WO2021068459A1 - 一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液 - Google Patents

一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液 Download PDF

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WO2021068459A1
WO2021068459A1 PCT/CN2020/080796 CN2020080796W WO2021068459A1 WO 2021068459 A1 WO2021068459 A1 WO 2021068459A1 CN 2020080796 W CN2020080796 W CN 2020080796W WO 2021068459 A1 WO2021068459 A1 WO 2021068459A1
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montmorillonite
add
methoxylated pectin
low
parts
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French (fr)
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祁雷
蒋海燕
奚庆华
黄中伟
顾志峰
孙华林
肖明兵
梁桂文
崔晓晖
吴征华
吴瑶
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南通大学附属医院
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Priority to ZA2020/06360A priority Critical patent/ZA202006360B/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals

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  • the invention relates to the technical field of medicament preparation, in particular to a suspension containing low-methoxylated pectin and montmorillonite for the treatment of acute diarrhea and a preparation method thereof.
  • Montmorillonite is a layered mineral composed of extremely fine-grained hydrated aluminosilicates. The name comes from the first discovered place of production-Montmorillon in France.
  • the montmorillonite subfamily belongs to one of the smectite minerals (the other subfamily is saponite). It is an important clay mineral, generally block or earthy.
  • Clay minerals contain water and some exchange cations between the crystal structure layers, have a high ion exchange capacity, and have a high water swelling capacity. Montmorillonite crystals belong to the monoclinic system of water-bearing layered silicate minerals.
  • the particles of montmorillonite are fine, about 0.2 to 1 micron, with colloidal dispersion characteristics, and are usually produced in the form of massive or soil-like aggregates.
  • the montmorillonite can be seen as flake crystals under the electron microscope, the color is white and gray, or light blue or light red.
  • the temperature reaches 100-200°C, the water molecules in the montmorillonite will gradually run away.
  • montmorillonite can also re-absorb water molecules or other polar molecules. When they absorb moisture, they can expand and exceed several times their original volume. Montmorillonite has many uses, and people use its characteristics in chemical reactions to produce adsorption and purification.
  • It can also be used as a filler for papermaking, rubber, cosmetics, petroleum decolorization and petroleum cracking catalysts, etc., as well as mud for geological drilling, adhesives for metallurgy, medicine, etc. (mainly manufacturing montmorillonite powder).
  • Diarrhea diseases can be divided into acute diarrhea diseases, persistent diarrhea diseases and chronic diarrhea diseases according to the course of the disease.
  • Smecta (montmorillonite powder) was registered in France in 1975 and has been successfully used in the treatment of diarrheal diseases in more than 60 countries around the world in 2002.
  • Smecta has done a large number of clinical trials in China, treating a total of 36,356 patients, including various types of diarrheal diseases in adults and children, with an effective rate of over 88%, and its market capacity in China far exceeds 1 billion yuan per year.
  • Natural montmorillonite is lamellar, with very small particles and a huge surface.
  • the surface area of each gram of montmorillonite can reach more than 100 planes.
  • montmorillonite particles are fine, the particles tend to agglomerate and agglomerate during the drying process. Shaped particles overlap.
  • montmorillonite is insoluble in water, but can swell after absorbing water, so that the overlapping flaky particles of montmorillonite are fully dispersed, and the interlayer ions and end ions are exposed. This is conducive to the interlayer ion exchange adsorption and end surface adsorption, and the montmorillonite absorbs water. After swelling, a visco-plastic shape is formed, and the layers can be slid to continuously cover the mucosal surface of the digestive tract.
  • Pectin is a natural polymer compound with good gelatinization and emulsification stabilization. It has been widely used in food, medicine, daily chemical and textile industries. Pectin can form a gel with elasticity. The mechanism of gel formation of pectin with different esterification degrees is different. Methoxy pectin must be at a low pH and high sugar concentration to form a gel. Generally, fruit is required. Gum content ⁇ 1%, sucrose concentration 58%-75%, pH 2.8-3.5.
  • the carboxyl group can be prevented from dissociating at pH 2.0 to 3.5, the highly hydrated and charged carboxyl group can be transformed into uncharged molecules, thereby reducing the repulsive force between molecules and reducing the hydration of the molecules, which is beneficial to the molecules.
  • the technical problem to be solved by the present invention is to provide a suspension containing low-methoxylated pectin and montmorillonite for the treatment of acute diarrhea and a preparation method thereof.
  • the particles of montmorillonite are finer after being prepared into the suspension. The greater the adsorption force, the stronger the protective effect on the mucosa of the digestive tract, which can effectively eliminate pathogens, and the pharmacological effect is faster.
  • adding low-methoxylated pectin can effectively increase the volume of the montmorillonite suspension. Absorption of water, reduce the granular roughness of the montmorillonite suspension, and improve the taste of the montmorillonite suspension.
  • Low-methoxylated pectin can also participate in and promote the fermentation of indigestible substances in the gastrointestinal tract. , The formation of normal stool.
  • the embodiments of the present invention provide a suspension containing low-methoxylated pectin and montmorillonite for the treatment of acute diarrhea, which comprises the following components in parts by mass: low-methoxylated fruit 100-1000 parts of gum, 100-1000 parts of montmorillonite, 100-2000 parts of glucose, 100-1000 parts of natural polymer suspending agent, 50 parts of sodium benzoate, sufficient purified water.
  • the present invention also provides a preparation method of a suspension containing low methoxylated pectin and montmorillonite for the treatment of acute diarrhea, including formulas for common patients and diabetic patients, wherein:
  • the general patient formula includes the following steps:
  • step (1-1) Add the preheated natural polymer suspending agent to the mixture obtained in step (1-1), fully stir, shake, and mix well, and wait for the temperature to cool to room temperature;
  • step (1-3) Add montmorillonite and sodium benzoate to the mixture obtained in step (1-2) and continue to fully stir, shake, and mix evenly;
  • step (1-4) Add sufficient amount of purified water to the mixture obtained in step (1-3), fully stir, and shake to extract a saturated suspension containing low-methoxylated pectin and montmorillonite;
  • the formula for diabetic patients includes the following steps:
  • step (2-2) Add the preheated natural polymer suspending agent to the mixture obtained in step (2-1), fully stir, shake, and mix well, and wait for the temperature to cool to room temperature;
  • step (2-2) Add montmorillonite and sodium benzoate to the mixture obtained in step (2-2) and continue to fully stir, shake, and mix evenly;
  • step (2-3) Add enough purified water to the mixture obtained in step (2-3), add an appropriate amount of sodium hydroxide to adjust the pH to about 7.0, and stir it fully, and after shaking, extract the low-methoxylated pectin and the mask. De-stone saturated suspension;
  • suspension containing low-methoxylated pectin and montmorillonite for the treatment of acute diarrhea can be added with flavor.
  • the flavor is strawberry flavor or orange flavor.
  • the beneficial effects of the above technical solutions of the present invention are as follows:
  • the present invention prepares montmorillonite into a suspension, which can make its particles finer, have greater adsorption, and have a stronger protective effect on the mucosa of the digestive tract, which can effectively eliminate pathogens.
  • the effect is faster, and the addition of low-methoxylated pectin can effectively increase the volume of the montmorillonite suspension, increase the adsorption of water, and reduce the particle-like roughness of the montmorillonite suspension.
  • Improve the mouthfeel of the montmorillonite suspension, and low-methoxylated pectin can also participate in and promote the fermentation of indigestible substances in the gastrointestinal tract to form normal stool.
  • Figure 1 is a schematic diagram of a suspension containing low-methoxylated pectin and montmorillonite prepared by the present invention
  • Figure 2 is a schematic diagram of the experimental results.
  • the embodiment of the present invention provides a suspension containing low-methoxylated pectin and montmorillonite for the treatment of acute diarrhea, which comprises the following components in parts by mass: 100-1000 parts of low-methoxylated pectin, 100-1000 parts of decalcification, 100-2000 parts of glucose (or sucrose, xylitol), 100-1000 parts of natural polymer suspending agent (preferably peach gum, gum arabic), 50 parts of sodium benzoate, sufficient purified water .
  • the embodiment of the present invention also provides a preparation method of a suspension containing low-methoxylated pectin and montmorillonite for the treatment of acute diarrhea, including the formula for common patients and diabetic patients, wherein the formula for common patients includes the following step:
  • step (1-1) Add the preheated natural polymer suspending agent to the mixture obtained in step (1-1), fully stir, shake, and mix well, and wait for the temperature to cool to room temperature;
  • step (1-3) Add montmorillonite and sodium benzoate to the mixture obtained in step (1-2) and continue to fully stir, shake, and mix evenly;
  • step (1-4) Add sufficient amount of purified water to the mixture obtained in step (1-3), fully stir, and shake to extract a saturated suspension containing low-methoxylated pectin and montmorillonite;
  • the formula for diabetic patients includes the following steps:
  • step (2-2) Add the preheated natural polymer suspending agent to the mixture obtained in step (2-1), fully stir, shake, and mix well, and wait for the temperature to cool to room temperature;
  • step (2-2) Add montmorillonite and sodium benzoate to the mixture obtained in step (2-2) and continue to fully stir, shake, and mix evenly;
  • step (2-3) Add enough purified water to the mixture obtained in step (2-3), add an appropriate amount of sodium hydroxide to adjust the pH to about 7.0, and stir well, and after shaking, extract the low-methoxylated pectin and the De-stone saturated suspension;
  • the saturated suspension containing low-methoxylated pectin and montmorillonite can be appropriately added with flavors to increase the pleasure of taking the medicine.
  • the flavor is strawberry flavor or orange flavor.
  • Drug-induced animal diarrhea models mainly use volumetric laxatives, stimulant laxatives or lubricating laxatives, such as using magnesium sulfate, castor oil, senna, paraffin oil, etc. to feed experimental animals.
  • senna as an example.
  • the research, experimental methods and results of therapeutic administration are as follows.
  • mice After successfully modeling the mice, they were divided into 3 groups: blank control group, montmorillonite group, suspension group containing low methoxylated pectin and montmorillonite, montmorillonite group, containing low methoxylated pectin and montmorillonite suspension group
  • the dosage of the suspension group of pectin and montmorillonite was calculated according to the same dosage of montmorillonite, and the blank control group was given the same volume of normal saline group.
  • Three experiments were performed, and the diarrhea rate and diarrhea index of the mice were observed each time. The results are shown in Figure 2A and Figure 2B.
  • Diarrhea rate number of animals with diarrhea/total number of animals in this group ⁇ 100%.
  • 2Diarrhea index loose stool rate x average loose stool grade.
  • the loose stool rate is the ratio of the number of loose stools discharged by each animal to the total number of stools.
  • the loose stool level indicates the degree of loose stools of each animal, and is graded according to the diameter of the filter paper contaminated by loose stools. It is divided into 4 levels: ⁇ 1cm is level 1, 1 ⁇ 1.9cm is level 2, 2 ⁇ 3cm is level 3, >3cm It is level 4.
  • Average loose stool level all loose stool levels/number of loose stools.

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Abstract

一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液及其制备方法。所述混悬液按质量份数包括如下组分：低甲氧基化果胶100-1000份、蒙脱石100-1000份、葡萄糖100-2000份、天然高分子助悬剂100-1000份、苯甲酸钠50份、足量的纯净水。

Description

一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液 技术领域
本发明涉及一种药剂制备技术领域，具体涉及一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液及其制备方法。
背景技术
蒙脱石(Montmorillonite)是由颗粒极细的含水铝硅酸盐构成的层状矿物，名称来源于首先发现的产地－－法国的Montmorillon。蒙脱石亚族属于蒙皂石族(smectite)矿物之一(另一亚族是皂石saponite),是重要的黏土矿物，一般为块状或土状。分子式(Na,Ca)0.33(Al,Mg) 2[Si 4O 10](OH) 2·nH 2O，中间为铝氧八面体，上下为硅氧四面体所组成的三层片状结构的黏土矿物，在晶体构造层间含水及一些交换阳离子，有较高的离子交换容量，具有较高的吸水膨胀能力。蒙脱石晶体属单斜晶系的含水层状结构硅酸盐矿物。
蒙脱石颗粒细小，约0.2～1微米，具胶体分散特性，通常都呈块状或土状集合体产出。蒙脱石在电子显微镜下可见到片状的晶体，颜色或白灰，或浅蓝或浅红色。当温度达到100～200℃时，蒙脱石中的水分子会逐渐跑掉。失水后的蒙脱石还可以重新吸收水分子或其他极性分子。当它们吸收水分后还可以膨胀并超过原体积的几倍。蒙脱石的用途多种多样，人们将它的特性运用到化学反应中以产生吸附作用和净化作用。它还可以作为造纸、橡胶、化妆品的填充剂，石油脱色和石油裂化催化剂的原料等，还可作为地质钻探用泥浆，冶金用粘合剂及医药等等方面(主要制造蒙脱石散)。
腹泻病按病程可分为急性腹泻病、迁延性腹泻病及慢性腹泻病。思密达(蒙脱石散剂)于1975年在法国注册，2002年已在全世界六十多个国家成功的用于腹泻病的治疗。思密达曾在中国做了大量的临床试验，治疗患者共36356例，包括成人及儿童的各类型腹泻性疾病，有效率超过88％，其在中国市场容量远超10亿元每年。
天然蒙脱石呈层片状，颗粒非常细小，表面巨大，每克蒙脱石的表面积可达100平面以上，天然蒙脱石颗粒虽然细，但在干燥过程中颗粒易聚集结块，使片状颗粒重叠。而且蒙脱石不溶于水，但吸水后可膨胀，使蒙脱石重叠的片 状颗粒充分分散，层间离子和端面离子暴露，这有利于层间离子交换吸附和端面吸附，蒙脱石吸水膨胀后产生粘塑形且层与层之间可滑动使其连续覆盖在消化道黏膜表面。
果胶是一种天然高分子化合物，具有良好的胶凝华和乳化稳定作用，已广泛用于食品、医药、日化及纺织行业。果胶能形成具有弹性的凝胶，不同酯化度的果胶形成凝胶的机制是有差别的，甲氧基果胶必须在低pH值和高糖浓度中才能形成凝胶，一般要求果胶含量<1％、蔗糖浓度58％～75％、pH2.8～3.5。因为在pH2.0～3.5时可阻止羧基离解，使高度水合作用和带电的羧基转变为不带电荷的分子，从而使分子间的斥力减小，分子的水合作用降低，结果有利于分子间的结合和三维网络结构的形成。蔗糖浓度达到58％～75％后，由于糖争夺水分子，致使中性果胶分子溶剂化程度大大降低，有利于形成分子氢键和凝胶。
发明内容
本发明要解决的技术问题是提供一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液及其制备方法，蒙脱石制成混悬液后的颗粒更细，吸附力更大，对消化道黏膜保护作用越强，可以有效消除病原体，药理作用发挥的更快，同时再加入低甲氧基化果胶，能够有效增加蒙脱石混悬液的体积，增加对水分的吸附力，降低蒙脱石混悬液的颗粒样的粗糙感，提高蒙脱石混悬液的口感，低甲氧基化果胶还能参与并促进胃肠道不易消化物质的发酵，形成正常粪便。
为解决上述技术问题，本发明的实施例提供一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液，按质量份数包括如下组分：低甲氧基化果胶100-1000份、蒙脱石100-1000份、葡萄糖100-2000份、天然高分子助悬剂100-1000份、苯甲酸钠50份、足量的纯净水。
本发明还提供一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液的制备方法，包括普通患者配合和糖尿病患者配方，其中，
所述普通患者配方包括如下步骤：
(1-1)将低甲氧基化果胶和葡萄糖(或蔗糖)按照1:1～1:10搅拌均匀，加入80℃的ddH 2O，充分搅拌；
(1-2)向步骤(1-1)所得混合物中加入预热的天然高分子助悬剂充分搅拌、 震荡、混合均匀，待温度冷却到室温；
(1-3)向步骤(1-2)所得混合物中加入蒙脱石、苯甲酸钠继续充分搅拌、震荡、混合均匀；
(1-4)将步骤(1-3)所得混合物加足量纯净水，充分搅拌，震荡后提取出含低甲氧基化果胶及蒙脱石饱和混悬液；
(1-5)定容、均质、灭菌、分装。
所述糖尿病患者配方包括如下步骤：
(2-1)将低甲氧基化果胶和木糖醇按照1:1～1:10搅拌均匀，加入80℃的ddH 2O，加入适量稀盐酸调节ph值到3.5-5.5之间，充分搅拌；
(2-2)向步骤(2-1)所得混合物中加入预热的天然高分子助悬剂充分搅拌、震荡、混合均匀，待温度冷却到室温；
(2-3)向步骤(2-2)所得混合物中加入蒙脱石、苯甲酸钠继续充分搅拌、震荡、混合均匀；
(2-4)将步骤(2-3)所得混合物加足量纯净水，加入适量氢氧化钠调节ph值到7.0左右，并充分搅拌，震荡后提取出含低甲氧基化果胶及蒙脱石饱和混悬液；
(2-5)定容、均质、灭菌、分装。
其中，所述治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液内可加有香精。
优选的，所述香精为草莓味香精或橙味香精。
本发明的上述技术方案的有益效果如下：本发明将蒙脱石制成混悬液，可使其颗粒更细，吸附力更大，对消化道黏膜保护作用越强，可以有效消除病原体，药理作用发挥的更快，同时再加入低甲氧基化果胶，能够有效增加蒙脱石混悬液的体积，增加对水分的吸附力，降低蒙脱石混悬液的颗粒样的粗糙感，提高蒙脱石混悬液的口感，低甲氧基化果胶还能参与并促进胃肠道不易消化物质的发酵，形成正常粪便。
附图说明：
图1为本发明制备的含低甲氧基化果胶及蒙脱石的混悬液的示意图；
图2为实验结果示意图。
具体实施方式
为使本发明要解决的技术问题、技术方案和优点更加清楚，下面将结合具体实施例进行详细描述。
本发明实施例提供一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液，按质量份数包括如下组分：低甲氧基化果胶100-1000份、蒙脱石100-1000份、葡萄糖(或者蔗糖、木糖醇)100-2000份、天然高分子助悬剂(优选桃胶、阿拉伯胶)100-1000份、苯甲酸钠50份、足量的纯净水。
本发明实施例还提供一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液的制备方法，包括普通患者配合和糖尿病患者配方，其中，所述普通患者配方包括如下步骤：
(1-1)将低甲氧基化果胶和葡萄糖(或蔗糖)按照1:1～1:10搅拌均匀，加入80℃的ddH 2O，充分搅拌；
(1-2)向步骤(1-1)所得混合物中加入预热的天然高分子助悬剂充分搅拌、震荡、混合均匀，待温度冷却到室温；
(1-3)向步骤(1-2)所得混合物中加入蒙脱石、苯甲酸钠继续充分搅拌、震荡、混合均匀；
(1-4)将步骤(1-3)所得混合物加足量纯净水，充分搅拌，震荡后提取出含低甲氧基化果胶及蒙脱石饱和混悬液；
(1-5)定容、均质、灭菌、分装。
所述糖尿病患者配方包括如下步骤：
(2-1)将低甲氧基化果胶和木糖醇按照1:1～1:10搅拌均匀，加入80℃的ddH 2O，加入适量稀盐酸调节ph值到3.5-5.5之间，充分搅拌；
(2-2)向步骤(2-1)所得混合物中加入预热的天然高分子助悬剂充分搅拌、震荡、混合均匀，待温度冷却到室温；
(2-3)向步骤(2-2)所得混合物中加入蒙脱石、苯甲酸钠继续充分搅拌、震荡、混合均匀；
(2-4)将步骤(2-3)所得混合物加足量纯净水，加入适量氢氧化钠调节ph 值到7.0左右，并充分搅拌，震荡后提取出含低甲氧基化果胶及蒙脱石饱和混悬液；
(2-5)定容、均质、灭菌、分装。
其中，所述含低甲氧基化果胶及蒙脱石的饱和混悬液内可适当加入香精，增加服药时的愉悦感。优选的，所述香精为草莓味香精或橙味香精。本发明制备的含低甲氧基化果胶及蒙脱石的混悬液对实验动物腹泻模型的治疗效果研究：
为了研究含低甲氧基化果胶及蒙脱石的混悬液治疗腹泻的机制，我们就目前常见的药物引起的动物腹泻模型进行了本发明的治疗腹泻效果研究。
药物诱发的动物腹泻模型主要使用容积性泻药、刺激性泻药或润滑性泻药，如利用硫酸镁、蓖麻油、番泻叶、石蜡油等喂服实验动物，我们以番泻叶为例，进行了治疗性给药的研究，实验方法及结果如下。
实验方法：
取番泻叶加水煮沸约10min，二层纱布过滤，滤液减压浓缩成0.3g/ml，低温保存，用时水浴加温至25℃。取昆明种小鼠，造型前10h前禁食，自由饮水。每天每只番泻叶煎剂0.5ml灌胃，连续两天。小鼠单只单笼饲养,鼠笼笼底垫有滤纸。腹泻率为100％。小鼠造模成功后，分为3组，空白对照组、蒙脱石组、含低甲氧基化果胶及蒙脱石的混悬液组，蒙脱石组、含低甲氧基化果胶及蒙脱石的混悬液组给药剂量按照同等的蒙脱石剂量计算，空白对照组给与同等体积的生理盐水组。进行三次实验，每次观察小鼠腹泻率及腹泻指数，结果如图2A和图2B所示。
注：①腹泻率＝腹泻的动物数/该组动物总数×100％。②腹泻指数＝稀便率×平均稀便级。式中稀便率为每只动物所排的稀便数与总便数之比。稀便级表示每只动物稀便的程度，以稀便污染滤纸的直径定级,分为4级：<1cm为1级,1～1.9cm为2级,2～3cm为3级,>3cm为4级。平均稀便级＝所有稀便级数/稀便次数。
结果显示：小鼠腹泻模型造模的同时立即给与蒙脱石、含低甲氧基化果胶及蒙脱石的混悬液后均能够有效降低小鼠腹泻率及腹泻指数，蒙脱石和含低甲氧 基化果胶及蒙脱石的混悬液相比，含低甲氧基化果胶及蒙脱石的混悬液对于降低小鼠腹泻率及腹泻指数明显优于蒙脱石组，差异有统计学意义。以上所述是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明所述原理的前提下，还可以作出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (5)

  1. 一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液，其特征在于，按质量份数包括如下组分：低甲氧基化果胶100-1000份、蒙脱石100-1000份、葡萄糖100-2000份、天然高分子助悬剂100-1000份、苯甲酸钠50份、足量的纯净水。
  2. 一种治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液的制备方法，其特征在于，包括普通患者配方和糖尿病患者配方，其中，
    所述普通患者配方包括如下步骤：
    (1-1)将低甲氧基化果胶和葡萄糖(或蔗糖)按照1:1～1:10搅拌均匀，加入80℃的ddH 2O，充分搅拌；
    (1-2)向步骤(1-1)所得混合物中加入预热的天然高分子助悬剂充分搅拌、震荡、混合均匀，待温度冷却到室温；
    (1-3)向步骤(1-2)所得混合物中加入蒙脱石、苯甲酸钠继续充分搅拌、震荡、混合均匀；
    (1-4)将步骤(1-3)所得混合物加足量纯净水，充分搅拌，震荡后提取出含低甲氧基化果胶及蒙脱石饱和混悬液；
    (1-5)定容、均质、灭菌、分装。
  3. 根据权利要求2所述的治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液的制备方法，其特征在于，所述糖尿病患者配方包括如下步骤：
    (2-1)将低甲氧基化果胶和木糖醇按照1:1～1:10搅拌均匀，加入80℃的ddH 2O，加入适量稀盐酸调节ph值到3.5-5.5之间，充分搅拌；
    (2-2)向步骤(2-1)所得混合物中加入预热的天然高分子助悬剂充分搅拌、震荡、混合均匀，待温度冷却到室温；
    (2-3)向步骤(2-2)所得混合物中加入蒙脱石、苯甲酸钠继续充分搅拌、震荡、混合均匀；
    (2-4)将步骤(2-3)所得混合物加足量纯净水，加入适量氢氧化钠调节ph值到7.0左右，并充分搅拌，震荡后提取出含低甲氧基化果胶及蒙脱石饱和混悬液；
    (2-5)定容、均质、灭菌、分装。
  4. 根据权利要求2或3所述的治疗急性腹泻的含低甲氧基化果胶及蒙脱石 的混悬液的制备方法，其特征在于，所述含低甲氧基化果胶及蒙脱石饱和混悬液内加有香精。
  5. 根据权利要求4所述的治疗急性腹泻的含低甲氧基化果胶及蒙脱石的混悬液的制备方法，其特征在于，所述香精为草莓味香精或橙味香精。
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