CN101664396A - Azithromycin soft capsules and preparation method thereof - Google Patents
Azithromycin soft capsules and preparation method thereof Download PDFInfo
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- CN101664396A CN101664396A CN200810119284A CN200810119284A CN101664396A CN 101664396 A CN101664396 A CN 101664396A CN 200810119284 A CN200810119284 A CN 200810119284A CN 200810119284 A CN200810119284 A CN 200810119284A CN 101664396 A CN101664396 A CN 101664396A
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- CN
- China
- Prior art keywords
- weight portions
- azithromycin
- acetic acid
- water
- propylene glycol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000007901 soft capsule Substances 0.000 title claims abstract description 80
- 229960004099 azithromycin Drugs 0.000 title claims abstract description 73
- MQTOSJVFKKJCRP-BICOPXKESA-N azithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)N(C)C[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 MQTOSJVFKKJCRP-BICOPXKESA-N 0.000 title claims abstract description 73
- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims abstract description 111
- DNIAPMSPPWPWGF-UHFFFAOYSA-N monopropylene glycol Natural products CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims abstract description 75
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 38
- 239000002775 capsule Substances 0.000 claims abstract description 20
- 239000002994 raw material Substances 0.000 claims abstract description 13
- 238000000034 method Methods 0.000 claims abstract description 12
- 238000003756 stirring Methods 0.000 claims abstract description 11
- 229940068918 polyethylene glycol 400 Drugs 0.000 claims abstract description 6
- 229960004063 propylene glycol Drugs 0.000 claims description 36
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 34
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 claims description 34
- 239000007788 liquid Substances 0.000 claims description 29
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 22
- 229960003511 macrogol Drugs 0.000 claims description 22
- 238000013019 agitation Methods 0.000 claims description 12
- 238000000748 compression moulding Methods 0.000 claims description 8
- 239000003814 drug Substances 0.000 claims description 8
- 238000001035 drying Methods 0.000 claims description 8
- 238000004519 manufacturing process Methods 0.000 claims description 8
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 abstract description 18
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 abstract description 12
- UOQHWNPVNXSDDO-UHFFFAOYSA-N 3-bromoimidazo[1,2-a]pyridine-6-carbonitrile Chemical compound C1=CC(C#N)=CN2C(Br)=CN=C21 UOQHWNPVNXSDDO-UHFFFAOYSA-N 0.000 abstract description 6
- 239000004310 lactic acid Substances 0.000 abstract description 6
- 235000014655 lactic acid Nutrition 0.000 abstract description 6
- 229940099563 lactobionic acid Drugs 0.000 abstract description 6
- 238000002474 experimental method Methods 0.000 abstract description 5
- 239000006184 cosolvent Substances 0.000 abstract description 2
- 239000002244 precipitate Substances 0.000 abstract 2
- DNIAPMSPPWPWGF-GSVOUGTGSA-N (R)-(-)-Propylene glycol Chemical compound C[C@@H](O)CO DNIAPMSPPWPWGF-GSVOUGTGSA-N 0.000 abstract 1
- 229940113115 polyethylene glycol 200 Drugs 0.000 abstract 1
- 235000013772 propylene glycol Nutrition 0.000 abstract 1
- 239000000126 substance Substances 0.000 description 10
- 239000002671 adjuvant Substances 0.000 description 8
- 238000012360 testing method Methods 0.000 description 8
- 238000005286 illumination Methods 0.000 description 5
- 238000011835 investigation Methods 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 3
- 239000012535 impurity Substances 0.000 description 3
- 238000012216 screening Methods 0.000 description 3
- 241000194017 Streptococcus Species 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 241000186216 Corynebacterium Species 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 241000193998 Streptococcus pneumoniae Species 0.000 description 1
- 241000193996 Streptococcus pyogenes Species 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- 206010013023 diphtheria Diseases 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 239000003120 macrolide antibiotic agent Substances 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 229940031000 streptococcus pneumoniae Drugs 0.000 description 1
- 238000004809 thin layer chromatography Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses azithromycin soft capsules and a preparation method thereof. The soft capsules comprise the following raw material components: azithromycin, polyethylene glycol 400, polyethylene glycol 200, water, acetic acid, 1,2-propanediol and the like. The soft capsules are prepared through the steps of stirring, pressing and the like in the preparation process. Experiments show that the azithromycin soft capsule preparations prepared by the preparation method have stable solution without precipitate, and particularly the acetic acid replaces the commonly used lactic acid, citric acid or lactobionic acid and other cosolvents, and the conventional process is changed by adding water in the process of preparing the soft capsules, and thus the content of the prepared soft capsule has no precipitate, is completely dissolved and has good stability to ensure the quality of the content of the capsule.
Description
Technical field
The present invention relates to a kind of soft capsule and preparation method thereof, particularly a kind of Azithromycin soft capsules and preparation method thereof.
Background technology
Azithromycin is 15 ring macrolide antibiotics, changes the peptide process by hindering antibacterial, thereby suppresses the synthetic of bacterioprotein.Experiment in vitro proof azithromycin comprises Gram-positive aerobe: staphylococcus aureus, streptococcus pyogenes, streptococcus pneumoniae, alpha-Hemolytic streptococcus and other streptococcus, diphtheria corynebacterium to multiple common pathogen is effective clinically.
Used clinically azithromycin is tablet, there is unusual bitterness when taking, and stability is not high, under high temperature or wet condition, all show mass change in various degree, still do not have at present a kind of Azithromycin soft capsules can reach the capsule content liquid stable do not have separate out, and the disclosed Azithromycin soft capsules preparation technology of prior art can't realize and poor stability.
Summary of the invention
One object of the present invention is to disclose a kind of Azithromycin soft capsules; The object of the invention also is to disclose this preparation of soft capsule technology.
The present invention seeks to be achieved through the following technical solutions:
The raw material of soft capsule of the present invention is composed as follows:
Azithromycin 10.0-40.0 weight portion
Macrogol 200 0-40.0 weight portion
PEG400 2.0-40.0 weight portion
Acetic acid 0.5-8.0 weight portion
1,2 propylene glycol 1.0-5.0 weight portion
Water 2.0-6.0 weight portion.
The raw material composition of soft capsule of the present invention is preferably:
Azithromycin 25.0 weight portions
Macrogol 200 11.0 weight portions
PEG400 4.0 weight portions
Acetic acid 6.6 weight portions
1,2 propylene glycol, 3.0 weight portions
Water 4.0 weight portions.
The raw material composition of soft capsule of the present invention is preferably:
Azithromycin 12.5 weight portions
PEG400 30.0 weight portions
Acetic acid 2.6 weight portions
1,2 propylene glycol, 3.0 weight portions
Water 2.0 weight portions.
The raw material composition of soft capsule of the present invention is preferably:
Azithromycin 38.0 weight portions
Macrogol 200 2.0 weight portions
PEG400 20.0 weight portions
Acetic acid 7.8 weight portions
1,2 propylene glycol, 4.0 weight portions
Water 3.0 weight portions.
The raw material composition of soft capsule of the present invention is preferably:
Azithromycin 12.5 weight portions
Macrogol 200 38.0 weight portions
PEG400 2.2 weight portions
Acetic acid 3.2 weight portions
1,2 propylene glycol, 1.0 weight portions
Water 5.0 weight portions.
Preparation of soft capsule method of the present invention is preferably as follows step:
Taking polyethylene glycol 400, Macrogol 200, water, acetic acid, 1,2 propylene glycol add in the Agitation Tank, and it is stirred, and add azithromycin under stirring condition, make medicine dissolve fully medicinal liquid, as capsule 's content, adopt the soft capsule production equipment, use mould compression moulding, drying, promptly.
Pharmaceutical composition of the present invention by the Azithromycin soft capsules preparation that adopts preparation method of the present invention and obtain can make the capsule content liquid stable do not have separate out, especially replace other cosolvents such as lactic acid, citric acid or lactobionic acid commonly used in the prior art with acetic acid, and in preparation soft capsule process, change common process and added water, this makes the soft capsule content for preparing not have and separates out, dissolving fully, good stability has guaranteed the quality of capsule 's content.
Following experimental example and embodiment are used to further specify but are not limited to the present invention.
The stability study of experimental example 1 Azithromycin soft capsules
1. influence factor's test
1.1 investigation sample: 070901,070801 batch of Azithromycin soft capsules, remove outer package;
The raw material of 070901 batch of Azithromycin soft capsules is formed and preparation method is:
Azithromycin 25.0g
Macrogol 200 11.0g
PEG400 4.0g
Acetic acid 6.6g
1,2 propylene glycol 3.0g
Water 4.0g;
Get PEG400, Macrogol 200, water, the acetic acid, 1 of above-mentioned recipe quantity, 2 propylene glycol add in the Agitation Tank, under stirring condition, add azithromycin, medicine is dissolved fully, get medicinal liquid, as capsule 's content, adopt the soft capsule production equipment, with No. 12 mould compression moulding, drying, get 100 soft capsules.
The raw material of 070801 batch of Azithromycin soft capsules is formed and preparation method is:
Azithromycin 12.5g
PEG400 30.0g
Acetic acid 2.6g
1,2 propylene glycol 3.0g
Water 2.0g;
PEG400, water, acetic acid, 1,2 propylene glycol of getting above-mentioned recipe quantity add in the Agitation Tank, add azithromycin under stirring condition, and medicine is dissolved fully, get medicinal liquid,, adopt the soft capsule production equipment as capsule 's content, with No. 12 mould compression moulding, drying, get 100 soft capsules.
1.2 investigation condition: room temperature (25 ± 2 ℃), high temperature (50 ℃), illumination (4500 ± 500Lx), place under the high humility conditions such as (RH92.5%), in 0,5,10 day sample analysis.
1.3 investigation project: character, disintegration, content, related substance
1.4 investigation method:
Disintegration: by rules of preparations capsule (two appendix IE of Chinese Pharmacopoeia version in the 2005) requirement of disintegration, according to method inspection under inspection technique disintegration (two appendix XA of Chinese Pharmacopoeia version in 2005) the capsule item.
Assay: microbial antibiotic checking method
Related substance: adopt thin layer chromatography
1.5 result of the test: see Table 1～6.
The influence factor result of the test of table 1:070901 Azithromycin soft capsules under 50 ℃ of hot conditionss
| Standing time | Outward appearance | Disintegration | Content (%) | Related substance |
| 0 day | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??21 | ??99.4 | ??＜3％ |
| 5 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??24 | ??99.6 | ??＜3％ |
| 10 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??25 | ??99.7 | ??＜3％ |
The influence factor result of the test of table 2:070801 Azithromycin soft capsules under 50 ℃ of hot conditionss
| Standing time | Outward appearance | Disintegration | Content (%) | Related substance |
| 0 day | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??23 | ??99.6 | ??＜3％ |
| 5 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??24 | ??99.5 | ??＜3％ |
| 10 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??24 | ??99.8 | ??＜3％ |
The influence factor result of the test of table 3:070901 Azithromycin soft capsules under 4500Lx strong illumination condition
| Standing time | Outward appearance | Disintegration | Content (%) | Related substance |
| 0 day | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??23 | ??99.5 | ??＜3％ |
| 5 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??25 | ??99.7 | ??＜3％ |
| 10 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??23 | ??99.9 | ??＜3％ |
The influence factor result of the test of table 4:070801 Azithromycin soft capsules under 4500Lx strong illumination condition
| Standing time | Outward appearance | Disintegration | Content (%) | Related substance |
| 0 day | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??22 | ??99.4 | ??＜3％ |
| 5 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??23 | ??99.8 | ??＜3％ |
| 10 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??24 | ??99.8 | ??＜3％ |
The influence factor result of the test of table 5:070901 Azithromycin soft capsules under the RH92.5% super-humid conditions
| Standing time | Outward appearance | Disintegration | Content (%) | Related substance |
| 0 day | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??24 | ??99.7 | ??＜3％ |
| 5 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??26 | ??99.7 | ??＜3％ |
| 10 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??24 | ??99.6 | ??＜3％ |
The influence factor result of the test of table 6:070801 Azithromycin soft capsules under the RH92.5% super-humid conditions
| Standing time | Outward appearance | Disintegration | Content (%) | Related substance |
| 0 day | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??24 | ??99.5 | ??＜3％ |
| 5 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??23 | ??99.7 | ??＜3％ |
| 10 days | Oval soft capsule, the faint yellow clear and bright oily liquids of content | ??26 | ??99.6 | ??＜3％ |
The result proves, the capsule content liquid high temperature (50 ℃), illumination (4500 ± 500Lx), under the high humility conditions such as (RH92.5%) stable do not have separate out, placed 5,10 days under 50 ℃ of hot conditionss of unpacked soft capsule, the capsule shells hardening, depression, detect related substance impurity speckle, but less than 3% contrast speckle, tiring there is not significant change; Unpacked soft capsule was placed 5 days under the 4500Lx illumination condition, the impurity speckle do not occur, placed 10 days, did not detect related substance impurity speckle, and tiring does not have significant change; Unpacked soft capsule was placed 5,10 days under relative humidity RH92.5% condition, and hydroscopicity is greater than 10%, capsule shells suction deliquescing, disintegration, content content conformance with standard.
Experimental example 2
1, the screening experiment of adjuvant acetic acid:
In taking polyethylene glycol 400 120g, 1,2 propylene glycol 12g mean allocation to four Agitation Tank, get lactic acid, citric acid, lactobionic acid and the acetic acid of 2.6g more respectively, add Agitation Tank, add the 12.5g azithromycin respectively under stirring condition, the result is as follows:
A. azithromycin 12.5g
PEG400 30g
Lactic acid 2.6g
1,2 propylene glycol 3.0g
Water 4.0g
???????????????????????????????????
Result: can not dissolve fully
B. azithromycin 12.5g
PEG400 30g
Citric acid 2.6g
1,2 propylene glycol 3.0g
Water 4.0g
???????????????????????????????????
Result: can not dissolve fully
C. azithromycin 12.5g
PEG400 30g
Lactobionic acid 2.6g
1,2 propylene glycol 3.0g
Water 4.0g
????????????????????????????????????
Result: can not dissolve fully
D. azithromycin 12.5g
PEG400 30g
Acetic acid 2.6g
1,2 propylene glycol 3.0g
Water 4.0g
????????????????????????????????????
The result: dissolving fully, character are stablized
Experimental result shows that A, B, three groups of azithromycins of C can not dissolve fully, finally can not make up-to-standard Azithromycin soft capsules in adjuvant; And the D group promptly adopts acetic acid as adjuvant, and azithromycin can dissolve fully, and the soft capsule character of making is stable.
2, the screening experiment of adjuvants such as PEG400, Macrogol 200, acetic acid, water
In taking polyethylene glycol 400 80g, 1,2 propylene glycol 12g mean allocation to four Agitation Tank, get lactic acid, citric acid, lactobionic acid and the acetic acid of 6.6g more respectively, add Agitation Tank, add the 25g azithromycin respectively under stirring condition, the result is as follows:
A. azithromycin 25.0g
PEG400 20g
Lactic acid 6.6g
1,2 propylene glycol 3.0g
Water 4.0g
??????????????????????????????????
Result: can not dissolve fully
B. azithromycin 25.0g
PEG400 20g
Citric acid 6.6g
1,2 propylene glycol 3.0g
Water 4.0g
???????????????????????????????????
Result: can not dissolve fully
C. azithromycin 25.0g
PEG400 20g
Lactobionic acid 6.6g
1,2 propylene glycol 3.0g
Water 4.0g
?????????????????????????????????
Result: can not dissolve fully
D. azithromycin 25.0g
PEG400 20g
Acetic acid 6.6g
1,2 propylene glycol 3.0g
Water 4.0g
???????????????????????????????????
The result: dissolving fully, viscosity is big
Experimental result shows that A, B, three groups of azithromycins of C can not dissolve fully, finally can not make up-to-standard Azithromycin soft capsules in adjuvant; And the D group promptly adopts acetic acid as adjuvant, and azithromycin can dissolve fully, but the capsule 's content viscosity that obtains is big, the up-to-standard Azithromycin soft capsules that can not make.
To replace the 20g PEG400 with 11g Macrogol 200 and 4g PEG400, as E group adjuvant prescription, other supplementary product consumptions are constant, and azithromycin can dissolve fully as a result, but the capsule 's content viscosity that obtains is still very big, the up-to-standard Azithromycin soft capsules that can not make.
E. azithromycin 25.0g
Macrogol 200 11.0g
PEG400 4.0g
Acetic acid 6.6g
1,2 propylene glycol 3.0g
???????????????????????????????
The result: dissolving fully, viscosity is bigger
Add water 4.0g on the basis of E group prescription, azithromycin can dissolve fully as a result, and the capsule 's content viscosity that obtains is suitable, can make up-to-standard Azithromycin soft capsules.
F. azithromycin 25.0g
Macrogol 200 11.0g
PEG400 4.0g
Acetic acid 6.6g
1,2 propylene glycol 3.0g
Water 4.0g
???????????????????????????????????
The result: dissolving fully, viscosity suit
The result shows: learn that by the adjuvant screening experiment F group is best prescription.
Following embodiment all can realize the beneficial effect of experimental example of the present invention.
The specific embodiment
Embodiment 1:
Azithromycin 250g
Macrogol 200 110g
PEG400 40g
Acetic acid 66g
1,2 propylene glycol 30g
Water 30g;
Get above-mentioned PEG400, Macrogol 200, water, acetic acid, 1,2 propylene glycol add in the Agitation Tank, under stirring condition, add azithromycin, medicine is dissolved fully, get medicinal liquid, as capsule 's content, adopt the soft capsule production equipment, use mould compression moulding, drying promptly gets 1000 of Azithromycin soft capsules.
Embodiment 2:
Azithromycin 125g
PEG400 300g
Acetic acid 26g
1,2 propylene glycol 30g
Water 20g;
Get in above-mentioned PEG400, water, acetic acid, 1, the 2 propylene glycol adding Agitation Tank, under stirring condition, add azithromycin, medicine is dissolved fully, get medicinal liquid,, adopt the soft capsule production equipment as capsule 's content, use mould compression moulding, drying promptly gets 1000 of Azithromycin soft capsules.
Embodiment 3:
Azithromycin 380g
Macrogol 200 20g
PEG400 200g
Acetic acid 78g
1,2 propylene glycol 40g
Water 30g;
Get above-mentioned PEG400, Macrogol 200, water, acetic acid, 1,2 propylene glycol add in the Agitation Tank, under stirring condition, add azithromycin, medicine is dissolved fully, get medicinal liquid, as capsule 's content, adopt the soft capsule production equipment, use mould compression moulding, drying promptly gets 1000 of Azithromycin soft capsules.
Embodiment 4:
Azithromycin 125g
Macrogol 200 380g
PEG400 22g
Acetic acid 32g
1,2 propylene glycol 10g
Water 50g;
Taking polyethylene glycol 400, Macrogol 200, water, acetic acid, 1,2 propylene glycol add in the Agitation Tank, under stirring condition, add azithromycin, medicine is dissolved fully, get medicinal liquid, as capsule 's content, adopt the soft capsule production equipment, use mould compression moulding, drying promptly gets 1000 of Azithromycin soft capsules.
Claims (6)
1, a kind of Azithromycin soft capsules is characterized in that this capsular raw material is composed as follows:
Azithromycin 10.0-40.0 weight portion
Macrogol 200 0-40.0 weight portion
PEG400 2.0-40.0 weight portion
Acetic acid 0.5-8.0 weight portion
1,2 propylene glycol 1.0-5.0 weight portion
Water 2.0-6.0 weight portion.
2, soft capsule as claimed in claim 1 is characterized in that this capsular raw material is composed as follows:
Azithromycin 25.0 weight portions
Macrogol 200 11.0 weight portions
PEG400 4.0 weight portions
Acetic acid 6.6 weight portions
1,2 propylene glycol, 3.0 weight portions
Water 4.0 weight portions.
3, soft capsule as claimed in claim 1 is characterized in that this capsular raw material is composed as follows:
Azithromycin 12.5 weight portions
PEG400 30.0 weight portions
Acetic acid 2.6 weight portions
1,2 propylene glycol, 3.0 weight portions
Water 2.0 weight portions.
4, soft capsule as claimed in claim 1 is characterized in that this capsular raw material is composed as follows:
Azithromycin 38.0 weight portions
Macrogol 200 2.0 weight portions
PEG400 20.0 weight portions
Acetic acid 7.8 weight portions
1,2 propylene glycol, 4.0 weight portions
Water 3.0 weight portions.
5, soft capsule as claimed in claim 1 is characterized in that this capsular raw material is composed as follows:
Azithromycin 12.5 weight portions
Macrogol 200 38.0 weight portions
PEG400 2.2 weight portions
Acetic acid 3.2 weight portions
1,2 propylene glycol, 1.0 weight portions
Water 5.0 weight portions.
6, as the arbitrary described preparation of soft capsule method of claim 1-5, it is characterized in that this method comprises the steps:
Taking polyethylene glycol 400, Macrogol 200, water, acetic acid, 1,2 propylene glycol add in the Agitation Tank, it is stirred, under stirring condition, add azithromycin, medicine is dissolved fully, get medicinal liquid, as capsule 's content, adopt the soft capsule production equipment, use mould compression moulding, drying, promptly.
Priority Applications (1)
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|---|---|---|---|
| CN2008101192840A CN101664396B (en) | 2008-09-02 | 2008-09-02 | Azithromycin soft capsules and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101192840A CN101664396B (en) | 2008-09-02 | 2008-09-02 | Azithromycin soft capsules and preparation method thereof |
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| CN101664396A true CN101664396A (en) | 2010-03-10 |
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Cited By (1)
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| CN112629990A (en) * | 2021-01-24 | 2021-04-09 | 深圳博泰尔生物技术有限公司 | Azithromycin reference substance and preparation method thereof |
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| CN1255111C (en) * | 2004-06-30 | 2006-05-10 | 宛六一 | Azithromycin soft capsule and its preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112629990A (en) * | 2021-01-24 | 2021-04-09 | 深圳博泰尔生物技术有限公司 | Azithromycin reference substance and preparation method thereof |
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