CN103127099A - Amoxicillin potassium clavulanate dry suspension and production process thereof - Google Patents
Amoxicillin potassium clavulanate dry suspension and production process thereof Download PDFInfo
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- CN103127099A CN103127099A CN2013100818881A CN201310081888A CN103127099A CN 103127099 A CN103127099 A CN 103127099A CN 2013100818881 A CN2013100818881 A CN 2013100818881A CN 201310081888 A CN201310081888 A CN 201310081888A CN 103127099 A CN103127099 A CN 103127099A
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- amoxicillin
- clavulanate potassium
- dry suspension
- clavulanate
- silica containing
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- ABVRVIZBZKUTMK-JSYANWSFSA-M potassium clavulanate Chemical compound [K+].[O-]C(=O)[C@H]1C(=C/CO)/O[C@@H]2CC(=O)N21 ABVRVIZBZKUTMK-JSYANWSFSA-M 0.000 title claims abstract description 81
- LSQZJLSUYDQPKJ-NJBDSQKTSA-N amoxicillin Chemical compound C1([C@@H](N)C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C(O)=O)(C)C)=CC=C(O)C=C1 LSQZJLSUYDQPKJ-NJBDSQKTSA-N 0.000 title claims abstract description 58
- 229960003022 amoxicillin Drugs 0.000 title claims abstract description 58
- LSQZJLSUYDQPKJ-UHFFFAOYSA-N p-Hydroxyampicillin Natural products O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)C(N)C1=CC=C(O)C=C1 LSQZJLSUYDQPKJ-UHFFFAOYSA-N 0.000 title claims abstract description 58
- 239000000725 suspension Substances 0.000 title claims abstract description 47
- 238000004519 manufacturing process Methods 0.000 title abstract description 4
- 229940038649 clavulanate potassium Drugs 0.000 claims description 71
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 52
- 239000000377 silicon dioxide Substances 0.000 claims description 26
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 18
- 229920003091 Methocel™ Polymers 0.000 claims description 12
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 12
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 12
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 claims description 12
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 12
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims description 10
- 239000000796 flavoring agent Substances 0.000 claims description 10
- 235000019634 flavors Nutrition 0.000 claims description 10
- 235000019359 magnesium stearate Nutrition 0.000 claims description 9
- 239000000314 lubricant Substances 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 8
- 150000003904 phospholipids Chemical class 0.000 claims description 8
- 235000012239 silicon dioxide Nutrition 0.000 claims description 8
- 235000013162 Cocos nucifera Nutrition 0.000 claims description 6
- 244000060011 Cocos nucifera Species 0.000 claims description 6
- XINCECQTMHSORG-UHFFFAOYSA-N Isoamyl isovalerate Chemical compound CC(C)CCOC(=O)CC(C)C XINCECQTMHSORG-UHFFFAOYSA-N 0.000 claims description 6
- 235000009508 confectionery Nutrition 0.000 claims description 6
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims description 5
- 235000010445 lecithin Nutrition 0.000 claims description 5
- 239000000787 lecithin Substances 0.000 claims description 5
- 229940067606 lecithin Drugs 0.000 claims description 5
- 238000003756 stirring Methods 0.000 claims description 5
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 claims description 4
- 239000006071 cream Substances 0.000 claims description 4
- XMGQYMWWDOXHJM-UHFFFAOYSA-N limonene Chemical compound CC(=C)C1CCC(C)=CC1 XMGQYMWWDOXHJM-UHFFFAOYSA-N 0.000 claims description 4
- 239000007968 orange flavor Substances 0.000 claims description 4
- 229940085605 saccharin sodium Drugs 0.000 claims description 4
- NRJAVPSFFCBXDT-HUESYALOSA-N 1,2-distearoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCCCCCCCCCCC NRJAVPSFFCBXDT-HUESYALOSA-N 0.000 claims description 3
- 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 description 2
- PXEDJBXQKAGXNJ-QTNFYWBSSA-L disodium L-glutamate Chemical compound [Na+].[Na+].[O-]C(=O)[C@@H](N)CCC([O-])=O PXEDJBXQKAGXNJ-QTNFYWBSSA-L 0.000 claims description 2
- 239000012467 final product Substances 0.000 claims description 2
- 235000013923 monosodium glutamate Nutrition 0.000 claims description 2
- 229940073490 sodium glutamate Drugs 0.000 claims description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 abstract 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 description 21
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 6
- 238000009825 accumulation Methods 0.000 description 6
- 238000004090 dissolution Methods 0.000 description 4
- 102000004190 Enzymes Human genes 0.000 description 3
- 108090000790 Enzymes Proteins 0.000 description 3
- 230000000844 anti-bacterial effect Effects 0.000 description 3
- 230000001186 cumulative effect Effects 0.000 description 3
- 239000012738 dissolution medium Substances 0.000 description 3
- 238000000338 in vitro Methods 0.000 description 3
- 238000013507 mapping Methods 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 208000019505 Deglutition disease Diseases 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 229940067631 phospholipid Drugs 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 150000003952 β-lactams Chemical class 0.000 description 2
- 241000606124 Bacteroides fragilis Species 0.000 description 1
- 108010065152 Coagulase Proteins 0.000 description 1
- 229920000858 Cyclodextrin Polymers 0.000 description 1
- 108090000204 Dipeptidase 1 Proteins 0.000 description 1
- 241000194033 Enterococcus Species 0.000 description 1
- 241000191940 Staphylococcus Species 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 241000191963 Staphylococcus epidermidis Species 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000004411 aluminium Substances 0.000 description 1
- 229940038195 amoxicillin / clavulanate Drugs 0.000 description 1
- AVKUERGKIZMTKX-NJBDSQKTSA-N ampicillin Chemical class C1([C@@H](N)C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C(O)=O)(C)C)=CC=CC=C1 AVKUERGKIZMTKX-NJBDSQKTSA-N 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000003781 beta lactamase inhibitor Substances 0.000 description 1
- 102000006635 beta-lactamase Human genes 0.000 description 1
- 229940126813 beta-lactamase inhibitor Drugs 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 1
- 229960001866 silicon dioxide Drugs 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 229940126085 β‑Lactamase Inhibitor Drugs 0.000 description 1
Images
Abstract
The invention discloses amoxicillin potassium clavulanate dry suspension and a production process thereof. The amoxicillin potassium clavulanate dry suspension is prepared from amoxicillin, potassium clavulanate, hydroxy propyl methylcellulose and the like in a mixing manner. The amoxicillin potassium clavulanate dry suspension has good compliance to a user.
Description
Technical field
The invention belongs to the pharmaceutical preparations technology field, relate to a kind of amoxicillin and clavulanate potassium oral solid formulation, relate in particular to a kind of dry suspension and production technology thereof that contains amoxicillin and clavulanate potassium (4:1).
Background technology
The amoxicillin is penbritin class antibiotic, and clavulanate potassium itself only has faint antibacterial activity, but has the enzyme inhibition of powerful wide spectrum beta-lactam, and both share, and can protect the amoxicillin to exempt from the beta-lactam enzyme hydrolysis.The amoxicillin and clavulanate potassium compound preparation is to producing enzyme staphylococcus aureus, staphylococcus epidermidis, coagulase negative staphylococcus and the equal tool good action of enterococcus, and some intestinal liver Cordycepps antibacterial, hemophilus influenza, moraxelle catarrhalis, bacteroides fragilis etc. that produce beta-lactamase is also had better antibacterial activity.Day by day universal by the compound preparation application clinically that amoxicillin and beta-lactamase inhibitor clavulanate potassium form.
At present, the amoxicillin and clavulanate potassium compound preparation comprises tablet, capsule and dry suspension take oral solid formulation as main.Yet tablet and capsule are unfavorable for that child, old people, bed patient and dysphagia patients take.Dry suspension has advantages of that divided dose administration, taking convenience, dissolution rate are high, but due to clavulanate potassium have draw by force moist, and the specific surface area of dry suspension is very large, cause in existing amoxicillin/clavulanate potassium dry suspension active component easily to be degraded, poor stability is prone to untoward reaction after the patient takes medicine.CN102614174A discloses a kind of dry suspension that contains amoxicillin and clavulanate potassium, and it is comprised of the component of following parts by weight: 200 parts of amoxicillin, clavulanate potassium 20-50 part, sodium carboxymethyl cellulose 80-115 part, cyclodextrin 1500-1600 part, polyethylene glycol 6000 42-55 part, mixing essence 18-25 part and magnesium stearate 4-8 part.Although the disclosed amoxicillin and clavulanate potassium dry suspension of the document efficiently solves clavulanate potassium because drawing by force the moist degradation problem of bringing, supplementary product consumption is too much, causes the weight and volume of every bag medicine larger, and the packing box cost of transportation is high.
Summary of the invention
In view of the deficiencies in the prior art, the invention reside in provides the amoxicillin and clavulanate potassium compound dried suspension that a kind of supplementary product consumption is few, stability is strong.
The object of the present invention is achieved like this: a kind of amoxicillin and clavulanate potassium dry suspension is formed by amoxicillin, silica containing clavulanate potassium phosphatide complexes, carboxylic propyl methocel, sodium lauryl sulphate, correctives, mix lubricant; In described silica containing clavulanate potassium phosphatide complexes, the weight ratio of clavulanate potassium, phospholipid and silicon dioxide is 1:0.8-1.5:0.3-0.7.
Preferably, above-mentioned amoxicillin and clavulanate potassium dry suspension, wherein said silica containing clavulanate potassium phosphatide complexes is prepared from as follows: clavulanate potassium and phospholipid are dissolved in chloroform, add silicon dioxide, stir, 40 ℃ of following evaporated under reduced pressure chloroforms are with the complex taking-up of evaporate to dryness, cross the 60-80 mesh sieve, and get final product.
Preferably, above-mentioned amoxicillin and clavulanate potassium dry suspension, wherein said phospholipid are selected from following one or more: lecithin, fabaceous lecithin, distearoyl phosphatidylcholine.
Preferably, above-mentioned amoxicillin and clavulanate potassium dry suspension, wherein the weight ratio of contained amoxicillin and clavulanate potassium is 4:1.
Further preferably, above-mentioned amoxicillin and clavulanate potassium dry suspension is comprised of the component of following weight portion: 250 parts of amoxicillin, silica containing clavulanate potassium phosphatide complexes 135-200 part, carboxylic propyl methocel 8-15 part, sodium lauryl sulphate 5-10 part, correctives 20-40 part, lubricant 3-6 part.
Again further preferably, above-mentioned amoxicillin and clavulanate potassium dry suspension, wherein said correctives are selected from following one or more: saccharin sodium, A Siba are sweet, sodium glutamate, orange flavor, cocoanut flavour, cream flavour, apple essence, Fructus Citri Limoniae essence.
Again further preferably, above-mentioned amoxicillin and clavulanate potassium dry suspension, wherein said lubricant are that magnesium stearate is or/and Pulvis Talci.
The amoxicillin and clavulanate potassium dry suspension that the present invention relates to can be prepared from according to being prepared as follows technique:
(1) take dry amoxicillin, carboxylic propyl methocel, sodium lauryl sulphate, correctives and lubricant, pulverize, the 60-80 order sieves rear standby;
(2) take dry clavulanate potassium, phospholipid and silicon dioxide, clavulanate potassium and phospholipid are dissolved in chloroform, add silicon dioxide, stir, 40 ℃ of following evaporated under reduced pressure chloroforms with the complex taking-up of evaporate to dryness, are crossed the 60-80 mesh sieve, get silica containing clavulanate potassium phosphatide complexes, standby;
(3) pour amoxicillin, silica containing clavulanate potassium phosphatide complexes, carboxylic propyl methocel, sodium lauryl sulphate, correctives and lubricant in mixer mix homogeneously, get dry suspension.
Compared with prior art, the amoxicillin and clavulanate potassium dry suspension supplementary product consumption of the present invention's preparation is few, and stability is high, and the active component stripping is fast, is fit to very much child, old people, bed patient and dysphagia patients and takes.
Description of drawings
Fig. 1 is the cumulative in vitro dissolution rate curve chart of clavulanate potassium in the dry suspension of embodiment 3 preparation.
Fig. 2 is the cumulative in vitro dissolution rate curve chart of clavulanate potassium in the dry suspension of embodiment 4 preparation.
Fig. 3 is the cumulative in vitro dissolution rate curve chart of clavulanate potassium in the dry suspension of embodiment 5 preparation.
The specific embodiment
Now further describe beneficial effect of the present invention by following examples; following examples only are used for the purpose of illustration; do not limit protection scope of the present invention, within the apparent change that while those of ordinary skills make according to the present invention and modification are also contained in the scope of the invention.
The preparation of embodiment 1 clavulanate potassium phosphatide complexes
Clavulanate potassium 625g and 650g lecithin are dissolved in chloroform, add 300g silicon dioxide, fully stir, 40 ℃ of following evaporated under reduced pressure chloroforms with the complex taking-up of evaporate to dryness, are crossed the 60-80 mesh sieve, namely get silica containing clavulanate potassium phosphatide complexes.
Clavulanate potassium 625g and 500g distearoyl phosphatidylcholine are dissolved in chloroform, add 200g silicon dioxide, fully stir, 40 ℃ of following evaporated under reduced pressure chloroforms, the complex of evaporate to dryness is taken out, cross the 60-80 mesh sieve, namely get silica containing clavulanate potassium phosphatide complexes.
The preparation of embodiment 3 amoxicillin and clavulanate potassium dry suspension
Preparation technology:
(1) take dry amoxicillin 250g, carboxylic propyl methocel 10g, the sweet 1.5g of sodium lauryl sulphate 7g, A Siba, cocoanut flavour 10g, apple essence 10g and magnesium stearate 4.5g, pulverize, the 60-80 order sieves rear standby;
(2) take the silica containing clavulanate potassium phosphatide complexes 158g of embodiment 1 preparation, standby;
(3) amoxicillin, silica containing clavulanate potassium phosphatide complexes, carboxylic propyl methocel, sodium lauryl sulphate, A Siba is sweet, cocoanut flavour, apple essence and magnesium stearate are poured mix homogeneously in mixer into, get dry suspension.
Get the amoxicillin and clavulanate potassium dry suspension of this example preparation, take 0.07mol/L hydrochloric acid solution 1L as dissolution medium, rotating speed 55r/min, operation in accordance with the law, the 5mL that takes a sample respectively 0,1,2,5,8, during 10min measures the clavulanic acid potassium content and calculates accumulation stripping percentage rate.Take time t as abscissa, average accumulated stripping percentage rate is the vertical coordinate mapping, and the accumulation stripping the results are shown in Figure 1.
The preparation of embodiment 4 amoxicillin and clavulanate potassium dry suspension
Preparation technology:
(1) take respectively dry amoxicillin 250g, carboxylic propyl methocel 15g, sodium lauryl sulphate 8g, saccharin sodium 2g, orange flavor 5g, cream flavour 15g and magnesium stearate 5g, pulverize, the 60-80 order sieves rear standby;
(2) take the silica containing clavulanate potassium phosphatide complexes 158g of embodiment 1 preparation, standby;
(3) pour amoxicillin, silica containing clavulanate potassium phosphatide complexes, carboxylic propyl methocel, sodium lauryl sulphate, saccharin sodium, orange flavor, cream flavour and magnesium stearate in mixer mix homogeneously, get dry suspension.
Get the amoxicillin and clavulanate potassium dry suspension of this example preparation, take 0.07mol/L hydrochloric acid solution 1L as dissolution medium, rotating speed 55r/min, operation in accordance with the law, the 5mL that takes a sample respectively 0,1,2,5,8, during 10min measures the clavulanic acid potassium content and calculates accumulation stripping percentage rate.Take time t as abscissa, average accumulated stripping percentage rate is the vertical coordinate mapping, and the accumulation stripping the results are shown in Figure 2.
The preparation of embodiment 5 amoxicillin and clavulanate potassium dry suspension
Preparation technology:
(1) take dry amoxicillin 250g, carboxylic propyl methocel 12g, the sweet 2g of sodium lauryl sulphate 10g, A Siba, cocoanut flavour 15g, apple essence 15g and magnesium stearate 5g, pulverize, the 60-80 order sieves rear standby;
(2) take the silica containing clavulanate potassium phosphatide complexes 135g of embodiment 2 preparations, standby;
(3) amoxicillin, silica containing clavulanate potassium phosphatide complexes, carboxylic propyl methocel, sodium lauryl sulphate, A Siba is sweet, cocoanut flavour, apple essence and magnesium stearate are poured mix homogeneously in mixer into, get dry suspension.
Get the amoxicillin and clavulanate potassium dry suspension of this example preparation, take 0.07mol/L hydrochloric acid solution 1L as dissolution medium, rotating speed 55r/min, operation in accordance with the law, the 5mL that takes a sample respectively 0,1,2,5,8, during 10min measures the clavulanic acid potassium content and calculates accumulation stripping percentage rate.Take time t as abscissa, average accumulated stripping percentage rate is the vertical coordinate mapping, and the accumulation stripping the results are shown in Figure 3.
The stability study of embodiment 6 amoxicillin and clavulanate potassium dry suspension
The dry suspension of embodiment of the present invention 3-5 preparation is packaged in the composite aluminium plastic pouch, is placed on 40 ℃ of temperature, carried out study on the stability 6 months under the acceleration environment of humidity 75%.Detect related substance and content in sampling in the 0th, 1,3,6 month, result is referring to table 1.
The accelerated test result of table 1 amoxicillin and clavulanate potassium dry suspension
Result of the test by table 1 can be found out, amoxicillin and clavulanate potassium dry suspension of the present invention is in the accelerated test process, the changes of contents of active component amoxicillin and clavulanate potassium is not obvious, its related substances when accelerating 6 months is no more than 0.30%, and this shows amoxicillin and clavulanate potassium dry suspension stability of the present invention better.
Claims (7)
1. an amoxicillin and clavulanate potassium dry suspension, is characterized in that: formed by amoxicillin, silica containing clavulanate potassium phosphatide complexes, carboxylic propyl methocel, sodium lauryl sulphate, correctives, mix lubricant; In described silica containing clavulanate potassium phosphatide complexes, the weight ratio of clavulanate potassium, phospholipid and silicon dioxide is 1:0.8-1.5:0.3-0.7.
2. amoxicillin and clavulanate potassium dry suspension according to claim 1, it is characterized in that: described silica containing clavulanate potassium phosphatide complexes is prepared from as follows: clavulanate potassium and phospholipid are dissolved in chloroform, add silicon dioxide, stir, 40 ℃ of following evaporated under reduced pressure chloroforms, the complex of evaporate to dryness is taken out, cross the 60-80 mesh sieve, and get final product.
3. amoxicillin and clavulanate potassium dry suspension according to claim 1 is characterized in that: described phospholipid is selected from following one or more: lecithin, fabaceous lecithin, distearoyl phosphatidylcholine.
4. amoxicillin and clavulanate potassium dry suspension according to claim 1, it is characterized in that: contained amoxicillin and the weight ratio of clavulanate potassium are 4:1.
5. amoxicillin and clavulanate potassium dry suspension according to claim 4, it is characterized in that: the component by following weight portion forms: 250 parts of amoxicillin, silica containing clavulanate potassium phosphatide complexes 135-200 part, carboxylic propyl methocel 8-15 part, sodium lauryl sulphate 5-10 part, correctives 20-40 part, lubricant 3-6 part.
6. according to claim 1-5 described amoxicillin and clavulanate potassium dry suspension of any one is characterized in that: described correctives is selected from following one or more: saccharin sodium, A Siba are sweet, sodium glutamate, orange flavor, cocoanut flavour, cream flavour, apple essence, Fructus Citri Limoniae essence.
7. according to claim 1-5 described amoxicillin and clavulanate potassium dry suspension of any one, it is characterized in that: described lubricant is that magnesium stearate is or/and Pulvis Talci.
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| CN102614174A (en) * | 2012-02-24 | 2012-08-01 | 南京臣功制药股份有限公司 | Dry suspension containing amoxicillin and potassium clavulanate |
-
2013
- 2013-03-14 CN CN201310081888.1A patent/CN103127099B/en active Active
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|---|---|---|---|---|
| US20040126429A1 (en) * | 2000-10-12 | 2004-07-01 | Beecham Pharmaceuticals (Pte) Limited | Novel formulation |
| US20110020408A1 (en) * | 2007-05-17 | 2011-01-27 | Ranbaxy Laboratories Limited | multilayered modified release formulation comprising amoxicillin and clavulanate |
| CN101406450A (en) * | 2007-10-12 | 2009-04-15 | 河南农业大学 | Technique for preparing compound amoxicillin oil suspension injection |
| CN101804051A (en) * | 2010-04-21 | 2010-08-18 | 海南美兰史克制药有限公司 | Liposome injection of pharmaceutical composition of amoxicillin sodium and clavulanate potassium |
| CN102614174A (en) * | 2012-02-24 | 2012-08-01 | 南京臣功制药股份有限公司 | Dry suspension containing amoxicillin and potassium clavulanate |
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