CN1275651C - Medical coating powder containing nano material - Google Patents
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- CN1275651C CN1275651C CN200410078365.2A CN200410078365A CN1275651C CN 1275651 C CN1275651 C CN 1275651C CN 200410078365 A CN200410078365 A CN 200410078365A CN 1275651 C CN1275651 C CN 1275651C
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Abstract
The present invention discloses medical coating powder containing nanometer material, which is prepared from the following ingredients by weight percentage: 55 to 65% of hypromellose, 8% of a copolymer of vinyl pyrrolidine and vinyl acetate, 15% of glycerol, 8% of span, 2 to 4% of a colorant and 2 to 10% of nanometer titania. The medical coating powder containing nanometer material has the advantages of simple production process, short period, time saving, energy saving, safety, wide application range, high performance-price ratio, no physiological toxicity, good damp resistance, high tensile strength, good impact resistance, good ductility, high brightness, good permeation resistance, good product stability, long storage time, good soluble performance, bacterium resistance, sterilization, irradiation resistance from ultraviolet light and color change resistance. Therefore, the defects of premixing agents with original sugar coatings and common coatings are overcome, and complicated and variable application needs for coating traditional Chinese medicine solid preparations are satisfied.
Description
Technical field
The present invention relates to a kind of medical coating powder and production technology thereof, particularly contain the medical coating powder of nano material.
Technical background
In the prior art, for the solid preparation (for example tablet, pill etc.) that makes medicine visually has aesthetic property, on preserving, has storage stability preferably, in gastrointestinal, has solubility preferably, so that conveniently take, often need be commonly referred to the coating of preparation at the suitable material of its surface parcel.For many years, sweet tablet is particularly also generally adopted based on the pharmacy corporation of producing the general medicine of Chinese patent medicine in domestic pharmaceutical factory, its operating procedure is numerous and diverse, tediously long, technology is difficult to grasp, the percent defective height, gain in weight is big, and bioavailability is low, and the storage stability of finished product is poor, difficult quality guarantee in expiration date of drug.Therefore, how to enhance productivity, to improve the quality of products by new technology, reduce production costs, making concessions has become the urgent problem that pharmacy corporation faces, this one in the people; Its two, at present, though there are more a spot of kinds also to adopt the film coating pre-mix dose than the sweet tablet advanced person to come coating, also simple with respect to sweet tablet in operation, moistureproof aspect also increases than sugar-coat.But, because it is that certain single variety sets, bad adaptability, and the most of pharmacy corporations of China are producing Chinese medicine, complicated component, easily the moisture absorption, fade, go mouldy etc., inherent coating performance far can not satisfy the needs of application.Its three, along with China joined WTO, how to adopt the film coating material of renewal and correlation technique realize the modernization of Chinese medicine, realize in line with international standards, improve the medicine outlet level and the medicine export capacity of China, become the problem that the pharmacy worker faces.
Medical coating powder is as a kind of adjuvant, and its so-called requirement according to sheet disposition matter design coating etc. only is the most basic prerequisite as this special adjuvant function.On the basis of this prerequisite, the performance of scientific and technological content of how to go to improve coating powder based on this present situation of producing the general medicine of Chinese medicine and above-mentioned pressing for and products thereof at China, make it both to have the characteristic of forefront packaging technique, the characteristics that have the strong glossiness of sweet tablet again, and then on the basis of these prerequisites, the product of the relatively low high performance-price ratio of a kind of price is provided, improves the competitiveness of product in market, to promote the change of China's pharmacy packaging technique.We recognize that nano material is a kind of emerging material, have the advantage of many uniquenesses, and are good etc. as hot strength height, excellent in abrasion resistance, toughness, because the nanoparticle size less than visible wavelength, demonstrates higher glossiness; Nano material has fine and close microstructure, and the dissolving that can suppress molecule is spread and the gas barrier of enhancement thin film; The function of the ultraviolet radiation preventing of nano material is the highest, is a kind of anti-preferably variable color material; The penetrable cell wall of the Coulomb attraction that electron transition produced because of the inner surface of nano material enters in the bacterial cell body again, the activity of destroying the antibacterial synzyme makes cell lose multiplication capacity and death is a kind of material with extraordinary antibiotic and sterilizing, automatic cleaning action.We by concentrate on studies, conscientiously comparison, optimization of C, added advanced nano material and made the widely applicable a kind of medical coating powder that contain nano material more more superior, to satisfy the urgent present situation that China pharmacy aspect faces than general coating pre-mixing agent performance.
By retrieval, we recognize that open source literature reported some medical coating raw material and processing technology thereof, as 1, Chinese patent＜application number 93105579.2＜title the film coating procedure＜publication number of strong VC Yinqiao tablets 1082889＜open day 1994.03.02＜applicant Sanghai Pharmaceutical Factory＜summary a kind of film coating procedure of strong VC Yinqiao tablets.This technology is that the sugar-coat technology with present strong VC Yinqiao tablets replaces with thin-film technique, film-coated prescription is: 30～40 parts of hydroxypropyl methylcellulose, 5～8 parts of II enteric acrylic resins, 6～10 parts of Polyethylene Glycol, 4～8 parts of Oleum Ricini, 4～8 parts of tweens, 14～18 parts of titanium dioxides, 6～10 parts of Pulvis Talci, 6～10 parts of magnesium stearate, 5～10 parts of edible pigment solutions, 350～420 parts of distilled water, ethanol add to 1000 parts.This technology saves time, material-saving, power saving, saving of labor, the drug quality height, and its moisture resistance, heat resistanceheat resistant, cold-resistant, wearability are better than coated tablet.2, Chinese patent＜application number〉00108518＜denomination of invention〉a kind of macromolecular coating powder for solid medicine and preparation method thereof＜applicant〉China Science ﹠ Technology University＜digest〉the present invention relates to solid chemicals coating and preparation method.Its coating component is: cellulose ether accounts for that 40-55%, inorganic filler, pigment account for 25-35%, other additives are 0-5%, and for 0.2-1%, plasticizer account for 20-30%, emulsifier content is 0.2-1%; Wherein cellulose ether is that viscosity is the water-soluble cellulose ether of 20-75 centipoise, and emulsifying agent is edible oil-in-water emulsifiers.Its preparation method is to place high-speed mixer to stir each component, makes its mix homogeneously, and then puts in the sealed container and stored 10-20 days.Be raw materials for production with the viscosity higher cellulose ether among the present invention, processing technology is simple, has reduced the manufacturing cost of coating powder, helps pharmaceutical production.3, Chinese patent＜application number〉01813976＜denomination of invention〉comprise " slow release " pharmaceutical composition＜applicant of lithium carbonate〉Unelhatt Corp.＜address〉Dublin, Ireland＜digest〉and the pharmaceutical composition of " once a day " that comprise 300mg to 900mg lithium carbonate amount with coated granule form of following composition: lithium carbonate 93%, ethyl cellulose 1.7%, Talcum 0.8%, polyvinylpyrrolidone 4.5%.＜claim〉the pharmaceutical composition of " once a day " that comprise 300mg to 900mg lithium carbonate amount with coated granule form of following composition: lithium carbonate 93%, ethyl cellulose 1.7%, Talcum 0.8%, polyvinylpyrrolidone 4.5%.4, Chinese patent＜application number〉99804552＜denomination of invention hydroxypropyl cellulose and anionic polymer compositions and as the purposes＜applicant of pharmaceutical film coating Hercules Inc＜address Delaware, USA,＜digest〉a kind of compositions, it contains hydroxypropyl cellulose and at least a anionic polymer, the aqueous solution of for example sodium carboxymethyl cellulose, and said composition is in the purposes of aspects such as coating substrate such as tablet, granule, pearl.5, Chinese patent＜application number〉99120382＜denomination of invention〉moisture coated composition and the method＜applicant who prepares solid pharmaceutical preparation〉Shin-Etsu Chemial Co., Ltd＜address〉Tokyo＜digest〉a kind of moisture coated composition, contain mean diameter and generally be at most 1 of 10 μ m, 2,4-benzenetricarboxylic acid hydroxypropyl emthylcellulose and plasticizer, said composition is coated on the solid pharmaceutical preparation, has acid resistance and be about 4 o'clock dissolved coating membranes at PH with formation.This coated preparation has improved bioavailability.6, Chinese patent＜application number〉99804552＜denomination of invention hydroxypropyl cellulose and anionic polymer compositions and as the purposes＜applicant of pharmaceutical film coating Hercules Inc＜address Delaware, USA＜digest a kind of compositions, it contains hydroxypropyl cellulose and at least a anionic polymer, the aqueous solution of for example sodium carboxymethyl cellulose, and said composition is in the purposes of aspects such as coating substrate such as tablet, granule, pearl.7, Chinese patent＜application number〉94109509＜denomination of invention〉have a pharmaceutical composition＜applicant of good dissolution properties〉Squibb Bristol Myers Co.＜address〉N.J.＜law change〉and look and remove day: 00.11.01＜digest〉provide a kind of even the ifetroban compositions of good dissolution properties has also been arranged under ageing state, its PH is at least 7 in being dispersed in water.Said composition comprises ifetroban salt, one or more plant alkalizing agent such as magnesium oxide or calcium carbonate, when existing, the form with tablet also comprises one or more kind fillers for example mannitol and/or microcrystalline Cellulose, one or more plant disintegrating agent such as crosslinked polyvinylpyrrolidone, one or more plant lubricant such as magnesium stearate, welcome one or more kind fluidizer such as colloidal silicas, one or more kind binding agents such as pregelatinized starch (dry adhesives) or polyvinylpyrrolidone (wet binder) and welcome a kind of film former such as hydroxypropyl cellulose and plasticizer of comprising are as 1,2, the film coating of 3-glycerol triacetate.8, Chinese patent＜application number〉98125528＜denomination of invention〉contain the stable oral pharmaceutical composition＜applicant of substituted pyridylsulfinyl benzimidazole〉Ranbaxy Laboratories Ltd.＜address〉India's New Delhi＜statutory status〉mandate＜digest〉a kind of stable and be fit to patient's pharmaceutical composition for oral administration is included the substituted pyridylsulfinyl benzimidazole and the pharmaceutically acceptable carrier of gastric acid secretion inhibiting activity.Carrier includes the unitary polymer of vinylpyrrolidone monomer.In optimized technical scheme; compositions is a capsule form; substituted pyridylsulfinyl benzimidazole and vinyl pyrrolidone polymer are mixture of powders or particle form, and they are included in the capsule shells, and this capsule shells is made by the enteric coating material or with enteric coating material coating.
Above-mentioned open source literature has been reported some coating materials and coated composition, we recognize that a lot of organic substances can be as the film former of coating material, as pyrrolidone polymer, hypromellose etc., but a lot of medical coating compound powder still exists comprehensive the physical-chemical parameters poor; Some coating materials and the coated composition of some open source literature reports are just set for certain single variety, the suitability is wideless, the coating performance does not satisfy the application need complicated and changeable of solid preparation of Chinese medicine coating, more adds nano material less than the complicated character at Chinese medicine in compositions and makes more superior, the widely applicable medical coating powder that contains nano material of various aspects of performance.
Summary of the invention
The inventor through repeatedly comparative test, has designed a kind of brand-new medical coating compound powder on the basis of fully having studied more existing coating material performances, overcome the deficiencies in the prior art.
Technical scheme of the present invention is achieved in that
The compositions that contains the medical coating powder of nano material of the present invention, the composition and the weight percentage of said composition are as follows:
Hypromellose (HPMC) 55-65%
PVP-VA64 (PVP/VA) 8%
Glycerol 15%
Span 8%
Coloring agent 2-4%
Titanium dioxide (nanoscale) 2-10%
Above-mentioned PVP-VA64 (PVP/VA) can replace it with polyvinyl alcohol (PVA) or polyvinylpyrrolidone.
Above-mentioned span can replace it with tween or carboxymethyl cellulose (CMC).
Above-mentioned coloring agent can be selected food stage or pharmaceutical grade pigment for use.
The effect of above-mentioned hypromellose (HPMC) is a film former, be used to pack Film coated tablets or be used to pack the sealing coat hybrid films, because gel formation process and the form of full-bodied HPMC in discharging environment, can significantly delay drug release, also be useful on the bigger slow releasing preparation of preparation dosage at present.PVP-VA64 (PVP/VA) or polyvinyl alcohol (PVA) have good dissolubility, film property and high-molecular surface active, colloid protective capability and with the compound ability of chemical compound lot, can be used as tablet, particulate film former; Glycerol has better intermiscibility as plasticizer with polymer; Span is a kind of surfactant, regulates the wet performance of whole coated systems; Titanium dioxide (nanoscale) in prescription mainly as functional additive, to strengthen the superiority of coating performance; Coloring agent is meant that the clothing film that can make that China's approval is used presents the material of certain color.
The concrete processing step that the present invention contains the medical coating powder making of nano material is:
(1) percentage by weight that requires according to above-mentioned prescription takes by weighing various components up to specification;
(2) will place mixer to stir except that the above-mentioned raw materials glycerol, the span, and make its mix homogeneously, mixing behind adding glycerol, the span obtains even batch mixing;
(3) above-mentioned batch mixing is placed exsiccator dry, 60～80 ℃ of baking temperatures;
(4) dried batch mixing is taken out, put cold back and pulverize;
(5) obtain finished product through 60～80 mesh sieves---contain the medical coating powder of nano material.
Compared with prior art, outstanding feature of the present invention, advantage and marked improvement are:
One, adopt advanced in the world at present nano material to produce the coating material technology.Overcome thoroughly that the operating procedure that original sweet tablet production technology exists is numerous and diverse, tediously long, technology is difficult to grasp, the percent defective height, gain in weight is big, bioavailability is low, the storage stability of finished product is poor, the defective of difficult quality guarantee etc. in expiration date of drug;
Two, overcome thoroughly that long, poor for applicability, inherent coating performance of general coating pre-mixing agent production cycle far can not satisfy the easy moisture absorption of solid preparation of Chinese medicine, the defective of the coating application need that fades, go mouldy etc.
Three, easy and simple to handle, save time, a kind of medical coating powder that contains nano material of energy-conservation, safety, environmental protection, super quality and competitive price, widely applicable, high performance-price ratio.
Four, produce the coating material technology with nano material, solid preparation is heat-resistingly resisted cold, wearability is good, humidity resistance is strong, hot strength is high, toughness is good, glossiness is high, gas barrier is strong; Product stability is good, the storage life is long, good solubleness, can antibiotic and sterilizing, thereby the anti-variable color of ultraviolet radiation preventing makes coated product taking conveniences such as tablet.
Five, the medical coating powder chemical property that contains nano material that obtains is stable, environmental protection, widely applicable, cost performance is high, no physiology toxicity;
Six, adopt this material to come coating can thoroughly improve Chinese medicine attribute complicated and changeable, solid preparation is heat-resistingly resisted cold, wearability is good, humidity resistance is strong, hot strength is high, toughness is good, glossiness is high, gas barrier is strong; Product stability is good, the storage life is long, good solubleness, can antibiotic and sterilizing, thereby the anti-variable color of ultraviolet radiation preventing makes coated product taking conveniences such as tablet;
Seven, behind the solid preparation coating, sheet heavily increases seldom, has kept former shape preferably, and it is clear to identify, and is convenient to identification, avoids wrongly taking, thereby has satisfied the application need complicated and changeable of solid preparation of Chinese medicine coating.
The medical coating powder that contains nano material of the present invention also can be used as the skin covering of the surface of solid preparation products such as cosmetics, food.
The specific embodiment
Embodiment 1
(1) gets 5 kilograms of Nano titanium dioxides; (2) take by weighing 60 kilograms hypromellose, 8 kilograms PVP-VA64 (PVP/VA), 4 kilograms of red stains; (3) above-mentioned raw materials is placed mixer stirred 20 minutes, make its abundant mix homogeneously, add 15 kilograms of glycerol, 8 kilograms of span, mixed 25 minutes, obtain even batch mixing; (4) above-mentioned batch mixing is placed exsiccator in 60～80 ℃ of dryings 3～4 hours; (5) dried batch mixing is taken out, puts coldly pulverize again; (6) obtain finished product through sieving at the 60-80 order---exsiccant a kind of medical coating powder that contains nano material.
Embodiment 2
(1) gets 2 kilograms of Nano titanium dioxides; (2) take by weighing 65 kilograms hypromellose, 8 kilograms polyvinylpyrrolidone, 8 kilograms Polyethylene Glycol, 2 kilograms of fruit green pigments; (3) above-mentioned raw materials is placed mixer stirred 20 minutes, make its abundant mix homogeneously, add 7 kilograms 8 kilograms of glycerol, span, mixed 25 minutes, obtain even batch mixing; (4) above-mentioned batch mixing was placed 60～80 ℃ of dryings of exsiccator 3～4 hours; (5) dried batch mixing is taken out, puts coldly pulverize again; (6) obtain finished product through sieving at the 60-80 order---exsiccant a kind of medical coating powder that contains nano material.
Embodiment 3
(1) gets 10 kilograms of Nano titanium dioxides; (2) take by weighing 60 kilograms hypromellose, 8 kilograms polyvinyl alcohol, 4 kilograms of yellow colorants; (3) above-mentioned raw materials is placed mixer stir 20 clocks, make its abundant mix homogeneously, add 10 kilograms 8 kilograms of glycerol, tweens, mixed 25 minutes, obtain even batch mixing; (4) above-mentioned batch mixing was placed 60～80 ℃ of dryings of exsiccator 3～4 hours; (5) dried batch mixing is taken out, puts coldly pulverize again; (6) obtain finished product---exsiccant a kind of medical coating powder that contains nano material through cross screening at the 60-80 order.
Embodiment 4
(1) gets 7 kilograms of Nano titanium dioxides; (2) take by weighing 65 kilograms hypromellose, 8 kilograms PVP-VA64 (PVP/VA), 2 kilograms of black colorants; (3) above-mentioned raw materials is placed mixer stirred 20 minutes, make its abundant mix homogeneously, add 10 kilograms 8 kilograms of glycerol, span, mixed 25 minutes, obtain even batch mixing; (4) above-mentioned batch mixing was placed 60～80 ℃ of dryings of exsiccator 3～4 hours; (5) dried batch mixing is taken out, puts coldly pulverize again; (6) obtain finished product---exsiccant a kind of medical coating powder that contains nano material through cross screening at the 60-80 order.
Embodiment 5
(1) gets 8 kilograms of Nano titanium dioxides; (2) take by weighing 58 kilograms hypromellose, 8 kilograms polyvinylpyrrolidone, 8 kilograms of carboxymethyl celluloses, 3 kilograms of yellow colorants; (3) above-mentioned raw materials is placed mixer stirred 20 minutes, make its abundant mix homogeneously, add 15 kilograms glycerol, mixed 25 minutes, obtain even batch mixing; (4) above-mentioned batch mixing was placed 60～80 ℃ of dryings of exsiccator 3～4 hours; (5) dried batch mixing is taken out, puts coldly pulverize again; (6) obtain finished product---exsiccant a kind of medical coating powder that contains nano material through cross screening at the 60-80 order.
Embodiment 6
(1) gets 6 kilograms of Nano titanium dioxides; (2) take by weighing 64 kilograms hypromellose, 8 kilograms polyvinylpyrrolidone, 2 kilograms of iron oxide red coloring agent; (3) above-mentioned raw materials is placed mixer stirred 20 minutes, make its abundant mix homogeneously, add 12 kilograms 8 kilograms of glycerol, tweens, mixed 25 minutes, obtain even batch mixing; (4) above-mentioned batch mixing was placed 60～80 ℃ of dryings of exsiccator 3～4 hours; (5) dried batch mixing is taken out, puts coldly pulverize again; (6) obtain finished product---exsiccant a kind of medical coating powder that contains nano material through cross screening at the 60-80 order.
Embodiment 7
(1) gets 3 kilograms of Nano titanium dioxides; (2) take by weighing 64 kilograms hypromellose, 8 kilograms polyvinylpyrrolidone, 15 kilograms Polyethylene Glycol, 2 kilograms of light green coloring agent; (3) above-mentioned raw materials is placed mixer stirred 20 minutes, make its abundant mix homogeneously, add 8 kilograms of tweens, mixed 25 minutes, obtain even batch mixing; (4) above-mentioned batch mixing was placed 60～80 ℃ of dryings of exsiccator 3～4 hours; (5) dried batch mixing is taken out, puts coldly pulverize again; (6) obtain finished product---exsiccant a kind of medical coating powder that contains nano material through cross screening at the 60-80 order.
Embodiment 8
(1) gets 10 kilograms of Nano titanium dioxides; (2) take by weighing 56 kilograms hypromellose, 8 kilograms polyvinylpyrrolidone, 3 kilograms of lemon yellow coloring agent; (3) above-mentioned raw materials is placed mixer stirred 20 minutes, make its abundant mix homogeneously, add 15 kilograms 8 kilograms of glycerol, tweens, mixed 25 minutes, obtain even batch mixing; (4) above-mentioned batch mixing was placed 60～80 ℃ of dryings of exsiccator 3～4 hours; (5) dried batch mixing is taken out, puts coldly pulverize again; (6) obtain finished product---exsiccant a kind of medical coating powder that contains nano material through cross screening at the 60-80 order.
Embodiment 9
(1) gets 9 kilograms of Nano titanium dioxides; (2) take by weighing 62 kilograms hypromellose, 8 kilograms polyvinylpyrrolidone, 4 kilograms of red stains; (3) above-mentioned raw materials is placed mixer stirred 20 minutes, make its abundant mix homogeneously, add 9 kilograms 8 kilograms of glycerol, tweens, mixed 25 minutes, obtain even batch mixing; (4) above-mentioned batch mixing was placed 60～80 ℃ of dryings of exsiccator 3～4 hours; (5) dried batch mixing is taken out, puts coldly pulverize again; (6) obtain finished product---exsiccant a kind of medical coating powder that contains nano material through cross screening at the 60-80 order.
Embodiment 10
Produce 10 kilograms of Nano titanium dioxides; (2) take by weighing 57 kilograms hydroxypropyl methylcellulose, 8 kilograms polyvinylpyrrolidone, 8 kilograms polyvinyl alcohol, 2 kilograms of yellow colorants; (3) above-mentioned raw materials is placed mixer stirred 20 minutes, make its abundant mix homogeneously, add 8 kilograms of 7 kilograms of glycerol, tweens, mixed 25 minutes, obtain even batch mixing; (4) above-mentioned batch mixing was placed 60～80 ℃ of dryings of exsiccator 3～4 hours; (5) dried batch mixing is taken out, puts coldly pulverize again; (6) obtain finished product---exsiccant a kind of medical coating powder that contains nano material through cross screening at the 60-80 order.The technical parameter that below is product of the present invention is measured:
The medical coating powder system that the present invention contains nano material adopts the medicinal raw material of safety non-toxic to form through processing and fabricating, it not only has the characteristic of general coating pre-mixing agent, but also have that consumption is little, film forming is fine and smooth, glossiness is strong, heat-resisting cold-resistant, wearability is good, hot strength is high, toughness is good, gas barrier strong, the characteristics of easily standardization, strong moistureproof, the anti-variable color of anti-ultraviolet radiation, antibiotic and sterilizing, automatic cleaning action; Thereby reach the purpose of Chinese medicine coating, make that product stability is good, the storage life is long.More more superior in order to confirm it than general coating pre-mixing agent performance, now two kinds of coating materials were carried out accelerated test 6 months by intending the listing packing, room temperature natural reserved 12 months, sampling regularly, key project is compared, detect according to the pertinent regulations of investigation project according to the Pharmacopoeia of the People's Republic of China 2000 editions.
(1) accelerated test.
Experimental condition: 40 ± 1 ℃ of temperature, RH75%
Sample packaging: PVC is packed
Sample source: research and development centre of company provides
Lot number: (containing nano material) 030701A 030702A 030703A.
(not containing nano material) 030701B 030702B 030703B.
The investigation time: on January 18,18 days～2004 July in 2003.
Investigation project: moisture absorption ratio aberration (Δ E value) microbial check.
Test method: each three batch sample of medical coating powder that will contain the medical coating powder of nano material and not contain nano material bottom set portion respectively are equipped with in mid-40 ± 1 ℃ calorstat of the hermetic container of saturated sodium chloride solution (RH75%) and placed 6 months, timing sampling, detect according to the pertinent regulations of investigation project, the results are shown in Table 1, table 2 according to the Pharmacopoeia of the People's Republic of China 2000 editions.
Table 1: the medical coating powder accelerated test investigation table that contains nano material
| Lot number | Period of storage | Store a month number | Moisture absorption ratio | Aberration (Δ E value) | Microbial check | ||
| Antibacterial (individual/g) | Mycete (individual/g) | Escherichia coli | |||||
| 30701A | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0 | 0.00 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 0.01％ | 0.04 | ＜10 | ＜10 | Do not detect | |
| On January 18th, 2004 | 6 | 0.02％ | 0.05 | ＜10 | ＜10 | Do not detect | |
| 030702A | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0.02％ | 0.01 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 0.04％ | 0.05 | ＜10 | ＜10 | Do not detect | |
| On January 18th, 2004 | 6 | 0.05％ | 0.07 | ＜10 | ＜10 | Do not detect | |
| 030703A | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0.01％ | 0.02 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 0.03％ | 0.03 | ＜10 | ＜10 | Do not detect | |
| On January 18th, 2004 | 6 | 0.06％ | 0.05 | ＜10 | ＜10 | Do not detect | |
Every as can be seen from Table 1 investigation result and 0 month are more constant.
Table 2: the medical coating powder accelerated test investigation table that does not contain nano material
| Lot number | Period of storage | Store a month number | Moisture absorption ratio | Aberration (Δ E value) | Microbial check | ||
| Antibacterial (individual/g) | Mycete (individual/g) | Escherichia coli | |||||
| 030701B | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0.58％ | 0.09 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 1.82％ | 0.56 | 40 | 10 | Do not detect | |
| On January 18th, 2004 | 6 | 3.38％ | 1.35 | 60 | 20 | Do not detect | |
| 030702B | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0.50％ | 0.10 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 2.03％ | 0.78 | 70 | 20 | Do not detect | |
| On January 18th, 2004 | 6 | 3.09％ | 1.26 | 90 | 30 | Do not detect | |
| 030703B | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0.53％ | 0.08 | ＜10 | 10 | Do not detect | |
| On October 18th, 2003 | 3 | 2.37％ | 0.73 | 50 | 30 | Do not detect | |
| On January 18th, 2004 | 6 | 3.15％ | 1.21 | 80 | 40 | Do not detect | |
Every as can be seen from Table 2 investigation result and bigger variation relatively took place in 0 month
(2) the room temperature investigation that keeps sample:
Experimental condition: room temperature is placed (25 ℃ ± 2 ℃ of temperature, RH60 ± 10%) naturally
Sample packaging: PVC is packed
Sample source: research and development centre of company provides
Lot number: (containing nano material) 030701A 030702A 030703A.
(not containing nano material) 030701B 030702B 030703B.
Investigation project: moisture absorption ratio aberration (Δ E value) microbial check
The investigation time: on July 18,18 days～2004 July in 2003
Test method: each three batch sample of medicinal bag powder that will contain the medical coating powder of nano material and not contain nano material are placed respectively at room temperature, in 1,3,6, the December timing sampling, detect according to the pertinent regulations of investigation project, the results are shown in Table 3, table 4 according to the Pharmacopoeia of the People's Republic of China 2000 editions.
Table 3: the medical coating powder room temperature test investigation table that contains nano material
| Lot number | Period of storage | Store a month number | Moisture absorption ratio | Aberration (Δ E value) | Microbial check | ||
| Antibacterial (individual/g) | Mycete (individual/g) | Escherichia coli | |||||
| 030701A | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0 | 0.00 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 0 | 0.00 | ＜10 | ＜10 | Do not detect | |
| On January 18th, 2004 | 6 | 0 | 0.01 | ＜10 | ＜10 | Do not detect | |
| On July 18th, 2004 | 12 | 0.02％ | 0.04 | ＜10 | ＜10 | Do not detect | |
| 030702A | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0 | 0.00 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 0 | 0.00 | ＜10 | ＜10 | Do not detect | |
| On January 18th, 2004 | 6 | 0.01％ | 0.01 | ＜10 | ＜10 | Do not detect | |
| On July 18th, 2004 | 12 | 0.03％ | 0.05 | ＜10 | ＜10 | Do not detect | |
| 030703A | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0 | 0.00 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 0 | 0.00 | ＜10 | ＜10 | Do not detect | |
| On January 18th, 2004 | 6 | 0.01％ | 0.03 | ＜10 | ＜10 | Do not detect | |
| On July 18th, 2004 | 12 | 0.04％ | 0.05 | ＜10 | ＜10 | Do not detect | |
As can be seen from Table 3, every investigation result and 0 month are more constant.
Table 4: the medical coating powder room temperature test investigation table that does not contain nano material
| Lot number | Period of storage | Store a month number | Moisture absorption ratio | Aberration (Δ E value) | Microbial check | ||
| Antibacterial (individual/g) | Mycete (individual/g) | Escherichia coli | |||||
| 030701B | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0.15％ | 0.01 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 0.42％ | 0.32 | 20 | 10 | Do not detect | |
| On January 18th, 2004 | 6 | 1.58％ | 0.81 | 50 | 20 | Do not detect | |
| On July 18th, 2004 | 12 | 2.88％ | 1.00 | 70 | 30 | Do not detect | |
| 030702B | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0.25％ | 0.00 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 0.34％ | 0.09 | 10 | 10 | Do not detect | |
| On January 18th, 2004 | 6 | 2.86％ | 0.70 | 50 | 30 | Do not detect | |
| On July 18th, 2004 | 12 | 3.38％ | 1.21 | 80 | 30 | Do not detect | |
| 030703B | On July 18th, 2003 | 0 | 0 | 0.00 | ＜10 | ＜10 | Do not detect |
| On August 18th, 2003 | 1 | 0.12％ | 0.12 | ＜10 | ＜10 | Do not detect | |
| On October 18th, 2003 | 3 | 0.92％ | 0.03 | 10 | 10 | Do not detect | |
| On January 18th, 2004 | 6 | 2.17％ | 0.83 | 70 | 10 | Do not detect | |
| On July 18th, 2004 | 12 | 3.08％ | 1.30 | 90 | 30 | Do not detect | |
As can be seen from Table 4, every investigation result and bigger variation relatively took place in 0 month
(3) conclusion: through medical coating powder that contains nano material and the medical coating powder that does not contain nano material have been carried out the superior function test, consolidated statement 1, table 2, table 3, table 4 are analyzed, it is more constant to contain the every investigation result of medical coating powder of nano material and 0 month, and does not contain the every investigation result of medical coating powder of nano material and bigger variation relatively took place in 0 month.The result shows that the medical coating powder that contains nano material has stronger superiority.
Claims (5)
1, contain the medical coating powder of nano material, it is characterized in that: it is made up of the composition of following material and weight percentage:
Hypromellose 55-65%
PVP-VA64 8%
Glycerol 15%
Span 8%
Coloring agent 2-4%
Nano titanium dioxide 2-10%.
2, the medical coating powder that contains nano material according to claim 1 is characterized in that: PVP-VA64 can be replaced with polyvinyl alcohol or polyvinylpyrrolidone.
3, the medical coating powder that contains nano material according to claim 1, it is characterized in that: span can be replaced with tween.
4, the medical coating powder that contains nano material according to claim 1 is characterized in that: coloring agent is selected food stage or pharmaceutical grade pigment for use.
5, a kind of processing technology that contains the medical coating powder of nano material as claimed in claim 1, it is characterized in that: (1) takes by weighing the material of following weight percent meter in proportion: hypromellose 55-65%, PVP-VA64 8%, glycerol 15%, span 8%, coloring agent 2-4%, Nano titanium dioxide 2-10%; (2) will place mixer to stir except that the above-mentioned raw materials glycerol, the span, and make its mix homogeneously, mixing behind adding glycerol, the span obtains even batch mixing; (3) above-mentioned batch mixing is placed exsiccator dry; (4) dried batch mixing is taken out, put cold back and pulverize; (5) sieve and obtain finished product.
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| Application Number | Priority Date | Filing Date | Title |
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| CN200410078365.2A CN1275651C (en) | 2004-09-27 | 2004-09-27 | Medical coating powder containing nano material |
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| Application Number | Priority Date | Filing Date | Title |
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| CN200410078365.2A CN1275651C (en) | 2004-09-27 | 2004-09-27 | Medical coating powder containing nano material |
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| CN1275651C true CN1275651C (en) | 2006-09-20 |
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Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
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| JP5946641B2 (en) * | 2008-09-25 | 2016-07-06 | アイエスピー インヴェストメンツ インコーポレイテッドＩｓｐ Ｉｎｖｅｓｔｍｅｎｔｓ Ｉｎｃ． | Smooth, high solid tablet coating composition |
| CN103893768B (en) * | 2014-04-04 | 2016-02-24 | 广东国方医药科技有限公司 | A kind of can in the gastrointestinal tract size reduction preparation method of nano material |
| CN104587472B (en) * | 2014-12-31 | 2017-12-15 | 广东国方医药科技有限公司 | A kind of nano si-containing O2Coating agent and preparation method thereof |
| CN104491865B (en) * | 2014-12-31 | 2018-01-19 | 广东国方医药科技有限公司 | A kind of coating agent containing nano-sized iron oxide and preparation method thereof |
| CN104548102B (en) * | 2014-12-31 | 2018-01-19 | 广东国方医药科技有限公司 | A kind of coating agent containing nano-ZnO and preparation method thereof |
| CN105412044B (en) * | 2015-12-31 | 2018-10-30 | 广东国方医药科技有限公司 | A kind of nano si-containing O2Capsules and preparation method thereof |
| CN108313367A (en) * | 2018-02-27 | 2018-07-24 | 湖南尔康制药股份有限公司 | A kind of vitamin C Yinqiao tablet of filling with inert gas packaging |
| CA3115516C (en) * | 2018-10-05 | 2023-04-25 | Isp Investments Llc | Smooth high solids film coating composition comprising water soluble cellulose ether, process for preparing the same and method of use thereof |
| CN110638778A (en) * | 2019-08-28 | 2020-01-03 | 株洲千金药业股份有限公司 | Tablet water-soluble coating and preparation method and application thereof |
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