CN1544040A - Medicine for increasing immunocompetence of children and its preparing process - Google Patents
Medicine for increasing immunocompetence of children and its preparing process Download PDFInfo
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- CN1544040A CN1544040A CNA2003101122351A CN200310112235A CN1544040A CN 1544040 A CN1544040 A CN 1544040A CN A2003101122351 A CNA2003101122351 A CN A2003101122351A CN 200310112235 A CN200310112235 A CN 200310112235A CN 1544040 A CN1544040 A CN 1544040A
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Abstract
The invention discloses a medicament for enhancing children's immunocompetence which comprises the following constituents with parts by weight, astragalus root 75-85, dried orange peel 5.5-7, white atractylodes rhizome 50-60, Chinese yam 75-85, ledebouriella root 22-32, oyster 75-85. The traditional Chinese composition according to the invention has the function of improving body immunocompetence. The invention also discloses the process for preparing the medicament.
Description
Technical field
The present invention relates to the field of Chinese medicines, relate in particular to a kind of immunity enhancement type Chinese medicine composition.
Background technology
According to the incomplete statistics of United Nations Children's Fund, developing country has 1,400 10000 children below 5 years old to die to have a delicate constitution every year approximately, the dystrophic disease.These children exist that immunity is poor, premunition is weak, the low disease basis of digestive function.The cold child of simple application immunomodulator or the easy donor of nutrition enhancer brings other secondary disease, serious side effects and untoward reaction.Then curative effect is not good enough for Chinese patent medicine at present.
Summary of the invention
The object of the present invention is to provide a kind of tonifying the lung consolidating superficial resistance, invigorating spleen and reinforcing stomach, human body immunity improving ability, prevent and treat the medicine of weak repeated respiratory tract infections in children.
Another object of the present invention is to provide a kind of manufacturing method for above mentioned medicine.
The medicine that the present invention strengthens the immunization programs for children ability is the medicament of being made by the following weight proportion raw material:
The Radix Astragali 75～85 Pericarpium Citri Reticulataes 5.5～7
The Rhizoma Atractylodis Macrocephalae 50～60 Rhizoma Dioscoreaes 75～85
Radix Saposhnikoviae 22～32 Concha Ostreaes 75～85
The weight proportion of each raw material of the present invention is preferred:
The Radix Astragali 80.5 Pericarpium Citri Reticulataes 6.5
The Rhizoma Atractylodis Macrocephalae 53.5 Rhizoma Dioscoreaes 80.5
Radix Saposhnikoviae 27 Concha Ostreaes 80.5
The preparation method of the medicine of enhancing immunization programs for children ability of the present invention may further comprise the steps:
A. get Rhizoma Dioscoreae, Pericarpium Citri Reticulatae and clean, it is standby to break into fine powder respectively;
B. get Concha Ostreae, the Radix Astragali decocts with water;
C. get the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, it is standby to collect volatile oil with steam distillation, and medicinal residues decoct with water 1.5 hours again, filters;
D. merge B, C item filtrate, be condensed into thick paste, 2/3 Rhizoma Dioscoreae powder in the adding steps A and the Pericarpium Citri Reticulatae powder mixing of full dose, dry and film-making;
E. 1/3 Rhizoma Dioscoreae powder in the Yu Xia steps A and syrup mixing are made sugar-coat.
Chinese medicine composition of the present invention is made up of the Radix Astragali, Rhizoma Dioscoreae, Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae etc., has tonifying Qi and lifting yang, invigorating spleen and reinforcing stomach, dampness, diuretic, hidroschesis, effect such as dispel the wind, reduce phlegm.Pharmacological evaluation shows that compositions of the present invention has the phagocytic function that increases mononuclear phagocyte system, and immune indexes improves, and especially IgA is apparent in view, increases T lymphocyte content, and the human body immunity improving ability improves effects such as body is cold-resistant, endurance; The recurrent respiratory tract infection number of times is reduced, and occurring degree reduces, the course of disease shortens, and good efficacy is arranged; Improve stomach and receive, the more preceding obesity of thin and weak child after the medication; Be applicable to the empty hyperhidrosis of juvenile's body, easily catch a cold, symptoms such as fatigue and weakness, inappetence.Because the present invention adopts the coated tablet dosage form, takes safe ready, the child is acceptant, and the process of taking finds no side effect.
The specific embodiment
Embodiment 1
Embodiment 1 is the preparation method of Chinese medicinal tablet of the present invention:
(A) get Rhizoma Dioscoreae 80.5 gram, Pericarpium Citri Reticulatae 6.5 grams are cleaned, it is standby to break into fine powder respectively;
(B) get Concha Ostreae 80.5 gram, the Radix Astragali 80.5 grams add decocting twice, 2 hours for the first time, 1.5 hours for the second time, put coldly, filter;
(C) get the Rhizoma Atractylodis Macrocephalae 53.5 gram, that Radix Saposhnikoviae 27 grams are collected volatile oil with steam distillation is standby, medicinal residues decoct with water 1.5 hours again, put coldly, filter;
(D) merge B, C item filtrate, be condensed into thick paste, 2/3 Rhizoma Dioscoreae powder in the adding steps A and the Pericarpium Citri Reticulatae powder mixing of full dose, drying is ground into fine powder, adds adjuvant and correctives mixing, granulation, drying, performance oil among the step C is used an amount of anhydrous alcohol solution, is sprayed in the dried particles tabletting after airtight 30 minutes equably;
(E) 1/3 Rhizoma Dioscoreae powder, one sugar in the Yu Xia steps A mixes the slurry coating.
Can make 1000 Chinese medicinal tablets by above-mentioned steps.The Chinese medicinal tablet chewing that the present invention makes is taken, and also can be ground into powdery warm water and take.
Embodiment 2
Embodiment 2 is a pharmacological testing of the present invention.
1, acute toxicity test
Choose 13 of the strong white mice of 18～22 gram bodies, male and female are not limit, and press the administration of 16g/Kg body weight oral dose, are equivalent to 572 times of clinical amounts, see and look into 72 hours, and none death of all animals does not also have any untoward reaction.
2, Chinese medicinal tablet of the present invention is to the influence of phagocytic function
(1) to the influence of colloid carbon granule removing speed in the white mice blood plasma:
Get 29 of body weight 17～22 gram healthy mices, male and female are not limit, and divide two groups at random, and wherein the water for injection group is irritated stomach once by 0.2ml/10g body weight, Chinese medicinal tablet group of the present invention by the 14mg/10g body weight every day, continuous 12 days.Pressed 24ml/10g body weight white mice tail vein injection india ink diluent on the 12nd day, injection prepared Chinese ink is got drop of blood with special capillary tube from mice vena orbitalis posterior clump respectively in the time of 2 minutes, 12 minutes and is gone into the ceramic whiteware that wash with heparin solution in advance and drip on the plate, with the accurate absorption of microsyringe 30 μ l and 0.1%Na
2CO
3The solution mix homogeneously with the blood charcoal concentration of the 200-10 of Hitachi type Vis-UV spectrophotometer colorimetric determination different time under maximum absorption wavelength 576nm, and calculates blood charcoal according to following formula and removes the K value,
The results are shown in Table 1:
Table 1
| Group | Number of animals | Dosage 10g every day | Phagocytic index X ± SD | ????t | ????p |
| The water for injection group | ????15 | ????0.2ML | ??-0.0721±0.2197 | ??11.686 | ???＜0.01 |
| Of the present invention group | ????14 | ????14mg | ??0.0324±0.0310 |
(2) to the influence of normal white mice immune organ:
Get 29 of body weight 17～22g healthy mices, male and female are not limit, and divide two groups at random, and wherein the water for injection group is irritated stomach once by 0.2ml/10g body weight dosage, Chinese medicinal tablet group of the present invention by 14mg/10g body weight dosage every day, continuous 12 days.After the 12nd natural gift another name is heavy, measure its height, take off cervical vertebra and put to death, dissection takes by weighing liver, spleen and thymic weight (go to adhere to fat and connective tissue only, take by weighing weight with analytical balance) and the results are shown in Table 2:
Table 2
| Group | The example number | Have a net increase of body weight g | The heavy g/10g body weight of liver | The heavy mg/10g body weight of spleen | Thymus mg/10g body weight | Height cm | |||||
| ? X±SD | ??P | ? X±SD | ??P | ? X±SD | ??P | ? X±SD | ?P | ? X±SD | ??P | ||
| The water for injection group | ??15 | ??1.48± ????1.55 | ??＜ ??0.01 | ??0.41± ????0.05 | ??＜ ??0.01 | ??48.52± ????16.64 | ??＜ ??0.01 | ??95.4± ????16.38 | ?＞ ?0.05 | ??8.21± ????0.5 | ??＞ ??0.05 |
| Tablet group of the present invention | ??14 | ??4.71± ????1.71 | ??0.417± ????0.06 | ??45.51± ????15.83 | ??98.78± ????16.21 | ??8.48± ????0.43 | |||||
(3) to the influence of the positive percent of white mice tail cell AMAE:
Get 28 of body weight 17～22g healthy mices, male and female are not limit, and divide two groups at random, and wherein the water for injection group is irritated stomach once by 0.2ml/10g body weight dosage, Chinese medicinal tablet group of the present invention by 14mg/10g body weight dosage every day, continuous 12 days.Irritate stomach in the 12 day and get blood by tail after 30 minutes, push jack.Behind the natural drying, will fix 30 seconds in 4 ℃ of formaldehyde-acetone buffer of blood sheet immersion.With flowing water flushing one minute, natural drying in the air immersed in the Incubating Solution more then, 37 ℃ of incubations 2 hours, and reuse flowing water flushing slide 3 minutes, air drying is used then than dye liquor and was redyed 1～2 hour, takes out slide, air drying.The oil mirror calculates the positive percent of lymphocyte ANAE down, the results are shown in Table 3:
Table 3
| Group | The example number | ANAE positive lymphocyte % X ± SD | ????T | ????P |
| The water for injection group | 15 | ????0.555±0.067 | ????4531 | ????＜0.01 |
| Tablet group of the present invention | 15 | ????0.671±0.068 |
Above-mentionedly experiment showed, that Chinese medicinal tablet of the present invention can significantly increase the phagocytic function of the mononuclear phagocyte system of white mice, weight increase, liver are heavy, increase ANAE positive lymphocyte percentage rate, increase cellular immune function, and the P value is all less than 0.01.
3, cold-resistant endurance effect
Get 20 of body weight 18～22g healthy mices, male and female are not limit, and divide two groups at random, are respectively normal saline group and invention tablet group.Above-mentioned normal saline group is pressed 0.2ml/10g body weight dosage, tablet group of the present invention and is pressed 14mg/10g body weight dosage and irritated behind the stomach 30 minutes.Observe swimming time, the water-bath capacity is 30cm
3, in fill 12 ℃ of tap waters.The white mice of 1/10 body weight of bearing a heavy burden is dropped in the water, and timing immediately is till the white mice submerged is no longer swum out of the water surface.Result such as table 4 when relatively each group adheres to swimming:
Table 4
| Group | The example number | Dosage/10g body weight | Swimming time/second (X ± SD) | ????P |
| The water for injection group | ????10 | ????0.2ml | ????52.8±9.48 | ????24％ |
| Tablet group of the present invention | ????10 | ????14mg | ????65.5±27.35 |
Above-mentionedly experiment showed, that Chinese medicinal tablet of the present invention has and improve the cold-resistant fatigue proof effect of white mice.Can significantly increase the phagocytic function of the mononuclear phagocyte system of white mice, weight increase, liver weigh, and increase T lymphocyte content, improve cellular immune function, improve cold-resistant, the endurance effect of body.Oral animal maximal tolerated dose (the P0.16g/Kg body weight is observed none death in 72 hours), white mice does not see toxic side effect, illustrates that the present invention is a kind of safe and effective medicine.
Embodiment 3
Embodiment 3 is a clinical trial data.
Sex: male 88 examples, women 77 examples, totally 165 examples.The masculinity and femininity ratio is 1.14: 1.
Age: minimum 9 months, maximum 12 years old; 32 examples below 3 years old, 3～5 years old 103 example,＞5 years old 30 example.
The recurrent respiratory tract infection medical history that all cases all have number of times not wait.165 routine weak children belong to insufficiency of lung-QI or deficiency of both lung and spleen by the Chinese medical discrimination typing, and wherein insufficiency of lung-QI type 76 examples account for 46.1%, and deficiency of both lung and spleen type 89 examples account for 53.9%.Main clinic symptoms sees Table 5:
Table 5
Blood routine examination: the minimum 8.3g of hemoglobin, the highest 14.1g; It is minimum 2,620,000 that red blood born of the same parents count, the highest by 4,240,000; Minimum 4600/ (mm) of numeration of leukocyte
3, the highest by 15900/ (mm)
3, see Table 6:
Table 6
| Blood routine examination | Hemoglobin (g%) | Red blood cell count(RBC) (ten thousand) | ||||
| ????＜10 | ????10～12 | ????＞12 | ??300～400 | ????＞400 | ????＜300 | |
| The example number | ????15 | ????37 | ????14 | ??20 | ????11 | ????3 |
| ????％ | ????22.7 | ????88.1 | ????21.2 | ??58.8 | ????32.4 | ????8.8 |
Three of immunologic function Ig check 119 examples, the minimum 20mg% of IgA, the highest 280mg%; The minimum 295mg% of IgG, the highest 1540mg%; The minimum 60mg% of IgM, the highest 280mg% sees Table 7:
Table 7
| Immunologic test | ???????????IgA(mg/ml) | ????IgG(mg/ml) | ???????????IgM(mg/ml) | ||||||
| ??0.2～0.5 | ??0.51～1 | ??＞1 | ??＜8 | ??8～10 | ??＞10 | ??＜1 | ??1～1.5 | ??＞1.5 | |
| Example | ??41 | ??45 | ??33 | ??30 | ??38 | ??51 | ??12 | ??68 | ??39 |
| ??％ | ??34.5 | ??37.8 | ??27.7 | ??25.2 | ??31.9 | ??42.9 | ??10.1 | ??57.1 | ??32.8 |
Therapeutic Method: chew clothes or be pressed into powder and feed.The child is 4/time more than 4 years old, below 4 years old 3/time.Every day four times.One month is a course of treatment, serve on for 1～5 course of treatment.
Curative effect judging standard:
(1) general curative effect evaluation criterion
Cure: finish the course of treatment afterwards not recur respiratory tract infection more than 6 months;
Produce effects: the minimizing of respiratory tract infection number of times is more than 2/3 during the treatment or after finishing the course of treatment, and attack degree significantly alleviates;
Effectively: the minimizing of respiratory tract infection number of times is more than 1/2 during the treatment or after finishing the course of treatment, and attack degree obviously alleviates;
Invalid: the respiratory tract infection number of times reduces less than 1/2, and symptom does not have obvious improvement.
(2) pattern of syndrome curative effect determinate standard
Recovery from illness: the cardinal symptom complete obiteration, integrated value reduces 〉=95%;
Produce effects: the cardinal symptom integrated value reduces 〉=70%;
Effectively: cardinal symptom, sign integrated value reduce 〉=30%;
Invalid: do not reach above standard person, integrated value reduces less than 30%.
Efficacy analysis:
1. each clinical unit's checking the results are shown in Table 8:
Table 8
| Guangzhou Children's Hospital | ??50 | ??27 | ??54.0 | ??18 | ??36.0 | ??5 | ??10.0 | ??45 | ??90.0 |
| Guangzhou No.2 People's Hospital | ??19 | ??5 | ??26.3 | ??11 | ??57.9 | ??3 | ??15.7 | ??16 | ??84.2 |
| The Fanyu District the People's Hospital | ??54 | ??21 | ??38.8 | ??27 | ??50.0 | ??6 | ??11.1 | ??48 | ??88.9 |
| Add up to | ??165 | ??73 | ??44.3 | ??75 | ??45.5 | ??17 | ??10.3 | ??148 | ??91.0 |
The present invention verifies 165 examples, total effective 148 examples, and total effective rate is 90%, wherein produce effects 73 examples account for 44.3%.
2. the typing curative effect sees Table 9:
Table 9
3. clinical symptoms and curative effect see Table 10:
Table 10
Can see that from last table the present invention improves significantly cardinal symptoms such as the cough of debility child, hyperhidrosis, stomach poor appetite, disappearance rate is respectively 50.8%, 80.2% and 72.5%.
4. the regulating action to immunologic function sees Table 11:
Table 11
5. every index relatively sees Table 12 before and after the treatment:
Table 12
Check before and after the index treatment that highly significant difference (P＜0.001) is arranged for above-mentioned five.In this batch of case, normal value (every case that provides is judged by the normal value of this institute) is provided for IgA, IgG before the treatment of part debility child, and treatment back majority can rise to normal level or increase.The present invention has regulating action to immunologic function.
Claims (7)
1, a kind of medicine that strengthens the immunization programs for children ability is the medicament of being made by the following weight proportion raw material:
The Radix Astragali 75～85 Pericarpium Citri Reticulataes 5.5～7
The Rhizoma Atractylodis Macrocephalae 50～60 Rhizoma Dioscoreaes 75～85
Radix Saposhnikoviae 22～32 Concha Ostreaes 75～85
2, the medicine of enhancing immunization programs for children ability according to claim 1 is characterized in that the weight proportion of each raw material is:
The Radix Astragali 80.5 Pericarpium Citri Reticulataes 6.5
The Rhizoma Atractylodis Macrocephalae 53.5 Rhizoma Dioscoreaes 80.5
Radix Saposhnikoviae 27 Concha Ostreaes 80.5
3, the medicine of enhancing immunization programs for children ability according to claim 1 and 2 is characterized in that also comprising correctives.
4, the medicine of enhancing immunization programs for children ability according to claim 1 and 2 is characterized in that described medicine is a tablet.
5, the preparation method of the described medicine of the arbitrary claim of claim 1～3 may further comprise the steps successively:
A. get Rhizoma Dioscoreae, Pericarpium Citri Reticulatae and clean, it is standby to break into fine powder respectively;
B. get Concha Ostreae, the Radix Astragali decocts with water;
C. get the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, it is standby to collect volatile oil with steam distillation, and medicinal residues decoct with water 1.5 hours again, filters;
D. merge B, C item filtrate, be condensed into thick paste, 2/3 Rhizoma Dioscoreae powder in the adding steps A and the Pericarpium Citri Reticulatae powder mixing of full dose, dry and film-making;
E. 1/3 Rhizoma Dioscoreae powder in the Yu Xia steps A and syrup mixing are made sugar-coat.
6, preparation method according to claim 5 is characterized in that Concha Ostreae, the Radix Astragali decoct with water twice among the described step B, 2 hours for the first time, and 1.5 hours for the second time.
7, preparation method according to claim 5, it is characterized in that powder is beaten in dry back among the step D, and add adjuvant and correctives mixing, granulation, drying, volatile oil among the described step C is sprayed on the dried particles tabletting after airtight 30 minutes after with anhydrous alcohol solution equably.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2003101122351A CN1261138C (en) | 2003-11-21 | 2003-11-21 | Medicine for increasing immunocompetence of children and its preparing process |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2003101122351A CN1261138C (en) | 2003-11-21 | 2003-11-21 | Medicine for increasing immunocompetence of children and its preparing process |
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| Publication Number | Publication Date |
|---|---|
| CN1544040A true CN1544040A (en) | 2004-11-10 |
| CN1261138C CN1261138C (en) | 2006-06-28 |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103494996A (en) * | 2013-09-29 | 2014-01-08 | 青岛农业大学 | Pharmaceutical composition for improving immunity of livestock and poultry and preparation method of pharmaceutical composition |
| CN103519293A (en) * | 2013-11-04 | 2014-01-22 | 付洪杰 | Fresh extract capable of improving child immunity and preparing method thereof |
| CN103830481A (en) * | 2014-03-26 | 2014-06-04 | 杨巧芝 | Medicine for treating recurrent respiratory tract infection of children |
| CN104435555A (en) * | 2014-12-17 | 2015-03-25 | 李君佩 | Traditional Chinese medicine granular preparation containing oysters and Chinese yams and preparation method of the traditional Chinese medicine granular preparation |
| CN105832954A (en) * | 2016-04-20 | 2016-08-10 | 广州康和药业有限公司 | Preparation method of medicine for enhancing children's immunity |
| CN114404511A (en) * | 2022-03-03 | 2022-04-29 | 广州康和药业有限公司 | Pharmaceutical composition for treating qi-deficiency cough caused by children recurrent respiratory tract infection and preparation method and application thereof |
-
2003
- 2003-11-21 CN CNB2003101122351A patent/CN1261138C/en not_active Expired - Lifetime
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103494996A (en) * | 2013-09-29 | 2014-01-08 | 青岛农业大学 | Pharmaceutical composition for improving immunity of livestock and poultry and preparation method of pharmaceutical composition |
| CN103519293A (en) * | 2013-11-04 | 2014-01-22 | 付洪杰 | Fresh extract capable of improving child immunity and preparing method thereof |
| CN103519293B (en) * | 2013-11-04 | 2015-02-11 | 付洪杰 | Fresh extract capable of improving child immunity and preparing method thereof |
| CN103830481A (en) * | 2014-03-26 | 2014-06-04 | 杨巧芝 | Medicine for treating recurrent respiratory tract infection of children |
| CN103830481B (en) * | 2014-03-26 | 2016-08-17 | 杨巧芝 | The medicine for the treatment of infantile respiratory tract infection repeatedly |
| CN104435555A (en) * | 2014-12-17 | 2015-03-25 | 李君佩 | Traditional Chinese medicine granular preparation containing oysters and Chinese yams and preparation method of the traditional Chinese medicine granular preparation |
| CN105832954A (en) * | 2016-04-20 | 2016-08-10 | 广州康和药业有限公司 | Preparation method of medicine for enhancing children's immunity |
| CN114404511A (en) * | 2022-03-03 | 2022-04-29 | 广州康和药业有限公司 | Pharmaceutical composition for treating qi-deficiency cough caused by children recurrent respiratory tract infection and preparation method and application thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1261138C (en) | 2006-06-28 |
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