组份制成的混合物，密封袋装，每袋5克；A compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents. It is a mixture of medicinal and food components at a weight ratio of 10:0.02:0.01: probiotics and vitamins, and packed in sealed bags , 5 grams per bag;
其中：among them:
(1)药食两用组份为：栀子5克、鸡内金5克、益智仁10克、葛根20克、乌梅20克、芡实10克、薏苡仁10克、大枣20克、小麦10克；(1) The medicinal and food components are: Gardenia 5g, Gallus gallus domesticus 5g, Yizhiren 10g, Pueraria lobata 20g, Ebony 20g, Gorgon 10g, Coix seed 10g, Jujube 20g, 10 grams of wheat;
(2)益生菌组份为：(2) The probiotic components are:
Lactobacillus.rhamnosus Lr-32菌1Billion、Lactobacillus.rhamnosus HN001菌1Billion、Lactobacillus.reuteri 1E1菌500Million、Lactobacillus.gasseriLg-36 200Million菌、Bifidobacterium.M-16V菌300Million、Bifidobacterium.infantis M-63菌100Million、Bifidobacterium bifidum BB-G90 300Million、Bifidobacterium.animalis.ssp.lactis HN019菌200Million、Bifidobacterium.longum BB536菌200Million、Akkermansia Muciniphila菌100Million、土壤单胞菌CS30 100Million、放线菌ICM34 100Million、发酵氨基酸球菌100Million；Lactobacillus.rhamnosus Lr-32 Bacteria 1Billion, Lactobacillus.rhamnosus HN001 Bacteria 1Billion, Lactobacillus.reuteri 1E1 Bacteria 500Million, Lactobacillus.gasseriLg-36 200Million Bacteria, Bifidobacterium.M-16V Bacteria 300Million Bifidobacterium, Million Bacterium Bifidobacterium 63Billion Bacteria BB-G90 300Million, Bifidobacterium.animalis.ssp.lactis HN019 200Million, Bifidobacterium.longum BB536 200Million, Akkermansia Muciniphila 100Million, Agromonas CS30 100Million, Actinomycetes ICM34 100Million, Fermented aminococcus 100Million;
(3)维生素组份为：维生素B1 1.5毫克、维生素B6 1.5毫克、维生素B12 10微克、维生素C 20毫克、维生素D 0.15毫克、维生素E 10毫克、叶酸0.6毫克、牛磺酸1克。(3) Vitamin components are: vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, and taurine 1 g.
其中所述的药食两用组份的制备方法为：The preparation method of the medicinal and food dual-use component is as follows:
取栀子5克、鸡内金5克、益智仁10克、葛根20克、乌梅20克、芡实10克、薏苡仁10克、大枣20克、小麦10克，加入原料8倍体积量的水提取2次.，每次1小时，减压浓缩得到提取物。Take 5 grams of Gardenia, 5 grams of Gallus gallus domesticus, 10 grams of Yizhiren, 20 grams of Pueraria lobata, 20 grams of ebony plum, 10 grams of ginseng, 10 grams of coix seed, 20 grams of jujube, 10 grams of wheat, add 8 times the volume of raw materials The water was extracted twice, 1 hour each time, and concentrated under reduced pressure to obtain an extract.
对照组实施例2Control Example 2
一种具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，它由重量比为50∶0.02∶0.01的矿物类和萜类组份、益生菌组份和维生素组份制成的混合物，密封袋装，每袋5克；A compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents. It is a mixture of minerals and terpenoids, probiotics and vitamins in a weight ratio of 50:0.02:0.01, sealed in a bag Packing, 5 grams per bag;
其中：among them:
(1)矿物类和萜类组份为：青礞石10克、石膏15克、花蕊石10克、牡蛎5克，冰片1克；(1) The mineral and terpenoid components are: bluestone 10g, gypsum 15g, stamenite 10g, oyster 5g, and borneol 1g;
(2)益生菌组份为：(2) The probiotic components are:
Lactobacillus.rhamnosus Lr-32菌1Billion、Lactobacillus.rhamnosus HN001菌1Billion、Lactobacillus.reuteri 1E1菌500Million、Lactobacillus.gasseriLg-36 200Million菌、Bifidobacterium.M-16V菌300Million、Bifidobacterium.infantis M-63菌100Million、Bifidobacterium bifidum BB-G90 300Million、Bifidobacterium.animalis.ssp.lactis HN019菌200Million、Bifidobacterium.longum BB536菌200Million、Akkermansia Muciniphila菌100Million、土壤单胞菌CS30 100Million、放线菌ICM34 100Million、发酵氨基酸球菌 100Million；Lactobacillus.rhamnosus Lr-32 Bacteria 1Billion, Lactobacillus.rhamnosus HN001 Bacteria 1Billion, Lactobacillus.reuteri 1E1 Bacteria 500Million, Lactobacillus.gasseriLg-36 200Million Bacteria, Bifidobacterium.M-16V Bacteria 300Million Bifidobacterium, Million Bacterium Bifidobacterium 63Billion Bacteria BB-G90 300Million, Bifidobacterium.animalis.ssp.lactis HN019 200Million, Bifidobacterium.longum BB536 200Million, Akkermansia Muciniphila 100Million, Agromonas CS30 100Million, Actinomycetes ICM34 100Million, Fermented aminococcus 100Million;
(3)维生素组份为：维生素B1 1.5毫克、维生素B6 1.5毫克、维生素B12 10微克、维生素C 20毫克、维生素D 0.15毫克、维生素E 10毫克、叶酸0.6毫克、牛磺酸1克。(3) Vitamin components are: vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, and taurine 1 g.
其中青礞石、石膏、花蕊石和牡蛎通过粉碎机粉碎得到(200目)。Among them, bluestone, gypsum, stamen and oyster are crushed by a crusher (200 mesh).
对照组实施例3Control Example 3
一种具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，它由重量比为50∶10∶0.01的矿物类和萜类组份、药食两用组份和维生素组份制成的混合物，密封袋装，每袋5克；A compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents. It is a mixture of mineral and terpenoid components, medicinal and food components and vitamin components in a weight ratio of 50:10:0.01. Packed in sealed bags, 5 grams per bag;
其中：among them:
(1)矿物类和萜类组份为：青礞石10克、石膏15克、花蕊石10克、牡蛎5克，冰片1克；(1) The mineral and terpenoid components are: bluestone 10g, gypsum 15g, stamenite 10g, oyster 5g, and borneol 1g;
(2)药食两用组份为：栀子5克、鸡内金5克、益智仁10克、葛根20克、乌梅20克、芡实10克、薏苡仁10克、大枣20克、小麦10克；(2) Medicine and food components are: Gardenia 5g, Gallus gallus domesticus 5g, Yizhiren 10g, Pueraria lobata 20g, Ebony 20g, Gorgon 10g, Coix seed 10g, Jujube 20g, 10 grams of wheat;
(3)维生素组份为：维生素B1 1.5毫克、维生素B6 1.5毫克、维生素B12 10微克、维生素C 20毫克、维生素D 0.15毫克、维生素E 10毫克、叶酸0.6毫克、牛磺酸1克。(3) Vitamin components are: vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, and taurine 1 g.
其中青礞石、石膏、花蕊石和牡蛎通过粉碎机粉碎得到(200目)；Among them, bluestone, gypsum, stamen and oyster are crushed by a crusher (200 mesh);
其中所述的药食两用组份的制备方法为：The preparation method of the medicinal and food dual-use component is as follows:
取栀子5克、鸡内金5克、益智仁10克、葛根20克、乌梅20克、芡实10克、薏苡仁10克、大枣20克、小麦10克，加入原料8倍体积量的水提取2次.，每次1小时，减压浓缩得到提取物。Take 5 grams of Gardenia, 5 grams of Gallus gallus domesticus, 10 grams of Yizhiren, 20 grams of Pueraria lobata, 20 grams of ebony, 10 grams of ginseng, 10 grams of coix seed, 20 grams of jujube, 10 grams of wheat, add 8 times the volume of raw materials The water was extracted twice, 1 hour each time, and concentrated under reduced pressure to obtain an extract.
实施例4Example 4
1临床资料1 clinical data
1.1选取50例确诊的抑郁症青少年患者，男22例，女28例，年龄(15.4±1.4)岁，随机分为5组，分别为实施例1组、实施例3组、对照组实施例1至3。5组患者一般资料比较无统计学差异。1.1 Select 50 confirmed depressed adolescent patients, 22 males and 28 females, aged (15.4±1.4) years old, and randomly divided into 5 groups, namely Example 1, Group 3, and Control Example 1 There was no statistical difference in general information of patients in the 5 groups.
1.2纳入标准：(1)符合CCMD-3情感性精神障碍诊断标准，(2)汉密尔顿抑郁表17项评分≥17分，(3)患者及家属知情并同意。排除语言及理解力障碍，合并严重心、肝、肾功能不全、器质性精神病及其它疾病引起的抑郁。1.2 Inclusion criteria: (1) Meet the CCMD-3 diagnostic criteria for affective mental disorders, (2) Hamilton Depression Table 17 scores ≥ 17 points, (3) patients and their families informed and agreed. Exclude language and comprehension disorders, combined with depression caused by severe heart, liver, kidney dysfunction, organic psychosis, and other diseases.
2治疗方法2 treatment methods
给药方法：本发明实施例1组、实施例3组、对照组实施例1至3组均口服制备得到的 复合制剂(开袋即食)，每天2次，每次10克，可与食物混合一起服用。用药3个月后进行治疗效果评测。Administration method: The compound preparation prepared by oral administration in the embodiment 1, group 3, and control group of the present invention (ready to eat after opening the bag), 2 times a day, 10 grams each time, can be mixed with food Take it together. The treatment effect was evaluated after 3 months of medication.
3疗效观察3 Observation of efficacy
3.1疗效评定方法3.1 Efficacy evaluation method
于治疗前及治疗后2、4、8、12周末，进行HAMD评分，按HAMD减分率判定疗效：减分率≥75％为痊愈，≥50％为显进，≥25％为进步，＜25％为无效。由主管医生与患者参照中华神经精神科学会拟订的疗效标准共同完成总体疗效评定，所有量表评定均由经过量表评定培训后的主治医师完成。Before treatment and at the weekend of 2, 4, 8, and 12 after treatment, the HAMD score was performed, and the curative effect was judged according to the HAMD reduction rate: a reduction rate of ≥75% means recovery, ≥50% means significant improvement, ≥25% means improvement, < 25% is invalid. The overall efficacy evaluation is completed by the doctor in charge and the patient in accordance with the efficacy standards drawn up by the Chinese Neuropsychiatric Association. All scale evaluations are completed by the attending physicians who have undergone scale evaluation training.
3.2统计学方法采用SPSS10.0统计软件进行分析。计数资料采用χ2检验，计量资料采用t检验。3.2 Statistical methods SPSS10.0 statistical software was used for analysis. Χ2 test was used for count data, t test was used for measurement data.
3.4治疗结果3.4 Treatment results
3.4.1总疗效评定：治疗后8周，本发明实施例1和实施例3治疗组取得了很好的治疗效果，相比对照组实施例1至3具有明显的进步。具体实验结果见表1。3.4.1 Evaluation of total curative effect: 8 weeks after treatment, the treatment groups of Example 1 and Example 3 of the present invention have achieved good therapeutic effects, which are significantly better than those of Examples 1 to 3 of the control group. The specific experimental results are shown in Table 1.
表1治疗组与对照组临床疗效比较Table 1 Comparison of clinical efficacy between the treatment group and the control group
| 组别Group | 例数Number of cases | 痊愈get well | 显进Hinjin | 进步progress | 无效invalid | 总有效率Total effective rate |
| 实施例1组Example 1 group | 1010 | 44 | 44 | 11 | 11 | 90％90% |
| 实施例1组Example 1 group | 1010 | 33 | 44 | 22 | 11 | 90％90% |
| 对照组实施例1Control Example 1 | 1010 | 00 | 33 | 33 | 44 | 60％60% |
| 对照组实施例2Control Example 2 | 1010 | 00 | 33 | 22 | 55 | 50％50% |
| 对照组实施例3Control Example 3 | 1010 | 00 | 22 | 11 | 77 | 30％30% |
3.4.2 HAMD评定结果：本发明实施例1和实施例3组治疗后2、4、8、12周与治疗前HAMD评分比较明显下降，且均有非常显著性差异(P＜0.01)，而对照组实施例1至3由于缺乏矿物微量元素、中药组份或益生菌后疗效显著降低，具体实验结果见表2。结果表明，实施例1和2治疗组与对照组相比均随着疗程的延长，HAMD总分显著降低，HAMD减分率显著增加。3.4.2 HAMD evaluation results: The HAMD scores of the groups of Example 1 and Example 3 of the present invention decreased significantly after 2, 4, 8, and 12 weeks after treatment and before treatment, and there were very significant differences (P<0.01). The curative effect of Examples 1 to 3 of the control group was significantly reduced due to lack of mineral trace elements, traditional Chinese medicine components or probiotics. The results showed that compared with the control group, the total HAMD scores of the treatment groups of Example 1 and 2 were significantly reduced with the prolongation of the treatment course, and the reduction rate of HAMD scores increased significantly.
表2治疗前后HAMD量表分变化比较(x±s)Table 2 Comparison of HAMD scale score changes before and after treatment (x±s)
| 组别Group | 例数Number of cases | 治疗前Before treatment | 2周Two weeks | 4周4 weeks | 8周8 weeks | 12周12 weeks |
| 实施例1组Example 1 group | 1010 | 29.2±3.229.2±3.2 | 22.5±3.222.5±3.2 | 13.2±3.013.2±3.0 | 10.3±2.010.3±2.0 | 7.5±1.27.5±1.2 |
| 实施例3组Example 3 group | 1010 | 28.9±3.028.9±3.0 | 24.4±3.124.4±3.1 | 14.7±2.814.7±2.8 | 12.2±2.812.2±2.8 | 8.0±1.18.0±1.1 |
| 对照组实施例1Control Example 1 | 1010 | 27.2±3.327.2±3.3 | 25.4±2.825.4±2.8 | 17.3±2.917.3±2.9 | 15.3±2.215.3±2.2 | 9.7±1.29.7±1.2 |
| 对照组实施例2Control Example 2 | 1010 | 28.7±3.228.7±3.2 | 26.3±2.726.3±2.7 | 18.2±2.818.2±2.8 | 16.2±2.416.2±2.4 | 10.1±1.010.1±1.0 |
| 对照组实施例3Control Example 3 | 1010 | 29.0±3.329.0±3.3 | 27.0±2.927.0±2.9 | 20.0±2.720.0±2.7 | 48.0±2.148.0±2.1 | 11.2±1.111.2±1.1 |
*与治疗前比较有显著差异P＜0.05；**与治疗前比较有显著差异P＜0.001。*Compared with before treatment, there is a significant difference P<0.05; **Compared with before treatment, there is a significant difference P<0.001.
3.4.3实验室检查 实施例1和实施例3组治疗后血、尿、粪常规检查和心电图、肾功能均未发现明显异常。3.4.3 Laboratory examination No obvious abnormalities were found in the routine examinations of blood, urine, feces, electrocardiogram, and renal function in the groups of Example 1 and Example 3 after treatment.
以上临床实验结果表明，本发明提供的复合制剂具有很好的防治抑郁症的功效，并且通过对比实验结果表明，本发明提供的实施例1的复合制剂药效好于实施例3，且实施例1和3的疗效优于对照组实施例1至3；说明本发明矿物类和萜类组份、药食两用组份：益生菌组份和维生素组份按实施例1用量配比药效最优，当缺失矿物类和萜类组份、药食两用组份或益生菌组份后，药效明显降低，说明各组份科学配比，可起到协同增效的作用，矿物可增加益生菌繁殖，改善肠道优势菌群，肠道微环境发挥改善情志的功效，二者相辅相成；并且药食两用成分可调理情志、健脾提高发育，促进健康，再辅助儿童、青少年生长的维生素提高免疫力。The above clinical experimental results show that the compound preparation provided by the present invention has a good effect of preventing and treating depression, and the comparative experimental results show that the compound preparation provided by the present invention in Example 1 has better efficacy than Example 3, and examples The curative effect of 1 and 3 is better than that of the control group Examples 1 to 3; it shows that the mineral and terpenoid components of the present invention, the medicinal and edible components: the probiotic component and the vitamin component are proportioned according to the dosage of Example 1. Optimum. When minerals and terpenoids, medicinal and edible components, or probiotics are missing, the efficacy is significantly reduced, indicating that the scientific ratio of the components can play a synergistic effect. Minerals can Increase the reproduction of probiotics, improve the dominant intestinal flora, and the intestinal microenvironment plays the role of improving emotions. The two complement each other; and the dual-purpose ingredients of medicine and food can regulate emotions, invigorate the spleen and improve development, promote health, and then assist children, The vitamins grown by teenagers improve immunity.
实施例5抗抑郁模型小鼠的实验研究Example 5 Experimental study on antidepressant model mice
1.材料与方法1. Materials and methods
1.1动物：SPF级ICR小鼠，雌雄各半，体重18～22g，自由饮水和摄食，动物及饲料购自南京青龙山动物养殖场。1.1 Animals: SPF grade ICR mice, male and female, weighing 18-22g, free drinking and eating, animals and feed are purchased from Nanjing Qinglongshan Animal Farm.
1.2药物及样品配置1.2 Drug and sample configuration
受试药物：本发明实施例1组、实施例3组、对照组实施例1至3，临用前稀释成0.5g/ml待用。Test drug: Example 1 group, Example 3 group of the present invention, Example 1 to 3 of the control group, diluted to 0.5 g/ml before use.
1.3分组及给药1.3 Grouping and administration
将SPF级ICR小鼠随机分组，雌雄各半，每组10只，分别为模型组、实施例1组、实施例3组、对照组实施例1至3组。每组均采用灌胃(ig)给药0.1ml/10g。The SPF ICR mice were randomly divided into groups, half male and half male, 10 mice in each group, which were respectively the model group, the example 1 group, the example 3 group, and the control group examples 1 to 3. Each group was administered 0.1ml/10g by gavage (ig).
1.4小鼠悬尾实验1.4 Mouse tail suspension experiment
末次给药1.5h后，将小鼠尾部距末端约1cm处用夹子固定，使其倒吊于距地面15cm左右的横杆上，动物为克服不正常体位而挣扎活动，但活动一段时间后，出现间断性不动，显示失望状态，累计各组6min内的不动时间。1.5 hours after the last administration, the tail of the mouse was fixed with a clip about 1 cm from the end, and the mouse was hung upside down on a crossbar about 15 cm from the ground. The animal struggled to overcome the abnormal posture, but after a period of activity, Intermittent immobility appeared, showing disappointment, and the total immobility time of each group within 6 minutes.
1.5强迫小鼠游泳实验1.5 Forced mice to swim experiment
末次给药2h后，将小鼠放于直径约18cm，水深15cm，水温25℃的容器内，测定6min之内小鼠漂浮不动的时间(即小鼠在水中停止挣扎，或动物呈漂浮状态，仅有细小的肢体运动以保持头部浮在水面)。2h after the last administration, place the mouse in a container with a diameter of about 18cm, a water depth of 15cm, and a water temperature of 25℃, and measure the time that the mouse floats within 6 minutes (that is, the mouse stops struggling in the water, or the animal is floating , Only small limb movements to keep the head floating on the water).
1.6数据处理1.6 Data processing
实验数据均以Mean±SEM表示，组间比较采用t检验。The experimental data are all expressed by Mean±SEM, and the comparison between groups is by t test.
2.实验结果2. Experimental results
2.1小鼠悬尾实验2.1 Mouse tail suspension experiment
在经典的小鼠悬尾抑郁模型中，单次给予相应药物，本发明提供的实施例1组和实施例3的复方制剂可显著缩短小鼠悬尾不动时间(P＜0.05或P＜0.01)，并且效果优于对照组实施例1至3组。具体实验结果如表3。In the classic mouse tail suspension depression model, a single administration of the corresponding drugs, the compound preparations of Example 1 and Example 3 provided by the present invention can significantly shorten the immobility time of mouse tail suspension (P<0.05 or P<0.01). ), and the effect is better than the control group of Examples 1 to 3. The specific experimental results are shown in Table 3.
表3对小鼠悬尾不动实验的影响Table 3 Effects on the experiment of tail suspension in mice
*：与模型组相比P＜0.05；**：与模型组相比P＜0.01*: P＜0.05 compared with the model group; **: P＜0.01 compared with the model group
2.2强迫小鼠游泳实验2.2 Forced mice swimming experiment
小鼠在强迫游泳模型中出现漂浮不动状态反映了动物的绝望行为，本发明提供的实施例1组和实施例3的复方制剂能明显缩短小鼠强迫游泳不动时间(P＜0.06)，表明本发明提供的复方制剂在此模型上有抗抑郁作用，并且效果优于对照组实施例1至3组，具体实验结果如表4。The floating immobile state of the mice in the forced swimming model reflects the desperate behavior of the animals. The compound preparations of Example 1 and Example 3 provided by the present invention can significantly shorten the forced swimming immobility time of the mice (P<0.06), It shows that the compound preparation provided by the present invention has an antidepressant effect on this model, and the effect is better than that of the control group Examples 1 to 3, and the specific experimental results are shown in Table 4.
表4中药复方组合物对小鼠强迫游泳不动实验的影响Table 4 The effect of Chinese herbal compound composition on the experiment of forced swimming immobility in mice
*与模型组相比P＜0.05*P＜0.05 compared with model group
以上实验结果表明，本发明提供的复方制剂对抑郁模型小鼠的行为具有调节作用，具有明显的抗抑郁作用。The above experimental results show that the compound preparation provided by the present invention has a regulating effect on the behavior of depression model mice and has obvious antidepressant effect.
以上实施方式只为说明本发明的技术构思及特点，其目的在于让熟悉此项技术的人了解本发明内容并加以实施，并不能以此限制本发明的保护范围，凡根据本发明精神实质所做的等效变化或修饰，都应涵盖在本发明的保护范围内。The above embodiments are only to illustrate the technical concept and features of the present invention, and their purpose is to let those familiar with the technology understand the content of the present invention and implement it, and cannot limit the scope of protection of the present invention. All equivalent changes or modifications should be covered by the protection scope of the present invention.
Claims (9)
- 一种具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，其特征在于，它包括A compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents, characterized in that it includes(1)矿物类和萜类组份：青礞石、石膏、花蕊石、牡蛎，冰片；(1) Mineral and terpenoid components: bluestone, gypsum, stamen, oyster, borneol;(2)药食两用组份：栀子、鸡内金、益智仁、葛根、乌梅、芡实、薏苡仁、大枣、小麦；(2) Medicine and food components: Gardenia, Gallus gallus domesticus, Yizhiren, Pueraria lobata, Ebony plum, Gorgon, Coix seed, Jujube, wheat;(3)益生菌组份：Lactobacillus.rhamnosus Lr-32菌、Lactobacillus.rhamnosus HN001菌、Lactobacillus.reuteri 1E1菌、Lactobacillus.gasseriLg-36菌、Bifidobacterium.M-16V菌、Bifidobacterium.infantis M-63菌、Bifidobacterium bifidum BB-G90、Bifidobacterium.animalis.ssp.lactis HN019菌、Bifidobacterium.longum BB536菌、Akkermansia Muciniphila菌、土壤单胞菌CS30、放线菌ICM34、发酵氨基酸球菌；(3) Probiotic components: Lactobacillus.rhamnosus Lr-32 bacteria, Lactobacillus.rhamnosus HN001 bacteria, Lactobacillus.reuteri 1E1 bacteria, Lactobacillus.gasseriLg-36 bacteria, Bifidobacterium.M-16V bacteria, Bifidobacterium.infantis M-63 bacteria, Bifidobacterium bifidum BB-G90, Bifidobacterium.animalis.ssp.lactis HN019, Bifidobacterium.longum BB536, Akkermansia Muciniphila, Agromonas CS30, Actinomycetes ICM34, Ferment aminococcus;(4)维生素组份：维生素B1、维生素B6、维生素B12、维生素C、维生素D、维生素E、叶酸、牛磺酸。(4) Vitamin components: vitamin B1, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, folic acid, taurine.
- 根据权利要求1所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，其特征在于，它包括：The compound preparation with the function of assisting in preventing and treating psychological depression in children and adolescents according to claim 1, characterized in that it comprises:(1)矿物类和萜类组份：青礞石5～15克、石膏5～25克、花蕊石5～10克、牡蛎5～15克，冰片2～6克；(1) Mineral and terpenoid components: bluestone 5-15g, gypsum 5-25g, stamenite 5-10g, oyster 5-15g, borneol 2-6g;(2)药食两用组份：栀子2～6克、鸡内金5～15克、益智仁5～15克、葛根5～25克、芡实5～25克、乌梅5～25克、薏苡仁5～15克、大枣5～25克、小麦5～15克；(2) Medicine and food components: Gardenia 2～6g, Gallus gallus domesticus 5～15g, Yizhiren 5～15g, Pueraria lobata 5～25g, Gorgon 5～25g, Ebony 5～25g , Coix seed 5-15 grams, jujube 5-25 grams, wheat 5-15 grams;(3)益生菌组份：(3) Probiotic components:Lactobacillus.rhamnosus Lr-32菌1～2 Billion、Lactobacillus.rhamnosus HN001菌1～2Billion、Lactobacillus.reuteri 1E1菌500～800 Million、Lactobacillus.gasseriLg-36 200～400 Million菌、Bifidobacterium.M-16V菌300～600 Million、Bifidobacterium.infantis M-63菌100～300 Million、Bifidobacterium bifidum BB-G90 300～600 Million、Bifidobacterium.animalis.ssp.lactis HN019菌200～400 Million、Bifidobacterium.longum BB536菌200～400 Million、Akkermansia Muciniphila菌100～200 Million、土壤单胞菌CS30 100～200 Million、放线菌ICM34 100～200 Million、发酵氨基酸球菌100～400 Million；Lactobacillus.rhamnosus Lr-32 bacteria 1～2 Billion, Lactobacillus.rhamnosus HN001 bacteria 1～2Billion, Lactobacillus.reuteri 1E1 bacteria 500～800 Million, Lactobacillus.gasseriLg-36 200～400 Million bacteria, Bifidobacterium.M-16V bacteria 300～M-16V bacteria 600 Million, Bifidobacterium.infantis M-63 bacteria 100～300 Million, Bifidobacterium bifidum BB-G90 300～600 Million, Bifidobacterium.animalis.ssp.lactis HN019 bacteria 200～400 Million, Bifidobacterium.longum BB536 bacteria 200～400 Million, Akkermansia Muciniphila bacteria 100～200 Million, soil monospora CS30 100～200 Million, actinomycetes ICM34 100～200 Million, ferment aminococcus 100～400 Million;(4)维生素组份：维生素B1 0.5～1.5毫克、维生素B6 0.5～2毫克、维生素B12 5～25微克、维生素C 5～20毫克、维生素D 0.02～0.15毫克、维生素E 5～10毫克、叶酸0.4～0.6毫克、牛磺酸1～4克。(4) Vitamin components: vitamin B1 0.5～1.5 mg, vitamin B6 0.5～2 mg, vitamin B12 5～25 micrograms, vitamin C 5～20 mg, vitamin D 0.02～0.15 mg, vitamin E 5～10 mg, folic acid 0.4～0.6mg, taurine 1-4g.
- 根据权利要求2所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，其特征在于，它包括：The compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents according to claim 2, characterized in that it comprises:(1)矿物类和萜类组份：青礞石10克、石膏15克、花蕊石10克、牡蛎5克，冰片1克；(1) Mineral and terpenoid components: 10 grams of bluestone, 15 grams of gypsum, 10 grams of stamenite, 5 grams of oysters, 1 gram of borneol;(2)药食两用组份：栀子5克、鸡内金5克、益智仁10克、葛根20克、乌梅20克、芡实10克、薏苡仁10克、大枣20克、小麦10克；(2) Medicine and food ingredients: Gardenia 5g, Gallus gallus domesticus 5g, Yizhiren 10g, Pueraria lobata 20g, Ebony 20g, Gorgon 10g, Coix seed 10g, Jujube 20g, Wheat 10gram;(3)益生菌组份：(3) Probiotic components:Lactobacillus.rhamnosus Lr-32菌1 Billion、Lactobacillus.rhamnosus HN001菌1 Billion、Lactobacillus.reuteri 1E1菌500Million、Lactobacillus.gasseriLg-36 200 Million菌、Bifidobacterium.M-16V菌300 Million、Bifidobacterium.infantis M-63菌100 Million、Bifidobacterium bifidum BB-G90 300 Million、Bifidobacterium.animalis.ssp.lactis HN019菌200Million、Bifidobacterium.longum BB536菌200 Million、Akkermansia Muciniphila菌100 Million、土壤单胞菌CS30 100 Million、放线菌ICM34 100 Million、发酵氨基酸球菌100Million；Lactobacillus.rhamnosus Lr-32 Bacteria 1 Billion, Lactobacillus.rhamnosus HN001 Bacteria 1 Billion, Lactobacillus.reuteri 1E1 Bacteria 500Million, Lactobacillus.gasseriLg-36 200 Million Bacteria, Bifidobacterium.M-16V Bacteria 300-Million, Bifidobacterium.M-16V Bacteria 300-Million, Bifidobacterium. 100 Million, Bifidobacterium bifidum BB-G90 300 Million, Bifidobacterium.animalis.ssp.lactis HN019 200Million, Bifidobacterium.longum BB536 200 Million, Akkermansia Muciniphila 100 Million, Agromonas CS30 100 Million, Actinomycetes , Fermented amino acid cocci 100Million(4)维生素组份：维生素B1 1.5毫克、维生素B6 1.5毫克、维生素B12 10微克、维生素C 20毫克、维生素D 0.15毫克、维生素E 10毫克、叶酸0.6毫克、牛磺酸1克。(4) Vitamin components: vitamin B1 1.5 mg, vitamin B6 1.5 mg, vitamin B12 10 micrograms, vitamin C 20 mg, vitamin D 0.15 mg, vitamin E 10 mg, folic acid 0.6 mg, taurine 1 g.
- 根据权利要求1至3任一项所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，其特征在于，The compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents according to any one of claims 1 to 3, characterized in that:矿物类和萜类组份、药食两用组份、益生菌组份、维生素组份的用量比为：10～100∶10～30∶0.01～1∶0.01～0.05。The dosage ratio of minerals and terpenoids, medicinal and edible components, probiotics, and vitamins is 10-100:10-30:0.01-1:0.01-0.05.
- 根据权利要求4所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，其特征在于，The compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents according to claim 4, characterized in that:矿物类和萜类组份、药食两用组份、益生菌组份、维生素组份的用量比为：50∶10∶0.02∶0.01。The dosage ratio of mineral and terpenoid components, medicinal and edible components, probiotic components, and vitamin components is 50:10:0.02:0.01.
- 根据权利要求5所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，其特征在于，The compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents according to claim 5, characterized in that:青礞石、石膏、花蕊石和牡蛎通过粉碎机粉碎得到。Bluestone, gypsum, stamen and oysters are crushed by a crusher.
- 根据权利要求4所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，其特征在于，The compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents according to claim 4, characterized in that:药食两用组份通过以下方法制备得到：The medicinal and food dual-use components are prepared by the following methods:取栀子、鸡内金、益智仁、葛根、乌梅、芡实、薏苡仁、大枣和小麦，加入原料5～10倍体积量的水提取2～3次.，每次0.5～2小时，减压浓缩得到提取物。Take gardenia, Gallus gallus domesticus, Yizhiren, Pueraria lobata, ebony, ginseng, coix seed, jujube and wheat, add 5-10 times the volume of the raw materials to extract 2 to 3 times. Each time 0.5 to 2 hours, Concentrate under reduced pressure to obtain an extract.
- 根据权利要求5所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂，其特征在于，将益生菌矿物粉与食品载体制备成胶囊、片剂或与葡萄糖制成糖果。The compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents according to claim 5, characterized in that the probiotic mineral powder and the food carrier are prepared into capsules or tablets or made into candies with glucose.
- 权利要求1至4任一项所述的具有辅助防治儿童、青少年心理抑郁的作用的复合制剂在制备防治儿童青少年心里抑郁的营养餐、保健品或功能饮料中的应用。The use of the compound preparation with the effect of assisting in preventing and treating psychological depression in children and adolescents according to any one of claims 1 to 4 in preparing nutritious meals, health products or functional drinks for preventing and treating depression in children and adolescents.
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| CN110974917A (en) * | 2019-11-25 | 2020-04-10 | 垒途智能教科技术研究院江苏有限公司 | Compound preparation with auxiliary effect of preventing and treating psychological depression of children and teenagers |
| CN112458016B (en) * | 2020-11-27 | 2021-11-19 | 石家庄君乐宝乳业有限公司 | Bifidobacterium bifidum i771, and separation and purification method and application thereof |
| CN114250179B (en) * | 2021-12-22 | 2023-06-27 | 苏州普瑞森生物科技有限公司 | Microorganism combination with weight-losing effect and application thereof |
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