CN101014253A - Human milk fortifiers and methods for their production - Google Patents

Abstract

The present invention relates to a human milk fortifier as well as to several uses and a method for the production of such a fortifier. A particularly beneficial fortifier can be realised in that at least one human component based on a product directly or indirectly derived from human mammary secretion during non-pregnant, pregnant, lactating and/or involuting periods is used, giving rise to an optimally adapted fortifying effect which is particularly useful in the context of feeding preterm infants.

Description

Human milk fortifier and production method thereof

Technical field

The present invention relates to human milk fortifier.It also relates to the concrete using method of these hardening agents and the production method of these hardening agents.

Technical background

Because its trophic component and immunology advantage, human milk is considered to the food of baby's the best usually.In addition, ripe donor human milk is considered to early stage neonate and adds the desirable food that protects premature labor in the chamber, LBWI.Yet, find that ripe donor breast can not provide some nutrients of q.s to satisfy the LBWI needs of growth fast.Owing to these reasons, adding to protect modern neonate from the own mother's of preemie breast has become first-selected food in the chamber.

But not only to premature labor, LBWI, ripe donor breast is not always supplied the suitable mixture of nutrients and immunizing composition, and the full-term newborn infant that is in some stages of development under specific circumstances also needs additive or augments food to obtain the best nutritional condition for ideal growth and best premunition etc.

Not only preemie but also full-term newborn infant are also used usually or are fed at the custom-designed commercial infant formula of these babies or themselves mother's breast.Now still in the research of carrying out about preemie's nutritional need.

Directly quote US6 at this, 294,206 background parts wherein very comprehensively, in detail and has synthetically been described problem and current situation in human milk fortifier field especially preemie's nursing field.

With respect to the estimation of baby's demand, preemie's human milk obviously lacks several compositions such as calcium, phosphorus and protein.When preemie's human milk was strengthened with protein and energy, the growth of LBWI was near situation about taking place in the uterus.In addition, when with calcium with when phosphor intensified, increasing appears in these mineral matters and bone density improves.Therefore, suggestion has been arranged, when the preemie used preemie's human milk feeding, human milk should be reinforced to satisfy preemie's nutritional need better.

At this approved demand, market is on sale home for the preemie of liquid and powder type breast hardening agent.For example can powder Enfamil  (MeadJohnson Nutritionals be arranged the commercial product that obtains, Evansville, Ind.) and liquid Similac Natural Care  (Ross Products Division of Abbott Laboratories, Chicago, ILL.).They not only comprise protein, fat and carbohydrate, also comprise a large amount of mineral matters and vitamin.The source of these compositions is for example whey concentrate (protein), soybean or coconut (fat) and corn syrup (carbohydrate), and that minerals and vitamins can be thought to be derived from is synthetic.Hardening agent they form, composition and energy source and trophic component aspect variant.Usually we can say that powder-product has the advantage that makes the breast milk dilution drop to minimum, yet, can use the liquid hardening agent to replenish her human milk supply if the breast milk supply is limited.

Now need be by preemie and well tolerable powder or the liquid human milk fortifier of full-term newborn infant, it can be added to people's donor Ruzhong, and it provides best nutritional condition to the baby, not only relates to institute's energy requirement but also relates to any other nutritional labeling useful or essential to the baby.

Summary of the invention

The vicarious reinforcement agent and the concrete application of this hardening agent and the method for producing this hardening agent that the purpose of this invention is to provide improved human milk.

The improvement hardening agent of being advised comprises based on directly or indirectly being derived from non-gestation, gestation, lactation and/or at least a people's composition of human milk secretion between convalescence.

Therefore the objective of the invention is according to claim 1 the hardening agent product, according to the using method of claim 18 with according to the production method of claim 23.

According to prior art; hardening agent, the especially hardening agent of preemie's field of nutrition, or based on non-human milk; promptly usually based on cow's milk, or based on synthetic fully system or depend on the system of carbohydrate (especially lactose), fat and the protein of plant origin.The composition that resembles vitamin and mineral matter and so on normally derives from synthetic.Yet well-known, especially for protein, carbohydrate, fat, and a lot of other milk compositions, as antibody etc., they highly depend on the species type.Especially (but not only) for the consideration of immunity and hormone aspect, therefore expectation keep being administered to the baby especially preemie's breast as far as possible near " natural " system, this yes mother's human milk.

Yet under many circumstances, mother's breast is secreted thing or can not be obtained, and perhaps mother's specific mammal gland secretion does not demonstrate the optimised quantity of the special component that allows the desirable feeding condition of baby, and it almost is inevitable therefore using hardening agent.Therefore key feature of the present invention is that surprised discovery can obtain best nutritional condition by hardening agent is provided, and but described hardening agent is to small part preferably basically based on the product that directly or indirectly is derived from human milk.Such hardening agent has (almost) perfectly species specificity composition and composition natively, and therefore can not only promote baby's ideal growth but also offer baby perfectly immunity and hormone supply.Especially for LBW, preemie's situation, these hardening agents are proved to be to be highly profitable.Along with the understanding of this fact that can only provide by breast-feeding baby's best foods constantly increases, newborn storehouse become become more and more popular and therefore the basic material supply of this hardening agent no longer be a problem.

It must be noted that in the scope of the used term of presents " hardening agent ", also it must be understood that the system of " being removed nutrient laden (derich) ".In other words, for example know usually that many preemies handle the limited in one's ability of lactose.Therefore also can be liquid/dry systems according to hardening agent of the present invention, it comprises still less (or not having) lactose (its corresponding lactose that has been removed).Adding such " hardening agent " in breast milk will cause its lactose content far fewer than not with the final dairy compositions of the composition of hardening agent.This is not limited to lactose, also is not limited to other composition such as protein, fat etc., and it can be reduced in hardening agent or even be removed fully.

In the present invention's first preferred embodiment, the hardening agent of being advised be do or liquid form, preferentially concentrated by selectivity.Preferably provide with powder type.

According to another preferred embodiment of the present invention, hardening agent derives from and waits to strengthen the human milk secretion of human milk same individual directly or indirectly.This has special advantage, the composition that the reinforcement of specific breast milk can any other source, thus reduced possible pollution or immunology is disturbed.

According to another preferred embodiment of the present invention, human milk, i.e. people's composition or hardening agent, with respect to original and natural origin in the product of mammal gland secretion, wherein at least a it water and/or non-water natural component by enrichment.In other words, the source material of hardening agent does not adopt its native form and composition, but processed make its special component such as protein or even a kind of specified protein by enrichment.The composition of these enrichments or composition combination can be such as being present in people's protein of milk, fat, carbohydrate, vitamin, mineral matter, hormone, enzyme, cell factor, antibody etc.Providing such specificity to strengthen agent allows to divide in breast milk and can't use this composition or this to form branch by the specific hardening agent of enrichment under the situation of capacity acquisition at certain composition or certain composition.FR specific hardening agent can be provided thus, and it can specifically need be used in combination individually according to relevant baby's (specific needs of baby) and the basic breast milk that is normally provided by mother (breast milk form in specific shortage) subsequently.Especially the useful hardening agent that is enriched with immunity (for example antibody) or hormonal activity composition that provides.These special components be extremely species specificity and therefore provide especially preemie's the brand-new mode of treatment and feeding infant that allows with the hardening agent form.

According to another preferred embodiment of the present invention, people's composition is to small part or preferred all through pasteurization and/or sterilization.This is to pollute relevant problem and in order to preserve for fear of the possible bacterium in donor Ruzhong, virus and other.

According to other preferred embodiment, hardening agent not only comprises the above-mentioned people's composition based on people's donor breast, and it also additionally comprises at least a inhuman complementary element.Inhuman composition for example can be inhuman, preferred cow's milk or newborn extract.As an alternative or as additional, other inhuman composition such as protein, fat, carbohydrate etc. can be provided, all these for example are plant origins.And can comprise vitamin, mineral matter, stabilizing agent, emulsifying agent etc. extraly, it can be natural or synthetic source.

The specific design of hardening agent can be subjected to basic substance, i.e. human milk, regioselective influence.As everyone knows, human milk is not only different with other species on forming, and between female individual even for a female individual, difference is arranged also, and depending on it is to feed in the beginning or obtain in finishing feeding at individuality, human milk is formed and also can be changed.Also have in addition every day variation, day with day between change, to the dependence of length period of pregnancy, and the human milk composition depends on the lactational stage, promptly from lactation in early days to lactation late period also be different.Can utilize this fact, according to the hardening agent of expectation, basic material (human milk) can be taken from the mother who is in the mammary gland secretion moment, such as: after the individual nursing beginning; When finishing to individual nursing; Lactation period.Like this, for example, but very high lactose of first Ruzhong protein and antibody horizontal and fat level are very low, and it can use as very specific hardening agent after simple drying without further isolation technics.Equally also can for example use transitional milk (7-21 days postpartum) or ripe breast (postpartum was greater than 21 days) to obtain specific composition combination and obtain thus that specificity is strengthened agent and without further handling as enrichment etc.

Can provide the extra-nutrition thing to the baby with above-mentioned hardening agent.This can so carry out: above-mentioned hardening agent is added in liquid (people also can be ox or based on the newborn substitute of the commercial baby milk prescription) breast (preferred own mother's of baby breast) and to the baby use this reinforcement human milk.The nutrition aspect that is applied in the premature labor LBWI like this is especially useful.Usually under these conditions, the amount with every milliliter of human milk 0-200mg, preferred 0-50mg adds such hardening agent.In fact, the reinforcement level depends on various parameters, such as health status of pregnant age, infant weight, mother and/or baby etc.Current reinforcement practice is based on total amount of heat, for example per 30 milliliters 20 calories or 24 calories.

Under the situation of hardening agent from human milk, it is from own mother or donor mother, use the average overall nutrients (fatty 3.8g/100ml, protein 1g/100ml, lactose 7.0g/100ml, energy 20Cal/30ml) of human milk, the recommended levels of protein is 2.5g/kg/ days, and infant weight is that 1kg and fluid absorption are 100ml/kg/ days.For example need subsequently the 1.5g dried protein hardening agent from human milk is added in the 100ml human milk.

If use liquid concentrate as hardening agent, similarly consideration also is suitable.

If one day volume of breast milk has 300ml and comprises 18.5g lactose (74cal), 2.4g protein (9.6cal) and 10.8g fat (97cal), to take in be 180.6cal or 18.6cal/oz to the total amount of heat of baby this day so.Mother can determine subsequently whether this is enough to the baby.She can add hardening agent, enrichment or remove nutrient laden breast or with unaltered newborn feeding.

The breast that can handle own mother is to satisfy baby's needs.Can obtain different product and piece together, such as the breast that is rich in protein, lactose-free milk, be rich in the breast of sIgA.

For the preemie, for example recommending protein level is 2.5g protein/kg/ days, recommends volume to be＜180ml/kg/ days and to recommend heat be 24cal/oz.This means for 1.730kg preemie 4.3g/ days protein level and 294 (300) ml/ days volume.

If for example there is not breast milk to use, also can use described hardening agent to improve newborn substitute.Relatively, advise that other method provides the extra-nutrition thing to the baby, preferred preemie, this method comprises hardening agent added in liquid milk and/or the commercial baby milk prescription and with this fortified milk and is administered to the baby.But it is also contemplated that the breast time spent that becomes a mother excessive, human milk based on mother is produced hardening agent, suitably preserve them, and according to circumstances use these hardening agents, can not produce mother oneself under the situation of the capacity breast breast of suitable composition (or have) and use these hardening agents then.

The invention still further relates to the method for producing above-mentioned hardening agent, wherein product directly or indirectly derives from non-gestation, gestation, lactation and/or the mammal gland secretion between convalescence, and this product to small part is separated into independently water and/or non-water constituent or water and/or the combination of non-water constituent.Preferably before or after the water of removing mammal gland secretion and/or non-water section, implement the separation of non-water section.For eliminating and possible bacterium, virus or the relevant problem of other pollution, can advise comprising at least one sterilisation step.Possible separating step comprises a lot of methods, such as freezing, dry, centrifugal, filtration, chelating, film separation, ultrafiltration, counter-infiltration, the separation of affinity post, dialysis or their combination.

It is interesting not only the baby being used the hardening agent advised, and is used for adult and can opens brand-new field.Thus according to another preferred embodiment, to advise a kind ofly providing the method for extra-nutrition thing or additional immune active ingredient to adult, it comprises the above-mentioned hardening agent of using drying or liquid form.

The further embodiment of the present invention is described in the dependent claims.

Description of drawings

Show the preferred embodiments of the invention in the accompanying drawings, wherein:

Fig. 1 is to use the device of filter separation or concentration components;

Fig. 2 shows, (real point) and the total protein content of (circle) afterwards before pasteurization;

Fig. 3 as shown in Figure 2, but show calcium content as the function of ultrafiltration time;

Fig. 4 as shown in Figure 2, but show lactose content as the function of ultrafiltration time;

Fig. 5 as shown in Figure 2, protein content is as the function of ultrafiltration time, 9 hours long running time;

Fig. 6-9 shows the breast milk analysis result as time (postpartum day) function, wherein

Fig. 6 shows the average fat content of different mother's breast milks in 10-60 days postpartum;

Fig. 7 shows the average protein content of different mother's breast milks in 10-60 days postpartum;

Fig. 8 shows the average lactose content of different mother's breast milks in 10-60 days postpartum; With

Fig. 9 shows the average energy content of different mother's breast milks in 10-60 days postpartum.

The specific embodiment

Do not limit the scope of the invention of asking for protection, based on the preparation of the hardening agent of human milk secretion and use and to illustrate by the following several embodiment that provide as claims.

In Fig. 1, show by using the device of filter element separation or concentration components.For this purpose, sample 1 is connected to filter element 3, and on the one hand it allows and leaches thing 4 and be passed to a container and allow supernatant flow back to sample/condensate container 1, wherein relies on pump 2 to promote circulation.

Use this filter (film that has, as 30kD) device so as to keep big key element such as protein and the composition that combines with these big key elements for example calcium (it is attached to casein, a kind of larger protein), allow little molecule such as water, lactose etc. to pass through simultaneously, and will use (60 ℃ of pasteurization steps, 30 minutes) as an option, observe the result shown in Fig. 2-5.

As shown in Figure 2, in fact in the concentrate total protein content can increase about 2 times.As what in Fig. 3, can see, because and combination of proteins, calcium also is enriched in the concentrating part.On the other hand, as what can see in Fig. 4, lactose keeps striding the quasi-equilibrium of film.

Fig. 5 shows long playing protein content, and in fact, protein content can obtain 10 times of increases after moving 9 hours, and promptly volume can drop to 50 milliliters from 500.

Utilize the centrifugal separation of carrying out fats portion on the one hand, carry out the protein of breast or the ultrafiltration of quite big molecular moiety on the other hand, can obtain the result shown in the table 1:

Table 1

			Enrichment
						g/150ml	Centrifugal, g/150ml	Centrifugal, g/6.7ml	Ultrafiltration, g/30ml
Fat
		6	0	6	0
Lactose						9	9	0	9
	Protein	1.5	1.5	0	1.5
Energy, Cal/oz						19.2	8.4	10.8	8.4

Fig. 6-9 shows the breast milk analysis result as time (postpartum day, 17 mothers) function.Can find out that especially at initial several days, nearly all composition all has very big variation.Especially during these stages, be fit to strengthen.Equally, as shown in Figure 9, bigger variation is arranged, subsequently the energy content balance more that becomes at lactational day (＞20 a days) energy content earlier.Among these 17 mothers, average energy is 22.4Cal/oz.So can use energy content in the human milk of current hypothesis, i.e. 20Cal/oz, and strengthen mother's oneself breast.Especially lactational early stage, some people has too much or very few additional breast, and this can cause unnecessary complex situations.

Embodiment 1

Gather the fluid sample (100ml) of human milk samples.Respectively postpartum greater than 10 days with gather human milk from mother of preemie or from the human milk donor during less than 90 days.From gathering newborn sample from the Ruzhong that breast is extruded the process at one day.The basic composition of this breast may be summarized as follows: 3.8% fat, 0.8% protein and 5.2% carbohydrate.Determine the actual energy content of newborn sample.The non-water section (butterfat) of breast is separated and the Ruzhong of top layer (butterfat) carefully being taken out and known volume is added to mother 140ml oneself reaches recommended levels at specific body weight and age preemie with the energy content in the Ruzhong that increases her with water section by centrifugal (10000rpm, 4 ℃).

In addition, can carry out the Bacteria Detection of pasteurization and standard hospital level as standard operation.

The g and D that can observe the preemie is similar to situation about taking place in the uterus.

Embodiment 2

Gather the fluid sample (150ml) of human milk samples.Respectively postpartum greater than 10 days and less than 90 days in, gather human milk from mother of baby's (preemie or ill full-term newborn infant) that special requirement is arranged or from the human milk donor.From gathering newborn sample from the Ruzhong that breast is extruded the process at one day.The basic composition of this breast may be summarized as follows: 3.8% fat, 0.8% protein and 5.2% carbohydrate.Determine the concentration of protein in the newborn sample.The non-water section (butterfat) of breast is separated with water section and take out top layer (butterfat) is careful by centrifugal (10000rpm, 4 ℃).Make water layer pass through and to concentrate water layer (30Kd Omega ultrafiltration slipstream filter membrane, Pall through the filter of lactoprotein subsequently; Temperature is cold as far as possible, is 19 ℃ in particular case).Water section is concentrated after 5 times and (made liquid pass through filter several times to obtain the average level as the protein content of estimating per hour to concentrate in 9 hours, and analyze the protein that concentrates, it is end-product, so that obtain real protein content before in strengthening step, using it), the concentrated milk protein matter of known volume is added to mother's 130ml oneself Ruzhong, thereby makes the Ruzhong protein content be increased to recommended levels at the preemie or the ill term infant at specific body weight and age.

In addition, can carry out pasteurization and standard hospital level Bacteria Detection as standard operation.

It is similar to situation about taking place in the uterus and can to observe the g and D of full-term newborn infant similar to the situation of the full-term newborn infant at similar age to observe preemie's g and D.

Embodiment 3

Gather the fluid sample (500ml) of human milk samples.Human milk picks up from postpartum greater than 90 days human milk donor.From several days processes, gathering newborn sample and freezing preservation from the Ruzhong that breast is extruded.The basic composition of this breast may be summarized as follows: 3.8% fat, 0.8% protein and 5.2% carbohydrate.Determine protein concentration in the newborn sample.The non-water section (butterfat) of breast is separated with water section and take out top layer (butterfat) is careful by centrifugal (10000rpm, 4 ℃).Water layer makes it concentrate (30Kd Omega ultrafiltration slipstream filter membrane, Pall by the filter that can not see through lactoprotein subsequently; Temperature is cold as far as possible, is 19 ℃ in particular case).After water section is concentrated 5 times (as described in the embodiment 2), concentrated solution with at a high speed (210000rpm, 4 ℃) thus centrifugal precipitation casein part.Except protein, casein partly comprises most calcium and phosphorus in the breast milk.To this part carry out pasteurization (the maintenance method, 60 ℃ continue 35 minutes; Use hospital's Bacteria Detection, in all preparation samples, obtain negative findings; Jeffery BS, Soma-Pillay P, Mak (2003) The effect of Pretoria Pasteurization onbacterial contamination of hand-expressed human breastmilk 49 (4) 240-4 J Trop Pediatr) and or as liquid or as the freezing preservation of dry powdered form until needs.This enrichment protein/calcium/the phosphorus of measuring amount partly is used to strengthen mother's oneself breast, and it is used for preemie or ill calcium and the phosphorus balance of full-term newborn infant to recover them.

It is similar to situation about taking place in the uterus and can to observe the g and D of full-term newborn infant similar to the situation of similar age full-term newborn infant to observe preemie's g and D.

Embodiment 4

Gather the fluid sample (1000ml) of human milk samples.Respectively postpartum greater than 10 days and less than 90 days in gather human milk from mother of preemie or from the human milk donor.From several days processes, gathering newborn sample and freezing preservation from the Ruzhong that breast is extruded.The basic composition of this breast may be summarized as follows: 3.8% fat, 0.8% protein and 5.2% carbohydrate.Determine protein concentration in the newborn sample.The non-water section (butterfat) of breast is separated with water section and take out top layer (butterfat) is careful by centrifugal (10000rpm, 4 ℃).Water layer makes it concentrate (30Kd Omega ultrafiltration slipstream filter membrane, Pall by the filter that can not see through lactoprotein subsequently; Temperature is cold as far as possible, is 19 ℃ in particular case).Water section is concentrated 5 times (as described in the embodiment 2), and makes it pass through affinity post (Pharmacia) to separate sIgA and lysozyme subsequently.SIgA and lysozyme soln are saved to when needing by pasteurization (as embodiment 3 described maintenance methods) and so that liquid form is freezing subsequently.The concentrated sIgA of measuring amount or lysozyme soln are used to strengthen the low mother's of sIgA in the breast milk or lysozyme concentration milk.

Embodiment 5

The fluid sample of collection human milk (50mg, 50ml).Human milk is gathered from about 20 days mother in postpartum.Feed beginning and the time gather described sample once specific, promptly its fat content is quite low.The basic composition of this breast may be summarized as follows: 3.8% fat, 1% protein, 7% carbohydrate, 67% energy.Use rotary evaporator to make the water section evaporation of this sample, thereby obtain dry sediment.This sediment is by careful transformation of ownership powdered and avoid violent grinding.6.2mg (breast based on 87.6% be water the fact (Jenness et al. (1970) Dairy Sci.Abstr., 32,599-612).More than the dried hardening agent that all water in Ruzhong and all macronutrients (macronutrients) keep coming from the dried forms of this operation has been removed in operation.

This powder is used as the hardening agent of the human milk that is derived from mother preemie.The 6.2mg hardening agent is added to from mother's the breast milk and feed to the preemie.The g and D that can observe the preemie is similar to situation about taking place in the uterus.

Embodiment 6

The hardening agent of additional embodiment 1 extraly, make that reaching 123-185/100kcal, folate level such as calcium level reaches that 30-45 μ g/100kcal, riboflavin level reach 80-620 μ g/100kcal, Cobastab is that 130-250 μ g/100kcal and vitamin C are 8.3-37mg/100kcal (Klein J.C. (2002) Nutrient Requirements for preterm infant formulas, J.Nutr.132,1395s-1577s).

This powder is used as the hardening agent of the human milk that is derived from mother preemie.Be added to the 6.2mg hardening agent from described mother's Ruzhong and feed to the preemie.The growth that can observe the preemie is approaching with situation about taking place in the uterus.

Embodiment 7

Gather the fluid sample (50mg) of human milk.Human milk picks up from the mother in 1 day postpartum.Gather described sample when once specific nursing finishes, promptly it is rich in fat accordingly.The basic composition of this breast can be summarized as follows: 3.8% fat, 1% protein, 7% carbohydrate, 67% energy.Use rotary evaporator to make the water section evaporation of this sample, thereby obtain dry sediment.This sediment is avoided acutely grinding in mortar by careful transformation of ownership powdered.Operation produces the dried hardening agent of 6.2mg thus.

This powder is used as the hardening agent of the human milk that is derived from mother preemie.Be added to the 6.2mg hardening agent from described mother's 50mg Ruzhong and feed to the preemie.The g and D that can observe the preemie is approaching with situation about taking place in the uterus.

In mother's 150ml oneself breast (EBM), 9.2g lactose, 1.2g protein, 5.44g fat are arranged.After series of computation, 11g butterfat (or fat) is added to her Ruzhong.This condensing protein that derives from ultrafiltration is the solution form.3.085g protein is arranged in 150ml.The total amount of these mothers' oneself that are 300ml through strengthening Ruzhong main nutrient matter and these will discharge 24 for every ounce from every kind of nutrients and the heat after transforming and block.Make in this way, need not use any artificial hardening agent, and only use so-called " real human milk fortifier ", promptly based on donor mother or same mother's hardening agent, can obtain accurately operation now and strengthen mother's oneself breast, with the premature's that satisfies her the nutrition and the needs of energy content.

Described information slip is shown among the embodiment of table 2.

Table 2:

		Real human milk fortifier		The mother's oneself who strengthens breast
						Nutrients	EBM (150ml)	Butterfat (g)	Concentrate (g/150ml)	300ml	Cal/300ml
Lactose	9.24		9.24	18.48	73.92
						Protein	1.215		3.085	4.3	17.2
Fat	5.44	11.1		16.5	148.6

Claims (27)

1. human milk fortifier, it comprises the people's composition based on the product that directly or indirectly is derived from people's mammary gland secretion thing, and described mammal gland secretion is at least one following period: non-pregnancy, the gestational period, lactation period, convalescence.

2. according to the hardening agent of claim 1, wherein it be substantially dry or liquid form, preferably concentrated by selectivity.

3. according to the hardening agent of aforementioned each claim, wherein from people's mammary gland secretion thing of the same individuality of waiting to strengthen human milk, directly or indirectly obtain described hardening agent.

4. according to the hardening agent of aforementioned each claim, wherein it is a powder type.

5. according to the hardening agent of aforementioned each claim, wherein with respect to initial and natural origin in the product of mammal gland secretion, described people's composition is rich at least a its water and/or non-water natural component.

6. according to the hardening agent of claim 5, wherein these compositions are selected from down group or its combination: protein; Fat; Carbohydrate; Vitamin; Mineral matter; Hormone; Cell; Especially calcium, phosphorus, sIgA, casein, lactoferrin, ALA, beta-casein, κ-casein, c3 complement, c4 complement, zinc, sodium, chlorine, aliphatic acid, oligosaccharides, seralbumin, lactose and/or lysozyme.

7. according to claim 5 or 6 each hardening agents, wherein at least a composition is an immune active ingredient.

8. according to the hardening agent of aforementioned each claim, wherein it is the extract that directly or indirectly derives from people's mammary gland secretion thing.

9. according to the hardening agent of aforementioned each claim, wherein people's composition at least in part, preferably fully by heat treatment, pasteurization and/or sterilization.

10. according to the hardening agent of aforementioned each claim, wherein it additionally comprises at least a non-people's of being derived from composition.

11. according to the hardening agent of claim 10, the wherein non-composition that is derived from the people is selected from down group or its combination: protein; Fat; Carbohydrate; Vitamin; Mineral matter; Hormone; Cell; Stabilizing agent; Emulsifying agent; Especially calcium, phosphorus, sIgA, lactoferrin, ALA, beta-casein, κ-casein, c3 complement, c4 complement, zinc, sodium, chlorine, aliphatic acid, oligosaccharides, seralbumin, lactose and/or lysozyme.

12. according to each hardening agent in claim 10 or 11, wherein inhuman composition is breast or the newborn extract of inhuman, preferred ox.

13. hardening agent according to aforementioned each claim, wherein people's composition is based on and is in lactational mammal gland secretion, and wherein it separates from described mammal gland secretion in the specific mammary gland secretion stage, the described specific mammary gland secretion stage such as: individuality is fed after the beginning; Individuality is fed when finishing; Lactation period.

14. with the newborn sample of supplying according to the hardening agent of aforementioned each claim.

15. according to the newborn sample of claim 14, wherein breast is a human milk.

16. according to the human milk samples of claim 15, wherein said sample is strengthened with hardening agent, described hardening agent directly or indirectly derives from from being reinforced people's mammary gland secretion thing of the same individuality of human milk.

17. according to the newborn sample of claim 14, wherein fortified milk is based on inhuman, preferred cow's milk.

18. provide the method for extra-nutrition thing to the baby, it comprise in fluid milk, add according among the claim 1-13 each hardening agent and such fortified milk is administered to the baby.

19. according to the method for claim 18, wherein fortified milk is based on human milk, is preferably based on the breast of the same individuality that oneself is used to prepare hardening agent.

20. according to the method for claim 18, wherein fortified milk is based on inhuman breast, preferred cow's milk or based on commercial baby milk prescription.

21. according to each method among the claim 18-20, wherein fortified milk is applied to premature labor, LBWI.

22. according to each method among the claim 18-21, wherein the addition of hardening agent is every ml breast 0-200mg.

23. preparation, wherein directly or indirectly is derived from non-gestation, gestation, lactation according to the method for each hardening agent among the claim 1-13 and/or between convalescence the product of mammal gland secretion be separated at least in part in the group of other or water and/or non-water constituent or water and/or non-water constituent.

24., wherein in removing mammal gland secretion, implement the separation of non-substantially water constituent before or after the water section according to the method for claim 23.

25. according to claim 23 or 24 each methods, comprising at least one heat treated, pasteurization and/or sterilization steps.

26. according to each method among the claim 23-25, wherein separate to use such as freeze drying, centrifugal, chelating, film and separate, filter, especially composition specificity filtration, ultrafiltration, counter-infiltration, affinity post separate, the method for dialysis or its combination and so on.

27. provide the method for extra-nutrition thing or additional immune active ingredient to adult, it comprise use drying or liquid form according to each hardening agent among the claim 1-13.

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