CN107303395A - A kind of pharmaceutical composition containing pronase and preparation method thereof - Google Patents

A kind of pharmaceutical composition containing pronase and preparation method thereof Download PDF

Info

Publication number
CN107303395A
CN107303395A CN201610241579.XA CN201610241579A CN107303395A CN 107303395 A CN107303395 A CN 107303395A CN 201610241579 A CN201610241579 A CN 201610241579A CN 107303395 A CN107303395 A CN 107303395A
Authority
CN
China
Prior art keywords
acid
pronase
sodium
pharmaceutical composition
carbonate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201610241579.XA
Other languages
Chinese (zh)
Other versions
CN107303395B (en
Inventor
卢迪
高莹
吴昀
赵焰平
周丽莹
刘亚男
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beijing Tide Pharmaceutical Co Ltd
Original Assignee
Beijing Tide Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Beijing Tide Pharmaceutical Co Ltd filed Critical Beijing Tide Pharmaceutical Co Ltd
Priority to CN201610241579.XA priority Critical patent/CN107303395B/en
Publication of CN107303395A publication Critical patent/CN107303395A/en
Application granted granted Critical
Publication of CN107303395B publication Critical patent/CN107303395B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a kind of novel form of the pharmaceutical composition containing pronase, contain active component pronase and sodium acid carbonate in said composition simultaneously, patient can be used directly, compared with existing medicine, patient medication is more convenient, safety, it is to avoid the bad phenomenon such as drug effect is not good caused by patient oneself is mismatched in using pharmaceutical procedures due to pronase and sodium acid carbonate consumption.

Description

A kind of pharmaceutical composition containing pronase and preparation method thereof
Technical field
The invention belongs to field of pharmaceutical preparations, more particularly to contain the pharmaceutical composition of pronase and its preparation side Method, said composition is used for gastrocopy.
Background technology
Gastrocopy is the important method for diagnosing disease of upper digestive tract, and due to containing mucus in stomach, and patient is carrying out stomach There is scope in saliva saliva, checking process easily to be disturbed by the foam sample mucus in oesophagus, stomach during spectroscopy, reduction is regarded Wild definition, is unfavorable for the detection of minimal disease.So as to increase disease fail to pinpoint a disease in diagnosis, misdiagnosis rate, extend the review time.Ball mountain refined one is total About more than 50% without clinical symptoms in the diagnostic experiences of the Japanese early carcinoma of stomach of knot, discovery early carcinoma of stomach, are examined mainly by gastrocopy It is disconnected, but China's early carcinoma of stomach recall rate is low, with the Japanese recall rate of early carcinoma more than 50% there is a larger gap, wherein gastroscopic observation Careful degree is the key factor of influence detection early carcinoma of stomach again.Therefore the stomach preparation before checking is important, but by Contain natural foam-like mucus in stomach, when there is gastric mucosal lesion, stomach intracavitary mucus and foam are more, make Checking on effect by To influence, and easily fail to pinpoint a disease in diagnosis minute lesion and the lesion that is not true to type, normal saline washing or attraction need to be used repeatedly, extends the review time, institute Gastrocopy quality can be improved with orally active defoamer before checking, shorten the review time.Conventional defoamer is favourable at present Many cacaine rubber cements, dyclonine and pronase enzyme granulate.
Also frequently with lidocaine mortar during domestic gastrocopy, this medicine contains a certain amount of dimeticone, but its Eliminate foaming in stomach unsatisfactory.Dyclonine is used for the anaesthetic of mucous membrane or skin as new, anaesthetizes Effect is fast, and intensity is deep, and toxicity is smaller, is difficult to have influence on nervous centralis.Dyclonine infusion is run into after foam into enteron aisle, weakens bubble Foam surface tension, makes its rapid disruption.Flavoring essence, sweetener contained by dyclonine can reduce the rejection feeling of patient, subtract The adverse reaction situations such as few Nausea and vomiting.Pronase is a kind of proteolytic enzyme, and gastric mucin peptide bond can be cut off and has Effect dissolving stomach mucus, improves gastrocopy visibility, because it just stablizes in the environment of pH values 7~10 and shows activity, institute To take sodium acid carbonate simultaneously as stomach acid neutralizing agent, the mechanism of action of it and traditional defoamer is entirely different, can be real molten Solution removes stomach mucus, and the apparent visual field is brought to gastrocopy, improves gastroscope for minute lesion, especially early carcinoma of stomach Recall rate.Therefore, increasing people is inclined to use pronase enzyme granulate to carry out gastrocopy.
Presently commercially available pronase is granule, it is necessary to 15-30min before gastrocopy, by 20000 units Pronase(1 bag)50-80ml drinking water is added to 1 gram of sodium acid carbonate(20-40℃)In, orally, should after shaking dissolving Usage is cumbersome, is unfavorable for patient medication.Therefore, clinically it is badly in need of a kind of pronase novel form of exploitation, improves medication Method, improves the compliance of patient.
The content of the invention
In view of the deficiencies of the prior art, the present invention provides a kind of drug regimen containing pronase and sodium acid carbonate Thing, said composition is prepared to the solid pharmaceutical preparation that can be used directly, and greatly facilitates the clinical application of patient.The mesh of the present invention Be achieved through the following technical solutions:
A kind of pharmaceutical composition containing pronase, composition contains active component pronase, acid source, alkali source Sodium acid carbonate is necessary in material, lubricant and other pharmaceutically acceptable excipient, wherein the alkali source material of said composition The content of other components is in composition, composition:
Pronase(Proportion) 9.24% ~ 35.00%
Sodium acid carbonate(Proportion) 11.5% ~ 68.14%
Acid source(Proportion) 12.28% ~ 25.9%
Alkali source material than sodium bicarbonate(Proportion) 3.37% ~ 45.3%
Lubricant(Proportion) 1.47% ~ 9.50%.
Pronase pharmaceutical composition of the present invention is put into fater disintegration after water, the pH of the aqueous solution for 7.0 ~ 10.0, preferably pH 7.5 ~ 9.5.
In the composition acid source be selected from anhydrous citric acid, citric acid, citric acid, tartaric acid, fumaric acid adipic acid, One or more of mixing in malic acid, acidic amino acid, wherein acidic amino acid can be aspartic acid or glutamic acid, excellent Anhydrous citric acid, acidic amino acid, citric acid are selected, its consumption can further be optimized for 14.71% ~ 23.26%;Alkali source material is removed Outside containing essential component sodium acid carbonate, can also there are sodium hydroxide, potassium hydroxide, sodium carbonate, potassium carbonate, saleratus, carbon One or more of mixing in sour calcium, disodium hydrogen phosphate, sodium dihydrogen phosphate, dipotassium hydrogen phosphate, potassium dihydrogen phosphate, basic amino acid Thing, wherein basic amino acid can be lysine, arginine or histidine, preferably phosphoric acid hydrogen dipotassium, potassium dihydrogen phosphate, alkalescence Amino acid, sodium carbonate, its consumption can further be optimized for 5.00% ~ 44.10%.
Lubricant is selected from soluble oil, water-insoluble lubricant or the mixture of the two in described composition, Soluble oil can be polyethylene glycol, lauryl sodium sulfate, Stepanol MG, L-Leu, sodium benzoate, oil Sour sodium, sodium chloride, sodium acetate, boric acid, preferably polyethylene glycol, lauryl sodium sulfate, its consumption for control 1.0% ~ 6.50%, 1.47% ~ 5.00% can be further optimized for, water-insoluble lubricant can be magnesium stearate, talcum powder, micro mist silicon Glue, sucrose fatty ester, sodium stearyl fumarate, aerosil, wherein preferably talc powder, superfine silica gel powder, stearic acid are rich Horse acid sodium, aerosil, its consumption can further be optimized for 0.99% ~ 2.50% for 0.47% ~ 3.00%.
Can also be containing filler, adhesive, foaming agent etc. in pharmaceutical composition of the present invention, wherein filler can With selected from lactose, mannose, sucrose, glucose, starch, microcrystalline cellulose, carboxymethyl cellulose, sodium carboxymethylcellulose, dextrin, Icing Sugar etc., its consumption is 1.00% ~ 6.00%, and adhesive can be selected from the hydroxypropyl methylcellulose aqueous solution, polyvinylpyrrolidone Ethanol(Water)Solution, olefin(e) acid resin aqueous solution, starch slurry, ethanol, syrup, polyvinylpyrrolidone and polyvinyl acetate copolymerization Thing, isopropanol, polyethylene glycol(12000-20000)Isopropanol or ethanol solution or the polyethylene glycol of low molecule amount(4000- 6000).
Composition of the present invention can also add appropriate flavouring, sweetener, essence or pigment, for improving Mouthfeel, strengthens the compliance of patient, and flavouring can be selected from menthol, peppermint oil, artificial vanilla, Chinese cassia tree and various fruity, sweet tea Taste agent can also be aspartame, honey, fructose, acesulfame potassium etc., can also add the essence of various tastes, such as lemon, Total consumption of the additive such as Orange flavor etc., wherein flavouring, sweetener, essence or pigment is no more than 3%.
Composition prepared by the present invention, its formulation is solid pharmaceutical preparation, can be tablet, granule or capsule.
The present invention can prepare pronase using dry granulation process, wet granulation or the progress of direct tablet compressing technique Enzyme solid pharmaceutical preparation, wherein wet granulation can using soda acid mixing granulation technique, soda acid difference granulating process, soda acid mixing it is non- Water granulation example technique, the present invention preferably dry granulation process or direct tablet compressing technique carry out the preparation of pronase enzyme preparation, And because pronase is extremely sensitive to water, therefore composition water content prepared by the present invention is less than 3%.
Embodiment
Embodiment 1
Prescription:
Preparation method:By the pronase of recipe quantity, sodium acid carbonate, polyethylene glycol, aerosil, dipotassium hydrogen phosphate, Anhydrous citric acid is placed in valve bag, is well mixed, direct tablet compressing.
Embodiment 2
Prescription:
Preparation method:By the pronase of recipe quantity, sodium acid carbonate, polyethylene glycol, superfine silica gel powder, lysine, anhydrous citron Acid is placed in valve bag, is well mixed, direct tablet compressing.
Embodiment 3
Prescription:
Preparation method:By the pronase of recipe quantity, sodium acid carbonate, lauryl sodium sulfate, aerosil, phosphoric acid hydrogen Dipotassium, citric acid are placed in valve bag, are well mixed, direct tablet compressing.
Embodiment 4
Prescription:
Preparation method:By the pronase of recipe quantity, sodium acid carbonate, polyethylene glycol, talcum powder, anhydrous citric acid, sodium carbonate It is placed in valve bag, is well mixed, direct tablet compressing.
Embodiment 5
Prescription:
Preparation method:The pronase of recipe quantity, sodium acid carbonate, sodium carbonate, superfine silica gel powder, glutamic acid, polyethylene glycol are put In valve bag, it is well mixed, direct tablet compressing.
Embodiment 6
Prescription:
Preparation method:By the pronase of recipe quantity, sodium acid carbonate, polyethylene glycol, sodium stearyl fumarate, phosphoric acid hydrogen two Sodium, citric acid are placed in valve bag, are well mixed, direct tablet compressing.
Embodiment 7
Prescription:
Preparation method:By the pronase of recipe quantity, sodium acid carbonate, aspartic acid, arginine, 0.0225g polyethylene glycol and 0.0075g aerosils are well mixed;Pulverize and sieve;By the particle and the polyethylene glycol of surplus and gas phase two after sieving The menthol of silica and recipe quantity, pigment, glucose, lemon essence are well mixed, tabletting.
Embodiment 8
Prescription:
Preparation method:By the pronase of recipe quantity, sodium acid carbonate, dipotassium hydrogen phosphate, glutamic acid, 0.01g polyethylene glycol and 0.015g sodium stearyl fumarates are well mixed;Pulverize and sieve;By the particle and the polyethylene glycol of surplus and gas phase after sieving The savory essence of artificial vanilla, pigment, sucrose, orange of silica and recipe quantity is well mixed, tabletting.
Embodiment 9
Prescription:
Preparation method:By the pronase of recipe quantity, sodium acid carbonate, dipotassium hydrogen phosphate, anhydrous citric acid, the poly- second of 0.01125g Glycol and 0.0075g superfine silica gel powders are well mixed;Pulverize and sieve;By the particle and the polyethylene glycol of surplus and gas phase after sieving Aspartame, the saccharin of silica and recipe quantity are well mixed, tabletting.
Comparative example 1
Prescription:
Preparation method:By the pronase of recipe quantity, sodium acid carbonate, polyethylene glycol, aerosil, dipotassium hydrogen phosphate, Anhydrous citric acid is placed in valve bag, is well mixed, direct tablet compressing.
Comparative example 2
Prescription:
Preparation method:By the pronase of recipe quantity, dipotassium hydrogen phosphate, potassium dihydrogen phosphate, lauryl sodium sulfate, micro mist silicon Glue is placed in valve bag, is well mixed, direct tablet compressing.
Comparative example 3
Prescription:
Preparation method:By the pronase of recipe quantity, sodium acid carbonate, disodium hydrogen phosphate, aspartic acid, the poly- second two of 0.0075g Alcohol and 0.0035g magnesium stearates are well mixed;Pulverize and sieve;By the particle and the polyethylene glycol of surplus and stearic acid after sieving Menthol, the glucose of magnesium and recipe quantity are well mixed, tabletting.
Test example 1
Sample prepared by embodiment 1-9 and comparative example 1-3 is tested, after sample survey outward appearance and disintegration phenomenon, disintegration The pH of solution and the water content of sample are measured, and testing result is as shown in table 1.
The water content testing result of pH value of solution and sample after the sample appearance of table 1 and disintegration phenomenon, disintegration
The result of table 1 shows that pronase solid pharmaceutical preparation tablet surface prepared by the present invention is bright and clean, and tablet can be quick in water Disintegration, dissolving is thorough, and the pH after disintegration is in the field of activity of medicine pronase, it is ensured that the drug effect hair of pronase Wave, preparation water content of the invention is low so that the tablet of preparation can be stablized to be preserved for a long time, further ensures the safety of medication Property.
The enzyme titration of test example 2
The preparation of reference substance solution:The tyrosine reference substance learnt from else's experience after drying 3 hours at 105 DEG C is appropriate, accurately weighed, plus 0.2mol/L hydrochloric acid solutions dissolve and are diluted to the solution for containing 25 μ g in every 1ml(Face and use brand-new).
The preparation of test sample stoste:This product 0.5g is taken, it is accurately weighed, put in 100ml measuring bottles, phosphorate phthalate buffer(Claim Potassium dihydrogen phosphate 1.80g, ADSP 7.57g are taken, the about 500ml that adds water makes dissolving;Calcium acetate 0.035g separately is taken, is added water 50ml makes dissolving, and 1000ml is added water to after the mixing of two liquid)Dissolve and be diluted to scale, shake up, precision measures 1ml, put 100ml amounts In bottle, the phthalate buffer that phosphorates is diluted to scale.
The preparation of casein substrate solution:Newborn casein 1g processed is taken, it is accurately weighed, dried 2 hours at 105 DEG C, determine it Loss on drying amount.The breast casein 1.0g processed based on dry product is weighed, above-mentioned phosphate buffer 40ml is added, adds in warm water Heat makes dissolving, after cooling, and pH value is adjusted to 7.4 with sodium hydroxide test solution, then the phthalate buffer that phosphorates shakes up to 50ml, preheating It is standby to 40 DEG C ± 1 DEG C(Face and use brand-new).
Determination method:3, test tube is taken, it is accurate respectively to add test sample stoste 1ml, put in 40 DEG C of ± 1 DEG C of water-baths and be incubated 5 minutes Accurate addition is preheated to 40 DEG C ± 1 DEG C of casein substrate solution 1ml afterwards, shakes up, timing, accurate in 40 DEG C of ± 1 DEG C of water-baths Reaction 10 minutes, it is accurate immediately to add trichloroacetic acid solution(Trichloroacetic acid 1.63g, sodium acetate 2.72g and glacial acetic acid 1.20g are taken, Add water and dissolve in right amount and be diluted to 100ml)2ml, shakes up, accurate in 40 DEG C of ± 1 DEG C of water-baths to place 20 minutes, and filtration takes continuous Filtrate is used as need testing solution.It is another to take 2, test tube, it is accurate respectively to add test sample stoste 1ml, put in 40 DEG C of ± 1 DEG C of water-baths and protect Temperature 5 minutes, precision adds trichloroacetic acid solution 2ml, shakes up, and precision addition is preheated to 40 DEG C ± 1 DEG C of casein substrate solution 1ml, shakes up, accurate in 40 DEG C of ± 1 DEG C of water-baths to place 20 minutes, and filtration takes subsequent filtrate as test sample blank solution.
Precision measures above-mentioned need testing solution, test sample blank solution, reference substance solution, each 1ml of 0.2mol/L hydrochloric acid solutions, Put respectively in test tube, each accurate addition sodium carbonate liquor(Natrium carbonicum calcinatum 4.24g is taken, the 100ml that adds water makes dissolving)5ml, then essence Close addition forint test solution(1→3)1ml, at 40 DEG C ± 1 DEG C place 20 minutes, be cooled to room temperature, in 4 hours according to it is ultraviolet-can See AAS(Chinese Pharmacopoeia four general rules 0401 of version in 2015), using water as blank, determined respectively at 660nm wavelength State the absorbance of 4 kinds of solution(Successively as A1、A2、A3、A4), it is calculated as follows:
Per 1mg enzyme activities containing pronase(Unit)=(A1- A2)×Ws×ns×1000/(A3- A4)×W×n×10×1/4 In formula:Ws and W is respectively the sampling amount of reference substance and test sample(g)Ns and n is respectively the extension rate of reference substance and test sample.
The enzyme potency test result of table 2
Note:Enzyme activity containing pronase should be 135-165 units in per 1mg.
The result of table 2 is shown, through enzyme titration, the active material contained in the pronase enzyme preparation prepared by the present invention Pronase can keep its effective active, and then ensure that the drug effect of pronase enzyme preparation, it is ensured that the treatment of medicine Effect.
The stability test of test example 3
Stability test assay method:According to《Chemicals stability study technological guidance's principle》Compiled with Chinese Pharmacopoeia Commission Write《Chinese Pharmacopoeia version four in 2015》In test method in " medicine stability test guideline " take this product to simulate City's packaging (aluminum-plastic packaged after with medicinal drier be encapsulated into Aluminum-plastic composite bag), is placed in 60 DEG C ± 2 DEG C, in RH75% ± 5% It is continuous place 0, sampling in 7,14,21 days, the enzyme activity of active component in preparation anaplasia at any time is investigated using enzyme titration method Change, as a result as shown in table 3.
The stability test result of table 3
Percentage sign is the enzyme activity percentage of pronase solid pharmaceutical preparation in table 3.From the data of table 3, using the present invention The pronase preparation stability of preparation is good, solve the main ingredient physicochemical property moisture absorption itself it is perishable, it is unstable the problem of, Severe cruel result of the test shows that the preparation enzyme activity reduction speed that before the deadline prepared by the present invention is slower, improves in clinical practice Validity.

Claims (12)

1. a kind of pharmaceutical composition containing pronase, said composition contains active component pronase, disintegrant, profit Lubrication prescription and other pharmaceutically acceptable excipient, it is characterised in that said composition alkali source material sodium acid carbonate is essential component, The content of other components is in said composition:
Pronase(Proportion) 9.24% ~ 35.00%
Sodium acid carbonate(Proportion) 11.5% ~ 68.14%
Acid source(Proportion) 12.28% ~ 25.9%
Alkali source material than sodium bicarbonate(Proportion) 3.37% ~ 45.3%
Lubricant(Proportion) 1.47% ~ 9.50%.
2. the pharmaceutical composition according to claim 1 containing pronase, it is characterised in that pronase medicine Composition is put into fater disintegration after water, and the pH of the aqueous solution is 7.0 ~ 10.0, preferably pH 7.5 ~ 9.5.
3. the pharmaceutical composition according to claim 1 containing pronase, it is characterised in that, acid source can select One kind or several from anhydrous citric acid, citric acid, citric acid, tartaric acid, fumaric acid adipic acid, malic acid, acidic amino acid Plant mixture.
4. the pharmaceutical composition according to claim 1 containing pronase, it is characterised in that alkali source material can be selected From sodium hydroxide, potassium hydroxide, sodium carbonate, sodium acid carbonate, potassium carbonate, saleratus, calcium carbonate, disodium hydrogen phosphate, di(2-ethylhexyl)phosphate One or more of mixtures in hydrogen sodium, dipotassium hydrogen phosphate, potassium dihydrogen phosphate, basic amino acid.
5. the pharmaceutical composition containing pronase according to claim 1,3, it is characterised in that acid source can be with Selected from anhydrous citric acid, acidic amino acid, citric acid.
6. the pharmaceutical composition containing pronase according to claim 1,4, it is characterised in that alkali source material can be with Selected from dipotassium hydrogen phosphate, potassium dihydrogen phosphate, basic amino acid, sodium carbonate.
7. the pharmaceutical composition according to claim 1 containing pronase, it is characterised in that lubricant is selected from water-soluble Property lubricant, water-insoluble lubricant or the mixture of the two, soluble oil be selected from polyethylene glycol, dodecyl sulphate One or more in sodium, Stepanol MG, L-Leu, sodium benzoate, enuatrol, sodium chloride, sodium acetate, boric acid, Water-insoluble lubricant is selected from magnesium stearate, talcum powder, superfine silica gel powder, sucrose fatty ester, sodium stearyl fumarate, gas phase two One or more in silica.
8. the pharmaceutical composition according to claim 1 containing pronase, it is characterised in that may be used also in said composition With containing filler, adhesive, foaming agent, wherein filler can be selected from lactose, mannose, sucrose, glucose, starch, micro- Crystalline cellulose, carboxymethyl cellulose, sodium carboxymethylcellulose, dextrin, Icing Sugar, adhesive can be water-soluble selected from hydroxypropyl methylcellulose Liquid, polyvinylpyrrolidone ethanol(Water)Solution, olefin(e) acid resin aqueous solution, starch slurry, ethanol, syrup, polyvinylpyrrolidone With polyvinyl acetate copolymer, isopropanol, polyethylene glycol(12000-20000)Isopropanol or ethanol solution or low molecule The polyethylene glycol of amount(4000-6000).
9. the pharmaceutical composition according to claim 1 containing pronase, should is characterized in that in said composition also Flavouring, sweetener, essence or pigment can be contained, flavouring can be selected from menthol, peppermint oil, artificial vanilla, Chinese cassia tree And various fruity, sweetener may be selected from aspartame, honey, fructose, acesulfame potassium.
10. the pharmaceutical composition according to claim 1 containing pronase, it is characterised in that the formulation of said composition Can be tablet, granule or capsule for solid pharmaceutical preparation.
11. the pharmaceutical composition containing pronase according to claim 1,10, it is characterised in that said composition Prepare using dry granulation process, wet granulation or direct tablet compressing technique, preferably dry granulation process or direct tablet compressing work Skill.
12. the pharmaceutical composition according to claim 1 containing pronase, it is characterised in that said composition it is aqueous Amount is less than 3%.
CN201610241579.XA 2016-04-19 2016-04-19 Pharmaceutical composition containing pronase and preparation method thereof Active CN107303395B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201610241579.XA CN107303395B (en) 2016-04-19 2016-04-19 Pharmaceutical composition containing pronase and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201610241579.XA CN107303395B (en) 2016-04-19 2016-04-19 Pharmaceutical composition containing pronase and preparation method thereof

Publications (2)

Publication Number Publication Date
CN107303395A true CN107303395A (en) 2017-10-31
CN107303395B CN107303395B (en) 2021-07-30

Family

ID=60151270

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201610241579.XA Active CN107303395B (en) 2016-04-19 2016-04-19 Pharmaceutical composition containing pronase and preparation method thereof

Country Status (1)

Country Link
CN (1) CN107303395B (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113575922A (en) * 2021-08-06 2021-11-02 四川轻化工大学 Phosphate additive and preparation method thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0958833A1 (en) * 1998-05-20 1999-11-24 Erasmus Universiteit Rotterdam Methods and means for preventing or treating inflammation

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0958833A1 (en) * 1998-05-20 1999-11-24 Erasmus Universiteit Rotterdam Methods and means for preventing or treating inflammation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
杨静 等: ""链霉蛋白酶用于胃镜检查前胃内黏液清洗的效果观察"", 《上海护理》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113575922A (en) * 2021-08-06 2021-11-02 四川轻化工大学 Phosphate additive and preparation method thereof

Also Published As

Publication number Publication date
CN107303395B (en) 2021-07-30

Similar Documents

Publication Publication Date Title
JP5237098B2 (en) Orally disintegrating tablet masking bitterness and method for producing the same
WO2018077310A1 (en) Vitamin c sodium-containing effervescent tablet and preparation method therefor
KR20040099265A (en) Novel substituted benzimidazole dosage forms and method of using same
KR20040047771A (en) Novel substituted benzimidazole dosage forms and method of using same
CA2440361A1 (en) Intraorally rapidly disintegrable preparation
JP2007277271A (en) New substituted benzimidazole dosage form and method for using the same
TW201442741A (en) Oral administration preparation with masked bitterness of silodosin
KR101203186B1 (en) Taste-masked pharmaceutical composition for oral administration and a process for the preparation thereof
JP5566408B2 (en) Dry syrup
MX2014004811A (en) Taste-masked pharmaceutical composition for oral administration and a process for the preparation thereof.
WO2009022674A1 (en) Medical composition containing rebamipide
CN103087042B (en) Salts of sitafloxacin and pharmaceutical purposes thereof
JPWO2016051782A1 (en) Orally administered preparations masking the bitterness of drugs with bitterness
US20060159759A1 (en) Tablet containing water-absorbing amino acid
CN102512386A (en) Amoxicillin or amoxicillin and clavulanate potassium instant chewable tablets for pet and preparation method for same
JP6618099B2 (en) Solid formulation with excellent stability
CN114469882A (en) Dextromethorphan quinidine orally disintegrating tablet and application thereof
CN107303395A (en) A kind of pharmaceutical composition containing pronase and preparation method thereof
JP2009179604A (en) Quickly disintegrating tablet in oral cavity
CN104758269A (en) Acetylcysteine effervescent tablet
CN113197878A (en) Acetaminophen taste masking granules and preparation method thereof
CN107007565A (en) A kind of Lurasidone HCl oral disintegrating tablet and preparation method thereof
JP5478170B2 (en) Orally disintegrating tablets
EP1283060B1 (en) Preparations for diagnosing infection with helicobacter pylori
JP6590436B1 (en) Solid formulation with excellent stability

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant