CN112263569B - Amoxicillin capsule and preparation method thereof - Google Patents
Amoxicillin capsule and preparation method thereof Download PDFInfo
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
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- 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
- A61K31/425—Thiazoles
- A61K31/429—Thiazoles condensed with heterocyclic ring systems
- A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
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Abstract
The invention belongs to the field of pharmaceutical preparations, and particularly relates to an amoxicillin capsule, which is prepared by the following steps: mixing the adhesive with the slow release effect with the active ingredients, carrying out hot melt extrusion granulation, then mixing with optional lubricant and glidant, and then carrying out capsule filling, wherein the added adhesive can effectively improve the slow release time of the amoxicillin capsule, and can reach an acceptable dissolution curve. The whole process is very simple, and the cost for realizing large-scale industrial production is lower.
Description
Technical Field
The invention relates to the field of pharmaceutical preparations, in particular to an amoxicillin capsule and a preparation method thereof.
Background
Amoxicillin is an amoxicillin antibiotic developed and developed by Beecham company (now, GSK company) in 1968, and has good antibacterial activity against Streptococcus species such as Streptococcus pneumoniae and hemolytic streptococcus, gram-negative aerobic bacteria such as Staphylococcus nonpenicillinase and enterococcus faecalis, gram-negative aerobic bacteria such as Escherichia coli, Proteus mirabilis, Salmonella, Haemophilus influenzae and Neisseria gonorrhoeae, and gram-negative bacteria such as beta-lactamase-nonproducent bacteria and helicobacter pylori. The amoxicillin combines with bacterial Penicillin Binding Proteins (PBPs) to inhibit the synthesis of bacterial cell walls to play a bactericidal role, so that the bacteria can quickly become spheroids to be dissolved and ruptured.
The chemical name of the amoxicillin is (2S,5R,6R) -3, 3-dimethyl-6- [ (R) - (-) -2-amino-2- (4-hydroxyphenyl) acetamido]-7-oxo-4-thia-1-azabicyclo [3.2.0]Heptane-2-carboxylic acid trihydrate, melting point 195 ℃, molecular formula C16H19N3O5S·3H2O, molecular weight 419.45, having the formula:
the biopharmaceutical classification system (BDDCS) of amoxicillin in vivo drug-based treatments belongs to the BDDCS3 class, i.e. highly soluble-low permeability drugs. Currently available amoxicillin formulations in the market are capsules, tablets, dry suspensions, chewable tablets, dispersible tablets, e.g. Amoxil capsules developed by the company NEOPHARMA. However, after the medicine is taken by a patient, the fluctuation of the blood concentration in the body is easy to be larger, and the stimulation effect on the gastrointestinal tract is larger. Therefore, there is a need to provide a drug delivery system that allows the drug to maintain and even improve the release rate of amoxicillin to provide the desired blood levels, increasing its bioavailability.
Currently, there have been many attempts in the art to develop a dosage form that satisfies the need in order to provide a dosage form that can provide amoxicillin, a drug with high dissolution-low permeability, into the gastrointestinal tract at a controlled release rate and release the drug in a manner that can control the release of the active ingredient.
CN108210475A discloses an amoxicillin capsule which is prepared from the following raw materials in parts by weight: 200 parts of amoxicillin, 5-10 parts of sodium carboxymethylcellulose, 1-1.5 parts of talcum powder and 0.5-3.5 parts of magnesium stearate. Compared with the prior art, the invention ensures that the amoxicillin capsule has higher dissolution rate by adjusting the particle size of the amoxicillin granules as the raw material and the proportion of the auxiliary materials, avoids the use of disintegrating agents such as carboxymethyl starch, crospovidone and the like, reduces the volume of the amoxicillin capsule, and can contain the lower raw material and the auxiliary materials by using the No. 1 capsule; the process steps of the amoxicillin capsule are simplified, the production cost is reduced, and the production efficiency is improved.
CN108578383A discloses an amoxicillin capsule, wherein the amoxicillin capsule is prepared by pretreating raw materials through a dry granulation process, then adding a lubricant and a glidant, mixing and filling, and the dissolution rate of the amoxicillin capsule can be controlled to a certain extent through the process of the prescription.
CN104856972B discloses an amoxicillin capsule and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The components contained in the amoxicillin capsule comprise amoxicillin, sodium dodecyl sulfate, talcum powder and magnesium stearate. The invention ensures higher dissolution rate of the amoxicillin by adjusting the particle size of the raw material amoxicillin particles and adjusting the proportion of the auxiliary materials, simplifies the production and preparation steps of the amoxicillin capsule, reduces the production cost and improves the production efficiency.
CN101390846B discloses an amoxicillin capsule and a production method thereof, in particular to a method for preparing the amoxicillin capsule by adopting a micronization technology. The method utilizes micronization technology to overcome the problem of poor dissolution rate of amoxicillin capsule in the prior art, and also improves the stability of the preparation, simplifies the preparation process and reduces toxic and side effects.
The related preparation process provided above, while somewhat advantageous in controlling the dissolution rate of amoxicillin capsules, there is a need for formulations and processes for amoxicillin capsules that provide the desired blood levels of amoxicillin at a rate of release and with improved bioavailability.
Disclosure of Invention
The invention aims to solve the technical problems and provides a binder with a sustained-release effect for preparing amoxicillin sustained-release granules, which is mixed with other lubricants and glidants to directly fill capsules so as to realize the sustained release of amoxicillin capsules and have an acceptable dissolution curve.
In order to solve the technical problems, the technical scheme adopted by the invention is as follows:
a preparation method of amoxicillin capsules comprises the following steps:
an amoxicillin capsule is prepared by mixing amoxicillin and a binder with sustained-release effect to prepare sustained-release granules, then mixing the granules with a glidant and a lubricant, and directly filling the capsules.
The inventors have found in their studies that the choice of binders for sustained release is critical for the preparation of amoxicillin capsules. The amoxicillin capsule preparation of the binder with sustained-release effect of the invention comprises the following components:
(a) the amoxicillin capsule comprises an amoxicillin active agent, which accounts for 70-90% of the filling amount and is dry weight basis;
preferably, the amoxicillin capsule contains 250mg of amoxicillin active ingredient in unit dosage form.
(b) The amoxicillin capsule comprises one or more pharmaceutically acceptable adhesives with slow release effect:
preferably, in the amoxicillin capsule, the acceptable binder for sustained release is one or more of Hypromellose (HPMC), Ethylcellulose (EC), hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxymethyl cellulose, sodium alginate, potassium alginate, agar, polyethylene, polypropylene, sodium carboxymethyl cellulose, carnauba wax, glyceryl behenate, glyceryl stearate, propylene glycol-stearate, and the like, but is not limited thereto.
Further preferably, in the amoxicillin capsule, the binder with sustained release effect is selected from one or more of Hypromellose (HPMC), Ethylcellulose (EC) and glyceryl behenate.
Still further preferably, in the amoxicillin capsule, the adjuvant with sustained-release effect is preferably glyceryl behenate.
Still further preferably, the binder with the slow release effect is glyceryl behenate, which is a mixture of monoester, diester and triester generated by esterifying behenic acid and glycerol, the contents of the three esters are respectively 15-23%, 40-60% and 21-35% as specified in the united states pharmacopoeia and european pharmacopoeia standards, and the melting point is about 69-74 ℃. Because the glyceryl behenate has good chemical inertness and the HLB value is 1, the glyceryl behenate does not swell and erode in the release process, and can effectively control the release of the medicament.
(c) The controlled release preparation comprises the following pharmaceutically acceptable lubricants:
the term "lubricant" as used in the present invention includes lubricants that reduce friction, heat and wear. Suitable lubricants include magnesium stearate, sodium stearyl fumarate, palmitic acid, calcium stearate, talc, carnauba wax, sodium lauryl sulfate, magnesium lauryl sulfate, aluminum stearate, zinc stearate, sodium stearate, calcium stearate, and stearic acid.
Further preferably, in the amoxicillin capsules, the medicinal lubricant is preferably magnesium stearate.
(d) Suitable pharmaceutically acceptable glidants in the amoxicillin capsules of the present invention are preferably colloidal silicon dioxide, aluminum silicate, talc, powdered cellulose, magnesium trisilicate, kaolin, magnesium stearate, titanium dioxide and starch.
Further preferably, in the amoxicillin capsule, the medicinal glidant is preferably one or more of colloidal silicon dioxide, talc and magnesium stearate.
Still further preferably, in the amoxicillin capsules, the pharmaceutically acceptable glidant is preferably colloidal silicon dioxide.
Suitable amoxicillin capsules are prepared by a process which comprises, for example, mixing together the following components for hot melt extrusion: an active agent and a binder having a slow release action. Mixing the prepared sustained-release granules with optional lubricant and glidant, and then filling capsules.
The inventor thinks of solving the problems by a hot-melt extrusion granulation process, adding a binder with slow release effect in a prescription, directly mixing a prescription amount of fat-soluble matrix and an active ingredient without adding an organic reagent, then directly extruding to prepare slow release granules, then crushing, then adding a lubricant and a glidant, mixing and directly filling capsules. The process for preparing the sustained-release granules is beneficial to further improving the bioavailability of the low-permeability medicament on one hand, and more importantly, the controlled-release tablet prepared by the production process has good controlled-release effect on the amoxicillin and can reach an acceptable dissolution curve.
Drawings
FIG. 1 is a dissolution profile of amoxicillin capsules prepared in examples 1, 2, 3, 4, 6 and 8.
FIG. 2 is a dissolution profile of a commercially available amoxicillin capsule and amoxicillin capsules prepared in example 6.
Detailed Description
The advantages of the present invention are further described below by way of examples, it being properly understood that: the examples of the present invention are given solely for the purpose of illustration and not as limitations of the present invention, and therefore, simple modifications of the present invention in the context of the methods of the present invention are intended to fall within the scope of the claims.
Example 1
The preparation method of the amoxicillin capsule in the embodiment comprises the following steps:
1) putting the glyceryl behenate and the amoxicillin into a low-shear V-shaped mixer for mixing for 30min to obtain mixed powder;
2) preparing the mixed powder obtained in the step 1) into slow-release granules by hot-melt extrusion;
3) adding colloidal silicon dioxide of a prescription amount into the sustained-release particles obtained in the step 2), mixing in a low-shear V-shaped mixer for 15min to obtain mixed powder;
4) adding magnesium stearate with a prescription amount into the mixed powder obtained in the step 3), mixing in a low-shear V-shaped mixer for 5min to obtain total mixed powder;
5) filling the total mixed powder obtained in the step 4) into capsules. The recipe compositions and hot melt parameters are shown in tables 1 and 2, respectively.
TABLE 1 Amoxicillin Capsule prescription composition
TABLE 2 temperature setting parameters of different modules of the hot-melt extruder
Example 2
The preparation method of the amoxicillin capsule in the embodiment comprises the following steps:
1) putting the glyceryl behenate and the amoxicillin into a low-shear V-shaped mixer for mixing for 30min to obtain mixed powder;
2) preparing the mixed powder obtained in the step 1) into slow-release particles by hot-melt extrusion;
3) adding colloidal silicon dioxide of a prescription amount into the sustained-release particles obtained in the step 2), mixing in a low-shear V-shaped mixer for 15min to obtain mixed powder;
4) adding magnesium stearate with a prescription amount into the mixed powder obtained in the step 3), mixing in a low-shear V-shaped mixer for 5min to obtain total mixed powder;
5) filling the total mixed powder obtained in the step 4) into capsules. The recipe compositions and hot melt parameters are shown in tables 3 and 4, respectively.
TABLE 3 Amoxicillin Capsule prescription composition
Table 4 temperature setting parameters of different modules of the hot melt extruder
Example 3
The preparation method of the amoxicillin capsule in the embodiment comprises the following steps:
1) putting the glyceryl behenate and the amoxicillin into a low-shear V-shaped mixer for mixing for 30min to obtain mixed powder;
2) preparing the mixed powder obtained in the step 1) into slow-release granules by hot-melt extrusion;
3) adding colloidal silicon dioxide of a prescription amount into the sustained-release particles obtained in the step 2), mixing in a low-shear V-shaped mixer for 15min to obtain mixed powder;
4) adding magnesium stearate with a prescription amount into the mixed powder obtained in the step 3), mixing in a low-shear V-shaped mixer for 5min to obtain total mixed powder;
5) filling the total mixed powder obtained in the step 4) into capsules. The recipe composition and hot melt parameters are shown in tables 5 and 6, respectively.
TABLE 5 Amoxicillin Capsule prescription composition
TABLE 6 temperature setting parameters for different modules of a hot melt extruder
Example 4
The preparation method of the amoxicillin capsule in the embodiment comprises the following steps:
1) putting the glyceryl behenate and the amoxicillin into a low-shear V-shaped mixer for mixing for 30min to obtain mixed powder;
2) preparing the mixed powder obtained in the step 1) into slow-release granules by hot-melt extrusion;
3) adding colloidal silicon dioxide of a prescription amount into the sustained-release particles obtained in the step 2), mixing in a low-shear V-shaped mixer for 15min to obtain mixed powder;
4) adding magnesium stearate with a prescription amount into the mixed powder obtained in the step 3), mixing in a low-shear V-shaped mixer for 5min to obtain total mixed powder;
5) filling the total mixed powder obtained in the step 4) into capsules. The recipe compositions and hot melt parameters are shown in tables 7 and 8, respectively.
TABLE 7 Amoxicillin Capsule prescription composition
TABLE 8 temperature setting parameters for different modules of a hot melt extruder
Example 5
The preparation method of the amoxicillin capsule in the embodiment comprises the following steps:
1) putting the glyceryl behenate and the amoxicillin into a low-shear V-shaped mixer for mixing for 30min to obtain mixed powder;
2) preparing the mixed powder obtained in the step 1) into slow-release granules by hot-melt extrusion;
3) adding colloidal silicon dioxide of a prescription amount into the sustained-release particles obtained in the step 2), mixing in a low-shear V-shaped mixer for 15min to obtain mixed powder;
4) adding magnesium stearate with a prescription amount into the mixed powder obtained in the step 3), mixing in a low-shear V-shaped mixer for 5min to obtain total mixed powder;
5) filling the total mixed powder obtained in the step 4) into capsules. The recipe compositions and hot melt parameters are shown in tables 9 and 10, respectively.
TABLE 9 Amoxicillin Capsule prescription composition
TABLE 10 temperature setting parameters for different modules of a hot-melt extruder
Example 6
The preparation method of the amoxicillin capsule in the embodiment comprises the following steps:
1) putting the glyceryl behenate and the amoxicillin into a low-shear V-shaped mixer for mixing for 30min to obtain mixed powder;
2) preparing the mixed powder obtained in the step 1) into slow-release granules by hot-melt extrusion;
3) adding colloidal silicon dioxide of a prescription amount into the sustained-release particles obtained in the step 2), mixing in a low-shear V-shaped mixer for 15min to obtain mixed powder;
4) adding magnesium stearate with a prescription amount into the mixed powder obtained in the step 3), mixing in a low-shear V-shaped mixer for 5min to obtain total mixed powder;
5) filling the total mixed powder obtained in the step 4) into capsules. The recipe compositions and hot melt parameters are shown in tables 11 and 12, respectively.
TABLE 11 Amoxicillin Capsule prescription composition
TABLE 12 temperature setting parameters for different modules of a hot melt extruder
Example 8
The preparation method of the amoxicillin capsule in the embodiment comprises the following steps:
1) putting the glyceryl behenate and the amoxicillin into a low-shear V-shaped mixer for mixing for 30min to obtain mixed powder;
2) preparing the mixed powder obtained in the step 1) into slow-release granules by hot-melt extrusion;
3) adding colloidal silicon dioxide of a prescription amount into the sustained-release particles obtained in the step 2), mixing in a low-shear V-shaped mixer for 15min to obtain mixed powder;
4) adding magnesium stearate with a prescription amount into the mixed powder obtained in the step 3), mixing in a low-shear V-shaped mixer for 5min to obtain total mixed powder;
5) filling the total mixed powder obtained in the step 4) into capsules. The recipe compositions and hot melt parameters are shown in tables 15 and 16, respectively.
TABLE 15 Amoxicillin Capsule prescription composition
TABLE 16 temperature setting parameters for different modules of a hot-melt extruder
Example 9
The preparation method of the amoxicillin capsule in the embodiment comprises the following steps:
1) putting the glyceryl behenate and the amoxicillin into a low-shear V-shaped mixer for mixing for 30min to obtain mixed powder;
2) preparing the mixed powder obtained in the step 1) into slow-release particles by hot-melt extrusion;
3) adding colloidal silicon dioxide of a prescription amount into the sustained-release particles obtained in the step 2), mixing in a low-shear V-shaped mixer for 15min to obtain mixed powder;
4) adding magnesium stearate with a prescription amount into the mixed powder obtained in the step 3), mixing in a low-shear V-shaped mixer for 5min to obtain total mixed powder;
5) filling the total mixed powder obtained in the step 4) into capsules. The recipe compositions and hot melt parameters are shown in tables 17 and 18, respectively.
TABLE 17 Amoxicillin Capsule prescription composition
TABLE 18 temperature setting parameters for different modules of a hot melt extruder
Verification of the embodiments
The dissolution profiles of the amoxicillin capsules obtained in examples 1-8 were evaluated and the results showed that the amoxicillin capsules prepared in example 6 exhibited release behavior with a controlled release effect similar to that of the commercially available amoxicillin capsules. The results are shown in FIGS. 1 and 2.
The dissolution test method of the amoxicillin capsule comprises the following steps: taking the product, determining dissolution and release by determination method (first method of 0931, general rule), using 900ml of water as dissolution medium, rotating at 100 rpm, operating according to method, taking appropriate amount of solution after 45 minutes, filtering, taking appropriate amount of subsequent filtrate, diluting with water to obtain product containing amoxicillin (according to C) in lmL16H19N3O5Smeter) 130. mu.g of the solution, and measuring the absorbance at a wavelength of 272nm by ultraviolet-visible spectrophotometry (general rule 0401); taking the contents in the different filling amount term, mixing uniformly, precisely weighing a proper amount (about equal to the average filling amount), adding water according to the marked amount for dissolving and quantitatively diluting to prepare solution containing about 130 mug in each lmL, filtering, taking the subsequent filtrate as the control solution, measuring by the same method, and calculating the dissolution amount of each granule. The limit is 80%, which should be met.
Claims (1)
1. The amoxicillin capsule is characterized by comprising an amoxicillin active agent accounting for 70-90% of the filling amount in a unit dosage form, wherein the amoxicillin active ingredient is 250mg in a dry weight basis, a sustained-release auxiliary material is glyceryl behenate, and a mixture of mono-, di-and tri-esters generated by esterification of behenic acid and glycerol, the contents of the three esters are respectively 15-23%, 40-60% and 21-35% in United states pharmacopoeia and European pharmacopoeia standards, the melting point is 69-74 ℃, the amoxicillin capsule further comprises a pharmaceutically acceptable lubricant and a pharmaceutically acceptable glidant, the pharmaceutically acceptable lubricant is magnesium stearate, the pharmaceutically acceptable glidant is colloidal silicon dioxide, and the amoxicillin capsule preparation method comprises the following steps: mixing amoxicillin and auxiliary materials with sustained-release effect, preparing sustained-release granules by hot-melt extrusion, then mixing the granules with a glidant and a lubricant, and directly filling capsules.
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