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CN115245554A - A kind of Poria medicinal composition with the effect of invigorating the stomach and eliminating the spleen and application thereof - Google Patents

A kind of Poria medicinal composition with the effect of invigorating the stomach and eliminating the spleen and application thereof Download PDF

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Publication number
CN115245554A
CN115245554A CN202110461472.7A CN202110461472A CN115245554A CN 115245554 A CN115245554 A CN 115245554A CN 202110461472 A CN202110461472 A CN 202110461472A CN 115245554 A CN115245554 A CN 115245554A
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China
Prior art keywords
parts
solution
acid
poria cocos
pachyman
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Inventor
戴甲木
侯凤飞
戴鑫汶
聂蔚
邹奇
唐心文
张豪
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Hunan Busky Pharmaceutical Co ltd
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Hunan Busky Pharmaceutical Co ltd
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Priority to CN202110461472.7A priority Critical patent/CN115245554A/en
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    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/076Poria
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Abstract

本发明涉及一种具有健胃消脾功效的茯苓药物组合物,包括如下重量份的原料:茯苓4~8份,山药2~5份,白扁豆2~5份,薏苡仁2~4份,大枣1~3份,芡实1~3份,砂仁1~3份,干姜1~3份,赤小豆1~4份,橘皮1~5份,山楂1~3份,麦芽1~2份,藿香1~4份,香薷1~3份,鱼腥草1~3份,蒲公英1~3份,薄荷1~3份,马齿苋1~3份,菊苣1~3份,紫苏叶1~3份,栀子1~3份。本发明的组合物从心肝肺脾肾各个角度对人体进行一定程度的调节,在健脾利湿和健胃消食上效果显著。The invention relates to a Poria medicinal composition with the functions of strengthening the stomach and eliminating the spleen, comprising the following raw materials in parts by weight: 4-8 parts of Poria cocos, 2-5 parts of yam, 2-5 parts of white lentils, 2-4 parts of Coix seed, 1-3 parts of jujube, 1-3 parts of Gorgon, 1-3 parts of Amomum, 1-3 parts of dried ginger, 1-4 parts of red bean, 1-5 parts of orange peel, 1-3 parts of hawthorn, 1-2 parts of malt 1 to 4 parts of Agaricus, 1 to 3 parts of Xiangshu, 1 to 3 parts of Houttuynia cordata, 1 to 3 parts of dandelion, 1 to 3 parts of mint, 1 to 3 parts of purslane, 1 to 3 parts of chicory, purple 1 to 3 parts of Su Ye and 1 to 3 parts of Gardenia. The composition of the present invention regulates the human body to a certain extent from various angles of the heart, liver, lung, spleen and kidney, and has remarkable effects on strengthening the spleen and removing dampness, strengthening the stomach and eliminating food.

Description

一种具有健胃消脾功效的茯苓药物组合物及其应用A kind of Poria medicinal composition with the effect of strengthening the stomach and eliminating the spleen and its application

技术领域technical field

本发明涉及生物医药领域,具体涉及一种具有健胃消脾功效的茯苓药物组合物及其应用及其制备方法和其应用。The invention relates to the field of biomedicine, in particular to a Poria cocos medicinal composition with the functions of invigorating the stomach and eliminating the spleen and its application, its preparation method and its application.

背景技术Background technique

胃的主要功能是两点:一是消化食物,人体摄入的食物都需要通过食管进入胃部,再经过胃的消化,再转入小肠;二是传输养分,胃部将食物消化之后提炼出食物中的营养素并将其通过血液传递到身体的各个部位,如果胃部能够很好的完成吸收营养素的工作,不但可以为体内其他的器官准时的传递营养,还能够增加食欲,振奋精神,反之如果胃部的消化功能减退,不仅会影响食欲,而且会出现口臭的现象,脾胃虚弱、消化不良大都表现为上腹部不适或者是疼痛、饱胀感、烧心、反胃等现象出现,常常因为胸闷、饱腹、腹胀等不适而不愿进食或者是食量很小,现有助消化药物大都治标不治本,对人体不能起到很好的调节作用,且不同程度的具有毒副作用,长期使用容易导致机体微环境失衡,影响身体健康。The main function of the stomach is two points: one is to digest food, the food ingested by the human body needs to enter the stomach through the esophagus, then be digested by the stomach, and then transferred to the small intestine; the other is to transport nutrients, the stomach digests the food and extracts it Nutrients in food are transmitted to all parts of the body through the blood. If the stomach can complete the work of absorbing nutrients, it can not only deliver nutrients to other organs in the body on time, but also increase appetite and invigorate the spirit. If the digestive function of the stomach decreases, it will not only affect appetite, but also cause bad breath. Weak spleen and stomach and indigestion are mostly manifested as upper abdominal discomfort or pain, fullness, heartburn, nausea and other phenomena, often due to chest tightness, Satiety, bloating and other discomforts and unwilling to eat or eat a small amount of food, most of the existing digestive aids cure the symptoms but not the root cause, can not play a good role in regulating the human body, and have different degrees of toxic and side effects, long-term use can easily lead to the body The imbalance of the microenvironment affects the health of the body.

茯苓为多孔菌目茯苓属菌类,具有利水渗湿、健脾、宁心安神等功效,广泛用于防治水肿尿少、痰饮眩悸、脾虚食少、便溏泄泻、心神不安、惊悸失眠等症。从茯苓中提取制备的羧甲基茯苓多糖具有优良的药理作用:1)依赖宿主的免疫系统,增强机体免疫力(特异性与非特异性),抑制与杀伤肿瘤细胞。通过激活补体,诱生多种淋巴细胞活性因子,增强巨噬细胞、NK细胞、T淋巴细胞与B淋巴细胞的活性,多途径协同增效发挥抗肿瘤、抗病毒作用;2)抑制肿瘤细胞DNA、RNA合成,直接杀死杀伤肿瘤细胞;3)提高肿瘤细胞膜上的唾液酸(SA)含量、抑制PI转换、降低花生四烯酸(C20)的含量,多途径抑制肿瘤细胞的分裂与增殖;Poria is a fungus belonging to the Poria family. It has the functions of diuretic and dampness, invigorating the spleen, calming the heart and soothing the nerves. It is widely used to prevent and treat edema, oliguria, phlegm and dizziness, spleen deficiency and lack of food, loose stools and diarrhea, restlessness, and palpitation. Insomnia embolism. The carboxymethyl tuckahoe polysaccharide extracted from Poria cocos has excellent pharmacological effects: 1) It depends on the immune system of the host, enhances the immunity of the body (specific and non-specific), and inhibits and kills tumor cells. By activating complement, a variety of lymphocyte activity factors are induced, and the activity of macrophages, NK cells, T lymphocytes and B lymphocytes is enhanced, and the multi-channel synergistic synergy plays an anti-tumor and anti-viral effect; 2) Inhibits tumor cell DNA , RNA synthesis, directly kill and kill tumor cells; 3) Increase the content of sialic acid (SA) on the tumor cell membrane, inhibit the conversion of PI, reduce the content of arachidonic acid (C 20 ), and inhibit the division and proliferation of tumor cells in multiple ways ;

4)增强肝脏SOD活性,清除氧自由基,化解致癌物质,防止正常细胞DNA变异。4) Enhance liver SOD activity, scavenge oxygen free radicals, dissolve carcinogens, and prevent DNA mutation in normal cells.

山药是入肺、健脾、补肾的佳品。山药含有淀粉酶、多酚氧化酶等物质,有利于脾胃消化吸收功能,是一味平补脾胃的药食两用之品。不论脾阳亏或胃阴虚,皆可食用。临床上常用治脾胃虚弱、食少体倦、泄泻等病症。山药含有多种营养素,有强健机体,滋肾益精的作用。但凡肾亏遗精,妇女白带多、小便频数等症,皆可服之。山药含有皂甙、黏液质,有润滑,滋润的作用,故可益肺气,养肺阴,治疗肺虚痰嗽久咳之症。Chinese yam is a good product for invigorating the lungs, invigorating the spleen and invigorating the kidneys. Yam contains amylase, polyphenol oxidase and other substances, which are beneficial to the digestion and absorption function of the spleen and stomach. Regardless of spleen yang deficiency or stomach yin deficiency, it can be eaten. Clinically, it is commonly used to treat spleen and stomach weakness, lack of appetite, fatigue, diarrhea and other symptoms. Yam contains a variety of nutrients, which can strengthen the body and nourish the kidney and essence. It can be used for any symptoms such as kidney deficiency and nocturnal emission, women with more leucorrhea and frequent urination. Chinese yam contains saponins and mucus, which have lubricating and moisturizing effects, so it can benefit lung qi, nourish lung yin, and treat lung deficiency and phlegm and chronic cough.

白扁豆的主要功能是健脾、利湿、止泻,白扁豆可以健脾胃、清暑湿,对于脾胃虚弱、暑湿泄泻、白带多的患者效果是非常好的。The main functions of white lentils are to invigorate the spleen, relieve dampness, and stop diarrhea. White lentils can strengthen the spleen and stomach, clear summer dampness, and are very effective for patients with weak spleen and stomach, diarrhea due to summer heat, and leucorrhea.

生薏米偏寒凉,利水渗湿最在行,可以去湿除风、清热排脓、除痹止痛,对小便不利、水肿、脚气和风湿疼痛等效果显著。Raw barley is cold and cool, and it is the most effective in diverting water and dampness. It can remove dampness and wind, clear heat and expel pus, remove arthralgia and relieve pain.

赤小豆入药,有行血补血、健脾去湿、利水消肿之效。其利尿通淋、除湿退黄之功应用历史悠久,成方较多,如《圣济总录》中赤小豆汤、《伤寒论》中麻黄连翘赤小豆汤、《圣惠方》中赤小豆散等。现代研究发现,其治疗急性肾炎、肝硬化腹水、水痘、腮腺炎、炎性外痔、皮肤病等疾病效果良好,同时还有抗氧化和雌激素样等多种作用。Chixiaodou is used as medicine, which has the effect of invigorating blood, invigorating spleen and removing dampness, diuresis and swelling. It has a long history of application in diuresis, drench, dehumidification and yellowing, and there are many prescriptions, such as Chixiaodou soup in "Shengji Zonglu", Mahuang Lianqiao Chixiaodou soup in "Treatise on Febrile Diseases", and Chixiaodou powder in "Shenghui Fang". Modern research has found that it has a good effect in the treatment of acute nephritis, liver cirrhosis, ascites, chickenpox, mumps, inflammatory external hemorrhoids, skin diseases and other diseases, and also has various effects such as antioxidant and estrogen-like.

发明内容SUMMARY OF THE INVENTION

本发明的目的在于提供一种具有健胃消脾功效的茯苓药物组合物,包括如下重量份的原料:茯苓4~8份,山药2~5份,白扁豆2~5份,薏苡仁2~4份,大枣1~3份,芡实1~3份,砂仁1~3份,干姜1~3份,赤小豆1~4份,橘皮1~5份,山楂1~3份,麦芽1~2份,藿香1~4份,香薷1~3份,鱼腥草1~3份,蒲公英1~3份,薄荷1~3份,马齿苋1~3份,菊苣1~3份,紫苏叶1~3份,栀子1~3份。The object of the present invention is to provide a Poria medicinal composition with the effect of invigorating the stomach and eliminating the spleen, comprising the following raw materials by weight: 4-8 parts of Poria cocos, 2-5 parts of Chinese yam, 2-5 parts of white lentils, 2-5 parts of Coix seed 4 servings, 1-3 servings of jujube, 1-3 servings of Gorgon, 1-3 servings of Amomum, 1-3 servings of dried ginger, 1-4 servings of red bean, 1-5 servings of orange peel, 1-3 servings of hawthorn, malt 1-2 parts, 1-4 parts of Agaricus, 1-3 parts of Xiangshu, 1-3 parts of Houttuynia cordata, 1-3 parts of dandelion, 1-3 parts of mint, 1-3 parts of purslane, 1-3 parts of chicory 1 to 3 servings of perilla leaves, and 1 to 3 servings of gardenia.

本发明的优选技术方案中,组合物中茯苓的含量为1-2.5份,优选为1.5-2份。In the preferred technical solution of the present invention, the content of Poria in the composition is 1-2.5 parts, preferably 1.5-2 parts.

本发明的优选技术方案中,组合物中的茯苓为茯苓粗粉、茯苓多糖碱化提取液、茯苓多糖、高取代度羧甲基茯苓多糖(CMP)的任一种。In a preferred technical solution of the present invention, the Poria cocos in the composition is any one of the Poria cocos coarse powder, the alkalized extract of the polysaccharide of the polysaccharide, the polysaccharide of the polysaccharide, and the polysaccharide of the high degree of substitution carboxymethyl polysaccharide (CMP).

本发明的优选技术方案中,所述高取代度羧甲基茯苓多糖的制备方法包括如下步骤:1)茯苓多糖加入到水或水醇混合液中,搅拌均匀后,加入茯苓多糖质量1-8%的碱性溶液,搅拌至完全溶解,得茯苓多糖碱化液;2)1.0-10mol/L氯乙酸与适当过量的2.0-10mol/L碱性溶液充分反应后,加入到1)步所得的茯苓多糖碱化液中,进行取代反应,分离,纯化,即得,所述适当过量是指碱性溶液中碱性物质的实际用量比其与氯乙酸发生中和反应所需理论用量过量0.5-40%。In the preferred technical solution of the present invention, the preparation method of the high-substitution carboxymethyl tuckahoe polysaccharide includes the following steps: 1) The tuckahoe polysaccharide is added to the water or water-alcohol mixed solution, and after stirring evenly, the tuckahoe polysaccharide quality 1-8 is added % alkaline solution, stirred until completely dissolved, to obtain Poria cocos polysaccharide alkaline solution; 2) after 1.0-10mol/L chloroacetic acid and an appropriate excess of 2.0-10mol/L alkaline solution are fully reacted, add to 1) step obtained In the alkaline solution of Poria cocos polysaccharide, carry out a substitution reaction, separate and purify, and then obtain, the appropriate excess means that the actual amount of the alkaline substance in the alkaline solution is 0.5- to 40%.

本发明的优选技术方案中,1)步所述茯苓多糖选自碱化提取法制得的茯苓多糖碱化提取液或碱提取酸沉淀法制得的茯苓多糖粗品。In the preferred technical solution of the present invention, the tuckahoe polysaccharide described in step 1 is selected from the tuckahoe polysaccharide alkalized extract prepared by the alkalization extraction method or the crude tuckahoe polysaccharide prepared by the alkali extraction acid precipitation method.

本发明的优选技术方案中,所述茯苓多糖碱化提取液的制备方法包括下述步骤,茯苓粉加入浓度为1.0-4.0mol/L的碱性溶液进行碱化提取,离心分离,取上清液,即得。In a preferred technical solution of the present invention, the preparation method of the alkalized extract of Poria cocos polysaccharide comprises the following steps: adding an alkaline solution with a concentration of 1.0-4.0mol/L to the Poria cocos powder for alkalization extraction, centrifugation, and taking the supernatant liquid, that is.

本发明的优选技术方案中,所述茯苓多糖的制备方法包括下述步骤,茯苓粉用浓度为1.0-4.0mol/L的碱性溶液搅拌提取,离心分离,取上清液;上清液加酸,所得酸沉淀物经离心、水洗,即得茯苓多糖,其中,所述的酸选自醋酸、盐酸、硫酸、硝酸的任一种。In the preferred technical solution of the present invention, the preparation method of the Poria polysaccharide comprises the following steps: the Poria powder is extracted by stirring with an alkaline solution with a concentration of 1.0-4.0 mol/L, centrifuged, and the supernatant is taken; the supernatant is added with acid, the obtained acid precipitate is centrifuged and washed with water to obtain Poria cocos polysaccharide, wherein the acid is selected from any one of acetic acid, hydrochloric acid, sulfuric acid and nitric acid.

本发明的优选技术方案中,所述碱性溶液的浓度为2.0-3.0mol/L。In a preferred technical solution of the present invention, the concentration of the alkaline solution is 2.0-3.0 mol/L.

本发明的优选技术方案中,所述水醇混合液为醇溶剂加水制得的溶液,所述醇溶剂选自甲醇、乙醇、丙二醇、乙酸乙酯、丙酮、二甲基亚砜、乙醚、异丙醇、二甲基甲酰胺的任一种或其组合。In the preferred technical scheme of the present invention, the water-alcohol mixed solution is a solution prepared by adding water to an alcohol solvent, and the alcohol solvent is selected from methanol, ethanol, propylene glycol, ethyl acetate, acetone, dimethyl sulfoxide, diethyl ether, isotope Any one or a combination of propanol, dimethylformamide.

本发明的优选技术方案中,1)步加入的碱性溶液为茯苓多糖质量的2-6%,优选1)步加入的碱性溶液为茯苓多糖质量的3-5%。In the preferred technical solution of the present invention, the alkaline solution added in step 1) is 2-6% of the mass of Poria cocos polysaccharide, and preferably the alkaline solution added in step 1) is 3-5% of the mass of Poria cocos polysaccharide.

本发明的优选技术方案中,所述碱性溶液由碱性物质加水溶解制得,所述碱性物质选自氢氧化钠、氢氧化钾、碳酸钠、碳酸钾的任一种或其组合。In a preferred technical solution of the present invention, the alkaline solution is prepared by dissolving an alkaline substance in water, and the alkaline substance is selected from any one of sodium hydroxide, potassium hydroxide, sodium carbonate, potassium carbonate or a combination thereof.

本发明的优选技术方案中,所述碱性物质选自氢氧化钠或氢氧化钾的任一种或其组合。In a preferred technical solution of the present invention, the alkaline substance is selected from any one of sodium hydroxide or potassium hydroxide or a combination thereof.

本发明的优选技术方案中,所述氯乙酸溶液的浓度为2.0-9.0mol/L,优选为3.0-8.0mol/L,更优选为4.0-7.0mol/L,还优选为4.5-6.0mol/L。In the preferred technical solution of the present invention, the concentration of the chloroacetic acid solution is 2.0-9.0 mol/L, preferably 3.0-8.0 mol/L, more preferably 4.0-7.0 mol/L, still preferably 4.5-6.0 mol/L L.

本发明的优选技术方案中,2)步所述碱性溶液的浓度为3.0-9.0mol/L,优选为4.0-8.0mol/L,更优选为5.0-7.0mol/L,还优选为5.5-6.5mol/L。In the preferred technical solution of the present invention, the concentration of the alkaline solution in step 2) is 3.0-9.0 mol/L, preferably 4.0-8.0 mol/L, more preferably 5.0-7.0 mol/L, and preferably 5.5- 6.5mol/L.

本发明的优选技术方案中,所述适当过量是指碱性溶液中碱性物质的实际用量比其与氯乙酸发生中和反应所需理论用量过量5-30%,优选为10-25%,更优选为15-20%。In the preferred technical solution of the present invention, the appropriate excess means that the actual amount of the alkaline substance in the alkaline solution is 5-30% more than the theoretical amount required for the neutralization reaction with chloroacetic acid, preferably 10-25%, More preferably it is 15-20%.

本发明的优选技术方案中,2)步所述反应液在30-100℃条件下取代反应1-5h。In the preferred technical solution of the present invention, the reaction solution in step 2) is subjected to substitution reaction at 30-100° C. for 1-5 hours.

本发明的优选技术方案中,2)步所述反应时间为2-4h,优选为2.5-3.5h。In the preferred technical solution of the present invention, the reaction time in step 2) is 2-4h, preferably 2.5-3.5h.

本发明的优选技术方案中,2)步所述反应温度为40-90℃,优选为50-85℃,更优选为60-82℃,还优选为75-80℃。In the preferred technical solution of the present invention, the reaction temperature in step 2) is 40-90°C, preferably 50-85°C, more preferably 60-82°C, and still preferably 75-80°C.

本发明的优选技术方案中,所述分离包括下述步骤,在2)步反应生成液中加入1.0-10mol/L的酸性溶液,调其pH5.0-7.0后,加入3-5倍体积的醇溶剂,析出CMP粗品,所述醇溶剂选自甲醇、乙醇、丙二醇、乙酸乙酯、异丙醇、乙醚、丙酮的任一种或其组合。In the preferred technical solution of the present invention, the separation includes the following steps: adding 1.0-10 mol/L acid solution to the reaction product in step 2), adjusting its pH to 5.0-7.0, adding 3-5 times the volume of an alcohol solvent, and the CMP crude product is precipitated, and the alcohol solvent is selected from any one or a combination of methanol, ethanol, propylene glycol, ethyl acetate, isopropanol, diethyl ether, and acetone.

本发明的优选技术方案中,所述酸性溶液由酸性物质加水溶解制得,所述酸性物质选自醋酸、盐酸、硫酸或硝酸的任一种或其组合。In a preferred technical solution of the present invention, the acidic solution is prepared by dissolving an acidic substance in water, and the acidic substance is selected from any one of acetic acid, hydrochloric acid, sulfuric acid or nitric acid or a combination thereof.

本发明的优选技术方案中,所述纯化包括下述步骤,将待纯化的CMP加水配成1.0-6.0%的水溶液,加入1.0-10mol/L的碱性溶液调pH9.0-12.0,搅拌至CMP完全溶解;加入30%H2O2溶液,其用量为溶解液总容积0.1‰-2.0‰,进行脱色反应;加入1.0-10mol/L的酸性溶液调pH5.0—7.0,超滤去除分子量小于0.7×104道尔顿的CMP及其他小分子杂质。In the preferred technical solution of the present invention, the purification includes the following steps: adding water to the CMP to be purified to prepare a 1.0-6.0% aqueous solution, adding 1.0-10 mol/L alkaline solution to adjust the pH to 9.0-12.0, and stirring until CMP is completely dissolved; add 30% H 2 O 2 solution, the amount of which is 0.1‰-2.0‰ of the total volume of the solution, to carry out decolorization reaction; add 1.0-10mol/L acid solution to adjust pH to 5.0-7.0, remove molecular weight by ultrafiltration CMP and other small molecule impurities less than 0.7×10 4 Daltons.

本发明的优选技术方案中,待纯化的CMP水溶液浓度为2.0-5.0%,优选为3-4%。In a preferred technical solution of the present invention, the concentration of the CMP aqueous solution to be purified is 2.0-5.0%, preferably 3-4%.

本发明的优选技术方案中,纯化步骤所用碱性溶液的浓度为2.0-9.0mol/L,优选为3.0-8.0mol/L,更优选为4.0-7.0mol/L,还优选为5.0-6.0mol/L。In the preferred technical solution of the present invention, the concentration of the alkaline solution used in the purification step is 2.0-9.0 mol/L, preferably 3.0-8.0 mol/L, more preferably 4.0-7.0 mol/L, still preferably 5.0-6.0 mol/L /L.

本发明的优选技术方案中,所述30%H2O2溶液的用量为溶解液总容积的0.5‰-1.0‰。In the preferred technical solution of the present invention, the dosage of the 30% H 2 O 2 solution is 0.5‰-1.0‰ of the total volume of the solution.

本发明的优选技术方案中,所述脱色反应温度为10℃-70℃,优选为15℃-60℃,更优选为20℃-50℃。In a preferred technical solution of the present invention, the decolorization reaction temperature is 10°C-70°C, preferably 15°C-60°C, more preferably 20°C-50°C.

本发明的优选技术方案中,所述脱色反应的时间为2-48h,优选为5-40h,更优选为10-30h,还优选为15-25h。In the preferred technical solution of the present invention, the time of the decolorization reaction is 2-48h, preferably 5-40h, more preferably 10-30h, still preferably 15-25h.

本发明的优选技术方案中,所述酸性溶液的浓度为1.0-9.0mol/L,优选为2.0-8.0mol/L,更优选为3.0-7.0mol/L,优选为4.0-6.0mol/L。In a preferred technical solution of the present invention, the concentration of the acidic solution is 1.0-9.0 mol/L, preferably 2.0-8.0 mol/L, more preferably 3.0-7.0 mol/L, preferably 4.0-6.0 mol/L.

本发明的优选技术方案中,所述超滤介质为DH—UF中空纤维超滤器。In the preferred technical solution of the present invention, the ultrafiltration medium is a DH-UF hollow fiber ultrafilter.

本发明的优选技术方案中,所述的分离纯化为多次分离纯化。In a preferred technical solution of the present invention, the separation and purification are multiple times of separation and purification.

本发明的优选技术方案中,CMP的取代度不低于1.05,优选不低于1.10,更优选不低于1.2。In the preferred technical solution of the present invention, the substitution degree of CMP is not less than 1.05, preferably not less than 1.10, more preferably not less than 1.2.

本发明的优选技术方案中,所述CMP的分子量为0.7×104-1.0×106道尔顿,优选为3.0×104-8×105道尔顿,更优选为6.0×104-5.0×105道尔顿,还优选为8.0×104-3.0×105道尔顿。In a preferred technical solution of the present invention, the molecular weight of the CMP is 0.7×10 4 -1.0×10 6 Daltons, preferably 3.0×10 4 -8×10 5 Daltons, more preferably 6.0×10 4 - 5.0×10 5 Daltons, preferably 8.0×10 4 to 3.0×10 5 Daltons.

本发明的优选技术方案中,所述CMP的聚合度为32<n<4545,优选为136<n<3636,更优选为272<n<2272,还优选为363<n<1363。In a preferred technical solution of the present invention, the degree of polymerization of the CMP is 32<n<4545, preferably 136<n<3636, more preferably 272<n<2272, and still preferably 363<n<1363.

本发明的优选技术方案中,组合物中还含有所需量的药学上可接受的载体。In a preferred technical solution of the present invention, the composition also contains a required amount of a pharmaceutically acceptable carrier.

本发明的优选技术方案中,所述药学上可接受的载体选自填充剂(又称稀释剂)、润滑剂(又称助流剂或抗粘着剂)、分散剂、湿润剂、粘合剂、调节剂、增溶剂(又称稳定剂)、抗氧剂、乳化剂、矫味剂、赋香剂的任一种或其组合。In a preferred technical solution of the present invention, the pharmaceutically acceptable carrier is selected from fillers (also known as diluents), lubricants (also known as glidants or anti-adhesives), dispersants, wetting agents, and adhesives , any one or a combination of regulators, solubilizers (also known as stabilizers), antioxidants, emulsifiers, flavoring agents, and flavoring agents.

本发明的优选技术方案中,所述的粘合剂选自糖浆、阿拉伯胶、明胶、山梨醇、黄芪胶、纤维素、微晶纤维素、羧甲基纤维素钠、乙基纤维素、羟丙甲基纤维素、明胶浆、糖浆、淀粉、羧甲基淀粉钠、淀粉乙醇酸钠、预胶化淀粉、改良淀粉、羟丙基淀粉、玉米淀粉、淀粉浆、聚乙烯吡咯烷酮的任一种或其组合。In the preferred technical scheme of the present invention, the binder is selected from syrup, gum arabic, gelatin, sorbitol, tragacanth, cellulose, microcrystalline cellulose, sodium carboxymethyl cellulose, ethyl cellulose, hydroxy Any of propyl methylcellulose, gelatin slurry, syrup, starch, sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, corn starch, starch slurry, polyvinylpyrrolidone or a combination thereof.

本发明的优选技术方案中,所述的填充剂选自乳糖、糖粉、糊精、淀粉或其衍生物、纤维素、微晶纤维素、羧甲基纤维素钠、乙基纤维素、羟丙甲基纤维素、硫酸钙、磷酸钙、磷酸氢钙、沉降碳酸钙、山梨醇、甘氨酸、羧甲基淀粉钠、淀粉乙醇酸钠、预胶化淀粉、改良淀粉、羟丙基淀粉、玉米淀粉的任一种或其组合。In the preferred technical scheme of the present invention, the filler is selected from lactose, powdered sugar, dextrin, starch or its derivatives, cellulose, microcrystalline cellulose, sodium carboxymethyl cellulose, ethyl cellulose, hydroxy Propylmethylcellulose, calcium sulfate, calcium phosphate, calcium hydrogen phosphate, precipitated calcium carbonate, sorbitol, glycine, sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, corn Any one or a combination of starches.

本发明的优选技术方案中,所述的润滑剂选自微粉硅胶、硬脂酸镁、滑石粉、氢氧化铝、硼酸、氢化植物油、聚乙二醇的任一种或其组合。In a preferred technical solution of the present invention, the lubricant is selected from any one or a combination of micropowder silica gel, magnesium stearate, talc, aluminum hydroxide, boric acid, hydrogenated vegetable oil, and polyethylene glycol.

本发明的优选技术方案中,所述的崩解剂选自淀粉、羧甲基淀粉钠、淀粉乙醇酸钠、预胶化淀粉、改良淀粉、羟丙基淀粉、玉米淀粉、聚乙烯吡咯烷酮、交联聚乙烯吡咯烷酮、微晶纤维素的任一种或其组合。In the preferred technical scheme of the present invention, the disintegrating agent is selected from starch, sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, corn starch, polyvinylpyrrolidone, Any one of bipolyvinylpyrrolidone, microcrystalline cellulose, or a combination thereof.

本发明的优选技术方案中,所述的湿润剂选自十二烷基硫酸钠、水、醇的任一种或其组合。In the preferred technical scheme of the present invention, the wetting agent is selected from any one of sodium lauryl sulfate, water, and alcohol or a combination thereof.

本发明的优选技术方案中,所述的乳化剂选自聚山梨酯-80、没酸山梨坦、普流罗尼克F-68,卵磷酯、豆磷脂的任一种或其组合。In a preferred technical scheme of the present invention, the emulsifier is selected from any one of polysorbate-80, sorbitan bisulfate, pluronic F-68, lecithin, soybean lecithin, or a combination thereof.

本发明的优选技术方案中,所述的酸碱调节剂选自无机酸、有机酸的任一种或其组合,优选选自柠檬酸、柠檬酸钠、苹果酸、苹果酸钠、盐酸、醋酸、醋酸钠、磷酸、磷酸氢钠、磷酸二氢钠、碳酸、碳酸钠、磺酸、磺酸钠、谷氨酸、酒石酸、酒石酸钠、乳酸、乳酸钠、富马酸、富马酸钠、衣康酸、抗坏血酸、抗坏血酸钠、烟酸、烟酸钠、延胡索酸、α-酮戊二酸、果酸、果酸钠、乙酸、草酸、琥珀酸、二氧化碳、枸橼酸、枸橼酸钠的任一种或其组合。In the preferred technical scheme of the present invention, the acid-base regulator is selected from any one of inorganic acids and organic acids or a combination thereof, preferably selected from citric acid, sodium citrate, malic acid, sodium malic acid, hydrochloric acid, acetic acid , Sodium acetate, phosphoric acid, sodium hydrogen phosphate, sodium dihydrogen phosphate, carbonic acid, sodium carbonate, sulfonic acid, sodium sulfonate, glutamic acid, tartaric acid, sodium tartrate, lactic acid, sodium lactate, fumaric acid, sodium fumarate, coating Aconic acid, ascorbic acid, sodium ascorbate, niacin, sodium nicotinate, fumaric acid, alpha-ketoglutaric acid, fruit acid, sodium fruit acid, acetic acid, oxalic acid, succinic acid, carbon dioxide, citric acid, sodium citrate one or a combination thereof.

本发明的优选技术方案中,所述的酸碱调节剂的浓度为0.5-8mol/L,优选为0.8-6mol/L,更优选为1-5mol/L,还优选为2-4mol/L。In the preferred technical solution of the present invention, the concentration of the acid-base regulator is 0.5-8 mol/L, preferably 0.8-6 mol/L, more preferably 1-5 mol/L, and still preferably 2-4 mol/L.

本发明的优选技术方案中,所述的稳定剂(增溶剂)选自甘油、吐温-80的任一种或其组合。In a preferred technical solution of the present invention, the stabilizer (solubilizer) is selected from any one of glycerol, Tween-80 or a combination thereof.

本发明的优选技术方案中,所述的抗氧剂选自山梨酸钾、亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠、二丁基苯酸的任一种或其组合。In the preferred technical scheme of the present invention, the antioxidant is selected from any one of potassium sorbate, sodium sulfite, sodium bisulfite, sodium metabisulfite, and dibutyl benzoic acid or a combination thereof.

本发明的优选技术方案中,所述的赋香剂选自香料、食用香料、食用香精的任一种或其组合。In a preferred technical solution of the present invention, the flavoring agent is selected from any one of spice, edible flavor, and edible essence or a combination thereof.

本发明的组合物可为本领域熟知的各种剂型,并可采用本领域常规的制剂技术制备得到。The compositions of the present invention can be in various dosage forms well known in the art, and can be prepared by conventional formulation techniques in the art.

本发明的优选技术方案中,所述组合物为口服制剂。In a preferred technical solution of the present invention, the composition is an oral preparation.

本发明的优选技术方案中,所述的口服制剂选自口服液(液体制剂)、糖浆剂、混悬液、片剂、胶囊剂、颗粒剂、丸剂、散剂、滴丸、合剂、露剂、泡腾剂、糊剂、乳剂、茶剂的任一种。In the preferred technical scheme of the present invention, the oral preparation is selected from oral liquid (liquid preparation), syrup, suspension, tablet, capsule, granule, pill, powder, dropping pill, mixture, dew, Any of effervescent, paste, emulsion, and tea.

本发明的优选技术方案中,还可将活性成分与药学上可接受的缓控释载体按其制备要求加以混合,再按照本领域熟知的缓控释制剂的制备方法,如加入阻滞剂包衣或将活性成分微囊化后再制成缓释微丸或控释微丸;所述的缓控释载体包括但不仅限于油脂性掺入剂、亲水胶体或包衣阻滞剂等,所述的油脂性掺入剂选自单硬脂酸甘油酯、氢化蓖麻油、矿油、聚硅氧烷、二甲基硅氧烷的任一种或其组合;所述的亲水胶体选自羧甲基纤维素钠、羟丙基纤维素、羟丙基甲基纤维素、PVP、阿拉伯胶、西黄耆胶、卡波普的任一种或其组合;所述的包衣阻滞剂选自乙基纤维素(EC)、羟丙甲基纤维素(HMPC)、聚乙烯吡咯烷酮(PVP)、邻苯二甲酸乙酸纤维素(CAP)、丙烯酸类树脂的任一种或其组合。In the preferred technical solution of the present invention, the active ingredient can also be mixed with a pharmaceutically acceptable sustained and controlled release carrier according to its preparation requirements, and then according to the preparation method of sustained and controlled release preparations well known in the art, such as adding a blocking agent bag Coating or microencapsulating the active ingredients and then making slow-release pellets or controlled-release pellets; the slow-release and controlled-release carriers include but are not limited to oleaginous admixtures, hydrocolloids or coating blockers, etc., Described oleaginous admixture is selected from any one or its combination of glycerol monostearate, hydrogenated castor oil, mineral oil, polysiloxane, dimethylsiloxane; Any one or a combination of sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, PVP, acacia, tragacanth, and carbopol; the coating retards The agent is selected from any one of ethyl cellulose (EC), hydroxypropyl methyl cellulose (HMPC), polyvinyl pyrrolidone (PVP), cellulose acetate phthalate (CAP), acrylic resin, or a combination thereof.

本发明的优选技术方案中,组合物包括如下重量份的原料:茯苓4份,山药2份,白扁豆2份,2薏苡仁2份,大枣1份,芡实1份,砂仁1份,干姜1份,赤小豆2份,橘皮2份,山楂1份,麦芽1份,藿香2份,香薷1份,鱼腥草1份,蒲公英1份,薄荷1份,马齿苋1份,菊苣1份,紫苏叶1份,栀子1份。In the preferred technical solution of the present invention, the composition comprises the following raw materials by weight: 4 parts of Poria, 2 parts of Chinese yam, 2 parts of white lentils, 2 parts of Coix seed, 1 part of jujube, 1 part of Gorgon Fructus, 1 part of Amomum glutinosa, 1 part of dried ginger, 2 parts of red bean, 2 parts of orange peel, 1 part of hawthorn, 1 part of malt, 2 parts of Agaricus, 1 part of coriander, 1 part of Houttuynia cordata, 1 part of dandelion, 1 part of mint, 1 part of purslane , 1 part of chicory, 1 part of perilla leaves, 1 part of gardenia.

本发明的另一目的在于提供一种具有健胃消脾功效的茯苓药物组合物的制备方法,组合物包括如下重量份的原料:茯苓4~8份,山药2~5份,白扁豆2~5份,薏苡仁2~4份,大枣1~3份,芡实1~3份,砂仁1~3份,干姜1~3份,赤小豆1~4份,橘皮1~5份,山楂1~3份,麦芽1~2份,藿香1~4份,香薷1~3份,鱼腥草1~3份,蒲公英1~3份,薄荷1~3份,马齿苋1~3份,菊苣1~3份,紫苏叶1~3份,栀子1~3份,具体制备方法包括下述步骤:将所有原料混合均匀后粉碎至60~140目,灭菌即得。Another object of the present invention is to provide a preparation method of a Poria cocos medicinal composition with the effect of strengthening the stomach and invigorating the spleen. The composition comprises the following raw materials in parts by weight: 4-8 parts of Poria cocos, 2-5 parts of yam, 2-5 parts of white lentils 5 servings, 2-4 servings of coix seed, 1-3 servings of jujube, 1-3 servings of Gorgon, 1-3 servings of Amomum, 1-3 servings of dried ginger, 1-4 servings of red bean, 1-5 servings of orange peel, 1-3 parts of hawthorn, 1-2 parts of malt, 1-4 parts of Agaricus, 1-3 parts of Xiangshu, 1-3 parts of Houttuynia cordata, 1-3 parts of dandelion, 1-3 parts of mint, 1-3 parts of purslane 3 parts, 1 to 3 parts of chicory, 1 to 3 parts of perilla leaves, and 1 to 3 parts of gardenia, the specific preparation method includes the following steps: mix all raw materials evenly, pulverize to 60-140 mesh, and sterilize.

本发明的另一目的在于提供本发明提供的一种具有健胃消脾功效的茯苓药物组合物用于制备改善胃肠功能的制品中的应用。Another object of the present invention is to provide the application of the Poria cocos medicinal composition provided by the present invention with the effect of invigorating the stomach and eliminating the spleen for preparing a product for improving gastrointestinal function.

本发明的优选技术方案中,所述改善胃肠功能选自增强免疫、抗病毒、保肝、抗菌、利尿、抗疲劳、防治便秘和胃肠炎症及消化不良的任一种。In a preferred technical solution of the present invention, the improving gastrointestinal function is selected from any one of enhancing immunity, anti-virus, protecting liver, antibacterial, diuretic, anti-fatigue, preventing and treating constipation, gastrointestinal inflammation and indigestion.

本发明的优选技术方案中,组合物的用量与患者的年龄、性别、健康状况、治疗现状、合并用药等因素相关,推荐用量为5-10g/次,2-3次/日。In the preferred technical scheme of the present invention, the dosage of the composition is related to factors such as the patient's age, gender, health status, treatment status, and concomitant medication, and the recommended dosage is 5-10 g/time, 2-3 times/day.

除非另有说明,本发明涉及液体与液体之间的百分比时,所述的百分比为体积/体积百分比;本发明涉及液体与固体之间的百分比时,所述百分比为体积/重量百分比;本发明涉及固体与液体之间的百分比时,所述百分比为重量/体积百分比;其余为重量/重量百分比。Unless otherwise specified, when the present invention relates to the percentage between liquid and liquid, the percentage is volume/volume percentage; when the present invention relates to the percentage between liquid and solid, the percentage is volume/weight percentage; the present invention When referring to percentages between solids and liquids, the percentages are weight/volume percentages; the remainder are weight/weight percentages.

与现有技术相比,本发明具有下述有益技术效果:Compared with the prior art, the present invention has the following beneficial technical effects:

(1)本发明的组合物科学筛选原料的组成及配比,以茯苓为主料,茯苓在健脾利湿具有一定的功效,然而单独作用或仅以其中几味原料结合使用时,其效果并不理想,而人体运行机理复杂,本发明不断调整试验配方并试验发现加入山药、白扁豆、薏苡仁、赤小豆这几位主料,并加入砂仁、干姜、橘皮、山楂、麦芽、藿香、香薷、鱼腥草、蒲公英、薄荷、马齿苋、菊苣、紫苏叶、栀子这些辅料后,各原料成分间复配而产生协同增效的效果,各原料成分协同从心肝肺脾肾各个角度对人体进行一定程度的调节,在健脾利湿和健胃消食上效果显著。(1) The composition of the present invention is scientifically screened for the composition and proportioning of the raw materials, with Poria as the main ingredient, and Poria has a certain effect in invigorating the spleen and removing dampness, but when used alone or only with several raw materials in combination, its effect It is not ideal, and the operating mechanism of the human body is complicated. The present invention continuously adjusts the test formula and finds that several main ingredients such as yam, white lentils, coix seed, and red bean are added, and Amomum glutinosa, dried ginger, orange peel, hawthorn, malt, After the accessories such as Agaricus, Fragrance, Houttuynia cordata, dandelion, mint, purslane, chicory, perilla leaves, and gardenia, the ingredients of the ingredients are compounded to produce a synergistic effect. The spleen and kidneys adjust the human body to a certain extent from all angles, and have significant effects on strengthening the spleen and eliminating dampness, strengthening the stomach and digesting food.

茯苓,味甘、淡,性平,归心、肺、脾、肾经,利水渗湿,健脾,宁心;山药,性甘,温、平,无毒,补虚赢,除寒热邪气,补中,益气力,补脾养胃,生津益肺,补肾涩精;白扁豆,健脾化湿,和中消暑;薏苡仁,健脾渗湿,除痹止泻,清热排脓;大枣,补中益气,养血安神;芡实,益肾固精,补脾止泻,祛湿止带;砂仁,味辛,性温,归脾、胃、肾经,芳香行散,降中有升,化湿开胃,温脾止泻;干姜,温中散寒,回阳通脉,燥湿消痰;赤小豆,利水消肿,解毒排脓;橘皮,散寒燥湿,利气消痰;山楂,消食健胃,行气散瘀;麦芽,行气消食,健脾开胃,退乳消胀;藿香,辛,微温,归脾、胃、肺经,芳香化湿,和胃止呕,辟秽和中,祛暑解表,具有很好的杀菌和防腐效果;香薷,发汗解表,和中利湿;鱼腥草,清热解毒,消痈排脓,利尿通淋,具有抗菌、抗病毒、提高机体免疫力、利尿等作用;蒲公英,入肝、胃经,清热解毒,消肿散结,解食毒,散滞气;薄荷,宣散风热,清头目,透疹,薄荷含有薄荷醇,具有防腐杀菌、利尿、化痰、健胃和助消化等功效;马齿苋,清热解毒,凉血止血;菊苣,清肝利胆,健脾消食,利尿消肿;紫苏叶,解表散寒,行气和胃;栀子,泻火除烦,清热利尿,凉血解毒。Poria, sweet in taste, mild in nature, calm in nature, returns to the heart, lung, spleen, and kidney meridians, diuresis and dampness, invigorates the spleen, calms the heart; Chinese yam, sweet in nature, warm, calm, non-toxic, invigorates deficiency, removes cold and heat pathogenic qi, nourishes Zhong, invigorating energy, invigorating the spleen and nourishing the stomach, invigorating body fluid and benefiting the lung, invigorating the kidney and astringent essence; white lentils, invigorating the spleen and removing dampness, and relieving heat stroke; Coix seed, invigorating the spleen and draining dampness, eliminating arthralgia and stopping diarrhea, clearing heat and expelling pus; jujube, Invigorating the middle and benefiting qi, nourishing the blood and soothing the nerves; Gorgon fruit, invigorating the kidney and solidifying the essence, invigorating the spleen and stopping diarrhea, removing dampness and stopping the belt; Amomum glutinosa, acrid in taste, warm in nature, returning to the spleen, stomach, and kidney meridians, fragrant and expelling, lowering the middle Rising, dispelling dampness and appetizing, warming the spleen and stopping diarrhea; dry ginger, warming the middle and dispelling cold, Huiyang and Tongmai, drying dampness and eliminating phlegm; Chixiaodou, reducing water and swelling, detoxifying and expelling pus; Phlegm; hawthorn, digestion and stomach, promoting qi and dissipating blood stasis; malt, promoting qi and digestion, invigorating spleen and appetizing, reducing milk and distension; Huoxiang, pungent, slightly warm, returning to spleen, stomach, lung meridian, aromatic and dampness, and stomach-stopping Vomiting, dispelling filth and neutralizing, dispelling summer heat and relieving table, have good bactericidal and antiseptic effect; Xiangzhu, sweating to relieve table, neutralize dampness; , antiviral, improve immunity, diuretic and other effects; dandelion, enter the liver and stomach meridians, clear heat and detoxify, reduce swelling and dissipate knots, detoxify food, disperse stagnant qi; peppermint, dispelling wind-heat, clearing the head, clearing the rash, Peppermint contains menthol, which has antiseptic and sterilizing, diuretic, phlegm-reducing, stomach-strengthening and digestive-aiding effects; purslane, clearing heat and detoxifying, cooling blood and stopping bleeding; chicory, clearing liver and gallbladder, strengthening spleen and digestion, diuresis and swelling; perilla Leaf, dispelling external cold, promoting qi and stomach; gardenia, purging fire and eliminating vexation, clearing heat and diuretic, cooling blood and detoxifying.

(2)本发明所述的药物组合物,其原料丰富,易于生产,口感清冽,香气清新,服用一段时间后可起到健脾宁心、消食健胃和行气散瘀的效果,对人体具有很好的保健作用,经济和社会效益显著。(2) The pharmaceutical composition of the present invention has rich raw materials, is easy to produce, has a clear mouthfeel, and has a fresh fragrance. After taking it for a period of time, it can play the effects of strengthening the spleen and calming the heart, reducing food and stomach, promoting qi and dissipating blood stasis, and has a beneficial effect on the human body. It has a good health care effect, and has significant economic and social benefits.

(3)本发明所述的药物组合物,不仅从功效,也从气味、口感以及安全性上做了充分考虑,其原料组分和配方经过了长期的试验和验证而得。(3) The pharmaceutical composition of the present invention is fully considered not only in terms of efficacy, but also in terms of smell, taste and safety, and its raw material components and formulations have been obtained through long-term tests and verifications.

(3)本发明所述的各原料均为药食同源,各组分和搭配经过了慎重考量和试验,无任何毒副作用。制备方法具有操作简便,成本效益显著,适合工业化大生产。(3) All the raw materials described in the present invention are of the same origin as medicine and food, and each component and combination have been carefully considered and tested, without any toxic and side effects. The preparation method has the advantages of simple operation, remarkable cost-effectiveness, and is suitable for large-scale industrial production.

具体实施方式Detailed ways

以下参照实施例说明本发明。但本发明不局限于实施例。The present invention will be described below with reference to Examples. However, the present invention is not limited to the examples.

实施例1Example 1

本实施例所述的茯苓组合物,包括如下原料:茯苓4kg,山药2kg,白扁豆2kg,薏苡仁2kg,大枣1kg,芡实1kg,砂仁1kg,干姜1kg,赤小豆2kg,橘皮2kg,山楂1kg,麦芽1kg,藿香2kg,香薷1kg,鱼腥草1kg,蒲公英1kg,薄荷1kg,马齿苋1kg,菊苣1kg,紫苏叶1kg,栀子1kg,将所有原料混合均匀后粉碎至60~140目得到混合粉,将混合粉分袋、灭菌即可。The Poria cocos composition described in this embodiment includes the following raw materials: 4kg of Poria cocos, 2kg of Chinese yam, 2kg of white lentils, 2kg of Coix seed, 1kg of jujube, 1kg of Gorgon fruit, 1kg of Amomum chinensis, 1kg of dried ginger, 2kg of red bean, 2kg of orange peel, Hawthorn 1kg, Malt 1kg, Agaricus 2kg, Fragrance 1kg, Houttuynia cordata 1kg, Dandelion 1kg, Mint 1kg, Purslane 1kg, Chicory 1kg, Perilla leaf 1kg, Gardenia 1kg, mix all the raw materials and grind to 60 ~140 mesh to get mixed powder, divide the mixed powder into bags and sterilize.

实施例2Example 2

本实施例所述的茯苓保健颗粒,包括如下原料:茯苓4kg,山药2kg,白扁豆2kg,薏苡仁2kg,大枣1kg,芡实1kg,砂仁1kg,干姜1kg,赤小豆2kg,橘皮2kg,山楂1kg,麦芽1kg,藿香2kg,香薷1kg,鱼腥草1kg,蒲公英1kg,薄荷1kg,马齿苋1kg,菊苣1kg,紫苏叶1kg,栀子1kg。The Poria health granules described in this embodiment include the following raw materials: Poria 4kg, Chinese yam 2kg, white lentils 2kg, Coix seed 2kg, jujube 1kg, Gorgon fruit 1kg, Amomum glutinosa 1kg, dried ginger 1kg, red bean 2kg, orange peel 2kg, Hawthorn 1kg, Malt 1kg, Agaricus 2kg, Fragrance 1kg, Houttuynia cordata 1kg, Dandelion 1kg, Mint 1kg, Purslane 1kg, Chicory 1kg, Perilla leaf 1kg, Gardenia 1kg.

其制备方法包括如下步骤:Its preparation method comprises the following steps:

1)浸泡:往茯苓复合料中加入占茯苓复合料8倍质量的水,将茯苓混合料搅拌浸润后浸泡60min;1) Soaking: add water that accounts for 8 times the mass of the Poria compound into the Poria compound, and soak the Poria compound for 60min after stirring and soaking;

2)提取:继续加入占茯苓复合料8倍质量的水,加热至沸腾后开始计时,保持微沸提取60min,过滤得第一提取液;往滤渣中继续加入占茯苓复合料6倍质量的水,加热至沸腾后开始计时,保持微沸提取50min,过滤得第二提取液;往滤渣中继续加入占茯苓复合料5倍质量的水,加热至沸腾后开始计时,保持微沸提取40min,过滤得第三提取液,合并第一提取液、第二提取液和第三提取液并过300目筛网得到混合提取液备用;2) Extraction: Continue to add water that accounts for 8 times the mass of the Poria compound material, start timing after heating to boiling, keep the micro-boiling extraction for 60 min, and filter to obtain the first extract; continue to add water that accounts for 6 times the mass of the Poria compound material to the filter residue , start timing after heating to boiling, keep the micro-boiling extraction for 50 min, and filter to obtain the second extract; continue to add water that accounts for 5 times the mass of the Poria composite material into the filter residue, start timing after heating to boiling, keep the micro-boiling extraction for 40 min, filter The third extraction solution is obtained, the first extraction solution, the second extraction solution and the third extraction solution are combined and passed through a 300-mesh screen to obtain a mixed extraction solution for subsequent use;

3)浓缩、干燥:将混合提取液加热浓缩至混合提取液质量为茯苓复合料质量的1倍为止而得到浓缩液,将浓缩液喷雾干燥而得到茯苓复合粉,喷雾干燥过程中加入占茯苓复合粉质量8份的可溶性淀粉或麦芽糊精或两者的混合物;3) Concentration and drying: the mixed extract is heated and concentrated until the quality of the mixed extract is 1 times the quality of the Poria cocos composite material to obtain a concentrated solution, the concentrated solution is spray-dried to obtain the Poria cocos composite powder, and the Zhan Poria composite powder is added in the spray drying process. 8 parts by mass of soluble starch or maltodextrin or a mixture of both;

4)调味:将茯苓复合粉与调味料混合均匀,调味料包括占茯苓复合粉质量1.03%的阿斯巴甜、1.03%的甜蜜素以及15%的木糖醇,添加时将茯苓复合粉与阿斯巴甜、甜蜜素以及木糖醇混合均匀即可,调味料也可以为占茯苓复合粉质量200%的白砂糖或蔗糖;4) Seasoning: Mix the Poria compound powder and seasonings evenly. The seasonings include aspartame, 1.03% sodium cyclamate and 15% xylitol, which account for 1.03% of the weight of the Poria compound powder. When adding, mix the Poria compound powder with Aspartame, sodium cyclamate and xylitol can be mixed evenly, and the seasoning can also be white granulated sugar or sucrose which accounts for 200% of the mass of Poria compound powder;

5)制粒:往调味后的茯苓复合粉中添加可溶性淀粉或麦芽糊精或两者的混合物使整体质量为茯苓复合粉质量的20倍,然后采用60%~80%乙醇溶液,在湿法混合制粒机中制粒得到茯苓保健颗粒,将茯苓保健颗粒灭菌后分袋包装即可。5) Granulation: Add soluble starch or maltodextrin or a mixture of the two to the seasoned Poria compound powder so that the overall mass is 20 times the mass of the Poria compound powder, and then use 60% to 80% ethanol solution in a wet process. The Poria health-care granules are obtained by granulating in a mixing granulator, and the Poria health-care granules are sterilized and then packaged in bags.

实施例3Example 3

本实施例所述的茯苓保健饮料,包括如下原料:茯苓4kg,山药2kg,白扁豆2kg,薏苡仁2kg,大枣1kg,芡实1kg,砂仁1kg,干姜1kg,赤小豆2kg,橘皮2kg,山楂1kg,麦芽1kg,藿香2kg,香薷1kg,鱼腥草1kg,蒲公英1kg,薄荷1kg,马齿苋1kg,菊苣1kg,紫苏叶1kg,栀子1kg。The Poria health drink described in this embodiment includes the following raw materials: Poria 4kg, Chinese yam 2kg, white lentils 2kg, Coix seed 2kg, jujube 1kg, Gorgon Fructus 1kg, Amomum chinensis 1kg, dried ginger 1kg, Chixiaodou 2kg, orange peel 2kg, Hawthorn 1kg, Malt 1kg, Agaricus 2kg, Fragrance 1kg, Houttuynia cordata 1kg, Dandelion 1kg, Mint 1kg, Purslane 1kg, Chicory 1kg, Perilla leaf 1kg, Gardenia 1kg.

其制备方法包括如下步骤:Its preparation method comprises the following steps:

1)浸泡:往茯苓复合料中加入占茯苓复合料8倍质量的水,将茯苓混合料搅拌浸润后浸泡60min;1) Soaking: add water that accounts for 8 times the mass of the Poria compound into the Poria compound, and soak the Poria compound for 60min after stirring and soaking;

2)提取:继续加入占茯苓复合料8倍质量的水,加热至沸腾后开始计时,保持微沸提取60min,过滤得第一提取液;往滤渣中继续加入占茯苓复合料6倍质量的水,加热至沸腾后开始计时,保持微沸提取50min,过滤得第二提取液;往滤渣中继续加入占茯苓复合料5倍质量的水,加热至沸腾后开始计时,保持微沸提取40min,过滤得第三提取液,合并第一提取液、第二提取液和第三提取液并过300目筛网得到混合提取液备用;2) Extraction: Continue to add water that accounts for 8 times the mass of the Poria compound material, start timing after heating to boiling, keep the micro-boiling extraction for 60 min, and filter to obtain the first extract; continue to add water that accounts for 6 times the mass of the Poria compound material to the filter residue , start timing after heating to boiling, keep the micro-boiling extraction for 50 min, and filter to obtain the second extract; continue to add water that accounts for 5 times the mass of the Poria composite material into the filter residue, start timing after heating to boiling, keep the micro-boiling extraction for 40 min, filter The third extraction solution is obtained, the first extraction solution, the second extraction solution and the third extraction solution are combined and passed through a 300-mesh screen to obtain a mixed extraction solution for subsequent use;

3)浓缩:将混合提取液加热浓缩至混合提取液质量为茯苓复合料质量的0.8倍为止而得到浓缩液;3) concentration: the mixed extract is heated and concentrated until the quality of the mixed extract is 0.8 times the quality of the Poria composite material to obtain a concentrated solution;

4)调味:将浓缩液与调味料混合后灭菌、分装即可,其中调味料包括占浓缩液质量1.03%的阿斯巴甜、1.03%的甜蜜素以及12%的木糖醇,添加时将浓缩液与阿斯巴甜、甜蜜素以及木糖醇混合均匀即可。4) Seasoning: mix the concentrate and seasonings, sterilize them and pack them separately, wherein the seasonings include aspartame, 1.03% sodium cyclamate and 12% xylitol, which account for 1.03% of the mass of the concentrate. Mix the concentrate with aspartame, cyclamate and xylitol evenly.

实施例4Example 4

本发明的组合物由下述重量份的组分制得:The composition of the present invention is prepared from the following components in parts by weight:

CMP 6kg,山药3kg,白扁豆3kg,薏苡仁3kg,大枣1.5kg,芡实1.5kg,砂仁1.5kg,干姜1.5kg,赤小豆3kg,橘皮3kg,山楂1.5kg,麦芽1.5kg,藿香3kg,香薷1.5kg,鱼腥草1.5kg,蒲公英1.5kg,薄荷1.5kg,马齿苋1.5kg,菊苣1.5kg,紫苏叶1.5kg,栀子1.5kg。CMP 6kg, yam 3kg, white lentil 3kg, coix seed 3kg, jujube 1.5kg, gorgonian 1.5kg, Amomum 1.5kg, dried ginger 1.5kg, red bean 3kg, orange peel 3kg, hawthorn 1.5kg, malt 1.5kg, Agaricus 3kg, Fragrance 1.5kg, Houttuynia cordata 1.5kg, dandelion 1.5kg, mint 1.5kg, purslane 1.5kg, chicory 1.5kg, perilla leaf 1.5kg, gardenia 1.5kg.

本发明的组合物的制备方法,包括下述步骤:The preparation method of the composition of the present invention comprises the following steps:

S1、将茯苓75kg用中药破碎机进行粗粉碎至10-200目,得到茯苓粗粉,称取所需量的茯苓粗粉;S1, 75kg of Poria cocos is coarsely pulverized to 10-200 mesh with a traditional Chinese medicine crusher, to obtain Poria cocos coarse powder, take by weighing the required amount of Poria cocos coarse powder;

1)茯苓粗粉投入到浸泡罐中,泵入400L水,搅拌均匀,浸泡12h;1) Put the coarse powder of Poria cocos into the soaking tank, pump 400L of water, stir evenly, and soak for 12h;

2)将400L浓度为2.25mol/L的氢氧化钠溶液缓慢泵入浸泡罐中,搅拌反应1h,过滤,取滤液;2) Slowly pump 400L of sodium hydroxide solution with a concentration of 2.25mol/L into the soaking tank, stir and react for 1h, filter, and take the filtrate;

3)在中和罐中投入向300L浓度为5.3mol/L的氯乙酸溶液后,再缓慢加入300L浓度为6.25mol/L的氢氧化钠溶液,搅拌至反应充分,冷却至室温;3) after dropping into the chloroacetic acid solution that 300L concentration is 5.3mol/L in the neutralization tank, slowly add the sodium hydroxide solution that 300L concentration is 6.25mol/L, stir until the reaction is sufficient, be cooled to room temperature;

4)将3)步反应液泵入2)步所得滤液中,充分混匀后,缓缓升温至75℃,恒温反应2.5h;4) Pump the reaction solution of step 3) into the filtrate obtained in step 2), after fully mixing, slowly heat up to 75°C, and react at constant temperature for 2.5h;

5)用6mol/L的盐酸溶液调4)步所得反应液的pH值5.0-7.0,加入相当于反应液3倍体积的95%乙醇,搅拌均匀,过滤、洗涤,取CMP醇析物;5) adjust the pH value 5.0-7.0 of the reaction solution obtained in step 4) with the hydrochloric acid solution of 6 mol/L, add 95% ethanol equivalent to 3 times the volume of the reaction solution, stir, filter, wash, and get the CMP alcohol eluate;

6)CMP醇析物在60℃干燥4h后,105℃干燥2h,得CMP粗制品37.5kg;6) After drying the CMP alcohol eluate at 60°C for 4h, then drying at 105°C for 2h, 37.5kg of CMP crude product was obtained;

7)将7.5kgCMP粗制品分散于250L双蒸水,加入6mol/L的氢氧化钠溶液调pH至10.0-13.0;加入1.25L浓度为30%的H2O2溶液,15℃脱色反应36h,去除有色杂质;加入6mol/L的盐酸溶液调pH值6.0,3000转/分离心分离30min,取滤液,滤液用DH-UF中空纤维超滤器滤除分子量0.7×104以下的CMP,以及微量的氯化钠、氯乙酸钠与羟乙酸钠等杂质后,滤液中加入3倍滤液体积的95%乙醇,进行醇析,过滤或离心,取CMP醇析物在60℃干燥4h后,105℃干燥2h,粉碎,得6.0kg羧甲基取代度1.0的CMP纯品:7) Disperse 7.5kg of CMP crude product in 250L of double distilled water, add 6mol/L sodium hydroxide solution to adjust the pH to 10.0-13.0; add 1.25L of H 2 O 2 solution with a concentration of 30%, decolorize at 15°C for 36h, Remove colored impurities; add 6mol/L hydrochloric acid solution to adjust the pH value to 6.0, centrifuge at 3000 rpm for 30min, take the filtrate, filter the filtrate with a DH-UF hollow fiber ultrafilter to remove CMP with a molecular weight below 0.7×104, and trace amounts of After impurities such as sodium chloride, sodium chloroacetate and sodium glycolate, add 3 times the volume of 95% ethanol to the filtrate, carry out alcohol precipitation, filter or centrifuge, take the CMP alcohol extract and dry it at 60°C for 4 hours, then dry at 105°C 2h, pulverized to obtain 6.0kg pure CMP product with carboxymethyl substitution degree of 1.0:

S2、将CMP纯品粉碎,过60目筛,加入所需量的其他原料,混合均匀后粉碎至60~140目得到混合粉,将混合粉分袋、灭菌即可。S2. Pulverize the pure CMP product, pass it through a 60-mesh sieve, add the required amount of other raw materials, mix evenly, and pulverize to 60-140 mesh to obtain a mixed powder, which can be divided into bags and sterilized.

实施例5Example 5

本发明的组合物由下述重量份的组分制得:The composition of the present invention is prepared from the following components in parts by weight:

CMP 6kg,山药3kg,白扁豆3kg,薏苡仁3kg,大枣1.5kg,芡实1.5kg,砂仁1.5kg,干姜1.5kg,赤小豆3kg,橘皮3kg,山楂1.5kg,麦芽1.5kg,藿香3kg,香薷1.5kg,鱼腥草1.5kg,蒲公英1.5kg,薄荷1.5kg,马齿苋1.5kg,菊苣1.5kg,紫苏叶1.5kg,栀子1.5kg。CMP 6kg, yam 3kg, white lentil 3kg, coix seed 3kg, jujube 1.5kg, gorgonian 1.5kg, Amomum 1.5kg, dried ginger 1.5kg, red bean 3kg, orange peel 3kg, hawthorn 1.5kg, malt 1.5kg, Agaricus 3kg, Fragrance 1.5kg, Houttuynia cordata 1.5kg, dandelion 1.5kg, mint 1.5kg, purslane 1.5kg, chicory 1.5kg, perilla leaf 1.5kg, gardenia 1.5kg.

本发明的组合物的制备方法,包括下述步骤:The preparation method of the composition of the present invention comprises the following steps:

S1、将茯苓75kg用中药破碎机进行粗粉碎至10-200目,得到茯苓粗粉,称取所需量的茯苓粗粉;S1, 75kg of Poria cocos is coarsely pulverized to 10-200 mesh with a traditional Chinese medicine crusher, to obtain Poria cocos coarse powder, take by weighing the required amount of Poria cocos coarse powder;

1)茯苓粗粉投入到浸泡罐中,泵入400L水,搅拌均匀,浸泡12h;1) Put the coarse powder of Poria cocos into the soaking tank, pump 400L of water, stir evenly, and soak for 12h;

2)将400L浓度为2.25mol/L的氢氧化钠溶液缓慢泵入浸泡罐中,搅拌反应1h,过滤,取滤液;2) Slowly pump 400L of sodium hydroxide solution with a concentration of 2.25mol/L into the soaking tank, stir and react for 1h, filter, and take the filtrate;

3)在中和罐中投入向300L浓度为5.3mol/L的氯乙酸溶液后,再缓慢加入300L浓度为6.25mol/L的氢氧化钠溶液,搅拌至反应充分,冷却至室温;3) after dropping into the chloroacetic acid solution that 300L concentration is 5.3mol/L in the neutralization tank, slowly add the sodium hydroxide solution that 300L concentration is 6.25mol/L, stir until the reaction is sufficient, be cooled to room temperature;

4)将3)步反应液泵入2)步所得滤液中,充分混匀后,缓缓升温至75℃,恒温反应2.5h;4) Pump the reaction solution of step 3) into the filtrate obtained in step 2), after fully mixing, slowly heat up to 75°C, and react at constant temperature for 2.5h;

5)用6mol/L的盐酸溶液调4)步所得反应液的pH值5.0-7.0,加入相当于反应液3倍体积的95%乙醇,搅拌均匀,过滤、洗涤,取CMP醇析物;5) adjust the pH value 5.0-7.0 of the reaction solution obtained in step 4) with the hydrochloric acid solution of 6 mol/L, add 95% ethanol equivalent to 3 times the volume of the reaction solution, stir, filter, wash, and get the CMP alcohol eluate;

6)CMP醇析物在60℃干燥4h后,105℃干燥2h,得CMP粗制品37.5kg;6) After drying the CMP alcohol eluate at 60°C for 4h, then drying at 105°C for 2h, 37.5kg of CMP crude product was obtained;

7)将7.5kgCMP粗制品分散于250L双蒸水,加入6mol/L的氢氧化钠溶液调pH至10.0-13.0;加入1.25L浓度为30%的H2O2溶液,15℃脱色反应36h,去除有色杂质;加入6mol/L的盐酸溶液调pH值6.0,3000转/分离心分离30min,取滤液,滤液用DH-UF中空纤维超滤器滤除分子量0.7×104以下的CMP,以及微量的氯化钠、氯乙酸钠与羟乙酸钠等杂质后,滤液中加入3倍滤液体积的95%乙醇,进行醇析,过滤或离心,取CMP醇析物在60℃干燥4h后,105℃干燥2h,粉碎,得6.0kg羧甲基取代度1.0的CMP纯品:7) Disperse 7.5kg of CMP crude product in 250L of double distilled water, add 6mol/L sodium hydroxide solution to adjust the pH to 10.0-13.0; add 1.25L of H 2 O 2 solution with a concentration of 30%, decolorize at 15°C for 36h, Remove colored impurities; add 6mol/L hydrochloric acid solution to adjust the pH value to 6.0, centrifuge at 3000 rpm for 30min, take the filtrate, and filter the filtrate with a DH-UF hollow fiber ultrafilter to remove CMP with a molecular weight below 0.7×10 4 , and trace amounts After removing impurities such as sodium chloride, sodium chloroacetate and sodium glycolate, add 3 times of filtrate volume of 95% ethanol to the filtrate, carry out alcohol precipitation, filter or centrifuge, take the CMP alcohol extract and dry it at 60 °C for 4 hours, then dry it at 105 °C. Dry for 2h and pulverize to obtain 6.0kg of CMP pure product with a degree of carboxymethyl substitution of 1.0:

S2、将CMP纯品粉碎,过60目筛。S2. Pulverize the pure CMP product and pass through a 60-mesh sieve.

S3、往CMP中所需量的其他原料,加入占茯苓复合料8倍质量的水,将茯苓混合料搅拌浸润后浸泡60min;S3, other raw materials of required amount in the CMP, add water that accounts for 8 times of the quality of the Poria cocos composite, and soak the Poria mixture for 60min after stirring and soaking;

S4、继续加入占茯苓复合料8倍质量的水,加热至沸腾后开始计时,保持微沸提取60min,过滤得第一提取液;往滤渣中继续加入占茯苓复合料6倍质量的水,加热至沸腾后开始计时,保持微沸提取50min,过滤得第二提取液;往滤渣中继续加入占茯苓复合料5倍质量的水,加热至沸腾后开始计时,保持微沸提取40min,过滤得第三提取液,合并第一提取液、第二提取液和第三提取液并过300目筛网得到混合提取液备用;S4. Continue to add water that accounts for 8 times the mass of the Poria composite material, start timing after heating to boiling, keep the micro-boiling extraction for 60 min, and filter to obtain the first extract; continue to add water that accounts for 6 times the mass of the Poria composite material to the filter residue, and heat Start timing after boiling, keep the micro-boiling extraction for 50 min, and filter to obtain the second extract; continue to add water that accounts for 5 times the mass of the Poria composite material to the filter residue, heat to boiling and start timing, keep the micro-boiling extraction for 40 min, and filter to obtain the first solution. Three extraction solutions, combine the first extraction solution, the second extraction solution and the third extraction solution and pass through a 300-mesh sieve to obtain a mixed extraction solution for subsequent use;

S5、将混合提取液加热浓缩至混合提取液质量为茯苓复合料质量的0.8倍为止而得到浓缩液;S5, the mixed extract is heated and concentrated until the quality of the mixed extract is 0.8 times the quality of the Poria composite material to obtain a concentrated solution;

S6、将浓缩液与调味料混合后灭菌、分装即可,其中调味料包括占浓缩液质量1.03%的阿斯巴甜、1.03%的甜蜜素以及12%的木糖醇,添加时将浓缩液与阿斯巴甜、甜蜜素以及木糖醇混合均匀即可。S6. Mix the concentrate and seasonings, sterilize them, and pack them separately. The seasonings include 1.03% aspartame, 1.03% cyclamate and 12% xylitol, which account for 1.03% of the quality of the concentrate. The concentrate is mixed with aspartame, cyclamate and xylitol.

实施例6Example 6

本发明的组合物由下述重量份的组分制得:The composition of the present invention is prepared from the following components in parts by weight:

CMP 6kg,山药3kg,白扁豆3kg,薏苡仁3kg,大枣1.5kg,芡实1.5kg,砂仁1.5kg,干姜1.5kg,赤小豆3kg,橘皮3kg,山楂1.5kg,麦芽1.5kg,藿香3kg,香薷1.5kg,鱼腥草1.5kg,蒲公英1.5kg,薄荷1.5kg,马齿苋1.5kg,菊苣1.5kg,紫苏叶1.5kg,栀子1.5kg。CMP 6kg, yam 3kg, white lentil 3kg, coix seed 3kg, jujube 1.5kg, gorgonian 1.5kg, Amomum 1.5kg, dried ginger 1.5kg, red bean 3kg, orange peel 3kg, hawthorn 1.5kg, malt 1.5kg, Agaricus 3kg, Fragrance 1.5kg, Houttuynia cordata 1.5kg, dandelion 1.5kg, mint 1.5kg, purslane 1.5kg, chicory 1.5kg, perilla leaf 1.5kg, gardenia 1.5kg.

本发明的组合物的制备方法,包括下述步骤:The preparation method of the composition of the present invention comprises the following steps:

S1、将茯苓75kg用中药破碎机进行粗粉碎至10-200目,得到茯苓粗粉,称取所需量的茯苓粗粉;S1, 75kg of Poria cocos is coarsely pulverized to 10-200 mesh with a traditional Chinese medicine crusher, to obtain Poria cocos coarse powder, take by weighing the required amount of Poria cocos coarse powder;

1)茯苓粗粉投入到浸泡罐中,泵入400L水,搅拌均匀,浸泡12h;1) Put the coarse powder of Poria cocos into the soaking tank, pump 400L of water, stir evenly, and soak for 12h;

2)将400L浓度为2.25mol/L的氢氧化钠溶液缓慢泵入浸泡罐中,搅拌反应1h,过滤,取滤液;2) Slowly pump 400L of sodium hydroxide solution with a concentration of 2.25mol/L into the soaking tank, stir and react for 1h, filter, and take the filtrate;

3)在中和罐中投入向300L浓度为5.3mol/L的氯乙酸溶液后,再缓慢加入300L浓度为6.25mol/L的氢氧化钠溶液,搅拌至反应充分,冷却至室温;3) drop into the chloroacetic acid solution that 300L concentration is 5.3mol/L in the neutralization tank, then slowly add the sodium hydroxide solution that 300L concentration is 6.25mol/L, stir until the reaction is sufficient, be cooled to room temperature;

4)将3)步反应液泵入2)步所得滤液中,充分混匀后,缓缓升温至75℃,恒温反应2.5h;4) Pump the reaction solution of step 3) into the filtrate obtained in step 2), after fully mixing, slowly heat up to 75°C, and react at constant temperature for 2.5h;

5)用6mol/L的盐酸溶液调4)步所得反应液的pH值5.0-7.0,加入相当于反应液3倍体积的95%乙醇,搅拌均匀,过滤、洗涤,取CMP醇析物;5) adjust the pH value 5.0-7.0 of the reaction solution obtained in step 4) with the hydrochloric acid solution of 6 mol/L, add 95% ethanol equivalent to 3 times the volume of the reaction solution, stir, filter, wash, and get the CMP alcohol eluate;

6)CMP醇析物在60℃干燥4h后,105℃干燥2h,得CMP粗制品37.5kg;6) After drying the CMP alcohol eluate at 60°C for 4h, then drying at 105°C for 2h, 37.5kg of CMP crude product was obtained;

7)将7.5kgCMP粗制品分散于250L双蒸水,加入6mol/L的氢氧化钠溶液调pH至10.0-13.0;加入1.25L浓度为30%的H2O2溶液,15℃脱色反应36h,去除有色杂质;加入6mol/L的盐酸溶液调pH值6.0,3000转/分离心分离30min,取滤液,滤液用DH-UF中空纤维超滤器滤除分子量0.7×104以下的CMP,以及微量的氯化钠、氯乙酸钠与羟乙酸钠等杂质后,滤液中加入3倍滤液体积的95%乙醇,进行醇析,过滤或离心,取CMP醇析物在60℃干燥4h后,105℃干燥2h,粉碎,得6.0kg羧甲基取代度1.0的CMP纯品:7) Disperse 7.5kg of CMP crude product in 250L of double distilled water, add 6mol/L sodium hydroxide solution to adjust the pH to 10.0-13.0; add 1.25L of H 2 O 2 solution with a concentration of 30%, decolorize at 15°C for 36h, Remove colored impurities; add 6mol/L hydrochloric acid solution to adjust the pH value to 6.0, centrifuge at 3000 rpm for 30min, take the filtrate, filter the filtrate with a DH-UF hollow fiber ultrafilter to remove CMP with a molecular weight below 0.7×104, and trace amounts of After impurities such as sodium chloride, sodium chloroacetate and sodium glycolate, add 3 times the volume of 95% ethanol to the filtrate, carry out alcohol precipitation, filter or centrifuge, take the CMP alcohol extract and dry it at 60°C for 4 hours, then dry at 105°C 2h, pulverized to obtain 6.0kg pure CMP product with carboxymethyl substitution degree of 1.0:

S2、将CMP纯品粉碎,过60目筛。S2. Pulverize the pure CMP product and pass through a 60-mesh sieve.

S3、往CMP中所需量的其他原料,加入占茯苓复合料8倍质量的水,将茯苓混合料搅拌浸润后浸泡60min;S3, other raw materials of required amount in the CMP, add water that accounts for 8 times of the quality of the Poria cocos composite, and soak the Poria mixture for 60min after stirring and soaking;

S4、继续加入占茯苓复合料8倍质量的水,加热至沸腾后开始计时,保持微沸提取60min,过滤得第一提取液;往滤渣中继续加入占茯苓复合料6倍质量的水,加热至沸腾后开始计时,保持微沸提取50min,过滤得第二提取液;往滤渣中继续加入占茯苓复合料5倍质量的水,加热至沸腾后开始计时,保持微沸提取40min,过滤得第三提取液,合并第一提取液、第二提取液和第三提取液并过300目筛网得到混合提取液备用;S4. Continue to add water that accounts for 8 times the mass of the Poria composite material, start timing after heating to boiling, keep the micro-boiling extraction for 60 min, and filter to obtain the first extract; continue to add water that accounts for 6 times the mass of the Poria composite material to the filter residue, heat Start timing after boiling, keep the micro-boiling extraction for 50 min, and filter to obtain the second extract; continue to add water that accounts for 5 times the mass of the Poria cocos composite material to the filter residue, start timing after heating to boiling, keep the micro-boiling extraction for 40 min, and filter to obtain the first solution. Three extraction solutions, combine the first extraction solution, the second extraction solution and the third extraction solution and pass through a 300-mesh sieve to obtain a mixed extraction solution for subsequent use;

S5、将混合提取液加热浓缩至混合提取液质量为茯苓复合料质量的0.8倍为止而得到浓缩液;S5, the mixed extract is heated and concentrated until the quality of the mixed extract is 0.8 times the quality of the Poria composite material to obtain a concentrated solution;

S6、将浓缩液与调味料混合后灭菌、分装即可,其中调味料包括占浓缩液质量1.03%的阿斯巴甜、1.03%的甜蜜素以及12%的木糖醇,添加时将浓缩液与阿斯巴甜、甜蜜素以及木糖醇混合均匀即可。S6. Mix the concentrate and seasonings, sterilize them and pack them separately. The seasonings include 1.03% of aspartame, 1.03% of sodium cyclamate and 12% of xylitol, which account for 1.03% of the quality of the concentrate. The concentrate is mixed with aspartame, cyclamate and xylitol.

S7、往调味后的茯苓复合粉中添加可溶性淀粉或麦芽糊精或两者的混合物使整体质量为茯苓复合粉质量的20倍,然后采用60%~80%乙醇溶液,在湿法混合制粒机中制粒得到茯苓保健颗粒,将茯苓保健颗粒灭菌后分袋包装即可。S7. Add soluble starch or maltodextrin or a mixture of the two to the seasoned Poria compound powder so that the overall mass is 20 times that of the Poria compound powder, and then use 60% to 80% ethanol solution to granulate by wet mixing The Poria health-care granules are obtained by granulating in the machine, and the Poria health-care granules are sterilized and then packaged in bags.

试验例1口感试验 Test Example 1 Taste Test

1、饮用人群:普通人群1. Drinking crowd: the general population

2、饮用时间:上午十点2. Drinking time: 10 am

3、饮用人数:200人,每组各100人3. Number of people drinking: 200 people, 100 people in each group

4、方法:取实施例1和实施例4得到的组合物各10g,泡制时需200mL的沸腾水,泡制时间为保温杯炮制15~20min,上午十点品尝,品尝前一个小时禁吃食物。4. Method: Take 10g of the compositions obtained in Example 1 and Example 4, and need 200mL of boiling water for brewing. The brewing time is 15-20min in the thermos cup, taste at ten o'clock in the morning, and fast for one hour before tasting. food.

5、指标:饮用后明显感觉清冽微苦有回甘,香气清新的记为好,饮用后感觉清冽较苦回甘浅,香气不明显的记为一般,饮用后感觉苦味重无回甘,气味难以接受的记为差。5. Indicators: After drinking, it is obvious that it is clear and slightly bitter and has a sweet taste. It is good to have a fresh aroma. After drinking, it is clear and slightly bitter and sweet, and the aroma is not obvious. It is recorded as normal. What is unacceptable is recorded as poor.

6、口感试验结果见表1。6. The results of the taste test are shown in Table 1.

表1Table 1

口感好(人群)good taste (crowd) 口感一般(人群)Average taste (crowd) 口感差(人群)Bad taste (crowd) 实施例1Example 1 8080 1818 22 实施例4Example 4 9292 88 00

试验例2功效对比试验 Test Example 2 Efficacy Comparison Test

1、饮用人群:饭后容易腹胀不消化人群1. Drinking crowd: People who are prone to abdominal distension and indigestion after meals

2、饮用时间:早、晚后半小时各服用一袋,连续15天2. Drinking time: take one bag in the morning and half an hour later in the evening, for 15 consecutive days

3、饮用人数:共100人,每组各50人3. Number of people drinking: 100 people in total, 50 people in each group

4、方法:取实施例1、实施例4得到的组合物各10g,泡制时需200mL的沸腾水,泡制时间为保温杯炮制15~20min,饮用时间为早晚各一次,饭后半小时饮用。4. Method: Take 10g of each of the compositions obtained in Example 1 and Example 4, 200mL of boiling water is required for brewing, the brewing time is 15-20min in a thermos cup, and the drinking time is once in the morning and once in the evening, half an hour after meals drink.

5、指标:连续服用15天后明显感觉腹胀不消化现象完全消失,精神状态得到改善的为显著有效;连续服用15天后腹胀不消化现象得到缓解,精神状态与服用前持平的为一般有效;连续服用15天后腹胀不消化现象完全没有得到缓解甚至加重、精神状态变差的为无效。5. Indicators: After 15 days of continuous use, the symptoms of abdominal distension and indigestion have disappeared completely, and the mental state has been improved, which is significantly effective; after 15 days of continuous use, the phenomenon of abdominal distension and indigestion is relieved, and the mental state is the same as before, it is generally effective; continuous use After 15 days, the symptoms of abdominal distension and indigestion are not relieved or even aggravated, and the mental state deteriorates as invalid.

数据以均数±标准差(X±S)表示,计数资料采用X2检验,等级资料采用Ridit分析,计量资料采用t检验。结果见表2。The data were expressed as mean±standard deviation (X±S), enumeration data using X2 test, rank data using Ridit analysis, measurement data using t test. The results are shown in Table 2.

表2Table 2

组别group 例数Number of cases 临控(例)Temporary control (example) 显效(例)Effective (example) 有效(例)Valid (example) 无效(例)invalid (example) 总有效率(%)Total Efficiency (%) 实施例1Example 1 5050 00 2828 1515 77 86*86* 实施例4Example 4 5050 00 3939 1111 00 100*100*

注:*P<0.01Note: *P<0.01

以上对本发明具体实施方式的描述并不限制本发明,本领域技术人员可以根据本发明作出各种改变或变形,只要不脱离本发明的精神,均应属于本发明权利要求保护的范围。The above description of the specific embodiments of the present invention does not limit the present invention, and those skilled in the art can make various changes or deformations according to the present invention, as long as they do not depart from the spirit of the present invention, they should all belong to the scope of protection of the claims of the present invention.

Claims (10)

1. The poria cocos medicinal composition with the effects of invigorating stomach and eliminating spleen is characterized by comprising the following raw materials in parts by weight: 4-8 parts of poria cocos, 2-5 parts of Chinese yam, 2-5 parts of white hyacinth bean, 2-4 parts of coix seed, 1-3 parts of Chinese date, 1-3 parts of gordon euryale seed, 1-3 parts of fructus amomi, 1-3 parts of dried ginger, 1-4 parts of phaseolus calcaratus, 1-5 parts of orange peel, 1-3 parts of hawthorn, 1-2 parts of malt, 1-4 parts of wrinkled gianthyssop herb, 1-3 parts of elsholtzia, 1-3 parts of heartleaf houttuynia herb, 1-3 parts of dandelion, 1-3 parts of mint, 1-3 parts of purslane, 1-3 parts of chicory, 1-3 parts of perilla leaf and 1-3 parts of cape jasmine.
2. The composition according to claim 1, wherein the poria cocos in the composition is any one of poria cocos coarse powder, pachyman alkalized extract, pachyman, and high-substitution-degree carboxymethyl pachyman (CMP).
3. The composition according to any one of claims 1-2, wherein said highly substituted carboxymethyl pachyman is prepared by a method comprising the steps of: 1) Adding pachymaran into water or water-alcohol mixed solution, stirring, adding alkaline solution with a mass of 1-8% of pachymaran, and stirring to completely dissolve to obtain pachymaran alkalized solution; 2) And (2) after fully reacting 1.0-10mol/L chloroacetic acid with proper excess 2.0-10mol/L alkaline solution, adding the obtained product into the pachyman alkalization solution obtained in the step 1), and performing substitution reaction, separation and purification to obtain the pachyman alkalization solution, wherein the proper excess is that the actual dosage of alkaline substances in the alkaline solution is 0.5-40% more than the theoretical dosage required by the neutralization reaction between the alkaline substances and chloroacetic acid.
4. The composition according to any one of claims 1-3, wherein the pachyman in step 1) is selected from the group consisting of an alkalized extract of pachyman obtained by alkalization extraction or a crude pachyman obtained by acid precipitation with alkali extraction.
5. The composition according to any one of claims 1 to 4, wherein the pachyman alkalizing extract is prepared by adding Poria cocos powder into an alkaline solution having a concentration of 1.0-4.0mol/L to conduct alkalizing extraction, centrifuging, and collecting the supernatant.
6. The composition according to any one of claims 1 to 5, wherein the pachyman is prepared by extracting Poria cocos powder with an alkaline solution having a concentration of 1.0-4.0mol/L under stirring, centrifuging, and collecting the supernatant; adding acid into the supernatant, centrifuging the obtained acid precipitate, and washing with water to obtain pachyman, wherein the acid is selected from one of acetic acid, hydrochloric acid, sulfuric acid, and nitric acid.
7. The composition according to any one of claims 1 to 6, wherein the composition further comprises a desired amount of a pharmaceutically acceptable carrier selected from any one of or a combination of fillers, lubricants, dispersants, wetting agents, binders, conditioning agents, solubilizers, antioxidants, emulsifiers, flavoring agents, and perfuming agents.
8. The composition according to any one of claims 1 to 7, wherein the composition comprises the following raw materials in parts by weight: 4 parts of poria cocos, 2 parts of Chinese yam, 2 parts of white hyacinth beans, 2 parts of coix seeds, 1 part of Chinese dates, 1 part of gordon euryale seeds, 1 part of fructus amomi, 1 part of dried ginger, 2 parts of phaseolus calcaratus, 2 parts of orange peels, 1 part of hawthorn fruits, 1 part of malt, 2 parts of agastache rugosus, 1 part of elsholtzia, 1 part of houttuynia cordata, 1 part of dandelion, 1 part of mint, 1 part of purslane, 1 part of chicory, 1 part of perilla leaves and 1 part of cape jasmine fruits.
9. The preparation method of the poria cocos medicinal composition with stomach and spleen invigorating effects according to any one of claims 1 to 8, wherein the composition comprises the following raw materials in parts by weight: 4-8 parts of poria cocos, 2-5 parts of Chinese yam, 2-5 parts of white hyacinth bean, 2-4 parts of coix seed, 1-3 parts of Chinese date, 1-3 parts of gordon euryale seed, 1-3 parts of fructus amomi, 1-3 parts of dried ginger, 1-4 parts of phaseolus calcaratus, 1-5 parts of orange peel, 1-3 parts of hawthorn, 1-2 parts of malt, 1-4 parts of wrinkled gianthyssop herb, 1-3 parts of elsholtzia, 1-3 parts of heartleaf houttuynia herb, 1-3 parts of dandelion, 1-3 parts of mint, 1-3 parts of purslane, 1-3 parts of chicory, 1-3 parts of perilla leaf and 1-3 parts of gardenia, and the specific preparation method comprises the following steps: all the raw materials are evenly mixed and crushed to 60 to 140 meshes, and then the mixture is sterilized to obtain the feed.
10. Use of the poria cocos pharmaceutical composition as defined in any one of claims 1-8 or the composition prepared by the method as defined in claim 9 for the preparation of a product for improving gastrointestinal function.
CN202110461472.7A 2021-04-27 2021-04-27 A kind of Poria medicinal composition with the effect of invigorating the stomach and eliminating the spleen and application thereof Pending CN115245554A (en)

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Application publication date: 20221028