CN115120569B - Method for removing static electricity among micropills - Google Patents
Method for removing static electricity among micropills Download PDFInfo
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- CN115120569B CN115120569B CN202210792157.7A CN202210792157A CN115120569B CN 115120569 B CN115120569 B CN 115120569B CN 202210792157 A CN202210792157 A CN 202210792157A CN 115120569 B CN115120569 B CN 115120569B
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- static electricity
- pellets
- micropills
- hydroxypropyl cellulose
- coating
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- 230000003068 static effect Effects 0.000 title claims abstract description 37
- 230000005611 electricity Effects 0.000 title claims abstract description 36
- 238000000034 method Methods 0.000 title claims abstract description 26
- 239000008188 pellet Substances 0.000 claims abstract description 40
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims abstract description 24
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims abstract description 24
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims abstract description 24
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims abstract description 23
- 239000000463 material Substances 0.000 claims abstract description 23
- 238000005507 spraying Methods 0.000 claims abstract description 23
- 239000003814 drug Substances 0.000 claims abstract description 21
- 238000002156 mixing Methods 0.000 claims abstract description 17
- 238000007599 discharging Methods 0.000 claims abstract description 10
- 239000011248 coating agent Substances 0.000 claims description 30
- 238000000576 coating method Methods 0.000 claims description 30
- 239000007788 liquid Substances 0.000 claims description 18
- 229940079593 drug Drugs 0.000 claims description 16
- 238000002360 preparation method Methods 0.000 claims description 13
- KAESVJOAVNADME-UHFFFAOYSA-N Pyrrole Chemical compound C=1C=CNC=1 KAESVJOAVNADME-UHFFFAOYSA-N 0.000 claims description 12
- 239000006187 pill Substances 0.000 claims description 12
- 238000003756 stirring Methods 0.000 claims description 10
- 238000001035 drying Methods 0.000 claims description 7
- 239000008213 purified water Substances 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 238000000889 atomisation Methods 0.000 claims description 5
- 239000007921 spray Substances 0.000 claims description 4
- 239000008298 dragée Substances 0.000 claims 1
- 238000011049 filling Methods 0.000 abstract description 7
- 238000012546 transfer Methods 0.000 abstract description 5
- 239000004698 Polyethylene Substances 0.000 abstract description 3
- -1 polyethylene Polymers 0.000 abstract description 3
- 229920000573 polyethylene Polymers 0.000 abstract description 3
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 239000000243 solution Substances 0.000 description 18
- 230000000052 comparative effect Effects 0.000 description 9
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 4
- 229960003943 hypromellose Drugs 0.000 description 4
- 239000000454 talc Substances 0.000 description 4
- 229910052623 talc Inorganic materials 0.000 description 4
- 235000012222 talc Nutrition 0.000 description 4
- 239000002775 capsule Substances 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 238000005303 weighing Methods 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000008021 deposition Effects 0.000 description 2
- 238000007865 diluting Methods 0.000 description 2
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 2
- 229960000197 esomeprazole magnesium Drugs 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- KWORUUGOSLYAGD-WLHYKHABSA-N magnesium;5-methoxy-2-[(r)-(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide Chemical compound [Mg+2].C([S@@](=O)C=1[N-]C2=CC=C(C=C2N=1)OC)C1=NC=C(C)C(OC)=C1C.C([S@@](=O)C=1[N-]C2=CC=C(C=C2N=1)OC)C1=NC=C(C)C(OC)=C1C KWORUUGOSLYAGD-WLHYKHABSA-N 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 239000013558 reference substance Substances 0.000 description 2
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 description 1
- 229920003114 HPC-L Polymers 0.000 description 1
- IWUCXVSUMQZMFG-AFCXAGJDSA-N Ribavirin Chemical compound N1=C(C(=O)N)N=CN1[C@H]1[C@H](O)[C@H](O)[C@@H](CO)O1 IWUCXVSUMQZMFG-AFCXAGJDSA-N 0.000 description 1
- 238000005299 abrasion Methods 0.000 description 1
- 239000008199 coating composition Substances 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000002702 enteric coating Substances 0.000 description 1
- 238000009505 enteric coating Methods 0.000 description 1
- 229960004770 esomeprazole Drugs 0.000 description 1
- SUBDBMMJDZJVOS-DEOSSOPVSA-N esomeprazole Chemical compound C([S@](=O)C1=NC2=CC=C(C=C2N1)OC)C1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-DEOSSOPVSA-N 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 239000004816 latex Substances 0.000 description 1
- 229920000126 latex Polymers 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- MQEUGMWHWPYFDD-UHFFFAOYSA-N magnesium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1h-benzimidazole Chemical compound [Mg].N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C MQEUGMWHWPYFDD-UHFFFAOYSA-N 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 229960000381 omeprazole Drugs 0.000 description 1
- 229960003117 omeprazole magnesium Drugs 0.000 description 1
- 239000008055 phosphate buffer solution Substances 0.000 description 1
- 238000011112 process operation Methods 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 229960000329 ribavirin Drugs 0.000 description 1
- HZCAHMRRMINHDJ-DBRKOABJSA-N ribavirin Natural products O[C@@H]1[C@H](O)[C@@H](CO)O[C@H]1N1N=CN=C1 HZCAHMRRMINHDJ-DBRKOABJSA-N 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
Classifications
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5089—Processes
Abstract
The invention belongs to the field of pharmaceutical preparations, and discloses a method for removing static electricity among micropills, which comprises the following steps: after the pellets are coated, spraying a hydroxypropyl cellulose solution according to the weight of the hydroxypropyl cellulose which is 2-5% of the mass of the pellets, controlling the temperature of the material at 40-50 ℃ when spraying the hydroxypropyl cellulose solution, and uniformly mixing the material with a small amount of talcum powder after the pellets are dried and discharged. The invention solves the problem of static electricity among the micropills by spraying the hydroxypropyl cellulose and then mixing a small amount of talcum powder, and the micropills are not adhered to the medical polyethylene film bags after discharging, thereby reducing the loss in the transfer process caused by static electricity, improving the convenience of the micropills in the use and transfer process, and simultaneously solving the problems of unstable filling quantity of the micropills and unqualified medicine quality caused by static electricity in the next step of dosing.
Description
Technical Field
The invention belongs to the field of pharmaceutical preparations, relates to a pellet preparation, and in particular relates to a method for removing static electricity among pellets.
Background
Pellets (pills) are spherical or spheroid oral preparations with a diameter of 0.2-1.5 mm. The micropill has the advantages of good fluidity, easy capsule filling, small filling quantity difference and the like, and is more applied to long-acting and sustained-release dosage forms in the current pharmaceutical process, and is widely applied to micropill coating. Because the volume of the pellets is small, the pellets cannot be coated in a rotating or rolling way when the preparation is coated and applied, and the main stream coating mode is fluidized bed bottom spray coating.
In the preparation process of the pellets, because the pellets are smaller, static electricity can be generated by continuous abrasion among the pellets, impact between the pellets and the surface of equipment, and the like, the static electricity phenomenon is particularly obvious in the drying stage of coating ending, the discharging and bagging process and the next working procedure such as the capsule filling stage, so that the pellets are adhered to the medicinal polyethylene film bags, the use and the transfer processes are extremely inconvenient, and even the unstable filling amount of the pellets during the dosage division can be caused, and the quality of the medicines is unqualified.
The existing method for solving the static electricity comprises the steps of increasing humidity, reducing temperature, grounding wires, adding static electricity liquid and the like, and the method is not very practical for solving the static electricity of the medicine. Firstly, the humidity is increased, the temperature is reduced, the original technological parameters are influenced, and the adhesion of the pellets can be possibly caused; secondly, the grounding wire is proved to have no obvious improvement on the electrostatic problem of the pellets through multiple experiments; finally, although static electricity can be removed by static electricity liquid, most of the existing static electricity liquid is not edible, so that the static electricity liquid is not feasible for medicines.
In addition, the pharmaceutical industry also has the ability to remove static electricity by adding talc to the coating formulation or mixing the talc after removal of the material, but both methods use larger amounts of talc. Meanwhile, talcum powder has pore-forming agent in the coating liquid, which can affect the drug release; the mixed talcum powder after discharging has the effect of reducing static electricity, can not absolutely eliminate the static electricity, and has the dosage of at least 0.5 percent of the mass of the pellets, and the problem of talcum powder deposition easily occurs after mixing.
Disclosure of Invention
The invention aims to solve the problem of static electricity of micropills, and provides a method for removing static electricity among micropills, which ensures that the micropills are beneficial to the next process operation (such as capsule filling), ensures the difference of pill loading and ensures the quality of medicines.
The technical problems to be solved by the invention can be realized by the following technical scheme:
a method of removing static electricity between pellets, comprising: after the pellets are coated, spraying a hydroxypropyl cellulose solution according to the weight of the hydroxypropyl cellulose which is 2-5% of the mass of the pellets, controlling the temperature of the material at 40-50 ℃ when spraying the hydroxypropyl cellulose solution, and uniformly mixing the material with a small amount of talcum powder after the pellets are dried and discharged.
The concentration of the hydroxypropyl cellulose solution is 3-5 wt%.
As a preferable technical scheme of the method for removing static electricity among the micropellets, an anti-adhesion agent can be added into the hydroxypropyl cellulose solution to reduce the viscosity of the hydroxypropyl cellulose solution, and the concentration of the anti-adhesion agent in the hydroxypropyl cellulose solution is 3-5%wt; the anti-sticking agent can be talcum powder.
As a further specific technical scheme of the method for removing static electricity among the micropellets, the coating of the micropellets and the spraying of the hydroxypropyl cellulose solution for coating are carried out in a fluidized bed; comprising the following steps: after the pellets are coated, a fluidized bed bottom spraying technology is adopted to spray a hydroxypropyl cellulose solution for coating, the air inlet temperature is set to 55+/-5 ℃, and the air quantity is 100-200 m 3 Per hour, the atomization pressure is 1.5-3.0 kg/cm 2 Controlling the liquid spraying speed to be 2-5 g/min and the material temperature to be 40-50 ℃; after coating, setting the air inlet temperature of the fluidized bed at 40-50 ℃, drying and discharging.
After the pellets are dried and discharged, the talcum powder is generally used in an amount of 0.1-0.3% by weight of the mass of the pellets (calculated by spraying the hydroxypropyl cellulose pellets).
The micropill is a micro-pill of a drug of the group of the ribavirin, and can be particularly an micro-pill of the esomeprazole.
It is another object of the present invention to provide the use of hydroxypropylcellulose for removing static electricity between pellets.
Compared with the prior art, the invention has the beneficial effects that:
(1) The invention solves the problem of static electricity among the micropills by spraying the hydroxypropyl cellulose and then mixing a small amount of talcum powder, the micropills are not adhered to the medical polyethylene film bag after discharging, the loss in the transfer process caused by static electricity is reduced, the convenience of the micropills in the use and transfer process is improved, and the problems of unstable filling quantity of the micropills and unqualified medicine quality caused by static electricity in the next step of dosing are solved.
(2) The invention can carry out pellet preparation and hydroxypropyl cellulose solution coating in the same equipment, has simple process and can be controlled within the required weight increasing range without affecting the drug release.
Drawings
FIG. 1 is a graph comparing the static removal effect of pellets; among them, pellets prepared in examples 1, 2, 1, 2, and 3 were obtained in this order from left to right.
Detailed Description
The invention will be further illustrated by the following examples, which are intended to illustrate, but not to limit, the invention.
The hydroxypropylcellulose used in the examples was HPC-L type product of Caddar, japan.
The micro-pills (particle size of 500-700 μm) of the drug used in the example refer to the prescription and the preparation process of the example 2 of Chinese patent CN1134666A, and the micro-pills with enteric coating are prepared by replacing omeprazole magnesium with the same amount of raw material drug Esomeprazole magnesium.
Example 1
The materials were weighed according to the following formula:
the preparation method comprises the following steps: adding the prescribed amount of hydroxypropyl cellulose into the prescribed amount of purified water, stirring for dissolving to obtain coating solution (the concentration of hydroxypropyl cellulose is 4%wt), adding the micro-pellets of the azole drugs into a fluidized bed, starting the bottom spraying of the fluidized bed, setting the air inlet temperature to 55 ℃, and setting the air quantity to 120m 3 /h, atomization pressure 2.0kg/cm 2 Controlling the spraying speed at 2-4 g/min, controlling the temperature of the material at 40-50 ℃ and performing spraying coating; after coating, controlling the temperature of the fluidized bed material to be 40-50 ℃, drying for 30min, discharging, and adding 0.4g of talcum powder for mixing.
Example 2
The materials were weighed according to the following formula:
the preparation method comprises the following steps: adding the prescription amount of hydroxypropyl cellulose into the prescription amount of purified water, stirring for dissolving, adding the prescription amount of talcum powder, stirring uniformly to obtain coating liquid, adding the micro-pellets of the azole drugs into a fluidized bed, starting the bottom spraying of the fluidized bed, setting the air inlet temperature to 55 ℃ and the air quantity to 140m 3 /h, atomization pressure 1.8kg/cm 2 Controlling the spraying speed at 3-5 g/min, controlling the material temperature at 40-50 ℃, and maintaining the stirring of the coating liquid to spray the liquid coating; after coating, controlling the temperature of the fluidized bed material to be 40-50 ℃, drying for 30min, discharging, and adding 0.3g of talcum powder for mixing.
Example 3
The materials were weighed according to the following formula:
the preparation method comprises the following steps: adding the prescription amount of hydroxypropyl cellulose into the prescription amount of purified water, stirring for dissolving to obtain coating liquid, adding the micro-pills of the azole drugs into a fluidized bed, starting the bottom spraying of the fluidized bed, setting the air inlet temperature to 55 ℃ and the air quantity to 150m 3 /h, atomization pressure 2.2kg/cm 2 Controlling the spraying speed at 2-4 g/min, controlling the material temperature at 40-50 ℃, and maintaining the stirring of the coating liquid to spray the liquid coating; after coating, controlling the temperature of the fluidized bed material to be 40-50 ℃, drying for 30min, discharging, and adding 0.3g of talcum powder for mixing.
Comparative example 1
The materials were weighed according to the following formula:
mixing: 200g of micro pill of a medicament of the group of lazole
Talc powder 1g
The preparation method comprises the following steps: adding talcum powder according to 0.5% of the weight of the micro-pill of the lazole drugs, and mixing.
Comparative example 2:
the materials were weighed according to the following formula:
mixing: 200g of micro pill of a medicament of the group of lazole
Talc powder 4g
The preparation method comprises the following steps: adding talcum powder according to 2% of the weight of the lazole micropill, and mixing.
Comparative example 3
Curing refers to the progressive film completion process that occurs from the aqueous dispersion by the incorporation of latex particles to form a coating. Static electricity removal refers to the elimination of charges on solids, liquids and even gases due to contact separation.
In view of the fact that the manner of spraying the hypromellose solution after coating the pellets is a common manner of curing the pellets, the inventors replaced the hypromellose of example 1 with hypromellose to observe the effect of removing static electricity.
The materials were weighed according to the following formula:
the preparation method comprises the following steps: adding the prescription amount of hypromellose into the prescription amount of purified water, stirring and dissolving to obtain coating liquid, adding the micro-pills of the azole drugs into a fluidized bed, starting the bottom spraying of the fluidized bed, setting the air inlet temperature to be 55 ℃, controlling the material temperature to be 40-50 ℃, and spraying liquid for coating; after coating, controlling the temperature of the fluidized bed material to be 40-50 ℃, drying for 30min, and discharging; 0.4g of talc was added and mixed.
Static electricity removal investigation
In fig. 1, pellets (i.e., pellets of a azole drug), example 1, example 2, comparative example 1, comparative example 2, and comparative example 3, which were prepared without any treatment, were shown to be in order from left to right. It can be seen that the pellets without any treatment had a large static electricity and the adhesion of the medicinal film bag was serious, the samples prepared in example 1, example 2 and example 3 (not shown) had little static electricity and no pellets adhered to the medicinal film bag, while the samples prepared in comparative example 1 and comparative example 3 had insignificant static electricity removing effect, and the comparative example 2 had a static electricity removing effect but had a talc powder deposition phenomenon because the amount of talc powder was as high as 2%.
Investigation of Release degree
The measuring method comprises the following steps: taking a sample (weighed according to a marked amount of 40 mg), taking a dissolution rate and release rate measuring method (general rule 0931, second method 1), taking 300mL of 0.l mol/L hydrochloric acid as a dissolution medium, rotating at 100 revolutions per minute, performing normal operation, adding 700mL of 0.086mol/L disodium hydrogen phosphate solution preheated to 37+/-0.5 ℃ into each dissolution cup after 2 hours, uniformly mixing, continuing normal operation at the constant rotating speed, filtering about 10mL of solution after 30 minutes, precisely measuring 5mL of continuous filtrate, precisely adding 1mL of 0.25mol/L sodium hydroxide solution, and shaking uniformly to serve as a sample solution; and (3) taking about 20mg of omeprazole reference substance, precisely weighing, placing into a 100mL measuring flask, adding 10mL of ethanol to dissolve, diluting to a scale by using 700mL of 0.086mol/L disodium hydrogen phosphate solution and 300mL of 0.1 mol/L hydrochloric acid solution, uniformly mixing, precisely weighing 10mL, placing into a 50mL measuring flask, diluting to the scale by using the pH 6.8 phosphate buffer solution, uniformly shaking, precisely weighing 5mL, precisely adding 1mL of 0.25mol/L sodium hydroxide solution, uniformly shaking, and taking as a reference substance solution. The dissolution amount was calculated by measuring the content method. The measurement results are shown in Table 1.
TABLE 1 results of drug Release test in micropill
From table 1, it is clear that there is no significant difference in the release rate of the esomeprazole magnesium pellets prepared in examples 1 to 3 compared to pellets without any treatment.
Claims (1)
1. A method for removing static electricity among micropellets, which is characterized by comprising the following steps: the materials were weighed according to the following formula: coating: 200g of a micro pill of a dragee, 4g of hydroxypropyl cellulose, 4g of talcum powder and 80g of purified water; mixing: 0.3g of talcum powder;
the preparation method comprises the following steps: adding the prescription amount of hydroxypropyl cellulose into the prescription amount of purified water, stirring for dissolving, adding the prescription amount of talcum powder, stirring uniformly to obtain coating liquid, adding the micro-pellets of the azole drugs into a fluidized bed, starting the bottom spraying of the fluidized bed, setting the air inlet temperature to 55 ℃ and the air quantity to 140m 3 /h, atomization pressure 1.8kg/cm 2 Controlling the spraying speed to be 3-5 g/min, controlling the material temperature to be 40-50 ℃, and maintaining the stirring of the coating liquid to spray the liquid coating; after coating, controlling the temperature of the fluidized bed material to be 40-50 ℃, drying for 30min, discharging, and adding 0.3g of talcum powder for mixing.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210792157.7A CN115120569B (en) | 2022-07-07 | 2022-07-07 | Method for removing static electricity among micropills |
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| CN202210792157.7A CN115120569B (en) | 2022-07-07 | 2022-07-07 | Method for removing static electricity among micropills |
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| CN115120569B true CN115120569B (en) | 2023-11-28 |
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| CN102697660A (en) * | 2012-06-04 | 2012-10-03 | 贵州景峰注射剂有限公司 | Method for eliminating static electricity in micro-pill room |
| CN104013580A (en) * | 2014-06-13 | 2014-09-03 | 海南葫芦娃制药有限公司 | Lansoprazole pellet, capsule and preparation method thereof |
| CN104248766A (en) * | 2013-06-28 | 2014-12-31 | 重庆药友制药有限责任公司 | Coating solution containing ethyl cellulose and preparation method thereof |
| CN112516100A (en) * | 2020-12-31 | 2021-03-19 | 珠海润都制药股份有限公司 | Espressol omeprazole magnesium enteric-coated tablet and preparation method thereof |
| CN113101276A (en) * | 2021-03-11 | 2021-07-13 | 浙江康德药业集团股份有限公司 | Esciprazole magnesium enteric-coated pellet and capsule and preparation method thereof |
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2022
- 2022-07-07 CN CN202210792157.7A patent/CN115120569B/en active Active
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1134666A (en) * | 1994-07-08 | 1996-10-30 | 阿斯特拉公司 | Multiple unit tableted dosage form I |
| JPH11189768A (en) * | 1997-12-26 | 1999-07-13 | Kao Corp | Antistatic agent composition for chemical fiber |
| JP2000327837A (en) * | 1999-05-17 | 2000-11-28 | Asahi Chem Ind Co Ltd | Composition containing cellulose as antistatic agent |
| CN102697660A (en) * | 2012-06-04 | 2012-10-03 | 贵州景峰注射剂有限公司 | Method for eliminating static electricity in micro-pill room |
| CN104248766A (en) * | 2013-06-28 | 2014-12-31 | 重庆药友制药有限责任公司 | Coating solution containing ethyl cellulose and preparation method thereof |
| CN104013580A (en) * | 2014-06-13 | 2014-09-03 | 海南葫芦娃制药有限公司 | Lansoprazole pellet, capsule and preparation method thereof |
| CN112516100A (en) * | 2020-12-31 | 2021-03-19 | 珠海润都制药股份有限公司 | Espressol omeprazole magnesium enteric-coated tablet and preparation method thereof |
| CN113101276A (en) * | 2021-03-11 | 2021-07-13 | 浙江康德药业集团股份有限公司 | Esciprazole magnesium enteric-coated pellet and capsule and preparation method thereof |
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Effective date of registration: 20231106 Address after: No.36 Shuanggao Road, Gaochun Economic Development Zone, Nanjing, Jiangsu Applicant after: Jiangsu Zhongbang Pharmaceutical Co.,Ltd. Applicant after: Nanjing Red Sun Pharmaceutical Research Institute Co.,Ltd. Applicant after: SOUTHEAST University Address before: No.36 Shuanggao Road, Gaochun Economic Development Zone, Nanjing, Jiangsu Applicant before: Jiangsu Zhongbang Pharmaceutical Co.,Ltd. Applicant before: Nanjing Red Sun Pharmaceutical Research Institute Co.,Ltd. |
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