CN112206218B - Metronidazole vitamin B6 composition - Google Patents
Metronidazole vitamin B6 composition Download PDFInfo
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- CN112206218B CN112206218B CN202011149929.2A CN202011149929A CN112206218B CN 112206218 B CN112206218 B CN 112206218B CN 202011149929 A CN202011149929 A CN 202011149929A CN 112206218 B CN112206218 B CN 112206218B
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- vitamin
- metronidazole
- lactitol
- pellet
- pellets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
-
- 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
- A61K31/4415—Pyridoxine, i.e. Vitamin B6
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention relates to a drug-containing pellet of metronidazole vitamin B6 and a preparation method thereof, and the technical scheme of the invention is as follows: a metronidazole-vitamin B6 medicated pellet contains: metronidazole, vitamin B6, sucrose starch pellet core, mannitol, a filling agent, a disintegrating agent and a binder, wherein the filling agent is selected from vitamins, the disintegrating agent is selected from calcium silicate, and the binder is selected from lactitol. The invention provides a metronidazole vitamin B6 drug-containing pellet with excellent performance.
Description
Technical Field
The invention relates to a metronidazole vitamin B6 drug-containing pellet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations.
Background
Pellets are a dose-dispersing, spherical or spheroidal oral formulation with a diameter of 0.5-1.5mm, a dose consisting of a plurality of discrete units, usually a dose consisting of tens to hundreds of pellets. The pellet preparation can be widely distributed in gastrointestinal tract after being taken, and the dispersion surface area of the medicine in the gastrointestinal tract is large due to dosage dumping and dispersion, so that the stimulation to the gastrointestinal tract is reduced or eliminated while the bioavailability of the medicine is increased. The drug release behavior of the pellet preparation is the sum of the drug release behaviors of each pellet forming one dose, and the errors or defects of the preparation of the individual pellets can not seriously affect the drug release behavior of the whole preparation, so the repeatability and the consistency of the drug release rule are superior to those of tablets. The pellet preparation can be filled in a capsule for whole granule swallowing or the capsule is opened for directly taking the pellets, and the pellets are easy to swallow, so the pellet preparation is particularly suitable for children or old people with swallowing difficulty.
Metronidazole is widely used to treat or prevent systemic or topical infections caused by anaerobic bacteria, such as infections of the abdominal cavity, digestive tract, female reproductive system, lower respiratory tract, skin and soft tissues, bones and joints, and also to treat septicemia, endocarditis, meningeal infections and colitis caused by the use of antibiotics. Tetanus is often treated in combination with Tetanus Antitoxin (TAT). Can also be used for oral cavity anaerobe infection. Vitamin B6 can relieve gastrointestinal discomfort caused by metronidazole.
Stability tests show that the metronidazole vitamin B6 pellets are easy to absorb moisture in the storage process, easy to change color in the process of placing under an accelerating condition in an exposed state, and the pellets are agglomerated and slow in dissolution.
Disclosure of Invention
The purpose of the invention is as follows: in order to solve the technical problems, the invention provides a metronidazole vitamin B6 drug-containing pellet and a preparation method thereof.
Tests show that the metronidazole vitamin B6 pellets can play the role of a disintegrant and can increase the stability of the pellets by adding a proper amount of calcium silicate.
The technical scheme of the invention is as follows:
a metronidazole-vitamin B6 medicated pellet contains: metronidazole, vitamin B6, sucrose starch pellet core, mannitol, a filling agent, a disintegrating agent and a binder, wherein the filling agent is selected from vitamins, the disintegrating agent is selected from calcium silicate, and the binder is selected from lactitol.
A metronidazole vitamin B6 medicated pellet contains unit dose of composition comprising: 200mg of metronidazole, 620 mg of vitamin B620 mg, 48-68mg of sucrose starch pill core, 18-45mg of lactitol, 37-68mg of mannitol and 6-16mg of calcium silicate.
Preferably, the composition of the present invention comprises: 200mg of metronidazole, 620 mg of vitamin B620 mg, 52-60mg of sucrose starch pill core, 21-37mg of lactitol, 40-60mg of mannitol and 8-15mg of calcium silicate.
Preferably, the metronidazole D50 is less than 10 μm and D90 is less than 20 μm in the composition.
Preferably, the vitamin B6D 50 is less than 10 μm and D90 is less than 20 μm in the composition.
Preferably, in the composition, the diameter of the sucrose starch pellet core is 400-500 μm. In the sucrose-starch pellet core, sucrose has good formability in the process of preparing the pellet core, starch can increase the hardness of the pellet core, and the pellet core with the sucrose proportion of 40-70% can not only keep the roundness of the pellet core, but also ensure the hardness of the pellet core, so that the pellet core cannot be broken due to friction and collision in the preparation process. The diameter of the sucrose starch pellet core is 400-500 mu m, so that the pellet core can be ensured to have good drug loading, no adhesion occurs among the pellets in the drug loading process, and the dissolution speed is high.
In the composition, calcium silicate is used as a disintegrant, and plays a positive role in the stability of the pellets, so that the pellets are protected to have stable performance. If disintegrating agents such as croscarmellose sodium, crospovidone and starch are used, the pellets can expand rapidly after absorbing water, so that the brittleness of the pellets is reduced easily in the storage process, and the shape and the dissolution rate of the pellets are affected.
The inventor finds that the lactitol serving as the adhesive can improve the drug delivery rate of the powder and obviously improve the hygroscopicity. The sample prepared by the invention can not absorb moisture after being exposed in the air for a long time, the appearance of the sample is not changed, the pellets are not adhered, the dissolution rate is not changed, and the property is very stable. The lactitol has certain sweetness, and can play a good taste masking role.
The invention also aims to provide a method for preparing the metronidazole vitamin B6 pellet, which comprises the following specific process steps:
step 1, adding vitamin B6 and lactitol in a prescription amount into a proper amount of purified water, and stirring until the vitamin B6 and the lactitol are completely dissolved for later use;
step 2, uniformly mixing metronidazole, mannitol and calcium silicate according to the prescription amount in a mixer for later use;
step 3, adding the sucrose starch pellet cores in the formula amount into a centrifugal granulator, spraying a lactitol solution while adding the mixed powder in the step 2 for medicine application, continuously spraying the rest lactitol after the medicine application is finished, and continuously centrifuging until the surfaces of the pellets are smooth and round;
and 4, drying and sieving the pellets obtained in the step 3, taking pellets with a 14-24-mesh sieve, and encapsulating.
Has the beneficial effects that:
the invention provides a metronidazole vitamin B6 drug-containing pellet with excellent performance. Has the following advantages:
1) the calcium silicate can not only quickly absorb water to promote the dissolution and absorption of the medicine, but also absorb the water in metronidazole and vitamin B6 in the process of placement, thereby being a very good protection to the stability of the calcium silicate.
2) The invention selects the lactitol as the adhesive, the lactitol is dissolved in water but has no hygroscopicity, the use of the lactitol can improve the medicine application rate of the powder, and meanwhile, the hygroscopicity is obviously improved, so that the sample cannot be adhered in the long-term placing process; meanwhile, the lactitol has certain sweetness, and can play a good taste masking role.
3) The diameter of the selected sucrose starch pellet core is 400-500 mu m, so that the pellet core can be ensured to have good drug loading, no adhesion occurs between the pellets in the drug loading process, and the dissolution speed is high.
4) The metronidazole vitamin B6 pellet has the advantages of stable quality, no obvious moisture absorption and agglomeration after long-term exposure in air, and no obvious change in properties and dissolution rate.
Detailed Description
In order to better explain the invention and its results, reference will now be made to the following examples. The scope of the invention is not limited to the specific versions of the embodiments.
In the embodiment and the comparative example of the invention, the metronidazole D50 is smaller than 10 μm, and the D90 is smaller than 20 μm; vitamin B6D 50 is less than 10 μm and D90 is less than 20 μm.
The sucrose starch pellet core manufacturers used in examples 1-3 and comparative examples 1-4 of the present invention: jiangsu Dongsheng medicine science and technology limited, pill core diameter: 400-500 μm, sucrose content: 40 to 70 percent.
Example 1
Prescription: 2000g of metronidazole, 6200 g of vitamin B, 480g of sucrose starch pill core, 370g of mannitol, 60g of calcium silicate, 180g of lactitol and 1000g of purified water.
10000 capsules are prepared according to the preparation method of the technical proposal of the specification. The yield of the centrifugal granulation process was counted, and the yield is 100% of the weight (g) of the drug-containing pellets/the total amount (g) of the feed, and the data are shown in table 1.
Example 2
Prescription: 2000g of metronidazole, 6200 g of vitamin B, 680g of sucrose starch pill core, 680g of mannitol, 160g of calcium silicate, 450g of lactitol and 1000g of purified water.
10000 capsules are prepared according to the preparation method of the technical proposal of the specification. The yield of the centrifugal granulation process was counted, which is the weight (g) of the drug-containing pellets/the total amount (g) of the feed multiplied by 100%, and the data are shown in table 1.
Example 3
Prescription: 2000g of metronidazole, 6200 g of vitamin B, 480g of sucrose starch pill core, 450g of mannitol, 90g of calcium silicate, 270g of lactitol and 1000g of purified water.
10000 capsules are prepared according to the preparation method of the technical proposal of the specification. The yield of the centrifugal granulation process was counted, and the yield is 100% of the weight (g) of the drug-containing pellets/the total amount (g) of the feed, and the data are shown in table 1.
Comparative example 1
Prescription: 2000g of metronidazole, 6200 g of vitamin B, 480g of sucrose starch pill core (400-500 mu m), 300g of mannitol, 20g of calcium silicate, 210g of lactitol and 1000g of purified water.
10000 capsules are prepared according to the preparation method of the technical proposal of the specification. The yield of the centrifugal granulation process was counted, and the yield is 100% of the weight (g) of the drug-containing pellets/the total amount (g) of the feed, and the data are shown in table 1.
Comparative example 2
Prescription: 2000g of metronidazole, 6200 g of vitamin B, 650g of sucrose starch pellet core (400-500 mu m), 370g of mannitol, 200g of calcium silicate, 100g of lactitol and 1000g of purified water.
10000 capsules are prepared according to the preparation method of the technical proposal of the specification. The yield of the centrifugal granulation process was counted, and the yield is 100% of the weight (g) of the drug-containing pellets/the total amount (g) of the feed, and the data are shown in table 1.
Comparative example 3
Prescription: 2000g of metronidazole, 6200 g of vitamin B, 650g of sucrose starch pill core (400-500 mu m), 370g of mannitol, 160g of crospovidone, 250g of lactitol and 1000g of purified water;
10000 capsules are prepared by the preparation method according to the technical scheme of the specification. The yield of the centrifugal granulation process was counted, and the yield is 100% of the weight (g) of the drug-containing pellets/the total amount (g) of the feed, and the data are shown in table 1.
Comparative example 4
Prescription: 2000g of metronidazole, 6200 g of vitamin B, 650g of sucrose starch pellet core (400-500 mu m), 370g of mannitol, 110g of calcium silicate, 170g of hydroxypropyl cellulose and 1000g of purified water.
10000 capsules are prepared according to the preparation method of the technical proposal of the specification. The yield of the centrifugal granulation process was counted, and the yield is 100% of the weight (g) of the drug-containing pellets/the total amount (g) of the feed, and the data are shown in table 1.
Comparative example 5
Prescription: 2000g of metronidazole, 6200 g of vitamin B, 480g of sucrose starch pellet core (the diameter of the pellet core is 300-400 mu m), 680g of mannitol, 200g of calcium silicate, 210g of lactitol and 1000g of purified water. The sucrose starch pellet core for the experiment is produced by Jiangsu Dongsheng medicine science and technology limited company, the diameter of the pellet core is 300-400 mu m, and the sucrose content is 40-70%.
10000 capsules are prepared according to the preparation method of the technical scheme of the specification, and pellets are adhered in the process of medicine application. The yield of the centrifugal granulation process was counted, and the yield is 100% of the weight (g) of the drug-containing pellets/the total amount (g) of the feed, and the data are shown in table 1.
Experimental example 1, examples 1-3 and comparative examples 1-5 show the yields of the products during the preparation process, and the results are shown in table 1.
TABLE 1 summary of the product yields of examples 1-3 and comparative examples 1-5
The experimental results show that the products of examples 1-3 use lactitol as a binder, and the yield of the metronidazole vitamin B6 pellets is remarkably improved compared with that of comparative examples 2, 4 and 5; comparative example 4 adopts hydroxypropyl cellulose as adhesive, hydroxypropyl cellulose has poor formability, the surfaces of the pellets are rough, friction and collision between the pellets are increased in the centrifugal medicine feeding process, the pellets are easy to break, and the yield is low; in the comparative example 5, the 300-400 mu m sucrose starch pellet cores are adopted, more pellets are adhered in the medicine feeding process, more medicines are adsorbed by the adhered pellets, less medicines are adsorbed by part of pellet cores, the sizes of the prepared medicine-containing pellets are not uniform, the medicine-containing pellets among 14-24 meshes are obviously reduced, and the yield is obviously reduced.
Comparative example 3 compared to examples 1-3, where the disintegrants were different, the results demonstrate that the selection of both disintegrants did not affect pellet yield.
Experimental example 2. 100 capsules of examples 1 to 3 and comparative examples 1 to 4 were taken, respectively, and the bare particles were placed in a petri dish, opened in an acceleration test chamber (40 ℃/RH 75%), sampled on days 0, 14 and 28, respectively, to measure dissolution rate, to observe properties of the pellets in the capsule (to take out the capsule contents), i.e., to observe color change and whether the pellets agglomerated, and the results are reported in tables 2 to 3.
TABLE 2 accelerated test investigation results, pellet Properties
Table 2 the data illustrates: the products of examples 1-3 have no obvious change in properties under accelerated test conditions and no agglomeration. The drug-containing pellets of comparative example 1, comparative example 3 and comparative example 4 all showed agglomeration under accelerated conditions, and all the appearances changed from white to pale yellow. The drug-containing pellet of comparative example 2 has no significant change in properties under accelerated conditions, and thus, it can be seen that the properties of the prepared product are not changed under accelerated conditions and have good stability by selecting lactitol as a binder and a certain amount of calcium silicate as a disintegrant.
TABLE 3 accelerated test results, dissolution
Note: the dissolution method comprises the following steps: basket method, rotational speed: 100rpm, medium: purified water, volume: 900ml, sampling time: and 20 min.
The data in table 3 show that the dissolution rates of the products in examples 1 to 3 are not significantly changed under the acceleration condition, the dissolution rates of the products in comparative examples 1, 3 and 4 are all significantly reduced under the acceleration condition, and the dissolution rate of the product in comparative example 2 is not significantly changed under the acceleration condition, but the dissolution rate is significantly reduced at 0 day because the surface of the pellet absorbs water too fast and micelles or gel layers are easily formed to influence the dissolution rate when the dosage of calcium silicate is too large. The dissolution rate stability of the sample prepared by the method is good in the storage process, and the property is very stable.
Claims (3)
1. A metronidazole vitamin B6 drug-containing pellet is characterized in that the unit dose of the drug-containing pellet contains: 200mg of metronidazole, 620 mg of vitamin B, 48-68mg of a sucrose starch pellet core, 18-45mg of lactitol, 37-68mg of mannitol, 6-16mg of calcium silicate, less than 10 mu m of metronidazole D50, less than 20 mu m of D90, less than 10 mu m of vitamin B6D 50, less than 20 mu m of D90, 500 mu m of the diameter of the sucrose starch pellet core, and 40-70 percent of sucrose in the sucrose starch pellet core.
2. The metronidazole vitamin B6 medicated pellet of claim 1, comprising: 200mg of metronidazole, 620 mg of vitamin B620 mg, 52-60mg of sucrose starch pill core, 21-37mg of lactitol, 40-60mg of mannitol and 8-15mg of calcium silicate.
3. The method for preparing metronidazole vitamin B6 medicated pellets as claimed in claim 1, characterized by comprising the following steps:
step 1, adding vitamin B6 and lactitol in a prescription amount into a proper amount of purified water, and stirring until the vitamin B6 and the lactitol are completely dissolved for later use;
step 2, uniformly mixing metronidazole, mannitol and calcium silicate according to the prescription amount in a mixer for later use;
step 3, adding the sucrose starch pellet cores in the formula amount into a centrifugal granulator, spraying a lactitol solution while adding the mixed powder in the step 2 for medicine application, continuously spraying the rest lactitol after the medicine application is finished, and continuously centrifuging until the surfaces of the pellets are smooth and round;
and 4, drying and sieving the pellets obtained in the step 3, taking pellets with a 14-24-mesh sieve, and encapsulating.
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| CN1785180B (en) * | 2005-11-17 | 2011-05-25 | 贵州神奇集团控股有限公司 | Method for detecting compound bismuth potassium citrate metronidazole |
| CN100490790C (en) * | 2007-04-28 | 2009-05-27 | 杭州民生药业集团有限公司 | Enteric coated omeprazole pellets capsule and the preparing method thereof |
| CN101332177A (en) * | 2007-06-25 | 2008-12-31 | 兴和株式会社 | Solid preparation containing ibuprofen, tranexamic acid and calcium silicate |
| CN103458878B (en) * | 2011-04-01 | 2015-11-25 | 武田药品工业株式会社 | Solid preparation |
| ES2869374T3 (en) * | 2014-06-25 | 2021-10-25 | Glaxosmithkline Ip Dev Ltd | Crystalline salts of (S) -6 - ((1-acetylpiperidin-4-yl) amino) -n- (3- (3,4-dihydroisoquinolin-2 (1h) -yl) -2-hydroxypropyl) pyrimidin-4- carboxamide |
| KR20190107712A (en) * | 2017-01-26 | 2019-09-20 | 트리아스텍 인코포레이티드 | Dosage forms of controlled release at specific gastrointestinal sites |
| CN111728972B (en) * | 2020-07-30 | 2023-05-16 | 迪沙药业集团有限公司 | Metronidazole vitamin B6 composition |
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Effective date of registration: 20210906 Address after: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Applicant after: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Address before: No.1 Qingdao South Road, Weihai Economic and Technological Development Zone, Shandong Province Applicant before: DISHA PHARMACEUTICAL GROUP Co.,Ltd. Applicant before: Dijia Pharmaceutical Group Co.,Ltd. |
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