CN108543061A - A kind of slow release tablet and preparation method thereof promoting oral cavity and/or Esophageal Mucosa reparation - Google Patents
A kind of slow release tablet and preparation method thereof promoting oral cavity and/or Esophageal Mucosa reparation Download PDFInfo
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- CN108543061A CN108543061A CN201810319457.7A CN201810319457A CN108543061A CN 108543061 A CN108543061 A CN 108543061A CN 201810319457 A CN201810319457 A CN 201810319457A CN 108543061 A CN108543061 A CN 108543061A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/193—Colony stimulating factors [CSF]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/661—Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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Abstract
The present invention relates to a kind of promotion oral cavity and/or the slow release tablets of Esophageal Mucosa reparation, including：Chip base comprising edible glue, maltose or mannitol, xylitol, D-sorbite, flavouring agent and plasticizer, wherein edible glue, maltose or mannitol, xylitol, D-sorbite, flavouring agent and plasticizer weight ratio be 20 30%：15 25%：20 30%：15 25%：3 5%：5 10%；And it is distributed in the functional components factor in chip base comprising recombined human granulocyte-macrophage stimulating factors.Solve the problems in the oral cavity of chemotherapy generation and/or the mucositis treatment of oesophagus.It is easy to operate the invention further relates to a kind of promotion oral cavity and/or the preparation method of the slow release tablet of Esophageal Mucosa reparation.
Description
Technical field
The present invention relates to field of medicaments, and in particular to a kind of slow release tablet and preparation method thereof promoting Mucous rehabilitation.
Background technology
Radiotherapy is one of the essential therapeutic arsenals of incidence and thoracic malignant tumors, especially nasopharyngeal carcinoma, lung cancer,
In the treatment of the tumours such as the cancer of the esophagus, the effect of radiotherapy is irreplaceable.Radiotherapy is while killing tumour cell, unavoidably
Ground can cause to damage to the normal structure around tumor tissues and in ray path, wherein relatively conventional is mucosa injury, packet
Include the mucous membrane etc. of oral cavity, pars oralis pharyngis and oesophagus.According to the difference of degree of injury, simple limitation inflammation is can behave as, mucous membrane is de-
Fall to form ulcer, severe patient can concurrent mucous membrane deep bacterium or fungal infection, soft palate or perforation of hard palate can be caused in oral cavity, in oesophagus
Esophageal perforation etc. can then be caused.The damage of mucous membrane not only causes patient diet, drinking-water obstacle, while the pain to differ with degree,
Patient is influenced to the tolerance degree and quality of life of radiotherapy, this is all related to the long-term control of tumour.
Although the incidence and severity of mucosa injury are using modern radiotherapy technology such as intensity modulated radiation therapy (IMRT)
It substantially reduces, but still can not be ignored compared with conventional radiotheraphy afterwards.Include especially chemotherapy, target with the use in conjunction of slow release tablet
To treatment and immunization therapy improve treat curative effect while, increase the probability of happening of side reaction and serious to some extent
Property.In addition, there are individual differences for the radiosensitivity between patient, identical (change) treatment scheme of putting is safety in some patientss
, but possible toxicity is apparent in another part patient, there is very big difficulty to the anticipation of mucosa reaction in clinical position at present,
To the Radiation mucositis disease that has occurred and that also without effective means.Therefore prevent the generation of mucosal inflammation and promote early stage glutinous
The quick reparation of film inflammation is crucial.By the improvement of radiotherapy technology, the radiation acceptable dose of mucous membrane of mouth is further decreased；It is logical
It crosses using certain slow release tablet or means reduction oral mucosa to the sensibility of radiation, it can be with mucosa reaction in preventive radiotherapy
Generation or there is serious mucosa reaction.
It is clinically directed to the treatment of chemicotherapy correlation mucositis at present, mainly using intravenously administrable or containing gargling administering mode.
Intravenous administration approach, it is inconvenient for use, and systemic reaction, it is obvious that excessively high including blood picture, blood viscosity is abnormal, low blood pressure headache,
Nausea or vomiting etc..Therefore the compliance for reducing patient to a certain extent, is unfavorable for preventative and therapeutic use.Containing gargling
The deficiency of administering mode, essentially consist in gargle it is existing time is short and pressing, and in order to keep the concentration of the drug in gargle,
Larger usually using the amount of gargle, economic benefit is poor.
Invention content
For the problems in the mucositis treatment for solving oral cavity and/or oesophagus that above-mentioned chemotherapy generates, the present invention provides one
Kind promotes the slow release tablet and preparation method thereof of oral cavity and/or Esophageal Mucosa reparation.
According to a kind of slow release tablet promoting oral cavity and/or Esophageal Mucosa reparation provided by the invention, including：Chip base,
Including edible glue, maltose or mannitol, xylitol, D-sorbite, flavouring agent and plasticizer, wherein edible glue, maltose or
Mannitol, xylitol, D-sorbite, flavouring agent and plasticizer weight ratio be 20-30%：15-25%：20-30%：15-
25%：3-5%：5-10%；And it is distributed in the functional components factor in chip base comprising recombinant human granulocyte-macrophage
Stimulating factor.
Preferably, edible glue is Arabic gum or gutta-percha.
Preferably, flavouring agent is butyric acid second propyl ester or ethyl butyrate.
Preferably, plasticizer is rest in peace resin or frankincense.
Preferably, chip base and the weight ratio of recombined human granulocyte-macrophage stimulating factors are 4：0.000075-0.0001.
Preferably, the functional components factor further includes 2- (3- amino Propylamino)-ethyl mercaptan phosphate.
Preferably, chip base, recombined human granulocyte-macrophage stimulating factors and 2- (3- amino Propylamino)-ethyl mercaptan phosphoric acid
The weight ratio of ester is 4：0.000075-0.0001：0.1-0.2.
Preferably, functional components factor even dispersion in chip base.
The present invention also provides a kind of promotion oral cavity and/or the preparation methods of the slow release tablet of Esophageal Mucosa reparation, including with
Lower step：S1：Uniform mixed edible glue, maltose, xylitol, D-sorbite, flavouring agent and plasticizer in pure water are formed
Chip base；S2：Chip base and the functional components factor are mixed, slow release tablet is formed.Preferably, the mixing temperature of step S1 is 50
℃-60℃.Preferably, step S2 is specially：Chip base is cooled to 25 DEG C -35 DEG C, recombinant humangranulocyte is first added into chip base
Macrophage stimulation factor adds 2- (3- amino Propylamino)-ethyl mercaptan phosphate；Continue to stir, natural cooling, after solidification
Tabletting is cut.
Preferably, the addition sequence of the functional components factor described in the step S2 is：Recombinant humangranulocyte is first added
Then macrophage stimulation factor adds 2- (3- amino Propylamino)-ethyl mercaptan phosphate.
A kind of slow release tablet promoting oral cavity and/or Esophageal Mucosa reparation provided by the invention, is given using oral slow-release
Prescription formula, when directly avoiding the general reaction of intravenous administration approach generation, and greatly extending contact of the drug with mucous membrane
Between.Drug is big by carrier concn of saliva, more economical saving.Although intravenous administration approach can make drug in mucous membrane reach certain
Concentration, but due to the damage of capillary in mucous membrane, the effective concentration of mucous membrane surface drug can be influenced.
Therefore, slow release tablet is using saliva as medium, is conducive to drug in the distribution of mucous membrane surface and drug into mucous membrane
Infiltration, form effective drug concentration levels in mucous membrane surface and be widely distributed in mucous membrane face, the distribution of drug is made more to accord with
The characteristic distributions that the combination of syndromes becomes, are unlikely to missed areas occur.
The prevention of chemicotherapy mucositis is extremely important, but in view of the shortcoming of existing clinical medicine measure, chemoprophylaxis
It is not easy to carry out, or intermittent can only execute, or executed in the patient for having high risk factor, which results in mucositis
Occur very common.The present invention uses the oral slow-release administering mode of class " chewing gum " mode, and administration is easy, improves patient
For the acceptance and compliance of drug, preventive administration can be executed in all patients, reduce patient and the general of mucositis occurs
Rate.For still there is the patient of mucositis, the concentration of drug can be improved by way of increasing drug frequency of use,
Further promote the reparation of inflammation.
In addition, the slow release tablet also has the function of saliva stimulating glandular secretion, this secretion work(for maintaining oral cavity body of gland
It can be extremely important.
Specific implementation mode
Below in conjunction with the specific implementation mode of the present invention, technical scheme of the present invention is described in detail, but such as
Lower embodiment is only to understand the present invention, and cannot limit the present invention, the feature in embodiment and embodiment in the present invention
It can be combined with each other, the invention can be implmented in many different forms as is defined and embodied by the claims.
Embodiment 1
A kind of the preparation method of the slow release tablet of oral cavity and/or Esophageal Mucosa reparation is promoted to include according to provided by the invention
Following steps：
Step S1, uniform mixed edible glue, maltose, xylitol, D-sorbite, flavouring agent and plasticising in pure water
Agent forms chip base；
Step S2, mixing chip base and the functional components factor, form slow release tablet.
Specifically, step S1 weighs edible glue 0.8g, maltose 1g, xylitol including being S11 according to following based formulas
1.2g, D-sorbite 0.6g, flavouring agent 0.2g and plasticizer 0.2g.In the present embodiment, edible glue uses Arabic gum, fragrance
Agent uses butyric acid second propyl ester, and plasticizer is using resin of resting in peace.Pure water is added, stir about 30-60 minutes at 50-60 DEG C, directly
It is completely dissolved to each component, is uniformly mixed, obtains chip base.
Chip base is cooled to 30 DEG C, the functional components factor is successively added into chip base by step S2 including being step S21
For：Recombined human granulocyte-macrophage stimulating factors 0.000075g and 2- (3- amino Propylamino)-ethyl mercaptan phosphoesterase 30 .1g；
Continue stirring 30-60 minutes；Make functional components factor even dispersion in chip base.Then, natural cooling, solidification tabletting cutting
Size is formed to be about 1 × 1.5 × 1.5cm, weigh about 4 grams of slow release tablet A.
Embodiment 2
Embodiment 2 is similar to Example 1, but there are following differences：
Edible glue：1.2g
Maltose：0.6g
Xylitol：0.8g
D-sorbite：1g
Flavouring agent：0.12g
Plasticizer：0.28g
Wherein, edible glue uses Arabic gum, flavouring agent to use butyric acid second propyl ester, and plasticizer is using resin of resting in peace.At this
Piece based formulas includes in embodiment：
The functional components factor includes：
Recombined human granulocyte-macrophage stimulating factors：0.0001g
2- (3- amino Propylamino)-ethyl mercaptan phosphate：0.2g
Ultimately form slow release tablet A.
Embodiment 3
Embodiment 3 is similar to Example 1, but there are following differences：
Edible glue：0.8g
Mannitol：1g
Xylitol：1.2g
D-sorbite：0.6g
Flavouring agent：0.2g
Plasticizer：0.2g
Wherein, edible glue uses gutta-percha, flavouring agent that ethyl butyrate, plasticizer is used to use frankincense.
The functional components factor includes：
Recombined human granulocyte-macrophage stimulating factors：0.000085g
2- (3- amino Propylamino)-ethyl mercaptan phosphate：0.2g
Ultimately form slow release tablet A.
Embodiment 4
Embodiment 4 is similar to Example 1, but there are following differences：
Piece based formulas includes：
Edible glue：1.08g
Maltose：0.6g
Xylitol：0.8g
D-sorbite：1g
Flavouring agent：0.12g
Plasticizer：0.4g
Wherein, edible glue uses Arabic gum, flavouring agent to use butyric acid second propyl ester, and plasticizer is using resin of resting in peace.
The functional components factor includes：
Recombined human granulocyte-macrophage stimulating factors：0.0001g
Ultimately form slow release tablet B.
Embodiment 5
Embodiment 5 is similar to Example 1, but there are following differences：
Piece based formulas includes：
Edible glue：1.2g
Mannitol：0.6g
Xylitol：0.8g
D-sorbite：1g
Flavouring agent：0.12g
Plasticizer：0.28g
Wherein, edible glue uses gutta-percha, flavouring agent that ethyl butyrate, plasticizer is used to use frankincense.
The functional components factor includes：
Recombined human granulocyte-macrophage stimulating factors：0.000075g.
Ultimately form slow release tablet B.
Embodiment 6
Embodiment 6 is similar to Example 1, but there are following differences：
Piece based formulas includes：
Edible glue：1.08g
Mannitol：0.6g
Xylitol：0.8g
D-sorbite：1g
Flavouring agent：0.12g
Plasticizer：0.4g
Wherein, edible glue uses gutta-percha, flavouring agent that ethyl butyrate, plasticizer is used to use frankincense.
The functional components factor includes：
Recombined human granulocyte-macrophage stimulating factors：0.000085g
Ultimately form slow release tablet B.
Above example is formed by slow release tablet A and slow release tablet B can be used for the mouth of head and neck neoplasm chemicotherapy patient
The prevention of chamber and throat mucositis；The treatment in the oral cavity and throat mucositis of head and neck neoplasm chemicotherapy patient；Breast tumor is put
The prevention of the Esophageal Mucosa inflammation of patients undergoing chemotherapy and the treatment of the Esophageal Mucosa inflammation of breast tumor chemicotherapy patient.Application method is such as
Under：
(1) slow release tablet A is used for preventive use, i.e., when mucositis not yet occurs：
(1) daily using three times；1 tablet once slow release tablet A；Including of mouth, holds time 20-30 minutes.
(2) put/chemotherapy before 30 minutes use 1 slow release tablet A.
(3) slow release tablet B is used for forward and backward 5-8 hours or so in what slow release tablet A was used, to keep opposite intermittent.
Medication example：
A, if receiving radiotherapy 8 points of patient morning：7：30 give slow release tablet A；13：00 and 20：00 gives slow release tablet
B；
B, if receiving radiotherapy at 3 points in patient afternoon：Morning 8：00 gives slow release tablet B；Afternoon 2：30 give slow release tablet
A；At night 21：00 gives slow release tablet B again.
(4) service life of slow release tablet A and slow release tablet B are worked as with chemicotherapy cycle phase.
(2) therapeutic use has occurred and that clinical visible mucositis：
On the basis of continuing to use preventive use, the access times of slow release tablet B can be increased to 4-5 times daily, same to time delay
2-4 weeks after the long period to chemicotherapy using slow release tablet B.
According to a kind of slow release tablet promoting oral cavity and/or Esophageal Mucosa reparation provided by the invention, volunteer patients' is first
The prepared slow release tablet patient compliance of step assessment display is good, easy to be easy-to-use；Relative to the patient without using slow release tablet
(control group patient), the oral mucosa inflammation using the head and neck neoplasm patient of slow release tablet is slighter, patients with lung cancer and oesophagus
The esophagitis reaction of cancer patient is also slighter, and considerably lighter, feeling of pain reduction is influenced on feed.
Above-described, only presently preferred embodiments of the present invention is not limited to the scope of the present invention, of the invention is upper
Stating embodiment can also make a variety of changes.Even if not carrying out according to the method provided by the invention.It is every to apply according to the present invention
Claims and description made by simple, equivalent changes and modifications, fall within the claim of patent of the present invention
Protection domain.The not detailed description of the present invention is routine techniques content.
Claims (10)
1. a kind of slow release tablet promoting oral cavity and/or Esophageal Mucosa reparation, which is characterized in that including：
Chip base comprising edible glue, maltose or mannitol, xylitol, D-sorbite, flavouring agent and plasticizer, wherein described
Edible glue, maltose or mannitol, xylitol, D-sorbite, flavouring agent and plasticizer weight ratio be 20-30%：15-
25%：20-30%：15-25%：3-5%：5-10%；And
The functional components factor being distributed in chip base comprising recombined human granulocyte-macrophage stimulating factors.
2. slow release tablet according to claim 1, which is characterized in that the edible glue is Arabic gum or gutta-percha.
3. slow release tablet according to claim 1, which is characterized in that the flavouring agent is butyric acid second propyl ester or butyric acid second
Ester.
4. slow release tablet according to claim 1, which is characterized in that the plasticizer is rest in peace resin or frankincense.
5. slow release tablet according to claim 1, which is characterized in that the chip base and recombinant human granulocyte-macrophage thorn
The weight ratio for swashing the factor is 4：0.000075-0.0001.
6. slow release tablet according to claim 1, which is characterized in that the functional components factor further includes 2- (3- ammonia
Base Propylamino)-ethyl mercaptan phosphate.
7. slow release tablet according to claim 6, which is characterized in that the chip base, recombinant human granulocyte-macrophage thorn
The weight ratio for swashing the factor and 2- (3- amino Propylamino)-ethyl mercaptan phosphate is 4：
0.000075-0.0001：0.1-0.2.
8. slow release tablet according to claim 1, which is characterized in that the functional components factor in chip base uniformly more
It dissipates.
9. a kind of slow release tablet for promoting oral cavity and/or Esophageal Mucosa reparation according to any one of claim 1-8
Preparation method, which is characterized in that this approach includes the following steps：
S1：Uniform mixed edible glue, maltose, xylitol, D-sorbite, flavouring agent and plasticizer in pure water form piece
Base；
S2：Chip base and the functional components factor are mixed, slow release tablet is formed.
10. preparation method according to claim 9, which is characterized in that the functional components factor described in the step S2
Addition sequence be：Recombined human granulocyte-macrophage stimulating factors are first added, then add 2- (3- amino Propylamino)-second
Mercaptan phosphate.
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