CN1105270A - Product containing secretion-type immunoglobulin A and preparing process thereof - Google Patents

Product containing secretion-type immunoglobulin A and preparing process thereof Download PDF

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Publication number
CN1105270A
CN1105270A CN 94112011 CN94112011A CN1105270A CN 1105270 A CN1105270 A CN 1105270A CN 94112011 CN94112011 CN 94112011 CN 94112011 A CN94112011 A CN 94112011A CN 1105270 A CN1105270 A CN 1105270A
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siga
precious
breast
goods
carrier
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CN 94112011
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Chinese (zh)
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汤祥菊
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CHINA TAOFEN FOUNDATION
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CHINA TAOFEN FOUNDATION
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Abstract

A product used in medicine, health care, food and cosmetics fields contains secretion-type immunoglobulin A (SIgA) as active component extracted from human colostrum, which is compounded with medicinal, edible, or exterior carrier. Its preparing process is disclosed.

Description

Product containing secretion-type immunoglobulin A and preparing process thereof
The invention belongs to biological product technical field.
SigA sIgA (be called for short SIgA) is the local antibody that is present in the exocrine secretion at positions such as human respiratory tract, digestive tract, urinary tract.In saliva, emulsion, tear, gastric juice, nose and bronchus juice, also extensively exist, but the highest with the content in the human colostrum.With the human colostrum is that raw material is higher through the concentration of the contained SIgA of rough liquid (claiming that again breast is precious) of extraction, has antibacterium and antiviral antibody, can be widely used in fields such as medical treatment, health care, food, cosmetics.
The objective of the invention is to utilize the SIgA that extracts in the human colostrum to be mixed with the goods in fields such as being used for medical treatment, health care, food, cosmetic product as the carrier of active component and medicinal or edible and external.
The invention discloses goods such as the medical treatment that contains the SigA sIgA (SIgA) that from human colostrum, extracts, health care, food, cosmetic product (claiming " breast is precious " goods again) and preparation method thereof.
The characteristics of " breast precious " of the present invention goods be treatment wide, nontoxic, have no side effect.In addition, because it is the natural materials of taking from human body, have the parent to concern with human body, be easy to absorb, the production effect is fast, especially to infant not only can remedy the innate immunity function poor, but also can avoid the hardship of having an injection.Also contain trace element and other factor in " breast is precious ", human health is had high value.
" breast precious " can be mixed with spray with pharmaceutical carrier, puts drops in one's eyes, oral liquid etc. is widely used for diseases prevention and treatment.Can treat upper respiratory tract infection, bronchitis, pulmonary infection, acute and chronic laryngitis, acute suppurative tonsillitis, viral keratitis, allergic rhinitis, children's, adult diarrhea, bacillary dysentery, typhoid fever bacillicarrier, oral ulcer, alopecia areata, seborrheic alopecia, pigmented spots, skin lesion dermatitis etc. clinically.
" breast is precious " can be mixed with health care oral liquid, beverage, confection, cake etc. with edible carrier.
" breast precious " can be mixed with cosmetic product with the external carrier, has the human body skin of promotion, the metabolic effect of hair, moistens face, shines the effect of appearance, pitch-black hair." breast is precious " can also be mixed with " artificial colostrum ", gives neonatal feeding, can improve neonatal immunologic function.
In addition, " breast is precious " also holds out broad prospects to the study on prevention aspect of AIDS, pulmonary carcinoma.
The precious clinical operating position of breast is as follows:
One. the observation of breast precious (the rough liquid of SIgA) treatment infantile diarrhea.
Therapeutic Method:
Adopt precious (the rough liquid of the SIgA) oral medication of breast.Pressing 3-6ml/kg/ day with the 1.9mg/30ml dose concentration calculates.List the curative effect statistics in data in five days, the person promptly calculated invalid standard in>five days.
The infantile diarrhea case is divided matched group and treatment group, and matched group is only used conventional antibiotic therapy, and the treatment group is only used " breast is precious " treatment.
Result: see Table 1, table 2.
Table 1. infantile diarrhea efficacy analysis
Cure the effective total effective rate of produce effects
Curative effect example number % example number % example number % %
Treatment organizes 189 56.25 97 28.87 23 6.84 91.06
Matched group 34 21.38 41 25.79 11 6.92 54.69
Invalid total
Example number % example number %
Treatment organizes 27 8.04 336 100
Matched group 73 45.91 159 100
Table 2. diarrhoea improvement natural law efficacy analysis
Improvement natural law<2 day % 3-5 days %〉% added up to % 5 days
Treatment organizes 160 47.62 123 36.61 53 15.77 336 100
Matched group 18 15.93 44 38.94 51 45.13 113 100
Annotate: 1. cure: no matter light expression is, in or severe diarrhoea, stool shaping or do not rush down the person through treating after.
2. produce effects: represent behind all severe diarrhea treatments times of defecation by>10 times/be reduced to<5 times/day persons.
3. take a turn for the better: represent that all severe changes into moderate or moderate and changes into slight or rare watery stool person that changes into the pasty state after treatment.
4. invalid: represent all above various degree diarrhoea, commentaries on classics person does not get better after the treatment.
Interpretation of result: total effective rate and inefficiency, treatment group and matched group statistical procedures, there is highly significant difference both equal P<0.01.
After effective natural law of treatment group and matched group (<5 days) and invalid natural law>5 were learned day by statistics and handled, there was highly significant difference P<0.01.<2 days and<5 days, also there was highly significant difference P<0.01.All with the treatment group for well.
Therefore, breast precious (the rough liquid of SIgA) has certain therapeutic effect to infantile diarrhea.
Two. the clinical observation of newborn precious liquid spraying Comprehensive Treatment bronchopneumonia.
Therapeutic Method:
On Comprehensive Treatment method basis (comprising antibiotics), use newborn precious 2.5mg, add normal saline 15ml spraying, every day twice, about at every turn 10-15 minute.Select 4-17 days not wait according to the state of an illness course of treatment.
Curative effect sees Table 3.
The newborn precious liquid spraying Comprehensive Treatment bronchopneumonia efficacy analysis of table 3.
The group case load is cured number good revolution invalid number total effective rate (%)
Treatment organizes 29 15 12 2 93.1
Matched group 29 13 12 4 86.21
The result: newborn precious liquid atomizing sucks and can be used as one of Comprehensive Treatment of pneumonia.
Three. " breast is precious " ultrasonic atomizatio sucks the observation of curative effect of treatment bronchial asthma.
Therapeutic Method:
The precious 5mg of breast is dissolved in and does the ultrasonic atomizatio suction in the 20ml normal saline, and once a day, two weeks were a course of treatment.
The result: breathe heavily through 7 routine bronchus are pouted after the stage of attack patient uses bronchial antispasmodic and merge newborn precious ultrasonic atomization therapy, asthma symptom mostly alleviates, and the bronchial antispasmodic of some cases is decrement also, and pulmonary function has the tendency of improvement.
Four. the clinical observation of " breast is precious " treatment infantile respiratory tract infection disease.
Therapeutic Method:
Two groups of cases, the matched group routine is with antibiotics and cough-relieving, anti-asthmatic, serious adding hormone therapy.The treatment group is also precious with breast, and general each 1/4 breast precious (2.5mg) carries out ultrasonic atomization therapy once a day.
The results are shown in Table 4, table 5, table 6.
The comparison of treatment course of treatment of table 4. treatment group and matched group
Treatment group matched group
The course of treatment (my god) case load % case load %
1-3 18 60 0 0
4-5 7 23.3 8 26.6
4-10 2 6.7 20 66.7
>11 3 10 2 6.7
Add up to 30 30
The curative effect of table 5. treatment group and matched group relatively
Curative effect
The group case load
Cure number % produce effects and count the good revolution % of % invalid number %
30 24 80 4 13.4 1 3.3 1* 3.3 are organized in treatment
Matched group 30 20 66.7 7 23.3 3 10 00
Table 6. treatment group and matched group curative effect are relatively
Group cure rate (%) shows than rate (%) improvement rate (%) inefficiency (%)
Treatment organizes 80 93.4 96.7 3.3
Matched group 66.7 90 100
The result: the SIgA that contains in the newborn treasured is the key factor of the local anti-infectious immunity of mucosa.Important function being arranged in treatment and prevention in the respiratory tract infection, is a kind of comparatively ideal medicine, not only can shorten the course of treatment, but also can improve curative effect.
Five. the observation of newborn precious liquid spraying treatment adult chronic bronchitis.
Therapeutic Method:
Patient is except that conventional therapy for the treatment group, and sprays with newborn precious liquid.This spray liquid is that newborn precious liquid 5mg+ gentamycin 80,000 m+ Chymotrypsin 5mg are mixed with 10ml, is generally the course of treatment 10 days.The results are shown in Table 7.
The newborn precious liquid spraying treatment adult chronic bronchitis of table 7. is observed
Severity extent
The treatment case load merges the significant figure effective percentage
The natural law expectoration breathe heavily more (+-
Figure 941120112_IMG2
) the Lu sound (twenty- ) medication (%)
3-5 6 4 4 2 4 1 6 100
6-7 4 4 4 2 4 4 4 100
Add up to 10 88485 10
Conclusion: in this medicine therapeutic process, the patient is very comfortable after all feeling to spray, and sensation is light, doing well,improving.
Six. the observation of the precious treatment of breast upper respiratory tract infection.
Therapeutic Method:
The precious 10mg/1 of breast propped up is distributed into 8mg(two feed rations) and the 4mg(daily dose), be loaded in the plastics eyedrops bottle.Infant is 4 in collunarium or drip chamber per hour, must lie on the back when dripping, and makes that medicinal liquid is fluence goes into nasopharynx part.(generally stop using night)
The results are shown in Table 8.
The curative effect of the precious treatment of table 8. breast upper respiratory tract infection
Curative effect Case load Recovery from illness produce effects and significant figure Effective percentage
The SigA group 86 78 90.69%
Matched group 86 52 60.46%
Conclusion: breast is precious to upper respiratory tract infection, and the particularly viral infection that causes also can be treated.Convenient drug administration, safely, be suitable for and promote the use of.
Seven. the precious treatment to viral oculopathy of breast is observed.
Therapeutic Method:
The precious lyophilized preparation 10mg/1 of breast props up, and is dissolved into aqueous solution with normal saline 5ml and is used for viral keratitis and viral conjunctivitis patient, local drop, per 2 hours 1 time.
The results are shown in Table 9.
The curative effect of the viral oculopathy of the precious treatment of table 9. breast
Curative day is on average controlled
Group example number 1-3 days 4 days 5-7 days natural law more more than 8 days
Comprehensive Treatment group 85 examples 57 examples 10 examples 18 examples 0 3.36 days
List is organized 10 examples, 2 examples, 8 examples 6.6 days with SIgA
Conventional therapy group 20 examples 00 15 examples 5 examples 7.2 days
Annotate: the Comprehensive Treatment group is newborn treasured+conventional medicine.
Conclusion: newborn precious eye drop pH is neutral, and nonirritant when uniting use with conventional medicine, can shorten the course of treatment, promotes healing.
Except that above-mentioned, newborn treasured can also be used for the treatment of the disease of ear, nose, specialty of pharyngolaryngology etc.
Another object of the present invention is to disclose the preparation method that contains SigA sIgA (SIgA) goods (newborn precious goods).
Concrete technology of the present invention such as figure five expressions.
Method of the present invention is characterized in that adopting low-temperature centrifugation, filter press technique to extract SIgA from human colostrum, has improved the upper prop method of saltouing of prior art.
Method of the present invention may further comprise the steps:
(1) from human colostrum, extract the rough liquid of SigA sIgA (SIgA) (or dry product) (breast is precious):
Get no history of virus hepatitis and HBsAg(hbs antigen) collecting colostrum in three days puerperal of negative puerpera is in cleaning container, detect HBsAg again one time, the colostrum of HBsAg feminine gender left in a week in 4 ℃ the refrigerator, separate out fat deposit, getting the following colostrum of fat deposit sucks in the cleaning container, carried out centrifugal 30 minutes, further remove fat, carry out secondary coarse filtration and fine straining with the acetic acid microporous filter membrane then, it is biochemical then synthetic that filtrate is regulated pH3~7 with 1NHCl, aseptic filtration, the sampling check chemical examination.Promptly get " breast is precious " rough liquid, get the dried frozen aquatic products preservation through freezing or through lyophilization.
(2) preparation " breast is precious " goods:
Will " breast precious " rough liquid (or dry product) be mixed with the goods of various medical treatment, health care, food, cosmetic product with medicinal or edible or external carrier, wherein the consumption of " breast is precious " and carrier is by weight for containing " breast is precious " 0.01~99.9% and containing the composition of carrier 99.9~0.01% with arbitrary proportion formulated 100%.
Above-mentioned medicinal, edible or external carrier is glucose, Mel, beta-carotene, vitamin C, glyceryl monostearate, stearic acid, white oil, nipalgin, sodium laurylsulfate, glycerol, triethanolamine and other conventional carriers.
Preparation method technology of the present invention is simple, especially adopts low-temperature centrifugation, filter press technique to extract SIgA from human colostrum, and extraction ratio doubles, and also can save 60% raw material.Every double centner breast treasured can be saved 60,000 yuan of RMB, for suitability for industrialized production creates favorable conditions.
The human colostrum extracting solution that obtains with preparation method of the present invention (breast is precious) quality standard is as follows: 1. content: SIgA 40mg/100ml.
2. hbs antigen (HBSAg) detects: feminine gender.
3. protein content: 1g/100ml.
4. sterility test: feminine gender.
5. Main Ingredients and Appearance S-IgA (SIgA) character prison is fixed:
(1) figure one. and S-IgA detects.
Wherein: going up the hole is sample, and following hole is that α heavy chain, groove are that anti-people α heavy chain principal figure proves that newborn precious extracting solution is corresponding with the α heavy chain, and contains SIgA.
(2) figure two. and S-IgA detects
Wherein 1,3 holes are sample, and 2,4 holes are the α heavy chain
Under arrange each hole and be anti-people α heavy chain serum.
The visible sample of this figure and α heavy chain, chain, the newborn precious extracting solution of proof contain SIgA mutually.
(3) figure three. detect SIgA activity in the newborn precious extracting solution
Last Kong Weiyuan doubly by must the time faller gill be respectively
1∶2、1∶4、1∶8、1∶16、1∶32。Mesopore is anti-people α serum.
The effective high activity of SIgA in the visible sample of this figure.
(4) figure four. and different pH are to the influence of SIgA in the beverage
Hole, a left side is the rough liquid of pH6.0 Sucus Citri Reticulatae liquid+equivalent
Mesopore is the rough liquid of pH3.0 Sucus Citri Reticulatae liquid+equivalent
Right hole is the rough liquid of pH7.0PBS+ equivalent
This figure can see that the diffusion circle size is consistent, illustrates that pH3.0-7.0 does not influence SIgA and tires.
Embodiment one: preparation " breast is precious " oral medicinal liquor
" breast is precious " stock solution 300 is restrained, and 20% glucose 1000ml is mixed with the oral liquid that every bottle of 5ml includes the SIgA1.5 gram according to a conventional method.
Example two: preparation " breast is precious " nutrition oral administration
With Mel, β carotin, vitamin C, the precious oral liquid that is mixed with every bottle of 10ml according to a conventional method of breast, wherein contain Mel 10%, β carotin 1000Iu, vitamin C 30 grams, newborn precious 1ml.
Example three: preparation " breast is precious " frost
Glyceryl monostearate 100 grams, stearic acid 140 grams, cured 240 grams of liquid, nipalgin 1 gram, sodium laurylsulfate 4 grams, glycerol 100 grams, triethanolamine 15 grams, distilled water 170ml, newborn precious 230ml are mixed with " breast is precious " frost that total amount is 1000 grams according to a conventional method.

Claims (4)

1, the goods that contain SigA sIgA, it is characterized in that these goods be by the S-IgA that from human colostrum, extracts as the carrier of active ingredient and medicinal or edible and external, with the weight ratio active ingredient be 0.01~99.0% with carrier be 99.9~0.1% formulated by arbitrary proportion.
2, the preparation method that contains the goods of SigA sIgA as claimed in claim 1 the method is characterized in that to comprise the following steps:
(1) from human colostrum, extract the rough liquid of SigA sIgA (SIgA) (or dry product) (breast is precious):
Get no history of virus hepatitis and HBsAg(hbs antigen) collecting colostrum in three days puerperal of negative puerpera is in cleaning container, detect HBgAg again one time, the colostrum of HBsAg feminine gender left in a week in 4 ℃ the refrigerator, separate out fat deposit, getting the following colostrum of fat deposit sucks in the cleaning container, carried out centrifugal 30 minutes, further remove fat, carry out secondary coarse filtration and fine straining with the acetic acid microporous filter membrane then, it is biochemical then synthetic that filtrate is regulated pH3~7 with 1NHCI, aseptic filtration, the sampling check chemical examination.Promptly get " breast is precious " rough liquid, get the dried frozen aquatic products preservation through freezing or through lyophilization.
(2) preparation " breast is precious " goods:
Will " breast precious " rough liquid (or dry product) be mixed with the goods of various medical treatment, health care, food, cosmetic product with medicinal or edible or external carrier, wherein the consumption of " breast is precious " and carrier is by weight becoming 100% composition for " breast treasured " 0.01~99.9% with arbitrary proportion preparation face with carrier 99.9~0.01%.
Above-mentioned medicinal, edible or external carrier is glucose, Mel, solatene, vitamin C, glyceryl monostearate, stearic acid, white oil, nipalgin, sodium laurylsulfate, glycerol, triethanolamine and other conventional carriers.
3, contain of the application of the goods of the SigA sIgA that from human colostrum, extracts as preparation medicine, health product, food, cosmetics.
4, the goods that contain secreting type immune globulin A according to claim 1 is characterized in that wherein said carrier medicinal or edible and external is glucose, Mel, solatene, vitamin C, glyceryl monostearate, stearic acid, white oil, nipalgin, sodium laurylsulfate, glycerol, triethanolamine.
CN 94112011 1994-01-14 1994-01-14 Product containing secretion-type immunoglobulin A and preparing process thereof Pending CN1105270A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Application Number Priority Date Filing Date Title
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CN1105270A true CN1105270A (en) 1995-07-19

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000059519A3 (en) * 1999-03-31 2001-01-11 Kapitz Carl Heinz Active agent and combination of active agents for human beings and animals
WO2002072142A3 (en) * 2001-03-12 2003-03-20 Univ Groningen Modulation of a balance between the gut mucosal immune system and the intestinal microflora
CN1313153C (en) * 2004-09-28 2007-05-02 翁维楷 Use of immunoglobulin and cell growth factor in preparing medicine for asthma
CN106636110A (en) * 2016-05-08 2017-05-10 杨岭燕 Kit for detecting gynecologic chronic pelvic inflammation and detection method thereof

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000059519A3 (en) * 1999-03-31 2001-01-11 Kapitz Carl Heinz Active agent and combination of active agents for human beings and animals
WO2002072142A3 (en) * 2001-03-12 2003-03-20 Univ Groningen Modulation of a balance between the gut mucosal immune system and the intestinal microflora
CN1313153C (en) * 2004-09-28 2007-05-02 翁维楷 Use of immunoglobulin and cell growth factor in preparing medicine for asthma
CN106636110A (en) * 2016-05-08 2017-05-10 杨岭燕 Kit for detecting gynecologic chronic pelvic inflammation and detection method thereof

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