CN1129452C - Buccal tablet of epidermal growth factor - Google Patents
Buccal tablet of epidermal growth factor Download PDFInfo
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- CN1129452C CN1129452C CN 01108194 CN01108194A CN1129452C CN 1129452 C CN1129452 C CN 1129452C CN 01108194 CN01108194 CN 01108194 CN 01108194 A CN01108194 A CN 01108194A CN 1129452 C CN1129452 C CN 1129452C
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- egf
- buccal tablet
- growth factor
- epidermal growth
- oral
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Abstract
The present invention relates to a biological buccal tablet for treating oral diseases of oral ulcer, gum bleeding, gingivitis, stomatitis, etc., which uses an epidermal growth factor as a main raw material, and contains excipient. The biological buccal tablet is characterized in that the buccal tablet also contains 0.00002 wt% to 0.002 wt% of EGF, 0.1 wt% to 1 wt% of EGF activator and 0.1 wt% to 1 wt% of EGF protective agent.
Description
The present invention relates to a kind of biological product class buccal tablet that is used for the treatment of oral diseases such as oral ulcer, gingival hemorrhage, gingivitis, stomatitis, specifically a kind of buccal tablet of epidermal growth factor.
Recurrent oral ulceration is the commonly encountered diseases and the frequently-occurring disease of the department of stomatology, and at present the topical remedy that uses clinically mostly is chemicals or Chinese medicine preparation, inanimate object goods still so far, however chemicals still is that Chinese medicine preparation all has obvious defects.
Treat stomatocace medicine as chemical classes:
1, amcinonide film (as " meaning can be pasted " etc.)
Be bilayer tablet, basic unit is an oral cavity epidermis binding agent, and the medicine layer is pregnant steroid hormone.Need when these product use the saliva moistening of medicine film basic unit is sticked to affected part in the oral cavity with finger with the medicine film then, promptly unhygienic also inconvenient, pharmaceutically active partly is a steroid hormone in addition, and human body is had certain side effect.
2, iodine buccal tablet (as Dobell etc.)
For being the oral buccal tablet of Main Ingredients and Appearance with iodine, iodine is used for the treatment of oral erosion can only plays bacteriostasis, and the reparation of wound surface is cut little ice, the mouthfeel extreme difference of iodine in addition is even it is still not good to add a large amount of correctivess.
The medicine of Chinese medicine class treatment oral disease for another example cures mainly as products such as SHANGLIAOHOUFENG SAN, watermelon crystal, Herba Pileae Scriptae, sirens and to be laryngopharynx swelling and pain, and is inoperative or effect is little to the treatment oral ulcer.This series products is mainly Borneolum Syntheticum and Borax at the active ingredient of oral ulcer, yet Borneolum Syntheticum and Borax only are used to suppress antibacterial, and is powerless to the oral mucosa reparation, its pharmacological action does not still have foundation, drug action is also not obvious, and administration can't accurate quantification, does not have clear and definite quality standard.
Generally speaking, the chemicals of above-mentioned treatment oral ulcer or Chinese medicine preparation all can only work the function that suppresses bacterial infection, and to improve oral mucosa self reparation, the subjective antisepsis ability is inoperative, is to cure the symptoms, not the disease.
Purpose of the present invention then is the obvious deficiency at above-mentioned existing chemicals and Chinese medicine preparation, and providing a kind of is the biological product class oral buccal tablet of primary raw material with the epidermal growth factor.
Technical solution of the present invention:
Epidermal growth factor (Epidermal Growth Factor, abbreviation EGF) single chain polypeptide of forming by 53 amino acid residues, contain three pairs of disulfide bond in the molecule, molecular weight is 6 KD, be a kind of important somatomedin of human endocrine, denier can promote the division and the growth of epidermis cell strongly.The biological effect of EGF comprises:
1. significantly promote the growth and breeding of epithelial tissue cell;
2. chemotaxis: in the process of wound repair, EGF has chemotaxis to inflammatory cell, fibroblast, epidermis cell, vascular endothelial cell, and it is moved to wound site, and division and proliferation quickens wound repair, also plays antiinflammation simultaneously;
3. strengthen intercellular substance albumen synthesis capability, make the collagen fiber linear arrangement;
4. promote that low molecular weight compound initiatively is transported to from the extracellular in the cell, to increase the nutrient substance of cell;
5. the activation glycolysis is to increase respiratory metabolism, activating phosphatase fructokinase;
6. promote new vessels formation and nucleic acid, proteinic synthetic, thereby by synthesizing of matter between the hamartoplasia important cells promoting all kinds of wound healings.
These biological effects show that epidermal growth factor can pass through conducted signal, cause that a series of biochemistrys change in the cell, start the gene relevant with cell division, make akinete enter cell division cycle, thereby make cell proliferation.The chemotaxis of EGF also has the antiinflammatory bacteriostasis efficacy to wound surface simultaneously.
Buccal tablet of epidermal growth factor of the present invention be a kind of be the biological product class oral buccal tablet that is used for the treatment of oral diseases such as oral ulcer of primary raw material with EGF; it comprises excipient; it is characterized in that described buccal tablet also contains EGF0.00002-0.002%; EGF activator 0.1-1%; EGF protective agent 0.1-1%, all percents are percetage by weight.
Concrete component of the present invention and content are: (weight percentage ranges)
EGF 0.00002-0.002％
EGF activator 0.1-1%
EGF protective agent 0.1-1%
Excipient 85-90%
Binding agent 5-10%
Lubricant 0.2-2%
Correctives 0.5-1%
Coloring agent 0.5-1%
Each composition is exemplified below:
EGF: as M-EGF (mEGF), CEGF (cEGF), hEGF
(rEGF), RhEGF (rhEGF).
EGF activator: as sucralfate or hydroxyprolyl-cellulose.
EGF protective agent: as aminoacids complex, vitamin, polysaccharide, metal ion phosphate.
Excipient: as lactose or sucrose.
Binding agent: as arabic gum or gelatin.
Lubricant: as magnesium stearate or Polyethylene Glycol (PEG).
Correctives: as stevioside, Mentholum, citric acid.
Coloring agent: green insoluble food coloring, if green lake.
The present invention adopts wet granule compression tablet, and its technological process is as follows: earlier with excipient, correctives and coloring agent mixing, add binding agent and make uniform soft material, granulate by the 14-16 mesh sieve, wet grain is dry in 40 ℃ of-50 ℃ of baking ovens, and dry granular is crossed 12-14 mesh sieve granulate.Other get 95% ethanol and Oleum menthae miscible; evenly be sprayed on grain and (or take out an amount of granule absorption Oleum menthae; again with all the other granule uniform mixings); evenly add lubricant; put in the open-top receptacle and placed one hour; to be mixed with the EGF activator of EGF and EGF protective agent again and evenly add the back tabletting promptly, through sealed packet adorn finished product.
Below with regard to quality standard of the present invention, raw material sources and pharmacology and clinical being further elaborated:
1, quality standard
[outward appearance] light green tablet, assorted some color＜0.5%, pitted skin＜0.5%
[weight] every 0.6g, weight differential＜± 5%
[hardness] is not less than 4kgf (measuring with the Mansanto durometer)
[drug content] EGF content is not less than the 0.12ug/ sheet, assay method: use the protein electrophorese method, with
Standard substance are the Rf value and the concentration depth relatively, qualitative, quantitative.
2, raw material sources
Source one: extract EGF from the submaxillary gland of animal, the submaxillary gland of mainly can have drawn from mice or calf is through dividing
Get the M-EGF (mEGF) and the long factor (cEGF) of cattle hypergene from purification.
Source two: from people's urine, extract purification hEGF (hEGF).
Source three: the genetic engineering recombination method is produced recombinant human epidermal growth factor (rhEGF).
3, pharmacology and clinical
I. pharmacological research
Rat skin lower injection EGF observes its variation to transglutaminase in rats'liver, skeletal muscle and the mucous membrane of small intestine tissue and glutamine synthetase.Show that EGF can significantly increase the activity of glutamine metabolism enzyme, increase the synthetic and utilization of the metabolic main energy sources substance-glutamine of intestinal mucosa, thereby promote the healing of intestinal mucosal barrier damage.
II. toxicological study
Obvious ANOMALOUS VARIATIONS does not all appear in ordinary circumstance, blood and biochemical indicator, histopathologic examination, organ coefficient and tectology through all animals of long term toxicity test of acute toxicity test in mice, rat long term toxicity test and dog.
III. pharmacodynamic study
When confirming to rat EGF, use experiment in vitro sucralfate or hydroxyprolyl-cellulose (HPC) can significantly dwindle the ulcer area.
IV. clinical research
Select 100 routine oral ulcer patients at random, the patient suffers from 1-30 days oral ulcer time and does not wait, and wherein 88 people repeatedly suffer from this disease, and 12 people are first patient, and all the patient is the adult and is and uses the treatment of EGF buccal tablet first.
[method] is divided into patient 4 groups at random: first group of 25 example used the EGF buccal tablet; Second group of 25 routine applied chemistry medicine class buccal tablet; The 3rd group of 25 example used Chinese medicine class buccal tablet; The 4th group of 25 examples are made blank, use the buccal tablet that only contains sucrose.
[result] medication the 3rd day, EGF organizes cure rate 72%, chemicals group cure rate 28%, Chinese drug-treated group cure rate 12%, blank group 0%.Medication the 6th day, EGF organizes cure rate 100%, chemicals group cure rate 68%, Chinese drug-treated group cure rate 56%, the blank group is according to day 0%, and symptom increases the weight of gradually.Learn processing, X by statistics
2Between check, EGF and other three groups significant difference is arranged all.(P＜0.05)
Can draw from above result and the invention has the advantages that: buccal tablet of epidermal growth factor of the present invention has significant curative effect to oral ulcer, gingivitis, gingival hemorrhage, stomatitis, also plays the effect of the above-mentioned oral disease of prevention simultaneously.This product cool taste is comfortable, and color and luster is elegant in appearance, and use is that health is convenient again, and the drug effect performance is lasting, is a kind of novel biological product buccal tablet.
The several embodiment of various details, but content of the present invention is not limited to this fully.
Embodiment 1:
Adding arabic gum 0.48kg makes uniform soft material after getting lactose 5.3kg, stevioside 60g and coloring agent 50g mixing, granulates by 16 mesh sieves.Wet grain is dry in 45 ℃ of baking ovens, and dry granular is crossed 14 mesh sieve granulate.Other get 95% ethanol 50ml and the 10g Oleum menthae miscible, evenly be sprayed on granule.Evenly add the 60g magnesium stearate, put in the open-top receptacle and placed one hour, again with M-EGF (mEGF) 0.08g, sucralfate 30g and 10g glycine, 5g lysine, 15g vitamin C, 1gNa
3PO
4The mixture mixing after add, press 10000 promptly.
Embodiment 2:
Reparation technology is with embodiment 1, and it is as follows to prepare burden:
RhEGF (rhEGF) 0.0012g
Sucralfate 10g
Chitin 15g
Vitamin C 15g
Na
3PO
41g
Lactose 5.4kg
Stevioside 10g
Citric acid 40g
Coloring agent 40g
Arabic gum 0.35kg
Oleum menthae 20g
Polyethylene Glycol 12g
Press 10000 promptly
Embodiment 3:
Reparation technology is with embodiment 1, and it is as follows to prepare burden:
CEGF (cEGF) 0.12g
Hydroxyprolyl-cellulose 60g
Glycine 20g
Lysine 10g
Chitin 8g
Catergen 0g
Na
3PO
4?0.5g
Sucrose 5.1kg
Stevioside 10g
Citric acid 40g
Coloring agent 50g
Gelatin 0.6kg
Oleum menthae 10g
Press 10000 promptly
Claims (2)
1, a kind of buccal tablet of epidermal growth factor; comprise excipient; it is characterized in that described buccal tablet also contains EGF0.00002-0.002%; EGF activator: sucralfate or hydroxyprolyl-cellulose 0.1-1%; the EGF protective agent: vitamin, metal ion phosphate 0.1-1%, all percents are percetage by weight.
2, buccal tablet of epidermal growth factor according to claim 1 is characterized in that EGF is M-EGF mEGF, CEGF cEGF, hEGF hEGF or genetic engineering reorganization epidermal growth factor rhEGF.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01108194 CN1129452C (en) | 2001-04-10 | 2001-04-10 | Buccal tablet of epidermal growth factor |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01108194 CN1129452C (en) | 2001-04-10 | 2001-04-10 | Buccal tablet of epidermal growth factor |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1318415A CN1318415A (en) | 2001-10-24 |
| CN1129452C true CN1129452C (en) | 2003-12-03 |
Family
ID=4657077
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 01108194 Expired - Fee Related CN1129452C (en) | 2001-04-10 | 2001-04-10 | Buccal tablet of epidermal growth factor |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1129452C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100784134B1 (en) | 2006-10-09 | 2007-12-12 | 주식회사 대웅 | Stable liquid compositions for treating mucositis comprising epidermal growth factor |
| CN105031614A (en) * | 2015-06-26 | 2015-11-11 | 天津市聚星康华医药科技有限公司 | Oral care composition capable of resisting to inflammation and relieving ulcer and application thereof |
| CN106691883A (en) * | 2016-12-23 | 2017-05-24 | 深圳前海七叶树生物科技有限公司 | Toothpaste and preparation method thereof |
-
2001
- 2001-04-10 CN CN 01108194 patent/CN1129452C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
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| CN1318415A (en) | 2001-10-24 |
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