CN115400181B - Preparation method of low-water-content callicarpa nudiflora capsule preparation - Google Patents
Preparation method of low-water-content callicarpa nudiflora capsule preparation Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title claims abstract description 51
- 239000002775 capsule Substances 0.000 title claims abstract description 44
- 241000404844 Callicarpa nudiflora Species 0.000 title claims abstract description 25
- 240000003690 Callicarpa japonica Species 0.000 claims abstract description 56
- 235000017595 Callicarpa japonica Nutrition 0.000 claims abstract description 56
- 239000000843 powder Substances 0.000 claims abstract description 32
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 29
- 239000011162 core material Substances 0.000 claims abstract description 23
- 238000001035 drying Methods 0.000 claims abstract description 23
- 229920001661 Chitosan Polymers 0.000 claims abstract description 22
- 229920002472 Starch Polymers 0.000 claims abstract description 16
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 16
- 235000019698 starch Nutrition 0.000 claims abstract description 16
- 239000008107 starch Substances 0.000 claims abstract description 16
- 239000007864 aqueous solution Substances 0.000 claims abstract description 13
- 239000002131 composite material Substances 0.000 claims abstract description 12
- 239000000706 filtrate Substances 0.000 claims abstract description 12
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 8
- 235000015424 sodium Nutrition 0.000 claims abstract description 8
- 239000011734 sodium Substances 0.000 claims abstract description 8
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 8
- 238000007873 sieving Methods 0.000 claims abstract description 7
- 239000000463 material Substances 0.000 claims abstract description 4
- 238000002156 mixing Methods 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 12
- 230000018044 dehydration Effects 0.000 claims description 10
- 238000006297 dehydration reaction Methods 0.000 claims description 10
- 238000003756 stirring Methods 0.000 claims description 9
- 229920000858 Cyclodextrin Polymers 0.000 claims description 8
- 239000001116 FEMA 4028 Substances 0.000 claims description 8
- 229960004853 betadex Drugs 0.000 claims description 8
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims description 7
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims description 7
- 238000001914 filtration Methods 0.000 claims description 6
- 239000002245 particle Substances 0.000 claims description 6
- 239000000084 colloidal system Substances 0.000 claims description 5
- 238000011049 filling Methods 0.000 claims description 5
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- 238000000605 extraction Methods 0.000 claims description 2
- 238000005406 washing Methods 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 abstract description 8
- 241000196324 Embryophyta Species 0.000 abstract description 6
- QFRYQWYZSQDFOS-UHFFFAOYSA-N verbascoside Natural products CC1OC(COC2C(O)C(COC3OC(C(O)C(O)C3O)C(=O)O)OC(Oc4cc(O)cc5OC(=CC(=O)c45)c6ccc(O)c(O)c6)C2O)C(O)C(O)C1O QFRYQWYZSQDFOS-UHFFFAOYSA-N 0.000 abstract description 6
- 229930185474 acteoside Natural products 0.000 abstract description 5
- FBSKJMQYURKNSU-ZLSOWSIRSA-N acteoside Chemical compound O[C@@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@H]1O[C@H]1[C@H](OC(=O)\C=C\C=2C=C(O)C(O)=CC=2)[C@@H](CO)O[C@@H](OCCC=2C=C(O)C(O)=CC=2)[C@@H]1O FBSKJMQYURKNSU-ZLSOWSIRSA-N 0.000 abstract description 5
- FBSKJMQYURKNSU-UKQWSTALSA-N acteoside I Natural products C[C@@H]1O[C@H](O[C@@H]2[C@@H](O)[C@H](OCCc3ccc(O)c(O)c3)O[C@H](CO)[C@H]2OC(=O)C=Cc4ccc(O)c(O)c4)[C@H](O)[C@H](O)[C@H]1O FBSKJMQYURKNSU-UKQWSTALSA-N 0.000 abstract description 5
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- 238000000227 grinding Methods 0.000 abstract 1
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- 239000000126 substance Substances 0.000 description 2
- 230000008961 swelling Effects 0.000 description 2
- XMIIGOLPHOKFCH-UHFFFAOYSA-N 3-phenylpropionic acid Chemical compound OC(=O)CCC1=CC=CC=C1 XMIIGOLPHOKFCH-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- GAMYVSCDDLXAQW-AOIWZFSPSA-N Thermopsosid Natural products O(C)c1c(O)ccc(C=2Oc3c(c(O)cc(O[C@H]4[C@H](O)[C@@H](O)[C@H](O)[C@H](CO)O4)c3)C(=O)C=2)c1 GAMYVSCDDLXAQW-AOIWZFSPSA-N 0.000 description 1
- 241001073567 Verbenaceae Species 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000005562 fading Methods 0.000 description 1
- 229930003944 flavone Natural products 0.000 description 1
- 150000002212 flavone derivatives Chemical class 0.000 description 1
- 235000011949 flavones Nutrition 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 229930013686 lignan Natural products 0.000 description 1
- 150000005692 lignans Chemical class 0.000 description 1
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- 238000004519 manufacturing process Methods 0.000 description 1
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- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 229930004725 sesquiterpene Natural products 0.000 description 1
- 150000004354 sesquiterpene derivatives Chemical class 0.000 description 1
- 239000007901 soft capsule Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 238000002061 vacuum sublimation Methods 0.000 description 1
- KDSWDGKIENPKLB-QJDQKFITSA-N verbascoside Chemical compound O[C@@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@H]1O[C@H]1[C@H](OC(=O)CCC=2C=C(O)C(O)=CC=2)[C@@H](CO)O[C@@H](OCCC=2C=C(O)C(O)=CC=2)[C@@H]1O KDSWDGKIENPKLB-QJDQKFITSA-N 0.000 description 1
- VHBFFQKBGNRLFZ-UHFFFAOYSA-N vitamin p Natural products O1C2=CC=CC=C2C(=O)C=C1C1=CC=CC=C1 VHBFFQKBGNRLFZ-UHFFFAOYSA-N 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
- 230000029663 wound healing Effects 0.000 description 1
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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)
- A61K36/85—Verbenaceae (Verbena family)
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- 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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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A61P35/00—Antineoplastic agents
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- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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Abstract
The invention provides a preparation method of a low-water-content callicarpa nudiflora capsule preparation, which comprises the following steps: (1) Taking the medicinal material filtrate of the nudiflora and purple plant, and vacuum dehydrating and drying at a low temperature of between-25 and-35 ℃ and between 90 and 120Pa to obtain a primary extract with the water content of between 6 and 10 percent; adding chitosan composite aqueous solution, standing, dehydrating and drying at-40 to-45 ℃ under vacuum at 40-60 pa for the second time, pulverizing and sieving to obtain dry extract powder of beautyberry leaf with water content less than 1%; (2) Adding magnesium stearate, starch and sodium carboxymethyl starch, grinding, granulating, and drying to obtain core material; (3) The core material is filled into a capsule to prepare the low-water-content callicarpa nudiflora capsule preparation, and the callicarpa nudiflora capsule preparation prepared by the invention is easier to store at high temperature, and effectively maintains the content of active ingredients such as acteoside and the like of the medicine at high temperature.
Description
Technical Field
The invention relates to the technical field of beautyberry, in particular to a preparation method of a low-water-content beautyberry capsule preparation.
Background
Beautyberry (Callicarpa nudiflora hook. Et Arn.) is a plant of Verbenaceae and is entered as a traditional national drug into the Chinese pharmacopoeia. The medicine mainly contains volatile oil, flavone, sesquiterpene, lignan, iridoid, phenylpropionic acid and other chemical active components, has the effects of resisting bacteria, resisting viruses, resisting inflammation, stopping bleeding, removing blood stasis, promoting wound healing, resisting tumor and the like, and is mainly distributed in areas of south Hainan, guangdong, guangxi and the like in China.
At present, the callicarpa nudiflora is mainly used for clinic in the form of tablets, capsules, granules, mixture, soft capsules and other dosage forms. For the capsule preparation, the capsule preparation is often easily influenced by environment such as temperature, humidity and the like in the process of storage and transportation, and the limitation of core material processing conditions leads to poor high-temperature stability of the capsule preparation, influences on chemical active ingredients of the beautyberry of the core material, and finally leads to reduced quality and clinical curative effect of the product. Therefore, a preparation process of a beautyberry capsule preparation with low water content is needed to ensure the pharmaceutical active ingredients and improve the stability of the capsule height Wen Cangchu and transportation.
Disclosure of Invention
In view of the above, the invention provides a preparation method of a low-water-content callicarpa nudiflora capsule preparation, which optimizes the processing technology of the callicarpa nudiflora capsule preparation, prepares the callicarpa nudiflora capsule preparation which is easier to store at high temperature by optimizing the processing technology of preparing a low-water-content core material, not only effectively improves the high-temperature stability of the capsule preparation, but also effectively maintains the content of active ingredients such as acteoside of the medicine, thereby realizing the efficient production of the callicarpa nudiflora capsule with low water content and high activity.
The technical scheme of the invention is realized as follows:
the invention provides a preparation method of a low-water-content callicarpa nudiflora capsule preparation, which comprises the following steps:
step 1: preparing dry extract powder of beautyberry leaves: cleaning the nudiflora plant, extracting with water for more than two times, filtering, mixing filtrates, and vacuum dehydrating and drying the filtrate at a low temperature of between-25 ℃ and-35 ℃ under a pressure of between 90 and 120Pa to obtain a primary extract with a water content of between 6 and 10 percent; adding chitosan composite aqueous solution, stirring and mixing, standing for 30-40 min, placing at-40 to-45 ℃ and under 40-60 pa pressure, performing secondary low-temperature vacuum dehydration and drying, crushing and sieving to obtain callicarpa nudiflora dry extract powder with the water content less than 1%;
step 2: taking the dry extract powder of the beautyberry leaf and the beautyberry leaf, adding magnesium stearate, starch and sodium carboxymethyl starch, carrying out colloid milling, granulating and drying to obtain a core material;
step 3: and filling the core material into a capsule to obtain the low-water-content callicarpa nudiflora capsule preparation.
Further described, in the step 1, the chitosan composite aqueous solution comprises 1-3 mg/ml chitosan and 6-10 mg/ml beta-cyclodextrin.
Further, in the step 1, the mass volume ratio of the primary extract and the chitosan composite aqueous solution is 1 kg:0.1-0.3L.
Further illustrating, in the step 1, after the nudiflora is cleaned, adding 6-8 times of volume of water for decoction and extraction for 2 times, each time for 60-100 min, filtering, and combining the filtrates.
Further, in the step 2, the core material comprises 8-10 parts of beautyberry dry extract powder, 6-8 parts of starch, 3-5 parts of magnesium stearate and 0.5-1 part of sodium carboxymethyl starch according to the weight part ratio.
Further illustratively, in step 2, the drying temperature is 40-45 ℃.
Further, in step 2, the particle size of the core material is 30 to 40 μm.
Compared with the prior art, the invention has the beneficial effects that:
according to the invention, the dry extract powder of the beautyberry is dehydrated in a segmented low-temperature vacuum dehydration mode, and the chitosan composite solution is added to form a swelling and wrapping state with the primary extract, so that the dry extract powder of the beautyberry with the water content less than 1% is obtained, the active ingredients of the beautyberry are effectively maintained, the lower water content of the dry extract powder of the beautyberry is facilitated to be realized, the dry extract powder of the beautyberry with the low water content is combined with chitosan-beta-cyclodextrin to form uniformly dispersed powder particles, the granulating uniformity of the dry extract powder of the beautyberry in a core material can be effectively improved, the obtained beautyberry capsule preparation has good high-temperature stability, the stability of the content of active ingredients such as acteoside in the beautyberry is maintained, the high-temperature preservation property is enhanced, and the beautyberry capsule preparation does not deform and deteriorate at 50-60 ℃.
Detailed Description
In order to better understand the technical content of the present invention, the following provides specific examples to further illustrate the present invention.
The experimental methods used in the embodiment of the invention are conventional methods unless otherwise specified.
Materials, reagents, and the like used in the examples of the present invention are commercially available unless otherwise specified.
Example 1-preparation method of low water content beautyberry capsule formulation, comprising the following steps:
s1: preparing dry extract powder of beautyberry leaves:
cleaning nudiflora plant, adding 8 times of water, decocting and leaching for 2 times, each time for 60min, filtering, mixing filtrates, vacuum sublimating and dehydrating at-25deg.C under 90pa pressure to obtain primary extract with water content of 6%; adding a chitosan composite aqueous solution containing 1mg/ml chitosan and 6mg/ml beta-cyclodextrin according to the mass-volume ratio of 1kg to 0.1L, stirring and mixing, standing for 30min, placing at-40 ℃ and 40pa pressure for secondary low-temperature vacuum sublimation dehydration drying, crushing and sieving to obtain beautyberry dry extract powder with the water content less than 1%;
s2: preparing a low-water-content beautyberry capsule preparation finished product:
a. taking 8 parts of the dry extract powder of the beautyberry leaf, prepared in the step S1, adding 6 parts of starch, 3 parts of magnesium stearate and 0.5 part of sodium carboxymethyl starch according to the weight ratio, mixing and stirring uniformly, carrying out colloid milling, granulating, and drying at 40 ℃ to obtain a core material with the particle size of 30-35 mu m;
b. and filling the core material into a capsule to obtain the low-water-content callicarpa nudiflora capsule preparation.
Example 2 a method for preparing a low moisture beautyberry capsule formulation comprising the steps of:
s1: preparing dry extract powder of beautyberry leaves:
cleaning nudiflora plant, adding 6 times of water, decocting and leaching for 3 times, each for 100min, filtering, mixing filtrates, vacuum dehydrating and drying at-35deg.C under 120pa pressure to obtain primary extract with water content of 10%; adding a chitosan composite aqueous solution containing 3mg/ml chitosan and 10mg/ml beta-cyclodextrin according to the mass-volume ratio of 1kg to 0.3L, stirring and mixing, standing for 40min, standing at-45 ℃ under 60pa pressure for secondary low-temperature vacuum dehydration and drying, crushing and sieving to obtain dry extract powder of callicarpa nudiflora with the water content less than 1%;
s2: preparing a low-water-content beautyberry capsule preparation finished product:
a. taking 10 parts of the dry extract powder of the beautyberry leaf, 8 parts of starch, 5 parts of magnesium stearate and 1 part of sodium carboxymethyl starch, mixing and stirring uniformly, carrying out colloid milling, granulating and drying at 45 ℃ to obtain a core material with the particle size of 35-40 mu m;
b. and filling the core material into a capsule to obtain the low-water-content callicarpa nudiflora capsule preparation.
Example 3-preparation method of low water content beautyberry capsule formulation comprising the following steps:
s1: preparing dry extract powder of beautyberry leaves:
cleaning nudiflora plant, adding 7 times of water, decocting and leaching for 3 times, each time for 90min, filtering, mixing filtrates, vacuum dehydrating and drying at-30deg.C under 100pa pressure to obtain primary extract with water content of 8%; adding a chitosan composite aqueous solution containing 2mg/ml chitosan and 8mg/ml beta-cyclodextrin according to the mass-volume ratio of 1kg to 0.2L, stirring and mixing, standing for 35min, standing at-42 ℃ under 50pa pressure for secondary low-temperature vacuum dehydration and drying, crushing and sieving to obtain dry extract powder of callicarpa nudiflora with the water content less than 1%;
s2: preparing a low-water-content beautyberry capsule preparation finished product:
a. taking 9 parts of the dry extract powder of the beautyberry leaf, 7 parts of starch, 4 parts of magnesium stearate and 0.6 part of sodium carboxymethyl starch, mixing and stirring uniformly, carrying out colloid milling, granulating and drying at 42 ℃ to obtain a core material with the particle size of 35-40 mu m;
b. and filling the core material into a capsule to obtain the low-water-content callicarpa nudiflora capsule preparation.
The invention verifies the influence of different beautyberry dry extract powders on the high-temperature stability of beautyberry capsule preparations through experiments.
Comparative example 1-preparation of beautyberry capsule preparation as in example 3 in the preparation of beautyberry dry extract powder, beautyberry filtrate is added with chitosan compound aqueous solution with the same dosage as in example 3 before low-temperature vacuum dehydration and drying, stirred and mixed, and after standing for 33min, directly placed at-42 ℃ and 50pa pressure for one-time low-temperature vacuum dehydration and drying to obtain beautyberry dry extract powder with water content less than 1%.
Comparative example 2-preparation method of beautyberry capsule formulation of example 3, in the preparation of beautyberry dry extract powder: drying the beautyberry filtrate at 35 deg.C under normal pressure to obtain primary extract with water content of 6-10%; adding a chitosan compound aqueous solution containing 2mg/ml chitosan and 8mg/ml beta-cyclodextrin according to the mass volume ratio of 1kg to 0.2L, stirring and mixing, standing for 35min, standing at normal pressure, dehydrating and drying at 45 ℃, crushing and sieving to obtain the dry extract powder of callicarpa nudiflora with the water content less than 1%.
Comparative example 3-preparation method of beautyberry capsule formulation of example 3, in the preparation of beautyberry dry extract powder: the primary extract was added with a chitosan complex aqueous solution containing 0.5mg/ml chitosan and 1mg/ml beta-cyclodextrin at a mass/volume ratio of 1kg:0.2L, and the rest was the same as in example 3.
Example 4-beautyberry capsule formulations prepared according to the preparation methods of example 3 and comparative examples 1 to 3 described above were used as experimental groups 1 to 4, respectively, for stability experiments.
Taking beautyberry capsules of each experiment group 1-4 with the same quality, packaging by a polyester/aluminum foil/polyethylene composite film (each granule contains 0.5g of beautyberry dry extract powder), respectively placing in a constant temperature acceleration box with the temperature of 50 ℃, the temperature of 55 ℃ and the humidity of 60 ℃ and 80%, taking out a proper amount of samples after the acceleration experiment is carried out for 24 hours, observing the appearance change of the products, and measuring the content of the verbascoside of the products by adopting an HPLC measuring method, wherein the results are shown in the following table:
as can be seen from the table, the prepared beautyberry capsule preparation in the experimental group 1 has good pill stability at 50-60 ℃ and no deformation and fading phenomenon, and meanwhile, the loss rate of the active ingredient content of the acteoside in the core material is low, can be controlled within 0.15%, and is easier to store at high temperature.
The loss rate of acteoside active ingredient content of the beautyberry capsule preparation prepared by the experiment group 2-4 is increased under the high-humidity and high-temperature environment of 50-60 ℃ and 80%, which shows that the invention carries out deep dehydration treatment in a combined segmented low-temperature vacuum dehydration mode under the condition that a swelling package state is formed between a chitosan compound solution and a primary extract by adding a certain proportion, thereby being beneficial to improving the granulating uniformity of beautyberry dry extract powder in a core material and improving the high-temperature stability of core liquid.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, alternatives, and improvements that fall within the spirit and scope of the invention.
Claims (5)
1. A preparation method of a low-water-content beautyberry capsule preparation is characterized by comprising the following steps: the method comprises the following steps:
step 1: preparing dry extract powder of beautyberry leaves: washing beautyberry medicinal materials, extracting with water for more than two times, filtering, mixing filtrates, and vacuum dehydrating and drying the filtrate at a low temperature of-25 ℃ to-35 ℃ and a pressure of 90-120 pa to obtain a primary extract with a water content of 6-10%; adding chitosan composite aqueous solution, stirring and mixing, standing for 30-40 min, placing at-40 to-45 ℃ and under 40-60 pa pressure, performing secondary low-temperature vacuum dehydration and drying, crushing and sieving to obtain callicarpa nudiflora dry extract powder with the water content less than 1%;
step 2: taking the dry extract powder of the beautyberry leaf and the beautyberry leaf, adding magnesium stearate, starch and sodium carboxymethyl starch, carrying out colloid milling, granulating and drying to obtain a core material;
step 3: filling the core material into a capsule to obtain a low-water-content beautyberry capsule preparation;
in the step 1, the chitosan composite aqueous solution consists of 1-3 mg/ml chitosan and 6-10 mg/ml beta-cyclodextrin;
in the step 1, the mass volume ratio of the primary extract and the chitosan composite aqueous solution is 1 kg:0.1-0.3L.
2. The method for preparing the low-water-content callicarpa nudiflora capsule preparation as claimed in claim 1, wherein the method comprises the following steps: in the step 1, the beautyberry medicinal material is taken, and then is added with 6 to 8 times of volume of water for decoction and extraction for 2 times, each time for 60 to 100 minutes, and the filtrate is filtered and combined.
3. The method for preparing the low-water-content callicarpa nudiflora capsule preparation as claimed in claim 1, wherein the method comprises the following steps: in the step 2, the core material consists of 8-10 parts of beautyberry dry extract powder, 6-8 parts of starch, 3-5 parts of magnesium stearate and 0.5-1 part of sodium carboxymethyl starch according to the weight part ratio.
4. The method for preparing the low-water-content callicarpa nudiflora capsule preparation as claimed in claim 1, wherein the method comprises the following steps: in the step 2, the drying temperature is 40-45 ℃.
5. The method for preparing the low-water-content callicarpa nudiflora capsule preparation as claimed in claim 1, wherein the method comprises the following steps: in the step 2, the particle size of the core material is 30-40 mu m.
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| CN1634444A (en) * | 2004-11-01 | 2005-07-06 | 海南九芝堂药业有限公司 | Nudiflower beautyberry leaf capsule or granule and preparation method thereof |
| CN103272260A (en) * | 2013-06-13 | 2013-09-04 | 海南医学院 | Chitosan composite medical dressing comprising callicarpa nudiflora extract and preparation method thereof |
| CN107951959A (en) * | 2017-12-22 | 2018-04-24 | 海南医学院 | A kind of callicarpa nudiflora plastics and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1634444A (en) * | 2004-11-01 | 2005-07-06 | 海南九芝堂药业有限公司 | Nudiflower beautyberry leaf capsule or granule and preparation method thereof |
| CN103272260A (en) * | 2013-06-13 | 2013-09-04 | 海南医学院 | Chitosan composite medical dressing comprising callicarpa nudiflora extract and preparation method thereof |
| CN107951959A (en) * | 2017-12-22 | 2018-04-24 | 海南医学院 | A kind of callicarpa nudiflora plastics and preparation method thereof |
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