CN113057950A - Oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granule preparation and preparation process thereof - Google Patents
Oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granule preparation and preparation process thereof Download PDFInfo
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- CN113057950A CN113057950A CN202010000345.2A CN202010000345A CN113057950A CN 113057950 A CN113057950 A CN 113057950A CN 202010000345 A CN202010000345 A CN 202010000345A CN 113057950 A CN113057950 A CN 113057950A
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- paracetamol
- bezoar
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- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 title claims abstract description 110
- 229960005489 paracetamol Drugs 0.000 title claims abstract description 86
- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 title claims abstract description 71
- 206010004542 Bezoar Diseases 0.000 title claims abstract description 52
- 239000008187 granular material Substances 0.000 title claims abstract description 49
- 238000002360 preparation method Methods 0.000 title claims abstract description 48
- 238000000576 coating method Methods 0.000 claims abstract description 84
- 239000011248 coating agent Substances 0.000 claims abstract description 76
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 claims abstract description 64
- 238000002156 mixing Methods 0.000 claims abstract description 45
- 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 43
- 229930006000 Sucrose Natural products 0.000 claims abstract description 43
- 229960004793 sucrose Drugs 0.000 claims abstract description 43
- 239000002994 raw material Substances 0.000 claims abstract description 42
- 235000009508 confectionery Nutrition 0.000 claims abstract description 36
- 239000001569 carbon dioxide Substances 0.000 claims abstract description 32
- 229910002092 carbon dioxide Inorganic materials 0.000 claims abstract description 32
- 239000000049 pigment Substances 0.000 claims abstract description 31
- 239000007788 liquid Substances 0.000 claims abstract description 29
- 229940046978 chlorpheniramine maleate Drugs 0.000 claims abstract description 24
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 24
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 22
- 239000008213 purified water Substances 0.000 claims abstract description 21
- 239000008199 coating composition Substances 0.000 claims abstract description 13
- 235000003599 food sweetener Nutrition 0.000 claims abstract description 11
- 239000003765 sweetening agent Substances 0.000 claims abstract description 11
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract description 9
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 9
- 239000005720 sucrose Substances 0.000 claims description 35
- 239000000463 material Substances 0.000 claims description 33
- 238000009835 boiling Methods 0.000 claims description 16
- 238000010438 heat treatment Methods 0.000 claims description 16
- 238000004806 packaging method and process Methods 0.000 claims description 16
- 238000007873 sieving Methods 0.000 claims description 16
- 239000002245 particle Substances 0.000 claims description 13
- 238000001816 cooling Methods 0.000 claims description 8
- 235000021552 granulated sugar Nutrition 0.000 claims description 8
- 239000007787 solid Substances 0.000 claims description 8
- 235000000346 sugar Nutrition 0.000 claims description 8
- 230000009191 jumping Effects 0.000 claims description 6
- 238000004519 manufacturing process Methods 0.000 claims description 3
- 240000001592 Amaranthus caudatus Species 0.000 claims description 2
- 235000009328 Amaranthus caudatus Nutrition 0.000 claims description 2
- 108010011485 Aspartame Proteins 0.000 claims description 2
- 235000005979 Citrus limon Nutrition 0.000 claims description 2
- 244000131522 Citrus pyriformis Species 0.000 claims description 2
- 235000005976 Citrus sinensis Nutrition 0.000 claims description 2
- 240000002319 Citrus sinensis Species 0.000 claims description 2
- 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 description 2
- 235000012735 amaranth Nutrition 0.000 claims description 2
- 239000004178 amaranth Substances 0.000 claims description 2
- 239000000605 aspartame Substances 0.000 claims description 2
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 2
- 229960003438 aspartame Drugs 0.000 claims description 2
- 235000010357 aspartame Nutrition 0.000 claims description 2
- 239000001525 mentha piperita l. herb oil Substances 0.000 claims description 2
- 239000010502 orange oil Substances 0.000 claims description 2
- 235000019477 peppermint oil Nutrition 0.000 claims description 2
- 229940013618 stevioside Drugs 0.000 claims description 2
- 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 description 2
- 235000019202 steviosides Nutrition 0.000 claims description 2
- 238000009472 formulation Methods 0.000 claims 5
- 239000000203 mixture Substances 0.000 claims 5
- 229960001280 amantadine hydrochloride Drugs 0.000 claims 1
- WOLHOYHSEKDWQH-UHFFFAOYSA-N amantadine hydrochloride Chemical compound [Cl-].C1C(C2)CC3CC2CC1([NH3+])C3 WOLHOYHSEKDWQH-UHFFFAOYSA-N 0.000 claims 1
- 239000000796 flavoring agent Substances 0.000 claims 1
- 235000019634 flavors Nutrition 0.000 claims 1
- 239000000576 food coloring agent Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 11
- 229940079593 drug Drugs 0.000 abstract description 5
- 239000000843 powder Substances 0.000 abstract description 4
- 235000019658 bitter taste Nutrition 0.000 abstract description 3
- 235000019640 taste Nutrition 0.000 abstract description 3
- 238000005516 engineering process Methods 0.000 abstract description 2
- 239000011521 glass Substances 0.000 abstract 1
- 239000004576 sand Substances 0.000 abstract 1
- 201000009240 nasopharyngitis Diseases 0.000 description 5
- 206010037660 Pyrexia Diseases 0.000 description 3
- 230000001754 anti-pyretic effect Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 206010028748 Nasal obstruction Diseases 0.000 description 2
- 206010039101 Rhinorrhoea Diseases 0.000 description 2
- 239000002221 antipyretic Substances 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 206010022000 influenza Diseases 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000005507 spraying Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 206010011224 Cough Diseases 0.000 description 1
- 206010013954 Dysphoria Diseases 0.000 description 1
- 206010017788 Gastric haemorrhage Diseases 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 206010068319 Oropharyngeal pain Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 201000007100 Pharyngitis Diseases 0.000 description 1
- 208000036071 Rhinorrhea Diseases 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000003266 anti-allergic effect Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 210000001156 gastric mucosa Anatomy 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 210000000214 mouth Anatomy 0.000 description 1
- 208000010753 nasal discharge Diseases 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/413—Gall bladder; Bile
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
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- Biotechnology (AREA)
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Abstract
The invention discloses an oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation and a preparation process thereof, wherein the granular preparation is prepared from the following components in parts by weight: raw material coating formula: 140 parts of acetaminophen 110-140 parts, 0.1-0.8 part of chlorpheniramine maleate and 3-10 parts of artificial bezoar; coating liquid: HPMC, 10-20 parts of edible pigment 0.03-0.15 part, sweetener 2-8 parts, ethanol solution 280-320 parts; (II) prescription of popping candy: 1900 parts of cane sugar, 1800-sand glass, 0.05-0.12 part of edible pigment and 90-120 parts of purified water; (III) granule mixing formula: 125-180 parts of coating raw materials, 1800-1900 parts of popping candy and 3-10 parts of edible essence. The oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules and the preparation process thereof, provided by the invention, adopt a powder coating technology to cover main bitter taste, and are doped with high-pressure carbon dioxide gas-filled cane sugar, so that the uncomfortable taste sense of children is avoided, the interestingness is increased, the children can accept the medicines better, and the granules are directly orally taken, do not need to be dissolved in warm water, and are more convenient to carry and take.
Description
Technical Field
The invention relates to the field of pharmaceutical preparations, in particular to an oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation and a preparation process thereof.
Background
The paracetamol and chlorphenamine maleate for children is mainly used for clinically treating common cold of children, paracetamol in a prescription has antipyretic and analgesic effects, has obvious antipyretic effect, small irritation to gastric mucosa, no gastric bleeding, no obvious side effect in conventional dosage, is a first-choice antipyretic for children more than 2 months, is used for fever caused by common cold or influenza, and is also used for relieving mild and moderate pain; chlorphenamine maleate has antiallergic effect, and can be used for relieving cough, nasal obstruction, watery nasal discharge, etc. caused by common cold, and artificial bezoar has relieving effect on infantile common cold, fever, sore throat, and dysphoria.
The pediatric paracetamol and chlorphenamine maleate is a compound preparation and is suitable for relieving symptoms of fever, headache, soreness of limbs, sneeze, rhinorrhea, nasal obstruction, pharyngalgia and the like caused by common cold and influenza of children. At present, the commercially available pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules have the problems of large granules, poor convenience due to the fact that the granules need to be taken with warm water, certain bitter taste of the medicine, poor adaptability of children and the like.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: aiming at the defects of the existing pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules, the paracetamol, atificial cow-bezoar and chlorphenamine maleate granules with better children oral administration adaptability and the preparation process thereof are provided.
In order to achieve the purpose, the invention adopts the following technical scheme:
the invention provides an oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation, which is prepared from the following components in parts by weight:
raw material coating formula:
acetaminophen 110-140 parts
0.1-0.8 part of chlorpheniramine maleate
Artificial bezoar 3-10 parts
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1800 portions of cane sugar and 1900 portions
0.05-0.12 portion of edible pigment
90-120 parts of purified water
(III) granule mixing formula:
125 portions of coating raw material and 180 portions (in terms of the amount of the paracetamol)
1800 portions of popping candy
3-10 parts of edible essence.
Further, the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation is prepared from the following components in parts by weight:
raw material coating formula:
acetaminophen 120-135 parts
0.3-0.6 part of chlorpheniramine maleate
Artificial bezoar 3-8 parts
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1820 portion of cane sugar and 1880 portion
0.08-0.15 parts of edible pigment
95-110 parts of purified water
(III) granule mixing formula:
138 portions and 168 portions of coating raw material (in terms of the amount of the paracetamol)
1820 and 1880 portions of popping candy
4-8 parts of edible essence.
Further, the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation is prepared from the following components in parts by weight:
raw material coating formula:
125 portions of acetaminophen
Chlorpheniramine maleate 0.5 part
Artificial bezoar 5 parts
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1850 parts of cane sugar
0.1 portion of edible pigment
Purified water 100 parts
(III) granule mixing formula:
150 parts of coating raw material (converted according to the amount of paracetamol)
Jumping candy 1850 parts
6 parts of edible essence.
Further, in the oral pediatric paracetamol, chlorpheniramine maleate and artificial bezoar granule preparation, the particle size of the paracetamol, the chlorpheniramine maleate and the artificial bezoar is 80-200 meshes.
Further, in the oral pediatric paracetamol and chlorphenamine maleate granules, the concentration of the ethanol solution is 40-60 wt%.
Further, in the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate particle preparation, the food pigment is one or two of lemon yellow and amaranth.
Further, in the oral pediatric paracetamol and chlorpheniramine maleate granule preparation, the sweetener is one or two of aspartame and stevioside.
Further, in the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate particle preparation, the edible essence is one or two of sweet orange oil and peppermint oil.
The second aspect of the invention provides a preparation process of the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granule preparation, which comprises the following steps:
step 1) raw material coating:
sieving acetaminophen, chlorphenamine maleate and artificial bezoar with 80 mesh sieve, placing in a boiling coating machine, and heating after starting up;
uniformly mixing HPMC, edible pigment, sweetener and ethanol solution according to the prescription amount to prepare coating liquid;
when the temperature of the materials in the boiling coating machine reaches 30-40 ℃, the coating liquid is sprayed, and the temperature of the materials is controlled below 40 ℃ in the whole coating process until the materials are completely sprayed;
after the coating is finished, sieving the coated material by a 40-mesh sieve to obtain coated particles;
step 2) preparation of high-pressure carbon dioxide aerated sucrose (popping candy):
placing the sucrose, the edible pigment and the purified water in the prescription amount in a pressure container and heating to 150 ℃;
vacuumizing the pressure container for 5-10min, injecting carbon dioxide to 4-6MPa, maintaining for 10-20min, and cooling to normal temperature;
then opening an air release valve to normal pressure to obtain solid sugar blocks, and granulating through a 16-mesh sieve for later use;
step 3), mixing and packaging:
adding edible essence into the coated raw materials, mixing, adding the granulated sugar, mixing, and packaging.
Further, in the preparation process of the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules, the pressure container in the step (2) is vacuumized and maintained for 6-8min, then carbon dioxide is injected to 5.2MPa, maintained for 15-16min and cooled to normal temperature.
By adopting the technical scheme, compared with the prior art, the invention has the following technical effects:
the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules provided by the invention have the advantages that the main bitter taste is covered by adopting a powder coating technology, and high-pressure carbon dioxide aerated sucrose (popping candy) is doped, so that the uncomfortable taste sense of children is avoided, the interestingness is increased, the children can accept the medicine, the granules are directly orally taken, the medicines do not need to be dissolved in warm water, and the carrying and the taking are more convenient.
Detailed Description
The present invention will be described in detail and specifically with reference to the following examples to facilitate better understanding of the present invention, but the following examples do not limit the scope of the present invention.
Example 1
The embodiment provides an oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation, which is characterized by being prepared from the following components in parts by weight (1000 bags):
raw material coating formula:
acetaminophen (110 g)
Chlorpheniramine maleate 0.3g
Calculus bovis factitius 6g
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1820g sucrose
0.06g of edible pigment
Purified Water 90g
(III) granule mixing formula:
coating raw material 131g (converted by the amount of acetaminophen)
1820g jumping candy
4g of edible essence.
Based on the above formula of the components, the embodiment further provides a preparation process of the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules, which comprises the following steps:
step 1) raw material coating:
sieving acetaminophen, chlorphenamine maleate and artificial bezoar with 80 mesh sieve, placing in a boiling coating machine, and heating after starting up;
uniformly mixing HPMC, edible pigment, sweetener and ethanol solution according to the prescription amount to prepare coating liquid;
when the temperature of the materials in the boiling coating machine reaches 35 ℃, spraying the coating liquid, and controlling the temperature of the materials below 40 ℃ in the whole coating process until the materials are completely sprayed;
after the coating is finished, sieving the coated material by a 40-mesh sieve to obtain coated particles;
step 2) preparation of high-pressure carbon dioxide aerated sucrose (popping candy):
placing the sucrose, the edible pigment and the purified water in the prescription amount in a pressure container and heating to 150 ℃;
vacuumizing the pressure container, maintaining for 5min, injecting carbon dioxide to 6MPa, maintaining for 14min, and cooling to normal temperature;
then opening an air release valve to normal pressure to obtain solid sugar blocks, and granulating through a 16-mesh sieve for later use;
step 3), mixing and packaging:
adding edible essence into the coated raw materials, mixing, adding the granulated sugar, mixing, and packaging.
Example 2
The embodiment provides an oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation, which is characterized by being prepared from the following components in parts by weight (1000 bags):
raw material coating formula:
120g of acetaminophen
Chlorpheniramine maleate 0.4g
Artificial bezoar 4g
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1840g of sucrose
0.09g of edible pigment
Purified Water 95g
(III) granule mixing formula:
coating raw material 142g (converted by amount of acetaminophen)
1840g of popping candy
4g of edible essence.
Based on the above formula of the components, the embodiment further provides a preparation process of the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules, which comprises the following steps:
step 1) raw material coating:
sieving acetaminophen, chlorphenamine maleate and artificial bezoar with 80 mesh sieve, placing in a boiling coating machine, and heating after starting up;
uniformly mixing HPMC, edible pigment, sweetener and ethanol solution according to the prescription amount to prepare coating liquid;
when the temperature of the materials in the boiling coating machine reaches 32 ℃, the coating liquid is sprayed, and the temperature of the materials is controlled below 40 ℃ in the whole coating process until the materials are completely sprayed;
after the coating is finished, sieving the coated material by a 40-mesh sieve to obtain coated particles;
step 2) preparation of high-pressure carbon dioxide aerated sucrose (popping candy):
placing the sucrose, the edible pigment and the purified water in the prescription amount in a pressure container and heating to 150 ℃;
vacuumizing the pressure container, maintaining for 5min, injecting carbon dioxide to 4MPa, maintaining for 20min, and cooling to normal temperature;
then opening an air release valve to normal pressure to obtain solid sugar blocks, and granulating through a 16-mesh sieve for later use;
step 3), mixing and packaging:
adding edible essence into the coated raw materials, mixing, adding the granulated sugar, mixing, and packaging.
Example 3
The embodiment provides an oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation, which is characterized by being prepared from the following components in parts by weight (1000 bags):
raw material coating formula:
acetaminophen 125g
Chlorpheniramine maleate 0.5g
Artificial bezoar 5g
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1850g of sucrose
0.1g of edible pigment
Purified Water 100g
(III) granule mixing formula:
coating raw material 150g (converted by amount of acetaminophen)
Jumping candy 1850g
6g of edible essence.
Based on the above formula of the components, the embodiment further provides a preparation process of the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules, which comprises the following steps:
step 1) raw material coating:
sieving acetaminophen, chlorphenamine maleate and artificial bezoar with 80 mesh sieve, placing in a boiling coating machine, and heating after starting up;
uniformly mixing HPMC, edible pigment, sweetener and ethanol solution according to the prescription amount to prepare coating liquid;
when the temperature of the materials in the boiling coating machine reaches 35 ℃, spraying the coating liquid, and controlling the temperature of the materials below 40 ℃ in the whole coating process until the materials are completely sprayed;
after the coating is finished, sieving the coated material by a 40-mesh sieve to obtain coated particles;
step 2) preparation of high-pressure carbon dioxide aerated sucrose (popping candy):
placing the sucrose, the edible pigment and the purified water in the prescription amount in a pressure container and heating to 150 ℃;
vacuumizing the pressure container, maintaining the vacuum for 8min, injecting carbon dioxide to 5MPa, maintaining the pressure for 15min, and cooling to normal temperature;
then opening an air release valve to normal pressure to obtain solid sugar blocks, and granulating through a 16-mesh sieve for later use;
step 3), mixing and packaging:
adding edible essence into the coated raw materials, mixing, adding the granulated sugar, mixing, and packaging.
Example 4
The embodiment provides an oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation, which is characterized by being prepared from the following components in parts by weight (1000 bags):
raw material coating formula:
paracetamol 132g
Chlorpheniramine maleate 0.5g
Calculus bovis factitius 6g
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1850g of sucrose
0.10g of edible pigment
Purified Water 110g
(III) granule mixing formula:
159g of coating Material (converted to the amount of Paracetamol)
Jumping candy 1850g
6g of edible essence.
Based on the above formula of the components, the embodiment further provides a preparation process of the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules, which comprises the following steps:
step 1) raw material coating:
sieving acetaminophen, chlorphenamine maleate and artificial bezoar with 80 mesh sieve, placing in a boiling coating machine, and heating after starting up;
uniformly mixing HPMC, edible pigment, sweetener and ethanol solution according to the prescription amount to prepare coating liquid;
when the temperature of the materials in the boiling coating machine reaches 38 ℃, the coating liquid is sprayed, and the temperature of the materials is controlled below 40 ℃ in the whole coating process until the materials are completely sprayed;
after the coating is finished, sieving the coated material by a 40-mesh sieve to obtain coated particles;
step 2) preparation of high-pressure carbon dioxide aerated sucrose (popping candy):
placing the sucrose, the edible pigment and the purified water in the prescription amount in a pressure container and heating to 150 ℃;
vacuumizing the pressure container, maintaining for 6min, injecting carbon dioxide to 4.5MPa, maintaining for 14min, and cooling to normal temperature;
then opening an air release valve to normal pressure to obtain solid sugar blocks, and granulating through a 16-mesh sieve for later use;
step 3), mixing and packaging:
adding edible essence into the coated raw materials, mixing, adding the granulated sugar, mixing, and packaging.
Example 5
The embodiment provides an oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation, which is characterized by being prepared from the following components in parts by weight (1000 bags):
raw material coating formula:
paracetamol 135g
Chlorpheniramine maleate 0.5g
Calculus bovis factitius 6g
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1880g sucrose
0.15g of edible pigment
Purified Water 110g
(III) granule mixing formula:
163g of coating raw material (converted into amount of paracetamol)
1880g popping candy
5g of edible essence.
Based on the above formula of the components, the embodiment further provides a preparation process of the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules, which comprises the following steps:
step 1) raw material coating:
sieving acetaminophen, chlorphenamine maleate and artificial bezoar with 80 mesh sieve, placing in a boiling coating machine, and heating after starting up;
uniformly mixing HPMC, edible pigment, sweetener and ethanol solution according to the prescription amount to prepare coating liquid;
when the temperature of the materials in the boiling coating machine reaches 38 ℃, the coating liquid is sprayed, and the temperature of the materials is controlled below 40 ℃ in the whole coating process until the materials are completely sprayed;
after the coating is finished, sieving the coated material by a 40-mesh sieve to obtain coated particles;
step 2) preparation of high-pressure carbon dioxide aerated sucrose (popping candy):
placing the sucrose, the edible pigment and the purified water in the prescription amount in a pressure container and heating to 150 ℃;
firstly, vacuumizing a pressure container and maintaining the vacuum for 10min, then injecting carbon dioxide to 4MPa, maintaining the pressure for 12min and then cooling to the normal temperature;
then opening an air release valve to normal pressure to obtain solid sugar blocks, and granulating through a 16-mesh sieve for later use;
step 3), mixing and packaging:
adding edible essence into the coated raw materials, mixing, adding the granulated sugar, mixing, and packaging.
Example 6
The embodiment provides an oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation, which is characterized by being prepared from the following components in parts by weight (1000 bags):
raw material coating formula:
acetaminophen (140 g)
Chlorpheniramine maleate 0.8g
Calculus bovis factitius 6g
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1900g sucrose
0.10g of edible pigment
Purified Water 115g
(III) granule mixing formula:
coating raw material 172g (converted by amount of acetaminophen)
Jumping candy 1900g
8g of edible essence.
Based on the above formula of the components, the embodiment further provides a preparation process of the oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules, which comprises the following steps:
step 1) raw material coating:
sieving acetaminophen, chlorphenamine maleate and artificial bezoar with 80 mesh sieve, placing in a boiling coating machine, and heating after starting up;
uniformly mixing HPMC, edible pigment, sweetener and ethanol solution according to the prescription amount to prepare coating liquid;
when the temperature of the materials in the boiling coating machine reaches 36 ℃, the coating liquid is sprayed, and the temperature of the materials is controlled below 40 ℃ in the whole coating process until the materials are completely sprayed;
after the coating is finished, sieving the coated material by a 40-mesh sieve to obtain coated particles;
step 2) preparation of high-pressure carbon dioxide aerated sucrose (popping candy):
placing the sucrose, the edible pigment and the purified water in the prescription amount in a pressure container and heating to 150 ℃;
vacuumizing the pressure container, maintaining the vacuum for 8min, injecting carbon dioxide to 4MPa, maintaining the pressure for 18min, and cooling to normal temperature;
then opening an air release valve to normal pressure to obtain solid sugar blocks, and granulating through a 16-mesh sieve for later use;
step 3), mixing and packaging:
adding edible essence into the coated raw materials, mixing, adding the granulated sugar, mixing, and packaging.
And (3) performance testing:
the oral pediatric paracetamol and chlorpheniramine maleate granules prepared in examples 1 to 6 were subjected to a drug dissolution test at PH6.8, and the test results are shown in the following table one:
TABLE-cumulative acetaminophen dissolution amount data (PH6.8) for pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules
From an analysis of the above table it can be seen that: in a medium with pH of 6.8, the paracetamol serving as the main drug in the pediatric paracetamol and chlorpheniramine maleate granular preparation prepared by the invention is dissolved out by less than 5% within 5 minutes, and can reach more than 80% after 15 minutes.
According to the pediatric paracetamol, yellow and chlorphenamine maleate granule preparation, the popping candy is added into the medicine, so that the oral interestingness of children is increased; the raw materials are coated with powder to cover up the peculiar smell of the medicine, and the medicine is basically not released (the dissolution is less than 5%) after 3-5 minutes in the oral cavity, namely the delayed release of the medicine is realized; the drug-containing granules coated with the powder are 40 meshes in size, namely the required particle size is less than 40 meshes, otherwise the taste is affected, and the swallowing discomfort of children is caused. In addition, the preparation process of the pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granules is simple, convenient to operate, low in production cost, suitable for industrial production, better in children oral administration adaptability and good in popularization and application values.
The embodiments of the present invention have been described in detail, but the embodiments are merely examples, and the present invention is not limited to the embodiments described above. Any equivalent modifications and substitutions to those skilled in the art are also within the scope of the present invention. Accordingly, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be covered by the present invention.
Claims (10)
1. An oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granular preparation is characterized by being prepared from the following components in parts by weight:
raw material coating formula:
acetaminophen 110-140 parts
0.1-0.8 part of chlorpheniramine maleate
Artificial bezoar 3-10 parts
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1800 portions of cane sugar and 1900 portions
0.05-0.12 portion of edible pigment
90-120 parts of purified water
(III) granule mixing formula:
125 portions of coating raw material and 180 portions (in terms of the amount of the paracetamol)
1800 portions of popping candy
3-10 parts of edible essence.
2. The oral pediatric paracetamol and chlorphenamine maleate granule preparation according to claim 1, which is prepared from the following components in parts by weight:
raw material coating formula:
acetaminophen 120-135 parts
0.3-0.6 part of chlorpheniramine maleate
Artificial bezoar 3-8 parts
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1820 portion of cane sugar and 1880 portion
0.08-0.15 parts of edible pigment
95-110 parts of purified water
(III) granule mixing formula:
138 portions and 168 portions of coating raw materials
1820-1880 parts of popping candy (in terms of the amount of paracetamol)
4-8 parts of edible essence.
3. The oral pediatric paracetamol and chlorphenamine maleate granule preparation according to claim 1, which is prepared from the following components in parts by weight:
raw material coating formula:
125 portions of acetaminophen
Chlorpheniramine maleate 0.5 part
Artificial bezoar 5 parts
Coating liquid:
(II) high-pressure carbon dioxide aerated sucrose (popping candy) prescription
1850 parts of cane sugar
0.1 portion of edible pigment
Purified water 100 parts
(III) granule mixing formula:
150 parts of coating raw material (converted according to the amount of paracetamol)
Jumping candy 1850 parts
6 parts of edible essence.
4. The oral pediatric paracetamol and chlorpheniramine maleate granules according to any one of claims 1 to 3, wherein the paracetamol, chlorpheniramine maleate and calculus bovis factitius have a particle size of 80 to 200 mesh.
5. The oral pediatric paracetamol and chlorpheniramine maleate granule formulation according to any one of claims 1 to 3 wherein the ethanol solution has a concentration of 40 to 60 wt%.
6. The oral pediatric paracetamol and amantadine hydrochloride granule formulation according to any one of claims 1 to 3, wherein the food coloring is selected from one or both of lemon yellow and amaranth.
7. The oral pediatric paracetamol and chlorpheniramine maleate granule formulation according to any one of claims 1 to 3 wherein the sweetener is selected from one or both of aspartame and stevioside.
8. The oral pediatric paracetamol and chlorpheniramine maleate granule formulation according to any one of claims 1 to 3 wherein the flavor is selected from one or both of sweet orange oil and peppermint oil.
9. A process for preparing an oral pediatric paracetamol and chlorpheniramine maleate granule formulation according to any one of claims 1 to 8, comprising the steps of:
step 1) raw material coating:
sieving acetaminophen, chlorphenamine maleate and artificial bezoar with 80 mesh sieve, placing in a boiling coating machine, and heating after starting up;
uniformly mixing HPMC, edible pigment, sweetener and ethanol solution according to the prescription amount to prepare coating liquid;
when the temperature of the materials in the boiling coating machine reaches 30-40 ℃, the coating liquid is sprayed, and the temperature of the materials is controlled below 40 ℃ in the whole coating process until the materials are completely sprayed;
after the coating is finished, sieving the coated material by a 40-mesh sieve to obtain coated particles;
step 2) preparation of high-pressure carbon dioxide aerated sucrose (popping candy):
placing the sucrose, the edible pigment and the purified water in the prescription amount in a pressure container and heating to 150 ℃;
vacuumizing the pressure container for 5-10min, injecting carbon dioxide to 4-6MPa, maintaining for 10-20min, and cooling to normal temperature;
then opening an air release valve to normal pressure to obtain solid sugar blocks, and granulating through a 16-mesh sieve for later use;
step 3), mixing and packaging:
adding edible essence into the coated raw materials, mixing, adding the granulated sugar, mixing, and packaging.
10. The process for preparing an oral pediatric paracetamol and atificial cow-bezoar and chlorphenamine maleate granules according to claim 9, wherein the pressure vessel in step (2) is evacuated and maintained for 6-8min, then carbon dioxide is injected to 5.2MPa, maintained for 15-16min and then cooled to normal temperature.
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| CN114886858A (en) * | 2022-04-08 | 2022-08-12 | 中国药科大学 | Corrective medicinal adjuvant composition and application thereof |
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