CN110840910B

CN110840910B - Composition for inhibiting gastrointestinal adverse reactions

Info

Publication number: CN110840910B
Application number: CN201911066842.6A
Authority: CN
Inventors: 曹健
Original assignee: Niubaiteng Beijing Medicine Technology Co ltd
Current assignee: Niubaiteng Beijing Medicine Technology Co ltd
Priority date: 2019-11-04
Filing date: 2019-11-04
Publication date: 2020-10-30
Anticipated expiration: 2039-11-04
Also published as: CN110840910A

Abstract

The invention discloses a composition for inhibiting gastrointestinal adverse reactions, which comprises pectin, galactomannan and sodium citrate; and discloses an aqueous solution of the composition, a preparation method and application thereof. The composition of the invention has certain repairing and protecting effects on weak gastrointestinal tract functions while improving gastrointestinal adverse reactions; and even if the calcium ion concentration is suddenly increased, the phenomenon of pre-gel or over-hard gel is not generated, the breaking strength of the gel is ensured to be within a certain expected range, and the load of the gastrointestinal tract of a patient is further reduced.

Description

Composition for inhibiting gastrointestinal adverse reactions

Technical Field

The invention belongs to the technical field of gastrointestinal tract function repair, and particularly relates to a composition which can inhibit gastrointestinal adverse reactions and better meet the physiological characteristics of a human body.

Background

Enteral nutrition is the means of providing support for a nutrient substrate and other various nutrients needed for metabolism via the gastrointestinal tract by oral or tube feeding. The intestinal nutrient has the advantages of intestinal nutrient and physiological characteristics, convenient administration, low cost, and capability of maintaining the integrity of intestinal mucosa structure and barrier function and maintaining various physiological functions of internal organs, and is the first choice for clinical nutritional support. However, clinical research data show that certain gastrointestinal complications such as esophageal reflux, diarrhea, abdominal distension, vomiting, aspiration and the like exist in enteral nutrition, gastrointestinal dysfunction and immunologic dysfunction of patients can be caused, nutritional support disorder is caused, and postoperative rehabilitation is affected.

In order to solve the problems, researchers use pectin to cooperate with sodium alginate, calcium chloride, vitamin C and other components to inhibit reflux or diarrhea, and good effects are obtained. However, the product is degraded in the production and storage processes, and visible precipitation appears, so that the viscosity of the product is influenced, and the quality and the efficacy stability of the product are further influenced; when high-concentration calcium ions are encountered, the phenomenon of pre-gel or over-hard gel is easily generated, and the load of the gastrointestinal tract of a patient is increased; in addition, the effect is single, the backflow or diarrhea of nutrient solution can be only inhibited, and no obvious auxiliary effect is generated on the repair of the gastrointestinal function of a patient.

Therefore, there is a need to research a more stable composition or aqueous solution thereof conforming to the physiological function of the human body, which has a certain promotion effect on the protection and repair of the gastrointestinal tract of the patient while solving the gastrointestinal tract reactions such as reflux and diarrhea, and thus, the safety and compliance of the patient are improved integrally.

Disclosure of Invention

The invention discloses a composition for inhibiting gastrointestinal adverse reactions, which has certain repairing and protecting effects on weak gastrointestinal functions while improving the gastrointestinal adverse reactions; and even if the calcium ion concentration is suddenly increased, the phenomenon of pre-gel or over-hard gel can not be generated, and the breaking strength of the gel is ensured to be within a certain expected range.

In order to achieve the purpose, the invention adopts the following technical scheme:

a composition for inhibiting gastrointestinal adverse effects comprises pectin, galactomannan and sodium citrate.

Galactomannan is a polysaccharide natural polymer compound, which can be decomposed by intestinal microorganisms after entering intestinal tract to generate short chain fatty acids (such as acetic acid, butyric acid and propionic acid); the short chain fatty acid can be absorbed and utilized as a nutrient substance, and has important physiological functions on the body, such as maintaining electrolyte balance, promoting intestinal epithelial proliferation, increasing blood flow, stimulating gastrointestinal hormone and the like. The galactomannan is added into the pectin solution, so that the breaking strength of gel formed by pectin can be adjusted, the gel can better meet the physiological requirements of human bodies, and the compliance and the safety of clinical use of patients are improved.

In the invention, the sodium citrate is used as buffer salt, and has the main functions of enabling the gel crushing strength of the composition solution to better meet the physiological requirements of the stomach and intestine of a human body, avoiding the phenomenon of pregelatinization or gel over-hardness of the composition caused by high-concentration calcium ions, and improving the administration compliance and the compliance of patients. It should be noted that not all buffer salts can be used to adjust the gel strength, and neither sodium chloride nor sodium tartrate can achieve the desired effect.

Preferably, the pectin is a low-ester pectin having a viscosity average molecular weight of 10000-100000, a degree of esterification of 5-25% and a degree of amidation of 19-25%.

The viscosity average molecular weight of pectin is too large, and the pectin reacts with calcium ions to generate firm insoluble gel which influences digestion and absorption; since the viscosity-average molecular weight is too small, the reactivity with calcium ions is low, and sufficient thickening cannot be achieved, the viscosity-average molecular weight, the degree of esterification, and the degree of amidation are preferably in the above-mentioned ranges.

Preferably, the weight ratio of pectin, galactomannan and sodium citrate is (3-5): (0.05-5): (0.1-2).

The water solution of the composition for inhibiting the gastrointestinal adverse reaction comprises the following components in parts by weight per liter: 30-50g of pectin, 0.5-50g of galactomannan, 1.0-20g of sodium citrate and the balance of purified water.

The pectin, the galactomannan and the sodium citrate are controlled within the range to have the best gum forming effect and moderate viscosity, and are beneficial to tube feeding input.

The pH of the aqueous solution of the composition for inhibiting the gastrointestinal adverse reaction is 3-5;

the viscosity of the aqueous solution of the composition for inhibiting the gastrointestinal adverse reaction is 30-110mPa.s, so that the composition is also suitable for the tube feeding delivery of patients who are not suitable for direct oral administration.

The osmotic pressure of the aqueous solution of the composition for inhibiting the gastrointestinal adverse reaction is 280-340mOsm, so that the tolerance and the compliance of the gastrointestinal tract can be ensured.

The gel breaking strength of the aqueous solution of the composition for inhibiting the gastrointestinal adverse reaction is 5-20g/cm³And can relieve gastrointestinal burden of patients with asthenia.

The water is purified water, preferably water for injection.

The above composition or aqueous solution thereof may further comprise any one or more of the following adjuvants, such as pH adjusting agents, flavoring agents, binders, antioxidants, colorants, and the like, for improving the taste, consistency, color, stability during storage, and the like of the aqueous solution of the composition.

The preparation method of the aqueous solution of the composition for inhibiting the gastrointestinal adverse reaction comprises the following steps:

(1) dissolving pectin in water to obtain pectin solution;

(2) adding galactomannan into pectin solution, stirring, and maintaining in 85 deg.C water bath for 90min to obtain mixed solution;

(3) and (3) after the mixed solution in the step (2) is cooled to room temperature, adding sodium citrate into the mixed solution, stirring and dissolving, filling, and sterilizing at 100 ℃ for 30 min.

Sterilizing at 100 deg.C for 30min without affecting the stability of the composition; below which no effective sterilization can be achieved, and above which the sample precipitates.

Preferably, in step (2), stirring is carried out at 800rpm for 2 h.

Preferably, the solution obtained in step (3) is packaged into polyester/aluminum/polyester/polyethylene (PET/AL/PET/PE) bags (100ml) and sealed, and sterilized by heating and pressurizing at 100 deg.C for 30 min.

The preparation process of the aqueous solution of the composition for inhibiting the gastrointestinal adverse reaction does not need calcium reduction treatment.

The use of the above composition for inhibiting gastrointestinal adverse effects or an aqueous solution of the above composition for inhibiting gastrointestinal adverse effects in the manufacture of a product for treating gastrointestinal reflux, abdominal distension or diarrhea while simultaneously repairing gastrointestinal function.

In summary, the beneficial effects of the invention include the following aspects:

1. the aqueous solution of the composition of the present invention is more suitable for patients who need to insert a tube feeding tube into the stomach or intestine through one side of nasal cavity, oral cavity or gastrointestinal fistulization opening, etc., and to drip essential diet or liquid diet from the tube, and can avoid or reduce the reaction of gastrointestinal reflux, diarrhea or vomiting;

2. the water solution of the composition is not subjected to calcium reduction treatment, the process is simple, and the industrial production is easy to realize;

3. the water solution of the composition has high stability, and the clinical use cost can be reduced to a certain extent;

4. the water solution of the composition has good repairing and protecting effects on gastrointestinal tract function of patients;

5. the gel breaking strength formed by the aqueous solution of the composition is more consistent with the gastrointestinal physiological function of a weak patient, and the composition has certain buffering capacity without pre-gel or gel hardening phenomenon even if high-concentration calcium ions are encountered.

Detailed Description

The technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The percentages of the components in the aqueous compositions of the examples and comparative examples are given by weight to volume.

Example 1

3% pectin, with a (viscosity average) molecular weight of 35000, a degree of esterification of 10%, a degree of amidation of 20%, 0.05% galactomannan, 0.1% sodium citrate, and an aqueous solution osmotic pressure of 280 mosm.

Dissolving pectin in purified water to prepare pectin aqueous solution, adding galactomannan, stirring at 800rpm for 2h, and maintaining the solution in 85 deg.C water bath for 90min to obtain mixed solution; cooling the mixed solution to room temperature, adding sodium citrate, stirring to dissolve, adjusting pH to 3-5(pH regulator is HCl or NaOH), packaging into polyester/aluminum/polyester/polyethylene (PET/AL/PET/PE) bags per 100ml, sealing, and sterilizing at 100 deg.C under pressure and heat for 30min to obtain composition water solution.

Example 2

3% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 1% galactomannan, 0.5% sodium citrate, osmotic pressure of aqueous solution 302mosm, the remainder of the same as in example 1.

Example 3

3% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 5% galactomannan, 2% sodium citrate, osmotic pressure of aqueous solution 338mosm, the remainder of example 1.

Example 4

4% pectin, with a (viscosity average) molecular weight of 35000, a degree of esterification of 10%, a degree of amidation of 20%, 0.5% galactomannan, 0.1% sodium citrate, and an aqueous osmotic pressure of 282mosm, the remainder being the same as in example 1.

Example 5

4% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 2% galactomannan, 0.5% sodium citrate, osmotic pressure of aqueous solution 316mosm, the remainder being the same as in example 1.

Example 6

4% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 2% galactomannan, 1.5% sodium citrate, osmotic pressure of aqueous solution 324mosm, the remainder of example 1.

Example 7

5% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 0.5% galactomannan, 0.1% sodium citrate, osmotic pressure 287mosm in aqueous solution, the remainder being the same as in example 1.

Example 8

5% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 2% galactomannan, 0.5% sodium citrate, osmotic pressure of aqueous solution 321mosm, the remainder of the same as in example 1.

Example 9

5% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 5% galactomannan, 1.5% sodium citrate, aqueous osmotic pressure 330mosm, otherwise the same as in example 1.

Example 10

3% pectin, with a (viscosity average) molecular weight of 75000, a degree of esterification of 15%, a degree of amidation of 23%, 1% galactomannan, 0.5% citric acid, and an osmotic pressure of aqueous solution of 307mosm, the remainder being the same as in example 1.

Example 11

4% pectin, with a (viscosity average) molecular weight of 75000, a degree of esterification of 15%, a degree of amidation of 23%, 2% galactomannan, 0.5% sodium citrate, and an osmotic pressure of 312mosm in aqueous solution, the remainder being the same as in example 1.

Example 12

5% pectin, 75000 (viscosity average) molecular weight, 15% degree of esterification, 23% degree of amidation, 2% galactomannan, 0.5% sodium citrate, osmotic pressure of aqueous solution 317mosm, the rest being the same as in example 1.

Example 13

4% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 5% galactomannan, 0.5% sodium citrate, osmotic pressure 311mosm in aqueous solution, the remainder being the same as in example 1.

Comparative example 1

3% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, no galactomannan, sodium citrate added, aqueous solution osmotic pressure 228mosm, otherwise the same as in example 1.

Comparative example 2

3% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 10% galactomannan, no sodium citrate added, aqueous osmotic pressure 269mosm, otherwise the same as in example 1.

Comparative example 3

3% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 1% galactomannan, 5% sodium citrate, aqueous osmotic pressure 363mosm, otherwise the same as in example 1.

Comparative example 4

3% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 1% galactomannan, 10% sodium citrate, aqueous osmotic pressure 407mosm, otherwise the same as in example 1.

Comparative example 5

3% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 0.01% galactomannan, no sodium citrate added, aqueous osmotic pressure 270mosm, otherwise the same as in example 1.

Comparative example 6

3% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 0.5% sodium citrate, no galactomannan added, aqueous osmotic pressure 278mosm, otherwise the same as in example 1.

Comparative example 7

4% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 0.3% galactomannan, 0.3% sodium citrate, aqueous solution osmotic pressure 295mosm, pH 1-2, otherwise the same as in example 1.

Comparative example 8

4% pectin, with a (viscosity-average) molecular weight of 35000, a degree of esterification of 10%, a degree of amidation of 20%, 2% galactomannan, 0.5% sodium citrate, and an aqueous osmotic pressure of 311mosm, pH 2-2.5, the remainder being as in example 1.

Comparative example 9

4% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 2% galactomannan, 0.5% sodium citrate, aqueous osmotic pressure 312mosm, pH 6-7, otherwise as in example 1.

Comparative example 10

5% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 5% sodium citrate, no galactomannan added, aqueous osmotic pressure 357mosm, otherwise the same as in example 1.

Comparative example 11

8% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 2% galactomannan, 0.5% sodium citrate, osmotic pressure of aqueous solution 328mosm, otherwise the same as in example 1.

Comparative example 12

4% pectin, (viscosity average) molecular weight 35000, degree of esterification 10%, degree of amidation 20%, 2% galactomannan, 0.5% sodium citrate, aqueous solution osmotic pressure 312mosm, 110 deg.C, 15min sterilization, the rest of example 1.

1. Stability testing of composition samples

Examples 1 to 13 and comparative examples 1 to 12 were prepared, and then stored at 40 ℃ for 2 years, and whether or not the aqueous composition solution was precipitated was visually observed at 0 day, 1 month, 3 months, 6 months, 12 months and 24 months, respectively, and evaluated according to the following criteria, and the results are shown in Table 1.

Very good: no precipitate is generated;

o: trace precipitation can be observed, but the solution can be quickly dispersed by shaking;

x: a large amount of precipitate is generated, and the precipitate cannot be redispersed even if shaken;

TABLE 1 appearance stability study

Group of

Day 0

1 month

3 month

6 month

12 month

24 months

Example 1

◎

○

×

Example 2

◎

Example 3

◎

Example 4

◎

○

Example 5

◎

Example 6

◎

Example 7

◎

○

Example 8

◎

Example 9

◎

Example 10

◎

Example 11

◎

Example 12

◎

Example 13

◎

Comparative example 1

◎

○

×

Comparative example 2

Gelatinizing

Comparative example 3

◎

Comparative example 4

◎

Comparative example 5

◎

○

×

Comparative example 6

◎

○

×

Comparative example 7

×

Comparative example 8

×

Comparative example 9

×

Comparative example 10

◎

×

Comparative example 11

×

Comparative example 12

×

The results of the examples in Table 1 show that the aqueous stability of the composition is greatly improved when the pectin content is 3-5%, the galactomannan content is 0.05-5.0%, and the sodium citrate content is 0.1-2.0%. The cross-machine direction comparisons of examples 1-3, 4-6, 7-9 show that the stability of the aqueous composition increases as the proportion of galactomannan increases, and thus show that the amount of galactomannan used affects the stability of the aqueous composition. The results of comparative examples 1, 5, 6 and 10 show that the stability of the composition is poor without galactomannan or with a galactomannan content of less than 0.05%, but that aqueous solutions of the composition form a viscous gum when the galactomannosan content is greater than 5.0% (see comparative example 2). Therefore, the galactomannan content is controlled to 0.05-5.0%, which is more suitable for patients with clinical tube feeding transfusion. Comparing the results of example 8 and comparative example 11, it can be seen that when the pectin content is more than 5%, the aqueous composition solution precipitates after sterilization, but if the pectin content is too low, the pectin content is limited to be colloidal, and when example 5 is compared with comparative examples 7, 8 and 9, the pH is less than 3 or more than 5(6-7), and the aqueous composition solution precipitates after sterilization at 100 ℃ for 30 min. Comparison of example 5 with comparative example 12 shows that the aqueous composition is likewise unstable when the sterilization temperature is above 100 ℃.

2. Viscosity Change test of aqueous composition

The aqueous solutions of the respective compositions, which were left at 40 ℃ for different periods of time (0 day, 1 month, 3 months, 6 months, 12 months and 24 months), were mixed with the aqueous calcium/sodium solution at a ratio of 1:2(V/V) for 5 minutes, and then the viscosity of the sample was measured using an NDJ-8S type viscometer (Shanghai squari apparatus Co., Ltd.), and the liquid temperature was measured at 25 ℃, using a No. 3 rotor, and a rotation speed of 30rpm, and the results are shown in Table 2.

The calcium chloride dihydrate concentration in the calcium/sodium water solution is 0.019mol/L, and the trisodium citrate dihydrate concentration is 0.020 mol/L.

Table 2 viscosity change test

Note: in the table "-" indicates that the sample had precipitated largely or was gelled, and therefore its viscosity was not measured.

The results in Table 2 show that the viscosity of the samples of the examples after reaction with calcium ions did not change significantly with the increase of the storage time, which further demonstrates the good stability of the aqueous solution of the composition. Comparative example 2 galactomannan content greater than 5.0%, self-gelling affects perfusion in tube fed patients. The comparison between example 2 and comparative examples 3 and 4 shows that the amount of sodium citrate affects the gelling property of the composition and the calcium ion solution, and the gelling effect is poorer when the concentration is higher. Comparative examples 7-9pH are either slightly acidic or slightly basic, and comparative example 12 is sterilized at more than 100 ℃ resulting in precipitation or denaturation of the sample, and therefore its viscosity for reaction with calcium ions was not investigated.

3. Pipe injection ease test

The aqueous solutions of the compositions of each set, which were left at 40 ℃ for various periods of time (0 day, 1 month, 3 months, 6 months, 12 months and 24 months), were injected into a 12Fr thick and 90cm long feeding tube using a 10mL syringe, and the viscosity and the injection time of each bag of the aqueous solution of the composition (100mL) were recorded and the ease of extrusion was evaluated according to the following criteria, and the results are shown in table 3.

Very good: easy injection;

o: resistant but problem-free injection;

x: and cannot be implanted.

TABLE 3 viscosity of aqueous solutions of compositions, time of bolus injection and ease of tube administration

Note: "-" indicates that viscosity measurements and ease of tube feeding were not performed because the samples had produced a large amount of precipitation or gelled severely.

The results in Table 3 show that as the galactomannan content increases, the viscosity of the aqueous composition increases and the bolus time increases. The viscosity is in the range of 30-110m.pas, and the composition solution is easily pushed by tube feeding. The composition of comparative example 2 gelled by itself and had a viscosity greater than 110m.pas and therefore could not or hardly be injected by tube feeding. Comparative examples 6-12 were not examined for viscosity in aqueous compositions, time of bolus injection, and ease of tube administration due to precipitation or denaturation of samples resulting from low amounts of galactomannan, acidic or alkaline pH, or sterilization above 100 ℃.

4. Gel breaking strength test:

the aqueous compositions prepared in examples 1, 4, 5, 6, 8, 11, 13 and comparative examples 1, 3, 4 were subjected to gel crushing strength test, and the sodium citrate in the aqueous composition of example 5 was replaced with an equal amount of NaCl or sodium tartrate as comparative example 13 and comparative example 14, respectively. Mixing the aqueous solution of each composition with calcium/sodium aqueous solution (calcium chloride dihydrate is 0.019mol/L, trisodium citrate dihydrate is 0.020mol/L) at a volume ratio of 1:2, stirring, gelling, standing at 37 deg.C for 2h, and determining gel breaking strength after gelling. The test method is referred to as 'Liqiaoqiao et al, influence factor of the breaking strength of amidated low-ester pectin gel, Chinese food additive'. In addition, the aqueous solution of the composition of example 5 was subjected to gel crushing strength tests for forming gels at different calcium ion concentrations by adjusting the calcium ion concentration in the aqueous calcium/sodium solution, and the results are shown in Table 4.

TABLE 4 measurement results of gel breaking strength of aqueous solution of composition

Note: "-" indicates that the sample was not gelled and therefore the gel break strength was not determined.

As can be seen from the results analysis of example 5 and example 13 of table 4, the addition of galactomannan can reduce the crushing strength of the composition to some extent; comparing the results of example 5 and example 6, it can be seen that the addition amount of potassium citrate has a certain buffering effect on the gel crushing strength; comparative examples 3 and 4 show that when the amount of sodium citrate is too large, the sample gumminess is affected, and the amount of sodium citrate needs to be controlled within a certain range. From the results of gel crushing strength of comparative example 1 and example 5 (adding calcium ions at different concentrations), it can be seen that the aqueous solution of the composition of example 5 shows a certain buffering capacity, and the gel crushing strength can be maintained within a certain range by appropriately increasing the calcium ion concentration. In addition, in example 5, sodium citrate was replaced with sodium chloride and sodium tartrate, respectively, in the same amount, and the composition could not form a gel under the same conditions. In conclusion, the breaking strength of the gel formed by the aqueous solution of the composition containing the sodium citrate is more consistent with the physiological characteristics of a human body, and the composition is helpful for postoperative recovery of patients.

5. Clinical trial

Data: 80 patients receiving tube feeding are admitted, and have no symptoms such as diarrhea and liver and kidney function abnormality, and the sources of the patients are ICU and oncology. Patients were randomly divided into two groups, 40 individuals in each of the experimental and control groups, and the two groups had no statistical difference (P > 0.05) in age, sex, height, weight, body surface area, etc., and had comparable demographic characteristics.

The method comprises the following steps: when enteral nutrition is administered to patients, the experimental group uses enteral nutrition + example samples, and the control group uses enteral nutrition + comparative example samples. Both groups of patients were treated routinely using nasogastric tubes (first enteral nutrition then the examples or comparative samples). Nutritional support is given according to the height, weight, age and activity degree of the patient, and the condition that the patient has diarrhea, abdominal distension and vomiting symptoms at 5 days, 10 days and 30 days is examined. The results were statistically processed: p is less than or equal to 0.05, and the difference has significant statistical significance; the results are shown in Table 5.

TABLE 5 clinical test results of incidence of adverse gastrointestinal reactions in each group

The results in Table 5 show that the patients of examples 1, 4, 5 and 13 experienced some reduction in the rate of diarrhea, abdominal distension and vomiting compared to comparative example 1 on both days 5 and 10, and that the treatment of diarrhea, abdominal distension and vomiting was significantly different (P.ltoreq.0.05) for examples 4, 5 and 13 and significantly different (P.ltoreq.0.05) for example 13 on day 10 for example 13 when the composition was administered for up to 30 days. As can be seen, the compositions of the examples are capable of promoting self-protection and repair of the gastrointestinal tract of a patient; the patient's diarrhea, abdominal distension and vomiting symptoms have a significant improvement with increasing galactomannan content; meanwhile, due to the existence of the sodium citrate, the gel breaking strength of the composition is kept within the range suitable for the physiological requirements of the gastrointestinal tract of patients with weakness, and the compliance and compliance of the patients in taking are greatly improved.

The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to the above-described embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An aqueous solution of a composition for inhibiting gastrointestinal adverse reactions, wherein the w/v content of each component in the aqueous solution is as follows: 3-5% of pectin, 0.05-5% of galactomannan and 0.1-2% of sodium citrate; the viscosity average molecular weight of the pectin is 10000-100000, the esterification degree is 5-25%, and the amidation degree is 19-25%; the pH value of the aqueous solution is 3-5.

2. The aqueous solution of the composition for inhibiting the undesired gastrointestinal effects as claimed in claim 1, wherein the viscosity of the aqueous solution is 30 to 110mPa.s, the osmotic pressure is 280mOsm, and the gel crushing strength is 5 to 20g/cm³。

3. An aqueous solution of a composition for inhibiting adverse gastrointestinal effects according to claim 2, wherein the water is purified water.

4. A method for preparing an aqueous solution of a composition for inhibiting gastrointestinal adverse effects according to any one of claims 1 to 3, comprising the steps of:

(1) dissolving pectin in water to obtain pectin solution;

(2) adding galactomannan into pectin solution, stirring, and maintaining in 80-90 deg.C water bath for 70-110min to obtain mixed solution;

(3) and (3) after the mixed solution in the step (2) is cooled, adding sodium citrate into the mixed solution, stirring and dissolving, filling, and sterilizing at 100 ℃ for 30 min.

5. The method for preparing an aqueous solution of a composition for inhibiting adverse gastrointestinal reactions as claimed in claim 4, wherein the stirring at 600-1000rpm in step (2) is performed for 1-3 h.

6. The method for preparing an aqueous solution of a composition for inhibiting gastrointestinal adverse effects according to claim 4, wherein the preparation process does not require a calcium reduction treatment.

7. Use of an aqueous solution of a composition according to any one of claims 1 to 3 for the treatment of gastrointestinal reflux, bloating or diarrhea while simultaneously repairing gastrointestinal function.