CN114010605A - Acetylcysteine granules and preparation method thereof - Google Patents
Acetylcysteine granules and preparation method thereof Download PDFInfo
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- CN114010605A CN114010605A CN202111422431.3A CN202111422431A CN114010605A CN 114010605 A CN114010605 A CN 114010605A CN 202111422431 A CN202111422431 A CN 202111422431A CN 114010605 A CN114010605 A CN 114010605A
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- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 title claims abstract description 64
- 229960004308 acetylcysteine Drugs 0.000 title claims abstract description 61
- 238000002360 preparation method Methods 0.000 title claims abstract description 11
- 239000008187 granular material Substances 0.000 title claims description 29
- 239000002245 particle Substances 0.000 claims abstract description 24
- 239000000843 powder Substances 0.000 claims abstract description 17
- 235000005979 Citrus limon Nutrition 0.000 claims abstract description 13
- 244000248349 Citrus limon Species 0.000 claims abstract description 13
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 13
- 229930006000 Sucrose Natural products 0.000 claims abstract description 13
- 229960004793 sucrose Drugs 0.000 claims abstract description 13
- 239000002994 raw material Substances 0.000 claims abstract description 12
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 11
- 229930195725 Mannitol Natural products 0.000 claims abstract description 11
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims abstract description 11
- 239000000594 mannitol Substances 0.000 claims abstract description 11
- 235000010355 mannitol Nutrition 0.000 claims abstract description 11
- 239000005720 sucrose Substances 0.000 claims abstract description 8
- 239000006188 syrup Substances 0.000 claims abstract description 7
- 235000020357 syrup Nutrition 0.000 claims abstract description 7
- 229940013618 stevioside Drugs 0.000 claims abstract description 4
- OHHNJQXIOPOJSC-UHFFFAOYSA-N stevioside Natural products CC1(CCCC2(C)C3(C)CCC4(CC3(CCC12C)CC4=C)OC5OC(CO)C(O)C(O)C5OC6OC(CO)C(O)C(O)C6O)C(=O)OC7OC(CO)C(O)C(O)C7O OHHNJQXIOPOJSC-UHFFFAOYSA-N 0.000 claims abstract description 4
- 235000019202 steviosides Nutrition 0.000 claims abstract description 4
- 238000007873 sieving Methods 0.000 claims description 20
- 238000001035 drying Methods 0.000 claims description 12
- 238000000034 method Methods 0.000 claims description 9
- 238000012216 screening Methods 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- 239000000463 material Substances 0.000 abstract description 7
- 239000003086 colorant Substances 0.000 abstract description 4
- 239000000796 flavoring agent Substances 0.000 abstract description 2
- 235000013355 food flavoring agent Nutrition 0.000 abstract description 2
- 239000007788 liquid Substances 0.000 abstract description 2
- 229960001855 mannitol Drugs 0.000 abstract description 2
- 239000007787 solid Substances 0.000 abstract description 2
- 241001465754 Metazoa Species 0.000 description 7
- 229920000609 methyl cellulose Polymers 0.000 description 6
- 239000001923 methylcellulose Substances 0.000 description 6
- 239000000047 product Substances 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- 241000699670 Mus sp. Species 0.000 description 5
- 239000000725 suspension Substances 0.000 description 4
- 208000024891 symptom Diseases 0.000 description 4
- 206010036790 Productive cough Diseases 0.000 description 3
- 239000007928 intraperitoneal injection Substances 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 208000024794 sputum Diseases 0.000 description 3
- 210000003802 sputum Anatomy 0.000 description 3
- 206010062717 Increased upper airway secretion Diseases 0.000 description 2
- 208000005392 Spasm Diseases 0.000 description 2
- 230000002159 abnormal effect Effects 0.000 description 2
- 230000037396 body weight Effects 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 208000026435 phlegm Diseases 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 1
- 238000012449 Kunming mouse Methods 0.000 description 1
- 241000699666 Mus <mouse, genus> Species 0.000 description 1
- 206010033799 Paralysis Diseases 0.000 description 1
- ZGSDJMADBJCNPN-UHFFFAOYSA-N [S-][NH3+] Chemical compound [S-][NH3+] ZGSDJMADBJCNPN-UHFFFAOYSA-N 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000007059 acute toxicity Effects 0.000 description 1
- 231100000403 acute toxicity Toxicity 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000000510 mucolytic effect Effects 0.000 description 1
- 230000001590 oxidative effect Effects 0.000 description 1
- 229920001184 polypeptide Polymers 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
- 229940081974 saccharin Drugs 0.000 description 1
- 235000019204 saccharin Nutrition 0.000 description 1
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- PXQLVRUNWNTZOS-UHFFFAOYSA-N sulfanyl Chemical compound [SH] PXQLVRUNWNTZOS-UHFFFAOYSA-N 0.000 description 1
- 125000003396 thiol group Chemical group [H]S* 0.000 description 1
Classifications
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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
- 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
- A61K9/1664—Compounds of unknown constitution, e.g. material from plants or animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/10—Expectorants
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pulmonology (AREA)
- Botany (AREA)
- Zoology (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses acetylcysteine particles and a preparation method thereof, and relates to the technical field of preparation of acetylcysteine particles, wherein the acetylcysteine particles comprise the following raw material components in parts by weight: 0.8-1.2 parts of acetylcysteine, 4.5-5.5 parts of cane sugar, 1.3-1.7 parts of mannitol, 0.80-0.90 part of syrup, 0.1-0.2 part of lemon powder essence and 0.25-0.35 part of steviosin. The raw materials of the acetylcysteine particles provided by the invention adopt acetylcysteine, sucrose and mannitol in compatibility, so that the stability is good; the lemon powder essence adopted in the raw material components is solid powder essence, and has smaller hygroscopicity than common liquid lemon essence; the raw material components contain very little stevioside serving as a flavoring agent; the acetylcysteine granular product provided by the invention reduces the using amount of auxiliary materials, is more scientific in auxiliary materials, does not contain a coloring agent, and is better for patients.
Description
Technical Field
The invention relates to the technical field of preparation of acetylcysteine particles, and particularly relates to acetylcysteine particles and a preparation method thereof.
Background
At present, no imported acetylcysteine granular product is on the market in China. The existing domestic acetylcysteine granule products are few, for example, acetylcysteine granules (trade name: Fulu, specification: 0.1g, 0.2g) are produced by Hainan Zanbang pharmaceutical Co., Ltd.
The N-acetyl-L-cysteine is an active ingredient of acetylcysteine particles and has strong mucolytic effect. It breaks the disulfide bond (-S-S) in the mucin polypeptide chain to decompose mucin compound through the sulfhydryl (-SH) which can react with electrophilic oxidizing group in the chemical structure, reduces the viscosity of phlegm and makes the phlegm easy to expectorate. N-acetyl-L-cysteine can also break DNA fibers in purulent sputum, so that the N-acetyl-L-cysteine can dissolve not only white sticky sputum but also purulent sputum. The acetylcysteine material itself has an odor of ammonia sulfide and is easily oxidized by absorbing moisture in the air. Therefore, the existing acetylcysteine granular product is added with more auxiliary materials and adopts coloring agents to cover the defects.
At present, an acetylcysteine granular product which is low in auxiliary material consumption, does not contain saccharin and does not contain a coloring agent does not exist.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides acetylcysteine granules and a preparation method thereof.
The acetylcysteine particles comprise the following raw material components in parts by weight: 0.8-1.2 parts of acetylcysteine, 4.5-5.5 parts of cane sugar, 1.3-1.7 parts of mannitol, 0.80-0.90 part of syrup, 0.1-0.2 part of lemon powder essence and 0.25-0.35 part of steviosin.
Preferably, the acetylcysteine particles comprise the following raw material components in parts by weight: 1 part of acetylcysteine, 5 parts of cane sugar, 1.5 parts of mannitol, 0.85 part of syrup, 0.15 part of lemon powder essence and 0.3 part of stevioside.
The preparation method of the acetylcysteine granules comprises the following steps:
s1, crushing and sieving sucrose to prepare sucrose powder for later use;
s2, sequentially sieving acetylcysteine, mannitol, lemon powder essence and steviosin for later use;
s3, mixing sucrose powder, acetylcysteine, mannitol, lemon powder essence and steviosin for the first time, adding syrup, mixing for the second time, and cutting to obtain wet granules;
and S4, carrying out primary drying, primary screening, secondary drying and secondary screening on the wet granules to obtain the acetylcysteine granules.
Preferably, in step S1, the sieving is 60-mesh sieving.
Preferably, in step S2, the sieving is 60-mesh sieving.
Preferably, in step S3, the first mixing is mixing for 10 minutes.
Preferably, in step S3, the second mixing and chopping is performed at a chopping speed of 15Hz for 3 minutes.
Preferably, in step S4, the first drying is performed at a drying temperature of 55 ℃ for 10-15 minutes; the first sieving is 12-mesh sieving.
Preferably, in step S4, the second drying is performed at a drying temperature of 55 ℃ for 10-30 minutes; the second sieving is 12-mesh sieving.
Preferably, in step S4, the water content of the acetylcysteine particles is less than or equal to 1.0%.
The invention has the beneficial effects that:
(1) the raw materials of the acetylcysteine particles provided by the invention adopt acetylcysteine, sucrose and mannitol in compatibility, so that the stability is good; the lemon powder essence adopted in the raw material components is solid powder essence, and has smaller hygroscopicity than common liquid lemon essence; the raw material components contain very little stevioside serving as a flavoring agent; the acetylcysteine granular product provided by the invention reduces the using amount of auxiliary materials, is more scientific in auxiliary materials, does not contain a coloring agent, and is better for patients.
(2) The preparation method of the acetylcysteine granules provided by the invention is simple to operate, stable in technology, scientific in raw material collocation, excellent in effect of the prepared product and high in commercial value.
Detailed Description
Hereinafter, embodiments of the present invention will be described in detail. The following examples are only for illustrating the technical solutions of the present invention more clearly, and therefore are only examples, and the protection scope of the present invention is not limited thereby.
It is to be noted that, unless otherwise specified, technical or scientific terms used herein shall have the ordinary meaning as understood by those skilled in the art to which the invention pertains.
Test example 1
Stability tests were carried out on the acetylcysteine granules obtained in the examples
The acetylcysteine granules prepared in the examples were placed in a greenhouse for 24 months for observation, and the results are shown in Table 1.
TABLE 1
| Sampling time (moon) | Content measurement (%) | Degradation products | Traits |
| 0 | 100.07 | Not detected out | White particles |
| 6 | 99.82 | Not detected out | White particles |
| 12 | 98.33 | Not detected out | White particles |
| 18 | 97.48 | Not detected out | White particles |
| 24 | 94.72 | Not detected out | White particles |
As is clear from Table 1, the acetylcysteine granules obtained in the examples were stable after being left in a greenhouse for 24 months.
Test example 2
The acetylcysteine particles prepared in the examples were subjected to measurement of the maximum tolerance of mice
The tested drugs are: the acetylcysteine granules prepared in the examples were tested in a suspension with 0.5% Methylcellulose (MC) at a maximum concentration of 1.67 g/ml.
Animals: 20 mice of the second-level Kunming species weigh 20 +/-2 g and are male and female halves.
The test method comprises the following steps: orally administered with 0.5% MC solvent at a dose of 33.4g/kg and a dose volume of 0.4ml/20 g.
And (4) observation: the animals were carefully recorded for 7 days after administration for abnormal reactions and death.
And (3) test results: the acetylcysteine granules prepared in the example are orally taken by mice by 33.4g/kg, and no obvious symptoms are produced in the animals.
Test example 3
The acetylcysteine particles prepared in the examples were subjected to mouse acute toxicity measurement
The tested drugs are: the acetylcysteine granules prepared in the examples were tested in suspensions of 0.229, 0.206, 0.185, 0.167, 0.150g/ml with 0.5% Methylcellulose (MC).
Animals: the second-level Kunming mouse has 50 mice, the weight of 20 plus or minus 2g and half of the male and female.
The test method comprises the following steps: the test animals were randomly divided into 5 groups of 10 animals each by body weight, and administered by intraperitoneal injection in a solvent of 0.5% MC. The 5 dose groups are 4.58, 4.12, 3.71, 3.34 and 3.00 respectively
g/kg. The adjacent metric ratio is 0.9. The administration volume was 0.4ml/20g body weight, and one administration was carried out.
And (4) observation: the animals were carefully recorded for 7 days after administration for abnormal reactions and death.
LD50The calculation method comprises the following steps: the Bliss method; LD50The parameters are shown in Table 2.
TABLE 2
LD50＝3.659g/kg。
The 95% confidence limit is 3.387-3.954 g/kg.
The 95% average confidence limit was 0.179 g/kg.
The acetylcysteine granules prepared in the embodiment have slow symptoms after intraperitoneal injection, no obvious symptoms appear in a group with 3.00g/kg dose, activities of other groups are reduced, but no obvious spasm appears, and paralysis and death appear in 1-5 days.
And (3) test results: the acetylcysteine granule suspension prepared in the examples was injected intraperitoneally into LD in mice50And the 95 percent average confidence limit is 3.659 +/-0.179 g/kg, and the acetylcysteine particle suspension prepared in the embodiment has the characteristics of acting on the intraperitoneal injection of mice: the symptoms are slow, no obvious spasm occurs, and the death time is long.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention, and they should be construed as being included in the following claims and description.
Claims (10)
1. An acetylcysteine particle, comprising: the acetylcysteine particles comprise the following raw material components in parts by weight: 0.8-1.2 parts of acetylcysteine, 4.5-5.5 parts of cane sugar, 1.3-1.7 parts of mannitol, 0.80-0.90 part of syrup, 0.1-0.2 part of lemon powder essence and 0.25-0.35 part of steviosin.
2. Acetylcysteine particles as in claim 1, wherein: the acetylcysteine particles comprise the following raw material components in parts by weight: 1 part of acetylcysteine, 5 parts of cane sugar, 1.5 parts of mannitol, 0.85 part of syrup, 0.15 part of lemon powder essence and 0.3 part of stevioside.
3. A process for the preparation of acetylcysteine granules according to any one of claims 1-2, wherein: the preparation method comprises the following steps: s1, crushing and sieving sucrose to prepare sucrose powder for later use; s2, sequentially sieving acetylcysteine, mannitol, lemon powder essence and steviosin for later use; s3, mixing sucrose powder, acetylcysteine, mannitol, lemon powder essence and steviosin for the first time, adding syrup, mixing for the second time, and cutting to obtain wet granules; and S4, carrying out primary drying, primary screening, secondary drying and secondary screening on the wet granules to obtain the acetylcysteine granules.
4. The method of preparing acetylcysteine granules according to claim 3, wherein: in step S1, the sieving is 60 mesh sieving.
5. The method of preparing acetylcysteine granules according to claim 3, wherein: in step S2, the sieving is 60 mesh sieving.
6. The method of preparing acetylcysteine granules according to claim 3, wherein: in step S3, the first mixing is mixing for 10 minutes.
7. The method of preparing acetylcysteine granules according to claim 3, wherein: in step S3, the second mixing and chopping is performed at a chopping speed of 15Hz for 3 minutes.
8. The method of preparing acetylcysteine granules according to claim 3, wherein: in step S4, the first drying is carried out at a drying temperature of 55 ℃ for 10-15 minutes; the first sieving is 12-mesh sieving.
9. The method of preparing acetylcysteine granules according to claim 3, wherein: in step S4, the second drying is carried out at a drying temperature of 55 ℃ for 10-30 minutes; the second sieving is 12-mesh sieving.
10. The method of preparing acetylcysteine granules according to claim 3, wherein: in step S4, the water content of the acetylcysteine particles is less than or equal to 1.0%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111422431.3A CN114010605A (en) | 2021-11-26 | 2021-11-26 | Acetylcysteine granules and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202111422431.3A CN114010605A (en) | 2021-11-26 | 2021-11-26 | Acetylcysteine granules and preparation method thereof |
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| Publication Number | Publication Date |
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| CN114010605A true CN114010605A (en) | 2022-02-08 |
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| CN202111422431.3A Pending CN114010605A (en) | 2021-11-26 | 2021-11-26 | Acetylcysteine granules and preparation method thereof |
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