WO2022151595A1

WO2022151595A1 - Thickening assembly with controllable viscosity at full shear rate

Info

Publication number: WO2022151595A1
Application number: PCT/CN2021/084878
Authority: WO
Inventors: 张科; 朱敏; 臧永春; 冯小深
Original assignee: 江苏祈瑞医药科技有限公司
Priority date: 2021-01-15
Filing date: 2021-04-01
Publication date: 2022-07-21
Also published as: CN112841611B; CN112841611A; ES2965300A2; ES2965300R1

Abstract

A thickening assembly with a controllable viscosity at a full shear rate. Auxiliary materials are added to a polysaccharide material and mixed until uniform, and spray granulation is then performed to prepare and obtain a thickening assembly. The polysaccharide material consists of 80-90% by mass of xanthan gum and 10-20% by mass of sodium alginate.

Description

Viscosity Controlled Thickening Component at Full Shear Rate

technical field

The invention relates to the field of formula food for special medical purposes, in particular to a thickening component with controllable viscosity under full shear rate for improving swallowing disorders.

Background technique

Dysphagia is usually due to aging or the effects of stroke, nasopharyngeal cancer, Parkinson's and other diseases. During eating, especially drinking, the epiglottis cannot be closed in time, which causes food or liquid to enter the trachea and cause aspiration, which can cause weight loss. Alleviation, dehydration, malnutrition and even pneumonia, etc., greatly affect the quality of life. In addition to clinically active treatment, changing the physical properties of food when patients eat daily can also effectively reduce aspiration. The usual practice is to add natural macromolecules to liquids or foods, which swell in water and cause the molecular chains to cross-link each other, which can slow down the liquid flow rate, increase the cohesion of the food, and reduce the aspiration rate.

Generally, the thickeners on the market mainly include starch and xanthan gum thickeners, and the starch thickeners will be degraded by salivary amylase, resulting in a decrease in viscosity. Xanthan gum thickeners are the most widely used thickeners at present. Because of their good cohesion, shear thinning properties and stability to solvent environment, xanthan gum has been widely used in clinical practice. Xanthan gum is a typical pseudoplastic fluid that exhibits different viscosities at different shear rates.

At present, the classification standard of thickening components is mainly based on the viscosity at a shear rate of 50S ^-1 . However, if only the viscosity at a single shear rate is considered, and the viscosity at other shear rates is ignored, it is often impossible to obtain its true value. complete physical properties. Since the human swallowing process is very complex, the corresponding shear rate during swallowing is still under discussion, and many scholars believe that it is above 100S ^-1 . Due to the obvious shear thinning properties of xanthan gum, in addition, the same colloid may have similar viscosity at 50S ^-1 , but the viscosity may be very different at other shear rates due to differences in molecular weight or molecular conformation. In the design process of the thickening component, only considering the viscosity under a single shear rate, it often cannot truly correspond to the shear rate of the food mass during the actual swallowing process of the patient, which is not conducive to the complete control of the physical properties of the product during product design. and maintain product stability. Therefore, it would be desirable to obtain a thickening assembly with controlled viscosity at all shear rates.

SUMMARY OF THE INVENTION

The purpose of the present invention is to solve the above-mentioned technical problems, provide a kind of low cost, easy to obtain raw materials, easy to produce, and is conducive to the complete control of product physical characteristics and the improvement of product stability during product design, so as to improve the eating safety of patients with dysphagia. sex and palatability.

The technical scheme is that after adding auxiliary materials to the polysaccharide material and mixing it uniformly, spray granulation is used to prepare a thickening component. Composition of sodium alginate.

The molecular weight of the xanthan gum is controlled to be between 2 million Da and 8 million Da, and the molecular weight of the sodium alginate is controlled to be between 100,000 Da and 500,000 Da.

The M/G ratio of the sodium alginate is controlled to be higher than 1.25.

The particle size of the thickening component obtained by controlled granulation is between 200 μm and 600 μm, and the water content is below 3 wt %. In the granulation process, the granulation temperature is controlled at 50-90° C., the air inlet volume is 60-90 m ³ /min, the spray rate is 1-7 ml/min, and the granulation time is 10-30 min.

Apply hydrophobic coating on the surface of the spray gun used, and the contact angle of the coating is greater than 100° to prevent the hydrophilic material from adhering to the surface of the spray gun and affecting the normal progress of granulation.

In view of the technical problems existing in the background art, the inventor further researched and found that when food passes through different parts of the digestive tract during the swallowing process, due to the different eating habits of patients and the different structures of different positions of the digestive tract, the muscles that are activated in sequence during the swallowing action process Different groups, the shear rate corresponding to swallowing is not a fixed value, but includes a complex change process of high and low shear rates, thus producing a thickening component with controllable viscosity at full shear rate, Complete control of the physical properties of the product is an important guarantee for improving the eating safety of patients with dysphagia. To this end, the inventors conducted specific molecular weight screening on the basis of traditional xanthan gum, and added sodium alginate with specific molecular weight and specific composition ratio. The xanthan gum (HXG) is a linear natural polymer polysaccharide with a molecular weight of one million, which is defined as a high molecular weight linear polysaccharide, while sodium alginate (HMALG) is a natural polymer linear polysaccharide with a molecular weight of one hundred thousand. , defined as low molecular weight linear polysaccharides. The shear viscosity curve of xanthan gum, which is a high molecular weight linear polysaccharide, is steeper than that of low molecular weight linear polysaccharides, while sodium alginate, which is a low molecular weight linear polysaccharide, is closer to Newtonian fluid, and there is no viscosity difference between xanthan gum and sodium alginate. Therefore, the combination of the two can achieve the control of the slope of the viscosity curve at the full shear rate. The obtained thickening component is redissolved in water at a concentration of 1-3wt% and does not agglomerate after stirring. The relative stability of viscosity change can still be maintained under the shear rate, which can effectively avoid the hidden danger of swallowing caused by the rapid decrease of viscosity. The viscosity under high and low shear rates can be effectively regulated by selecting the molecular weight of different components. Preferably, the molecular weight of the xanthan gum is controlled to be between 2 million Da and 8 million Da, and the molecular weight of the sodium alginate is controlled to be 100,000 Da. ～500,000 Da, relative to the molecular weight of xanthan gum, the molecular weight of the sodium alginate is too high, which will lead to a limited ability to increase the viscosity under high shear rate. Although the shear curve is too low, the viscosity is close to Newtonian fluid. will drop sharply and cannot be controlled. The mass proportion of sodium alginate in the polysaccharide material is 20%-10%, too much will lead to excessive viscosity under high shear rate, increase the work of swallowing, and bring unpleasant feeling of swallowing to patients. If it is too small, the control effect on the viscosity of xanthan gum under high shear and low shear rate cannot be achieved.

Further, considering that the calcium ion concentration in the beverage varies in actual use, the G fragment (guluronic acid) in the sodium alginate is sensitive to calcium ions and easily causes complexation, so the concentration of sodium alginate should be controlled. The M/G ratio is higher than 1.25, below which gelation may occur, causing the problem of drastic changes in viscosity.

The added auxiliary materials include but are not limited to fillers, binders or other additives, and the amount of the additives can be referred to the usage amount of the additives in the existing thickening components, which is not limited here. Specifically, the filler can be selected from dextrin, gum arabic, etc., and the binder can be selected from dextrin, gum arabic, potassium chloride, sodium citrate, sodium gluconate, magnesium chloride, and the like. The dextrin in the added auxiliary material can be selected from maltodextrin or resistant dextrin.

The thickening component of the invention fully considers the real situation of the swallowing process of patients with dysphagia, and adopts polysaccharide materials with specific physical parameters to meet the stability requirements of viscosity changes under different shear rates, and can flexibly adapt to the actual swallowing process of patients. It can be formulated according to the situation and eating requirements, which can effectively improve the eating safety and palatability of patients with dysphagia, and has the advantages of low production cost, easy preparation and good flexibility.

Description of drawings

FIG. 1 is a comparison diagram of steady-state shear viscosity curves of Comparative Example 1 and Comparative Example 2. FIG.

FIG. 2 is a comparison diagram of the steady-state shear viscosity curves of Example 1 and Comparative Example 3. FIG.

FIG. 3 is a graph of steady state shear viscosity curves of Examples 2 and 3. FIG.

FIG. 4 is a graph of steady state shear viscosity curves of Examples 4 and 5. FIG.

Detailed ways

In the following examples, the molecular weight of the xanthan gum is between 2 million Da and 8 million Da, which can be purchased from commercial companies, or obtained by gel filtration or dialysis; the molecular weight of the sodium alginate is 100,000 Da. Da ~ 500,000 Da, and the M/G ratio is higher than 1.25, which can be purchased from commercial companies, or obtained by gel filtration, dialysis or enzymatic hydrolysis.

Example 1

HXG xanthan gum (2.4 million Da) 29.3 g, HMALG sodium alginate (molecular weight 300,000 Da, M/G=1.25) 7.3 g and dextrin 61.7 g were mixed uniformly and then sent to a spray granulator for granulation; 1.7 g of potassium chloride was dissolved in 50 g of water to prepare a slurry for spraying. The spray gun coating contact angle is 105°.

The parameters of the spray granulator are as follows: control the granulation temperature at 70°C, the air inlet volume at 80m ³ /min, the spray rate at 6ml/min, and the granulation time at 30min to obtain a thickening component a1 (with a particle size of 300 μm to 500 μm, and a water content of 2wt%).

Example 2

HXG xanthan gum (4.5 million Da) 48g, HMALG sodium alginate (molecular weight 200,000 Da, M/G=1.30) 5.3g and dextrin 45g were mixed uniformly and sent to a spray granulator for granulation; 1.7 g of potassium chloride was dissolved in 50 g of water to prepare a slurry for spraying. The spray gun coating contact angle is 110°.

The parameters of the spray granulator are as follows: control the granulation temperature at 60°C, the air inlet volume at 70m ³ /min, the spray rate at 4ml/min, and the granulation time at 15min to obtain a thickening component a2 (with a particle size of 200μm-400μm, and a water content of 3wt). %).

Example 3

HXG xanthan gum (4.5 million Da) 42.6g, HMALG sodium alginate (molecular weight 200,000 Da, M/G=1.30) 10.6g, dextrin 45.1g, mixed evenly and sent to a spray granulator for granulation; 1.7 g of magnesium chloride was dissolved in 50 g of water to prepare a slurry for spraying. The rest are the same as in Example 2, and a thickening component a3 is obtained (the particle size is between 200 μm and 400 μm, and the water content is 3 wt %). The spray gun coating contact angle is 120°.

Example 4

Mix 29.3 g of HXG xanthan gum (8 million Da), 7.3 g of HMALG sodium alginate (molecular weight 500,000 Da, M/G=1.40) and 61.7 g of dextrin and then send it to a spray granulator for granulation; 1.7 g of magnesium chloride was dissolved in 50 g of water to prepare a slurry for spraying. The spray gun coating contact angle is 120°.

The parameters of the spray granulator are as follows: control the granulation temperature at 90°C, the air inlet volume at 90m3/min, the spray rate at 7ml/min, and the granulation time at 30min to obtain a thickening component a4 (with a particle size of 400μm-600μm, and a water content of 2wt). %).

Example 5

HXG xanthan gum (2 million Da) 20.6g, HMALG sodium alginate (molecular weight 100,000 Da, M/G=1.40) 3.6g and gum arabic 74.1g were mixed uniformly and then sent to a spray granulator for granulation; 1.7 g of sodium gluconate was dissolved in 50 g of water to prepare a slurry for spraying. The spray gun coating contact angle is 120°.

The parameters of the spray granulator were as in Example 4, and a thickening component a5 was obtained (the particle size was between 300µm and 500µm, and the water content was 2wt%).

Comparative Example 1

HXG xanthan gum (molecular weight 2.4 million Da) 33.3 g, dextrin 65 g, potassium chloride 1.7 g, the rest are the same as in Example 1, to obtain thickening component b1.

Comparative Example 2

HMALG sodium alginate (molecular weight 300,000 Da, M/G=1.40) 33.3 g, dextrin 65 g, potassium chloride 1.7 g, the rest are the same as in Example 1, to obtain thickening component b2.

Comparative Example 3

HXG xanthan gum (2.4 million Da) 29.3g, dextrin 69g, potassium chloride 1.7g, the rest are the same as in Example 1, to obtain thickening component b3.

Put 3g of thickening components a1-a5 and b1-b3 into 100g of water respectively, stir and disperse, measure the apparent viscosity with a rheometer after 10 minutes, use a cone-plate rotor, and set the shear rate to 1S ^-1 -500S ^-1 . The apparent viscosity steady state shear curve was obtained and the results were as follows:

The curve with a small number of points in Fig. 1 is the steady-state shear curve of the thickening component b1, and the curve with a large number of points is the steady-state shear curve of the thickening component b2. As can be seen from Figure 1, the viscosity curves of the thickening group b1 and b2 have an obvious intersection (shear rate 27S ^-1 ). At low shear rate, the viscosity of b2 is lower than that of b1, and at high shear rate, the viscosity of b2 higher than b1. The steady-state shear curve of b1 shows that it has obvious shear-thinning behavior, and it is a typical non-Newtonian fluid with a large slope of the viscosity curve. The steady-state shear curve of b2 shows that the viscosity drop is relatively gentle, which is closer to Newtonian fluid. But the viscosity at 50S ^-1 , b2 is higher than b1.

In Fig. 2, the curve with a small number of points is the steady-state shear curve of the thickening component a1, and the curve with a large number of points is the steady-state shear curve of the thickening component b3. It can be seen from Figure 2 that the viscosity of the thickening component a1 added with HMALG sodium alginate (molecular weight 300,000 Da, M/G=1.25) has little change at 50S ^-1 at a concentration of 3wt%, which is 250mPas, which is still in line with JSDR2013. Standard (medium viscosity 150mPas-300mPas), the viscosity changed slightly under high shear and low shear rate, the high shear rate viscosity increased slightly, and the low shear rate viscosity decreased slightly, see Table 1 for details.

Table 1

In Fig. 3, the curve with a small number of points is the steady-state shear curve of the thickening component a2, and the curve with a large number of points is the steady-state shear curve of the thickening component a3. As can be seen from Figure 3, under the condition of shear rate 50S ^-1 , the viscosity value conforms to the high viscosity range (300mPas-500mPas) of JSDR2013. As the addition ratio of HMALG sodium alginate (molecular weight 200,000 Da) increased, the viscosity increased at high shear rate and decreased at low shear rate. The specific viscosity index is shown in Table 2. By selecting different high and low molecular weight polysaccharides and controlling the mixing ratio of the two, the viscosity at high and low shear rates can be flexibly adjusted, and diversified products can be designed.

Table 2

In Fig. 4, the curve with a large number of points is the steady-state shear curve of the thickening component a4, and the curve with a small number of points is the steady-state shear curve of the thickening component a5. As can be seen from Figure 4, under the condition of shear rate 50S ^-1 , the viscosity value of a4 conforms to the high viscosity range (300mPas-500mPas) of JSDR2013, the viscosity value of a5 conforms to the medium viscosity range (150mPas-300mPas) of JSDR2013, and the molecular weight is low It will cause a sharp drop in viscosity, so more additions are required. The specific viscosity index is shown in Table 3. By selecting polysaccharides with different molecular weights, the viscosity under high and low shear rates can be flexibly controlled, and diversified products can be designed.

table 3

Claims

A thickening component with controllable viscosity under full shear rate is characterized in that, after adding auxiliary materials to polysaccharide material and mixing uniformly, spray granulation to prepare thickening component, and the polysaccharide material accounts for 80%-90% by mass. % xanthan gum and 20%-10% sodium alginate by mass.
The thickening component with controllable viscosity under full shear rate according to claim 1, wherein the molecular weight of the xanthan gum is controlled to be between 2 million Da and 8 million Da, and the molecular weight of the sodium alginate is controlled to be 10 10,000 Da to 500,000 Da.
The thickening component with controllable viscosity under full shear rate according to claim 2, wherein the M/G ratio of the sodium alginate is controlled to be higher than 1.25.
The thickening component with controllable viscosity under full shear rate according to any one of claims 1 to 3, wherein the thickening component obtained by controlling granulation has a particle size of 200 μm-600 μm and a water content of 3wt %the following.
The thickening component with controllable viscosity under full shear rate according to claim 4, characterized in that, in the granulation process, the granulation temperature is controlled at 50-90° C., the air inlet volume is 60-90 m 3 /min, and the spray The rate is 1-7ml/min, and the granulation time is 10-30min.
The thickening component with controllable viscosity under full shear rate according to claim 4, characterized in that the surface of the spray gun used is subjected to hydrophobic coating, and the contact angle of the coating is greater than 100°.