CN115554375A - Stomach calming Xiangsha granules with high molding rate, low hygroscopicity and good dissolubility and fluidity - Google Patents
Stomach calming Xiangsha granules with high molding rate, low hygroscopicity and good dissolubility and fluidity Download PDFInfo
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- CN115554375A CN115554375A CN202211471175.1A CN202211471175A CN115554375A CN 115554375 A CN115554375 A CN 115554375A CN 202211471175 A CN202211471175 A CN 202211471175A CN 115554375 A CN115554375 A CN 115554375A
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- 239000008187 granular material Substances 0.000 title claims abstract description 57
- 238000000465 moulding Methods 0.000 title claims abstract description 27
- 230000001914 calming effect Effects 0.000 title claims abstract description 8
- 210000002784 stomach Anatomy 0.000 title claims abstract description 8
- 239000000463 material Substances 0.000 claims abstract description 54
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 25
- 239000008101 lactose Substances 0.000 claims abstract description 25
- 239000002994 raw material Substances 0.000 claims abstract description 19
- 244000303040 Glycyrrhiza glabra Species 0.000 claims abstract description 13
- 235000006200 Glycyrrhiza glabra Nutrition 0.000 claims abstract description 13
- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 claims abstract description 13
- 235000011477 liquorice Nutrition 0.000 claims abstract description 13
- 238000000605 extraction Methods 0.000 claims abstract description 12
- 238000002360 preparation method Methods 0.000 claims abstract description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 24
- 239000000284 extract Substances 0.000 claims description 23
- 239000003814 drug Substances 0.000 claims description 11
- 239000000796 flavoring agent Substances 0.000 claims description 10
- 235000013355 food flavoring agent Nutrition 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 239000009612 ping-wei Substances 0.000 claims description 8
- 239000007788 liquid Substances 0.000 claims description 7
- 241001673966 Magnolia officinalis Species 0.000 claims description 6
- 108010011485 Aspartame Proteins 0.000 claims description 5
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical group 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 5
- 229960003438 aspartame Drugs 0.000 claims description 5
- 235000010357 aspartame Nutrition 0.000 claims description 5
- 239000000605 aspartame Substances 0.000 claims description 5
- 238000001914 filtration Methods 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 238000002791 soaking Methods 0.000 claims description 4
- 244000141331 Amomum villosum Species 0.000 claims description 2
- 239000002245 particle Substances 0.000 abstract description 21
- 238000010521 absorption reaction Methods 0.000 description 14
- 238000000034 method Methods 0.000 description 13
- 238000012360 testing method Methods 0.000 description 12
- 230000008569 process Effects 0.000 description 10
- 229920002472 Starch Polymers 0.000 description 6
- 239000008107 starch Substances 0.000 description 6
- 235000019698 starch Nutrition 0.000 description 6
- 229920001353 Dextrin Polymers 0.000 description 5
- 239000004375 Dextrin Substances 0.000 description 5
- 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 description 5
- 229930006000 Sucrose Natural products 0.000 description 5
- 239000002671 adjuvant Substances 0.000 description 5
- 235000019425 dextrin Nutrition 0.000 description 5
- 239000005720 sucrose Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 4
- 238000002474 experimental method Methods 0.000 description 4
- 238000005259 measurement Methods 0.000 description 4
- 238000005303 weighing Methods 0.000 description 4
- 238000004458 analytical method Methods 0.000 description 3
- 239000002131 composite material Substances 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 235000019640 taste Nutrition 0.000 description 3
- 238000012795 verification Methods 0.000 description 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 238000004364 calculation method Methods 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 206010012601 diabetes mellitus Diseases 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000000080 wetting agent Substances 0.000 description 2
- 241001127714 Amomum Species 0.000 description 1
- 102000003712 Complement factor B Human genes 0.000 description 1
- 108090000056 Complement factor B Proteins 0.000 description 1
- 244000273928 Zingiber officinale Species 0.000 description 1
- 235000006886 Zingiber officinale Nutrition 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 238000000540 analysis of variance Methods 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 235000008397 ginger Nutrition 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 239000004576 sand Substances 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 230000007480 spreading Effects 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 238000005728 strengthening Methods 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 238000012418 validation experiment Methods 0.000 description 1
- 239000000052 vinegar Substances 0.000 description 1
- 235000021419 vinegar Nutrition 0.000 description 1
- 238000005550 wet granulation Methods 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
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/57—Magnoliaceae (Magnolia family)
- A61K36/575—Magnolia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/89—Cyperaceae (Sedge family)
- A61K36/8905—Cyperus (flatsedge)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9064—Amomum, e.g. round cardamom
-
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The invention discloses a stomach calming Xiangsha granule with high molding rate, low hygroscopicity and good dissolubility and fluidity. The xiangshapingwei granules with high forming rate, low hygroscopicity and good dissolubility and fluidity consists of raw materials and auxiliary materials, wherein the raw materials consist of 300 to 500 parts by weight of fried rhizoma atractylodis, 200 to 300 parts by weight of ginger-fried mangnolia officinalis, 100 to 200 parts by weight of dried orange peel, 30 to 40 parts by weight of fructus amomi, 100 to 200 parts by weight of vinegar-fried rhizoma cyperi and 40 to 50 parts by weight of liquorice, and the auxiliary material is lactose. The preparation method comprises the steps of pretreatment, extraction and post-treatment. The preparation process is stable and reliable, the conditions are reasonable and feasible, the reproducibility is good, and the prepared particles have high forming rate, low hygroscopicity and good dissolubility and fluidity.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a stomach calming granule containing aucklandia root and amomum fruit, which has high molding rate, low hygroscopicity and good dissolubility and fluidity.
Background
At present, from the production angle of most granules, the compressibility and the binding effect of sucrose as an auxiliary material are relatively good, most of conventional auxiliary materials in the granules are selected from sucrose, the stomach-calming and xiangsha granules have the main functions of strengthening spleen, stabilizing and drying dampness, are used for improper diet, food-dampness stagnation, gastral cavity swelling pain and dyspepsia, and are also used as the auxiliary material of the stomach-calming and xiangsha granules.
Disclosure of Invention
The invention considers the problem of patient compliance, simultaneously considers the problems of forming rate, hygroscopicity, dissolubility and the like of the xiangsha pingwei granules, carries out deep research and analysis on the auxiliary materials of the xiangsha pingwei granules, develops a preparation process which has stable process, reasonable and feasible production conditions, high forming rate, low hygroscopicity and good dissolubility and fluidity for preparing the xiangsha pingwei granules, simultaneously expands the applicable population of the xiangsha pingwei granules, and particularly expands the population of diabetes patients.
The invention aims to provide the stomach calming fragrant sand particles which are high in molding rate, low in hygroscopicity, and good in dissolubility and fluidity.
The invention aims to realize that the xiangsha pingwei granules with high molding rate, low hygroscopicity and good dissolubility and fluidity are composed of raw materials and auxiliary materials, wherein the raw materials comprise 300 to 500 parts by weight of fried rhizoma atractylodis, 200 to 300 parts by weight of ginger-roasted cortex magnoliae officinalis, 100 to 200 parts by weight of dried orange peel, 30 to 40 parts by weight of fructus amomi, 100 to 200 parts by weight of vinegar-roasted rhizoma cyperi and 40 to 50 parts by weight of liquorice, and the auxiliary material is lactose; the preparation method comprises the steps of pretreatment, extraction and post-treatment, and specifically comprises the following steps:
A. pretreatment: crushing the raw material fructus amomi in the formula ratio to obtain a material a;
B. extraction:
1) Alcohol extraction: adding ethanol with the mass of 4-6 times of that of the material a into the material a, soaking and extracting for 40-50h to obtain an extracting solution b and medicine residues c;
2) Decocting the residue c and cortex Magnolia officinalis, glycyrrhrizae radix, rhizoma Atractylodis, rhizoma Cyperi, and pericarpium Citri Tangerinae in water, filtering to obtain medicinal liquid d and residue e;
C. and (3) post-treatment:
1) Recovering ethanol from the extracting solution b, and concentrating to obtain a fructus amomi concentrated solution f;
2) Concentrating the liquid medicine d to obtain an extract g;
3) Uniformly mixing the fructus amomi concentrated solution f and the extract g with auxiliary materials in the formula ratio, and then granulating to obtain the stomach-calming xiangsha granules of the amomum villosum, which have high target object forming rate, low hygroscopicity and good dissolubility and fluidity;
the mass ratio of the fructus amomi concentrated solution f to the extract g to the auxiliary material lactose is (0.1 to 0.5): 1: (2.25 to 3).
The invention adopts the specific auxiliary material lactose and the specific lactose formula proportion, thus realizing the specific technical proposal of high molding rate, low hygroscopicity and good fluidity of the prepared particles; meanwhile, the preparation process of the invention is stable and reliable, the conditions are reasonable and feasible, and the reproducibility is good.
Detailed Description
The invention is further illustrated by the following examples, but is not intended to be limited in any way, and any modifications or alterations based on the teachings of the invention are intended to fall within the scope of the invention.
The xiangshapingwei granules with high molding rate, low hygroscopicity and good dissolubility and fluidity comprise raw materials and auxiliary materials, wherein the raw materials comprise 300 to 500 parts by weight of fried rhizoma atractylodis, 200 to 300 parts by weight of ginger-roasted cortex magnoliae officinalis, 100 to 200 parts by weight of dried orange peel, 30 to 40 parts by weight of fructus amomi, 100 to 200 parts by weight of vinegar-roasted rhizoma cyperi and 40 to 50 parts by weight of liquorice, and the auxiliary material is lactose; the preparation method comprises the steps of pretreatment, extraction and post-treatment, and specifically comprises the following steps:
A. pretreatment: crushing the raw material fructus amomi in the formula ratio to obtain a material a;
B. extraction:
1) Alcohol extraction: adding ethanol with the mass being 4-6 times of that of the material a into the material a, soaking and extracting for 40-50h to obtain an extracting solution b and medicine residues c;
2) Decocting the residue c and cortex Magnolia officinalis, glycyrrhrizae radix, rhizoma Atractylodis, rhizoma Cyperi, and pericarpium Citri Tangerinae in water, filtering to obtain medicinal liquid d and residue e;
C. and (3) post-treatment:
1) Recovering ethanol from the extracting solution b, and concentrating to obtain a fructus amomi concentrated solution f;
2) Concentrating the liquid medicine d to obtain an extract g;
3) And uniformly mixing the fructus amomi concentrated solution f and the extract g with auxiliary materials in the formula ratio, and granulating to obtain the stomach-calming xiangsha granules with high target object forming rate, low hygroscopicity and good dissolubility and fluidity.
The mass ratio of the fructus amomi concentrated solution f to the extract g to the auxiliary material lactose is (0.1 to 0.5): 1: (2.25 to 3).
The mass ratio of the fructus amomi concentrated solution f to the extract g to the auxiliary material lactose is (0.1 to 0.3): 1: (2.3 to 2.8).
The mass ratio of the fructus amomi concentrated solution f to the extract g to the auxiliary material lactose is 0.125:1:2.5.
the raw materials comprise, by weight, 300-400 parts of fried rhizoma atractylodis, 200-250 parts of ginger-roasted cortex magnoliae officinalis, 100-150 parts of dried orange peel, 35-40 parts of fructus amomi, 100-150 parts of vinegar-roasted rhizoma cyperi and 45-50 parts of liquorice.
The raw materials comprise 384 parts of fried rhizoma atractylodis, 240 parts of ginger-fried mangnolia officinalis, 144 parts of dried orange peel, 36 parts of fructus amomi, 144 parts of vinegar-fried rhizoma cyperi and 48 parts of liquorice.
The raw materials consist of 400 to 500 parts of fried rhizoma atractylodis, 250 to 300 parts of ginger-fried mangnolia officinalis, 150 to 200 parts of dried orange peel, 30 to 35 parts of fructus amomi, 150 to 200 parts of vinegar-fried rhizoma cyperi and 40 to 45 parts of liquorice.
The raw materials comprise 462 parts of fried rhizoma atractylodis, 283 parts of ginger-roasted cortex magnoliae officinalis, 188 parts of dried orange peel, 33 parts of fructus amomi, 179 parts of vinegar-roasted rhizoma cyperi and 44 parts of liquorice.
The auxiliary material also comprises a flavoring agent.
The flavoring agent is aspartame.
The adding amount of the flavoring agent is 0.5 to 1 percent of the total mass of the granules.
The adding amount of the flavoring agent is 0.66 percent of the total mass of the granules.
The invention is further illustrated by the following specific examples:
example 1
The invention relates to a molding process research of xiangsha pingwei granules with high molding rate, low hygroscopicity and good dissolubility and fluidity:
1. standard prescription
384g of rhizoma atractylodis (fried), 240g of mangnolia officinalis (roasted with ginger), 144g of pericarpium citri reticulatae, 36g of fructus amomi, 144g of rhizoma cyperi (roasted with vinegar) and 48g of liquorice.
2. Research on molding process
2.1 extraction
Alcohol extraction: pulverizing fructus Amomi into coarse powder, soaking in 150g ethanol for 48 hr, and filtering.
Boiling in water: decocting fructus Amomi dregs, cortex Magnolia officinalis, glycyrrhrizae radix, rhizoma Atractylodis, rhizoma Cyperi, and pericarpium Citri Tangerinae with water for 2 times, 1.5 hr each time, adding water: the first time is 4 to 5 times of the medicinal materials, the second time is 3 to 4 times of the medicinal materials, and the liquid medicines are filtered and merged.
2.2 concentration
Recovering ethanol from fructus Amomi extractive solution, and concentrating to appropriate amount;
the water extract is merged and concentrated into extract with the relative density of 1.25 to 1.28g/ml (50 to 60 ℃), and the concentration temperature is 50 to 80 ℃.
2.3 screening of Single adjuvants
Wet granulation is adopted, and dextrin, lactose, soluble starch and dextrin are selected: lactose (1: soluble starch (1: soluble starch (1). The moldability, solubility, hygroscopicity and flowability of the extract after granulation were used as the index. The type of excipients used in the granules was screened for a composite score. The results are shown in Table 2.
Measurement of Molding Rate: the particle size and particle size distribution were measured by 0982 (second method, double sieving method) according to the general rules of the "Chinese pharmacopoeia (fourth) 2020 edition. Granules that could pass through sieve No. 1 and could not pass through sieve No. 5 were defined as acceptable granules, and the molding ratio (%) = (acceptable granule weight)/total granule weight × 100%.
Determination of moisture absorption rate: the desiccator with NaCl supersaturated solution at the bottom was incubated in a constant temperature incubator at 20 ℃ for 48 hours to reach 75% RH. Putting a certain amount of particle samples into a weighing bottle which is dried to constant weight, uniformly spreading the particles to the thickness of about 2mm, precisely weighing the particles, putting the particles into a dryer with the relative humidity of 75%, weighing the particles, opening a bottle cover, weighing the particles after 48 hours, and calculating the moisture absorption rate. Moisture absorption (%) = (weight after particulate absorption-original weight before particulate absorption)/original weight before particulate absorption × 100%.
Determination of solubility: the measurement was carried out according to 0104 granules (soluble granule test method) of general rules of preparation in the 2020 edition of Chinese pharmacopoeia (four parts). 10g of the sample particles were weighed, 200mL (70 ℃) of hot water was added, and the mixture was rapidly stirred until the particles were completely melted or slightly turbid. The stopwatch records the time required.
Determination of flowability: the angle of repose (alpha) of particles is measured by adopting a fixed funnel method, 3 funnels are placed in series and fixed on an iron support, the height of the funnels from coordinate paper on a horizontal desktop is enabled to be appropriate, the height of the lower mouth end of the lowest funnel from the coordinate paper is h, sample particles are slowly poured into the funnel along the wall of the uppermost funnel until the particles on the coordinate paper are piled up and touch the lower mouth end of the lowest funnel, the radius r of the bottom of the cone is measured, and the alpha calculation formula is (tg alpha = h/r).
And (3) comprehensive scoring: the weight coefficient of each index was 0.25, and the total score (%) = [ (particle size/maximum particle size) × 0.25+ (minimum moisture absorption rate)/moisture absorption rate) × 0.25+ (minimum angle of repose/angle of repose) × 0.25+ (minimum solubility/solubility) × 0.25 × 100%.
TABLE 1 compatibility prescription of different adjuvants and principal drugs
TABLE 2 recipe of different auxiliary materials and principal drugs for hygroscopicity, formability, solubility, fluidity and comprehensive score
And (4) analyzing results: the results in table 2 show that dextrin is used as an auxiliary material, the granule forming rate is high, but dextrin has poor water solubility, less ideal dissolubility and larger hygroscopicity, and the prepared granules are hard and have poor mouthfeel; soluble starch is used as an auxiliary material, so that the hygroscopicity is low, but the dissolubility is poor. The lactose is used as an auxiliary material, so that the forming rate, the dissolubility, the hygroscopicity and the fluidity are good, and the comprehensive score is high; the ratio of lactose: dextrin (1): starch (1: starch (1. Therefore, in order to keep better physicochemical properties of the granules, lactose is selected as an auxiliary material to prepare the granules.
2.4 orthogonal test optimized preparation forming process
On the basis of single auxiliary material investigation, the influence of different feeding proportions of the auxiliary materials on the hygroscopicity, the formability and the dissolubility of the granules is further investigated, and more proper auxiliary material proportions are selected for the granule forming. The dosage of the auxiliary materials is selected as a factor A (extract: auxiliary material ratio), the volume fraction of the wetting agent ethanol is selected as a factor B, the dosage of the wetting agent is selected as a factor C (extract: ethanol ratio) to be used as an investigation index, and the experimental level is designed according to different factors. See table 3.
TABLE 3 orthogonal test design factor horizon
TABLE 4 orthogonal test design Table and results
TABLE 5 analysis of variance results
Note: f 0.05 （2，2）=19。
According to the analysis result of the orthogonal test, the optimal process is A 2 B 3 C 1 Namely extract: the dosage ratio of the auxiliary materials is 1.
2.5 proportion and amount of adjuvants and extract
According to the analysis result of the orthogonal test, the adding amount of the auxiliary material lactose has significant influence on the comprehensive score of the granules, so under the condition, a single-factor test is adopted, the influence of different matching ratios of the lactose and the extract on the indexes is further considered by taking the hygroscopicity, the formability, the angle of repose and the dissolubility of the granules as indexes, and further optimization is carried out.
2.5.1 selection of amount of adjuvant
Taking 5 parts of the stomach-calming xiangsha granule extract and the fructus amomi concentrated solution respectively, uniformly mixing the extract and the fructus amomi concentrated solution with different dosages of auxiliary materials (lactose) according to the specified amount in the following table 6, granulating and drying to obtain the stomach-calming xiangsha granule extract.
Table 6 recipe of different proportions of auxiliary materials and extract
And (3) investigating each index: the ratio of lactose to extract is selected according to the operability, properties, hygroscopicity, moldability, angle of repose and dissolubility of the granules in the granulation process, and the hygroscopicity, moldability, angle of repose and dissolubility are used as indexes to comprehensively evaluate, preferably the optimal ratio, wherein the comprehensive index = (25/maximum molding rate) × molding rate + (minimum angle of repose × 25)/angle of repose + (minimum moisture absorption × 25)/moisture absorption + (minimum dissolubility × 25)/dissolubility.
2.5.2 measurement of moldability
The particle formability was measured according to the experimental procedure and the formability score was calculated using the formula: (25/maximum molding ratio). Times.molding ratio, the results are shown in Table 7. As is clear from Table 7, formulation 3 is the most excellent in moldability.
TABLE 7 measurement of moldability
2.5.3 determination of the Angle of repose
The angle of repose of the particles was determined according to the experimental procedure and 3 times and the average was calculated. The angle of repose score calculation uses the formula: (minimum angle of repose × 25)/angle of repose, the results are shown in Table 8. As is clear from Table 8, the flowability of formula 3 was the best.
TABLE 8 determination of angle of repose
2.5.4 determination of hygroscopicity
The hygroscopicity of the granules was determined according to the experimental procedure, and 2 groups were made in total, and the average value was calculated. The moisture absorption rate value is calculated by using a formula: (minimum moisture absorption rate. Times.25)/moisture absorption rate, the results are shown in Table 9. As can be seen from Table 9, formula 5 has the lowest moisture absorption rate and is not easily affected by moisture.
TABLE 9 determination of hygroscopicity
2.5.5 determination of solubility
The particle solubility was determined according to the experimental procedure, 2 groups were made in total, and the average was calculated. The solubility score is calculated using the formula: (minimum solubility. Times.25)/solubility, the results are shown in Table 10. As can be seen from Table 10, formula 3 exhibited the fastest melting speed.
TABLE 10 determination of the solubility
2.5.6 characterization
TABLE 11 description of the traits
2.5.7 composite score
The results of the four tests on moldability, moisture absorption rate, angle of repose, and solubility were evaluated in combination and are shown in Table 12.
TABLE 12 composite score
According to the data comprehensive scores in the table, the comprehensive score of the prescription 3 (namely the proportion of lactose to extract is 2.5: extract (2.5.
3. Best process verification test
In order to verify the repeatability and feasibility of the optimized stomach calming granule molding process, repeated tests are carried out for 3 times according to the optimal process, and as a verification test, the process is found to be stable and reliable, the conditions are reasonable and feasible, the reproducibility is good, the molding rate of the prepared granule is high, the hygroscopicity is low, and the dissolubility and the fluidity are good. The results of the validation experiment are shown in Table 13.
TABLE 13 results of the verification tests
Determination of a flavoring agent: the prescription uses lactose as an auxiliary material, the prepared granules have poor taste, and a certain amount of flavoring agent is added for improving the compliance and the compliance of patients to the medicine. The aspartame is added into the materials, and people with different tastes are used for testing, so that when the addition of the aspartame is increased to 0.66%, the purpose of taste correction is achieved, meanwhile, the applicable people can be increased, and the aspartame can be popularized and used in diabetes patients.
4. Comparison of samples with lactose and sucrose as adjuvants
Respectively taking lactose and sucrose as auxiliary materials to prepare 3 batches of stomach-calming Xiangsha granule samples, and detecting and comparing the samples. The experimental result shows that compared with the original common auxiliary material sucrose of the stomach calming Xiangsha granules, the sample prepared by taking lactose as the auxiliary material has good forming rate, hygroscopicity and fluidity, and higher comprehensive score, is a more ideal auxiliary material, and can enable the preparation quality to be more stable. The data are shown in Table 14.
TABLE 14 detection and comparison data of Xiangsha Pingwei granule sample
Claims (9)
1. The stomach calming Xiangsha granules with high molding rate, low hygroscopicity and good dissolubility and fluidity are characterized by comprising raw materials and auxiliary materials, wherein the raw materials comprise, by weight, 300 to 500 parts of fried rhizoma atractylodis, 200 to 300 parts of ginger-roasted cortex magnoliae officinalis, 100 to 200 parts of dried orange peel, 30 to 40 parts of fructus amomi, 100 to 200 parts of vinegar-roasted rhizoma cyperi and 40 to 50 parts of liquorice, and the auxiliary materials are lactose; the preparation method comprises the steps of pretreatment, extraction and post-treatment, and specifically comprises the following steps:
A. pretreatment: crushing the raw material fructus amomi in the formula ratio to obtain a material a;
B. extraction:
1) Alcohol extraction: adding ethanol with the mass of 4-6 times of that of the material a into the material a, soaking and extracting for 40-50h to obtain an extracting solution b and medicine residues c;
2) Decocting the residue c and cortex Magnolia officinalis, glycyrrhrizae radix, rhizoma Atractylodis, rhizoma Cyperi, and pericarpium Citri Tangerinae in water, filtering to obtain medicinal liquid d and residue e;
C. and (3) post-treatment:
1) Recovering ethanol from the extracting solution b, and concentrating to obtain a fructus amomi concentrated solution f;
2) Concentrating the liquid medicine d to obtain an extract g;
3) Uniformly mixing the fructus amomi concentrated solution f and the extract g with auxiliary materials in the formula ratio, and then granulating to obtain the stomach-calming xiangsha granules of the amomum villosum, which have high target object forming rate, low hygroscopicity and good dissolubility and fluidity;
the mass ratio of the fructus amomi concentrated solution f to the extractum g to auxiliary material lactose is (0.1 to 0.5): 1: (2.25 to 3).
2. The xiangshapingwei granules with high molding rate, low hygroscopicity and good dissolubility and fluidity as claimed in claim 1, wherein the raw materials comprise, by weight, 300 to 400 parts of fried rhizoma atractylodis, 200 to 250 parts of ginger-processed cortex magnoliae officinalis, 100 to 150 parts of dried orange peel, 35 to 40 parts of fructus amomi, 100 to 150 parts of vinegar-processed rhizoma cyperi and 45 to 50 parts of liquorice.
3. The xiangshapingwei granules as claimed in claim 2, wherein the raw materials comprise 384 parts by weight of parched rhizoma atractylodis, 240 parts by weight of ginger-processed magnolia bark, 144 parts by weight of dried orange peel, 36 parts by weight of fructus amomi, 144 parts by weight of vinegar-processed rhizoma cyperi and 48 parts by weight of liquorice.
4. The xiangshapingwei granules with high molding rate, low hygroscopicity and good dissolubility and fluidity as claimed in claim 1, wherein the raw materials comprise, by weight, 400 to 500 parts of fried rhizoma atractylodis, 250 to 300 parts of ginger-processed cortex magnoliae officinalis, 150 to 200 parts of dried orange peel, 30 to 35 parts of fructus amomi, 150 to 200 parts of vinegar-processed rhizoma cyperi and 40 to 45 parts of liquorice.
5. The xiangshapingwei granules with high molding rate, low hygroscopicity and good dissolubility and fluidity as claimed in claim 4, wherein the raw materials comprise 462 parts by weight of fried rhizoma atractylodis, 283 parts by weight of ginger-fried magnolia officinalis, 188 parts by weight of dried orange peel, 33 parts by weight of fructus amomi, 179 parts by weight of vinegar-fried rhizoma cyperi and 44 parts by weight of liquorice.
6. The xiangshapingwei granules with high molding rate, low hygroscopicity and good dissolubility and fluidity as claimed in claim 1, wherein the auxiliary materials further comprise a flavoring agent.
7. The xiangshapingwei granules of claim 6 having high molding rate, low hygroscopicity, good solubility and good flowability, wherein said flavoring agent is aspartame.
8. The xiangsha pingwei granules as claimed in claim 6 or 7, which has high molding rate, low hygroscopicity, good dissolubility and good fluidity, wherein the addition amount of the flavoring agent is 0.5 to 1 percent of the total mass of the granules.
9. The xiangshapingwei granules of claim 8 having high molding rate, low hygroscopicity, good dissolvability and good flowability, wherein the amount of said flavoring agent added is 0.66% of the total mass of the granules.
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| CN115531324A (en) * | 2022-11-23 | 2022-12-30 | 昆明中药厂有限公司 | Ginseng and poria cocos granules with high forming rate, low hygroscopicity and good fluidity and capable of strengthening spleen and stomach |
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