CN106974265A - A kind of enteral nutritional composition - Google Patents

A kind of enteral nutritional composition Download PDF

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Publication number
CN106974265A
CN106974265A CN201710034103.3A CN201710034103A CN106974265A CN 106974265 A CN106974265 A CN 106974265A CN 201710034103 A CN201710034103 A CN 201710034103A CN 106974265 A CN106974265 A CN 106974265A
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China
Prior art keywords
nutritional composition
enteral nutritional
cellulose
composition according
enteral
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CN201710034103.3A
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Chinese (zh)
Inventor
孙姣
骆彬
崔瑞峰
张辉
刘凯
卢韵
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Jiangsu Hengrui Medicine Co Ltd
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Jiangsu Hengrui Medicine Co Ltd
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Publication of CN106974265A publication Critical patent/CN106974265A/en
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

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  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention relates to a kind of enteral nutritional composition.Specifically, enteral nutritional composition of the present invention contains colloid and cellulose.Colloid and cellulose can make the insoluble granule in enteral nutrition product keep suspending, prevent it from settling or luming.Enteral nutritional composition stability of the present invention is improved significantly.

Description

A kind of enteral nutritional composition
Technical field
The invention belongs to field of pharmaceutical preparations, it is related to a kind of enteral nutritional composition.
Background technology
Enteral nutrition is a kind of nutrition branch for being provided through intestines and stomach and being metabolized the nutriment needed and other various nutrients Hold mode.With going deep into recent years to intestines and stomach 26S Proteasome Structure and Function research, people progressively recognize that intestines and stomach do not disappear merely Change and absorb organ, while being important immune organ.Just because of this, than Parenteral nutrition, the superiority of enteral nutrition Except be embodied in nutrient directly through intestinal absorption, utilize, more accord with physiology, convenient drug administration, low-cost outer, more display helps to maintain The advantage of intestinal mucosa structure and integrality of barrier function.Therefore when determining to provide which kind of nutritional support mode, preferred enteral nutrition Turn into the common recognition of numerous clinicians.
The different enteral nutrition product of a variety of compositions, some of list marketings, such as CN1439298A are reported Disclosed enteral nutrition product, is listed with the auspicious element of trade name；CN1439299A discloses another enteral nutrition product, its It can be listed so that trade name is auspicious；CN1122457C is disclosed the product also disclosed that and also listed with all strength with trade name health； Separately there is CN101027074 to also disclose that a kind of enteral nutrition product.
As the enteral nutrition product for providing whole nutrition or nutritional supplementation, often by protein, carbohydrate, fat Nutrition is constituted necessary to the human bodies such as fat, fiber, mineral matter, trace element, vitamin.Because composition is extremely complex, cause In system in addition to the solution being made up of water-soluble composition and the emulsion droplet largely existed, also water insoluble material is deposited .Such as insoluble calcium salt (tricalcium phosphate, calcium carbonate, calcium hydroxide etc.), insoluble soybean polyoses or soybean fiber, very As for a small amount of protein precipitation produced by technique.If this part insoluble substance can not be suspended among system, can Slowly assemble, be deposited in product bottom.
Because the commercially available enteral nutrition product shelf-life is longer, up to even 2 years a year and a half, therefore sedimentation problem was aobvious Obtain particularly evident.In general, standing time is longer, precipitates more, degree of scatter poorer., can when as the nutritional supplementation used time It can not enough cause precipitation scattered incomplete because of shaking dynamics, can if things go on like this cause patient part's nutrient supplement not enough (such as calcium constituent), it is particularly evident that this embodies in the patient for needing full nutrition treatment.Therefore the steady of enteral nutrition product is improved Qualitative is very necessary.
For supensoid agent, stabilizer or suspending agent are often added, by increasing the viscosity of system, reduction medicine is micro- The sinking speed of grain, is attracted to microparticle surfaces formation diaphragm and hinders the means such as particulate merging and flocculation to reach improvement system Physical stability purpose.
Suspending agent is generally divided into low molecule suspending agent (such as glycerine) and polymeric retention aid suspension.Polymeric retention aid suspension is divided into day again Right polymeric retention aid suspension such as Arabic gum, tragacanth, xanthans, carragheen, sodium alginate, agar, starch slurry etc., are commonly called as Colloidal type；Synthesis or semi-synthetic polymeric retention aid suspension, such as methylcellulose, ethyl cellulose, sodium carboxymethylcellulose, crystallite are fine Element, hydroxypropyl cellulose, carbopol, PVP, glucan etc. are tieed up, cellulose family is commonly called as.
We have found that colloidal type stabilizer and cellulose family stabilization are used alone in the enteral nutrition product of complicated Agent can not play stabilization well, or even can occur serious consistency problem.Due to being rich in enteral nutrition product Mineral matter, such as monovalent ion Na+、K+、Cl-、F-、I-, divalent ion Ca2+、Zn2+、Mg2+、Cu2+、Mn2+、SO4 2-, trivalent ion Fe3+、Cr3+、PO4 3-Deng.Cellulose family stabilizer is used alone can be due to not being resistant to ion higher in enteral nutrition product Concentration, causes its compatibility with system poor, product is flocculated.And the sample for using single colloidal type suspending agent to prepare Product outward appearance is slightly poor, the phenomenons such as floating oil and layering occurs.Therefore, pole need to solve the sedimentation of insoluble substance in enteral nutritional composition Problem, improves its stability.
The content of the invention
It is an object of the invention to provide a kind of enteral nutritional composition of stabilization.
Enteral nutritional composition of the present invention, contains colloid and cellulose.
The addition of colloid and cellulose, improves the stability of composition, so as to solve because insoluble in enteral nutrition product Property species precipitate and cause the problem of nutrient supplement is not enough.
The colloid that the present invention is used can be selected from the one or more of following material：Arabic gum, tragacanth, xanthan Glue, carragheen, pectin, locust bean gum, guar gum, gellan gum, sodium alginate, agar.It preferably is selected from carragheen, pectin, gellan gum With the one or more in xanthans.
In the most preferred embodiment of the present invention, the colloid is gellan gum.
The content of the colloid is unrestricted, as long as containing a small amount of above-mentioned colloid, you can play stable effect.In order to make The convenience of agent, in a preferred embodiment of the present invention, the content range of the colloid can be total based on enteral nutrition product Weight meter is no more than 0.2%；It is preferred that 0.0025-0.15%；More preferably 0.005-0.1%；Most preferably 0.01-0.05%.
The cellulose that the present invention is used can be selected from the one or more of following material：Methylcellulose, ethyl cellulose, Sodium carboxymethylcellulose, microcrystalline cellulose, hydroxypropyl cellulose, carbopol, PVP, glucan etc..It is preferred that carboxymethyl cellulose One or more in plain sodium or microcrystalline cellulose.In a preferred embodiment of the present invention, rising surely used in the present invention Tailor-made cellulose, which does not include soybean dietary fiber, inulin often used in enteral nutritional composition etc., to be used to supplement human body institute Those nutritional ingredients of cellulose are needed, these compositions are used mainly as nutritional ingredient, it can not play stabilization or steady Determine effect not good.
In a preferred embodiment of the present invention, described enteral nutritional composition, it contains mineral matter.It is wherein described Mineral matter can contain the one or more in calcium, magnesium, zinc, iron, manganese, chromium.
In presently preferred embodiment, it contains many selected from insoluble calcium salt, insoluble soybean Sugar or soybean fiber, protein in any one or a few.
The content range of the cellulose is not particularly limited, and can be based on enteral nutrition product gross weight meter 0.005%-0.2%；It is preferred that 0.01%-0.15%；Most preferably 0.015-0.1%.
Enteral nutritional composition of the present invention can contain emulsifying agent, such as soybean lecithin, single double glycerol stearates Ester, sucrose fatty ester, stearoyl lactate, diacetyl tartarate list double glyceride, Tween-80 Deng one or more.Based on enteral nutrition product gross weight, the emulsifier content is about 0.05%~2%.
Enteral nutritional composition of the present invention, in addition to adding colloid and cellulose, remaining nutritional ingredient is conventional Needed by human body composition.As an exemplary example, composition of the invention can also contain in addition to colloid and cellulose Following composition：
Protein 46.8-70.2g Molybdenum 80-120 μ g
Fat 57.6-86.4g Selenium 53.6-80.4 μ g
Carbohydrate 83.2-124.8g Vitamin A 1.6-4.2mg
Dietary fiber 9-15.6g Vitamine D3 3.68-7.50 μ g
Sodium 0.64-1.06g Vitamin E 21.6-44.0mg
Potassium 1.376-2.194_g Vitamin K1 52.8-145.0 μ g
Chloride 0.992-1.488_g Vitamin B1 1.04-2.10mg
Calcium 400-700mg Vitamin B2 1.36-3.00mg
Phosphorus 400-700mg Niacinamide 9.6-16.2mg
Magnesium 176-264mg Vitamin B6 1.28-2.65mg
Iron 10.4-15.6mg Vitamin B12 2.08-4.95 μ g
Zinc 8-12mg Pantothenic acid 3-68-6.95mg
Copper 0.9-1.7mg Biotin 104-190 μ g
Manganese 1.9-3.5mg Folic acid 104-215 μ g
Iodide 106.4-159.6 μ g Vitamin C 70-700mg
Fluoride L.04-1.56mg Choline 212.8-319.2mg
Chromium 52.8-79.2 μ g
As another exemplary example, composition of the present invention, can also be containing such as in addition to colloid and cellulose Lower composition：
Enteral nutritional composition of the present invention solves the settlement issues of insoluble substance, and compatibility is good.Together When compared to single type stabilizer is used, it is less using the consumption of stabilizer during compound stabilizer, that is, save cost, reduction adds Plus influence of the agent to patient, be conducive to industrialized production again.
Embodiment
The present invention is further described by following examples and comparative example.These embodiments and comparative example are only used for Bright property purpose, and the scope being not intended to limit the invention.
Comparative example 1
In order to investigate influence of the stabilizer to enteral nutrition product stability, the enteral nutrition for being added without stabilizer is devised The basic prescription of product, wherein containing protein 58.5g, carbohydrate 104g, lipase 37 2g, dietary fiber 13g, sodium 800mg, Potassium 1.72g, chlorine 1.24g, calcium 500mg, phosphorus 500mg, magnesium 220mg, iron 13mg, zinc 10mg, copper 1.3mg, manganese 2.7mg, the μ of iodine 133 G, fluorine 1.3mg, the μ g of chromium 66, molybdenum 0.1mg, the μ g of selenium 67, dehydroretinol mg, the μ g of vitamine D3 4.6, vitamin E 27mg, vitamin The μ g of K 66, vitamin B1 1.3mg, vitamin B2 1.7mg, niacinamide 12mg, vitamin B6 1.6mg, the μ of vitamin B12 2.6 G, pantothenic acid 4.6mg, biotin 0.13mg, folic acid 0.13mg, vitamin C 80mg, choline 266mg, purified water add to 1000ml.
The specific formula that feeds intake is as follows：
In preparing tank add total amount be 600-750g purified water, start stirring after add thereto casein sodium, Lactalbumin, maltodextrin, sucrose, DEXTROSE ANHYDROUS, lactose, soybean fiber, inulin, sodium chloride, potassium citrate, potassium chloride, Tricalcium phosphate, calcium carbonate, magnesia, magnesium chloride, ferric pyrophosphate, zinc sulfate, copper sulphate, manganese chloride, KI, chromium chloride, molybdenum Sour sodium, sodium selenite, sodium fluoride, vitamin D3Dry powder, vitamin C, vitamin B1, Riboflavine sodium phosphate, niacinamide, D-VB5 Calcium, vitamin B6, folic acid, vitamin B12, Bio, Choline Chloride, mixed fruit essence, its fully dispersed dissolving is made For aqueous phase.Fish oil, linseed oil, sunflower oil, safflower seed oil, median chain triglyceride oil, soybean lecithin, single double stearic acid are sweet Grease, Retinol Palmitate, vitamin E, vitamin K1Dispersing and dissolving, is used as oil phase in a shear condition.By oil phase and water Mixing shearing is mutually carried out, colostrum is prepared.The purified water of surplus is added into colostrum, stirring is removed and defoamed.After will be except defoaming Mixed liquor by homogenizer carry out homogeneous, be cooled to afterwards room temperature enter stand tank preserve, will stand tank Chinese medicine liquid automatic It is filled on bottle placer in Brown Glass Brown glass bottles and jars only and nitrogen charging, rolls lid.Packaged bottled product is placed in rotary water-bath sterilizer Middle to be sterilized, 120-122 DEG C of temperature, F0 values can obtain enteral nutrition product in 10-20 minutes.
Embodiment 1~7
In order to investigate influence of the stabilizer to enteral nutrition product stability, on the basis of above-mentioned enteral nutrition product prescription (be added without any stabilizer for comparative example 1) adds different natural polymeric retention aid suspensions as stabilizer, and prescription is shown in Table 1.
Table 1 adds the enteral nutrition product 1L prescriptions of different natural polymeric retention aid suspensions
Enteral nutrition product is investigated using appearance character, viscosity as index.Wherein viscosity measurement is as follows：Sample is light After light shaking, measured with Brookfield rotation viscometers, temperature is 20 DEG C, using No. 61 rotors 100rpm condition It is lower to determine.Each sample is placed 1M further to investigate its stability under 40 DEG C of acceleration environments, 2 are the results are shown in Table.In this table, with And in the form of the application hereinafter, the number for a certain character "+" number illustrates its order of severity, specifically, example Such as precipitation, ++++﹥ +++ ﹥ ++ ﹥+.
The enteral nutrition product evaluation index and result of the different prescriptions of table 2
As can be seen from Table 2, when not adding stabilizer, there is obvious floating oil and heavy after placing 1M at 40 degree in product Form sediment.After colloid is added as stabilizer, although floating oil slightly improves with precipitation, the feelings incompatible with system are also occurred in that Condition, such as the system for adding xanthans occurs in that layering.In addition it is used as stabilizer containing carragheen, locust bean gum, guar gum Product occur in that a small amount of blob of viscose, show that the amount for adding stabilizer is higher, but still sunk in the case of such a higher concentration Form sediment.Only pectin, gellan gum effect are slightly good.
Embodiment 8~14
Different synthesis or semi-synthetic polymeric retention aid suspension are added on the basis of comparative example as stabilizer, 3 are specifically shown in Table.
Table 3 adds the enteral nutrition product 1L prescriptions of different synthesis or semi-synthetic polymeric retention aid suspension
Enteral nutrition product is investigated using appearance character as index, each sample is placed 1M to enter under 40 DEG C of acceleration environments One step investigates its stability, the results are shown in Table 4.
The enteral nutrition product evaluation index and result of the different prescriptions of table 4
As can be seen from Table 4, individually using cellulose family stabilizer to prepare sample effect poor, flocculates, table Light fibers element class stabilizer and Miscibility are poor.Analysis reason be such stabilizer be not resistant in enteral nutrition product compared with Caused by high ion concentration.
Embodiment 15~22
Gellan gum, pectin, xanthans, carragheen, microcrystalline cellulose and sodium carboxymethylcellulose are mixed according to following table and made TPF product is prepared for stabilizer, 5 are specifically shown in Table.Investigated using appearance character as index, and by each sample Place 1M under 40 DEG C of acceleration environments further to investigate its stability, stability result is shown in Table 6.
The colloid of different proportion is constituted with cellulose in the enteral nutrition product 1L of table 5
The enteral nutrition product evaluation index and result of the different prescriptions of table 6
Embodiment 23~31
Gellan gum, microcrystalline cellulose, sodium carboxymethylcellulose are mixed as stabilizer using certain proportion, enteral battalion is prepared Product is supported, 7 are specifically shown in Table.Investigated using appearance character as index, and each sample is placed into 1M under 40 DEG C of acceleration environments Further to investigate its stability, stability result is shown in Table 8.
The gellan gum of different proportion is constituted with cellulose in the enteral nutrition product 1L of table 7
The enteral nutrition product evaluation index and result of the different prescriptions of table 8
As can be seen from Table 8, gellan gum is mixed with microcrystalline cellulose, sodium carboxymethylcellulose with certain proportion Afterwards, the stability of product can be obviously improved, and compatibility is good.Colloid is combined after use with cellulose, stabilizer is total Amount is significantly reduced, but stability is good.
Comparative example 1 and the product of embodiment 29 (must not be freezed into) closed preservation 12M below 25 DEG C.As a result such as table 9 below institute Show.
The comparative example 1 of table 9 with the product of embodiment 29 is closed preserve 12 months after assay

Claims (12)

1. a kind of enteral nutritional composition, it is characterised in that contain colloid and cellulose.
2. enteral nutritional composition according to claim 1, described colloid is selected from Arabic gum, tragacanth, xanthan One or more in glue, carragheen, pectin, locust bean gum, guar gum, gellan gum, sodium alginate, agar, preferably carragheen, One or more in pectin, gellan gum and xanthans.
3. enteral nutritional composition according to claim 1, described cellulose is selected from methylcellulose, ethyl cellulose One or more in element, sodium carboxymethylcellulose, microcrystalline cellulose, hydroxypropyl cellulose, carbopol, PVP, glucan, One or more in preferably carboxymethyl cellulose sodium or microcrystalline cellulose.
4. enteral nutritional composition according to claim 1 or 2, wherein the content of the colloid is combined based on enteral nutrition Thing gross weight meter is no more than 0.2%；It is preferred that 0.0025-0.15%；More preferably 0.005-0.1%；Most preferably 0.01-0.05%.
5. the enteral nutritional composition according to claim 1 or 3, wherein the content of the cellulose is based on enteral nutrition group Compound gross weight meter is 0.005%-0.2%；It is preferred that 0.01%-0.15%；Most preferably 0.015-0.1%.
6. enteral nutritional composition according to claim 1, it contains mineral matter.
7. enteral nutritional composition according to claim 6, wherein described mineral matter contain selected from calcium, magnesium, zinc, iron, One or more in manganese, chromium.
8. enteral nutritional composition according to claim 1, it contains many selected from insoluble calcium salt, insoluble soybean Sugar or soybean fiber, protein in any one or a few.
9. enteral nutritional composition according to claim 1, it contains emulsifying agent, preferably soybean lecithin, single double stearic acid Glyceride, sucrose fatty ester, stearoyl lactate, diacetyl tartarate list double glyceride, polyoxyethylene sorbitol acid anhydride list oil The one or more such as acid esters.
10. enteral nutritional composition according to claim 9, the emulsifier content about 0.05%~2%.
11. the enteral nutritional composition according to claim any one of 1-10, the composition is emulsion, suspension, powder Agent or granular form.
12. a kind of improve the method for enteral nutritional composition stability, it is characterised in that adds any one of claim 1-5 institute The colloid and cellulose stated.
CN201710034103.3A 2016-01-19 2017-01-17 A kind of enteral nutritional composition Pending CN106974265A (en)

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CN2016100356496 2016-01-19

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109674038A (en) * 2017-10-19 2019-04-26 江苏正大丰海制药有限公司 A kind of oral complete nutritional composition
CN110973644A (en) * 2019-12-16 2020-04-10 广州白云山汉方现代药业有限公司 Casein and whey protein compounded nutritional suspension and preparation thereof
CN113795565A (en) * 2019-03-29 2021-12-14 切尔西科技有限公司 Tracer compositions
CN114365841A (en) * 2021-12-15 2022-04-19 北京诺康达医药科技股份有限公司 Total nutrient milk suitable for patients with nephropathy and preparation method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109674038A (en) * 2017-10-19 2019-04-26 江苏正大丰海制药有限公司 A kind of oral complete nutritional composition
CN113795565A (en) * 2019-03-29 2021-12-14 切尔西科技有限公司 Tracer compositions
CN110973644A (en) * 2019-12-16 2020-04-10 广州白云山汉方现代药业有限公司 Casein and whey protein compounded nutritional suspension and preparation thereof
CN114365841A (en) * 2021-12-15 2022-04-19 北京诺康达医药科技股份有限公司 Total nutrient milk suitable for patients with nephropathy and preparation method thereof
CN114365841B (en) * 2021-12-15 2024-04-19 北京诺康达医药科技股份有限公司 Total nutrient milk suitable for nephrosis patients and preparation method thereof

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