CN104223086B - Composite dendrobium huoshanense lozenge and preparation method thereof - Google Patents
Composite dendrobium huoshanense lozenge and preparation method thereof Download PDFInfo
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- CN104223086B CN104223086B CN201410514544.XA CN201410514544A CN104223086B CN 104223086 B CN104223086 B CN 104223086B CN 201410514544 A CN201410514544 A CN 201410514544A CN 104223086 B CN104223086 B CN 104223086B
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- 241001678082 Dendrobium huoshanense Species 0.000 title claims abstract description 17
- 238000002360 preparation method Methods 0.000 title claims description 7
- 239000007937 lozenge Substances 0.000 title abstract description 6
- 239000002131 composite material Substances 0.000 title abstract 3
- 239000000843 powder Substances 0.000 claims abstract description 83
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 30
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims abstract description 18
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 16
- 229930195725 Mannitol Natural products 0.000 claims abstract description 16
- 239000000594 mannitol Substances 0.000 claims abstract description 16
- 235000010355 mannitol Nutrition 0.000 claims abstract description 16
- 239000004376 Sucralose Substances 0.000 claims abstract description 15
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 15
- 239000000463 material Substances 0.000 claims abstract description 15
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims abstract description 15
- 235000019408 sucralose Nutrition 0.000 claims abstract description 15
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 7
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 7
- HNJBEVLQSNELDL-UHFFFAOYSA-N pyrrolidin-2-one Chemical compound O=C1CCCN1 HNJBEVLQSNELDL-UHFFFAOYSA-N 0.000 claims abstract description 6
- 239000008187 granular material Substances 0.000 claims description 41
- 239000002671 adjuvant Substances 0.000 claims description 31
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 14
- 150000001875 compounds Chemical class 0.000 claims description 12
- 229940046011 buccal tablet Drugs 0.000 claims description 10
- 239000006189 buccal tablet Substances 0.000 claims description 10
- 238000002156 mixing Methods 0.000 claims description 10
- 239000000203 mixture Substances 0.000 claims description 10
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 8
- 238000001035 drying Methods 0.000 claims description 5
- 238000005469 granulation Methods 0.000 claims description 3
- 230000003179 granulation Effects 0.000 claims description 3
- 238000005453 pelletization Methods 0.000 claims description 3
- 238000010298 pulverizing process Methods 0.000 claims description 3
- 238000004080 punching Methods 0.000 claims description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract description 13
- 230000006870 function Effects 0.000 abstract description 10
- 239000003814 drug Substances 0.000 abstract description 9
- 230000036039 immunity Effects 0.000 abstract description 8
- 210000004072 lung Anatomy 0.000 abstract description 6
- 210000003734 kidney Anatomy 0.000 abstract description 4
- 210000002784 stomach Anatomy 0.000 abstract description 3
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 abstract description 2
- 241001633680 Polygonatum odoratum Species 0.000 abstract description 2
- 210000001124 body fluid Anatomy 0.000 abstract description 2
- 239000010839 body fluid Substances 0.000 abstract description 2
- 229940041616 menthol Drugs 0.000 abstract description 2
- 210000000952 spleen Anatomy 0.000 abstract description 2
- 241000234435 Lilium Species 0.000 abstract 1
- 230000003750 conditioning effect Effects 0.000 abstract 1
- 229940069328 povidone Drugs 0.000 abstract 1
- 238000012360 testing method Methods 0.000 description 16
- 229920003081 Povidone K 30 Polymers 0.000 description 11
- 239000000080 wetting agent Substances 0.000 description 10
- 230000000694 effects Effects 0.000 description 8
- 238000005516 engineering process Methods 0.000 description 8
- 239000002245 particle Substances 0.000 description 8
- 238000000034 method Methods 0.000 description 7
- 239000000047 product Substances 0.000 description 6
- 239000011230 binding agent Substances 0.000 description 5
- 238000004140 cleaning Methods 0.000 description 5
- 230000002708 enhancing effect Effects 0.000 description 5
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- 230000033228 biological regulation Effects 0.000 description 4
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- 235000009508 confectionery Nutrition 0.000 description 4
- 238000002474 experimental method Methods 0.000 description 4
- 235000013402 health food Nutrition 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 238000005303 weighing Methods 0.000 description 4
- 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 3
- 229930006000 Sucrose Natural products 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 239000012141 concentrate Substances 0.000 description 3
- 229960004756 ethanol Drugs 0.000 description 3
- 150000004676 glycans Chemical class 0.000 description 3
- 229920001282 polysaccharide Polymers 0.000 description 3
- 239000005017 polysaccharide Substances 0.000 description 3
- 238000012216 screening Methods 0.000 description 3
- 239000005720 sucrose Substances 0.000 description 3
- 239000003826 tablet Substances 0.000 description 3
- 235000019640 taste Nutrition 0.000 description 3
- 244000210789 Lilium lancifolium Species 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004556 brain Anatomy 0.000 description 2
- 239000003431 cross linking reagent Substances 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 238000013507 mapping Methods 0.000 description 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 238000012797 qualification Methods 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000000811 xylitol Substances 0.000 description 2
- 235000010447 xylitol Nutrition 0.000 description 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 2
- 229960002675 xylitol Drugs 0.000 description 2
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- 206010013952 Dysphonia Diseases 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 240000008058 Lilium brownii Species 0.000 description 1
- 235000015982 Lilium brownii Nutrition 0.000 description 1
- 235000002156 Lilium lancifolium Nutrition 0.000 description 1
- 241001634090 Lilium pumilum Species 0.000 description 1
- 241001359444 Lilium tenuifolium Species 0.000 description 1
- 101001031591 Mus musculus Heart- and neural crest derivatives-expressed protein 2 Proteins 0.000 description 1
- 241000233855 Orchidaceae Species 0.000 description 1
- 241001474728 Satyrodes eurydice Species 0.000 description 1
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 1
- 210000001744 T-lymphocyte Anatomy 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 238000003915 air pollution Methods 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 235000019606 astringent taste Nutrition 0.000 description 1
- 239000002585 base Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 235000013373 food additive Nutrition 0.000 description 1
- 239000002778 food additive Substances 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 235000008216 herbs Nutrition 0.000 description 1
- 238000010237 hybrid technique Methods 0.000 description 1
- 201000001421 hyperglycemia Diseases 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 235000013372 meat Nutrition 0.000 description 1
- 210000002864 mononuclear phagocyte Anatomy 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000004451 qualitative analysis Methods 0.000 description 1
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- 230000011514 reflex Effects 0.000 description 1
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- 230000033764 rhythmic process Effects 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 239000001117 sulphuric acid Substances 0.000 description 1
- 235000011149 sulphuric acid Nutrition 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 230000035922 thirst Effects 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/20—Agglomerating; Granulating; Tabletting
- A23P10/28—Tabletting; Making food bars by compression of a dry powdered mixture
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Mycology (AREA)
- Health & Medical Sciences (AREA)
- Nutrition Science (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a composite dendrobium huoshanense lozenge which consists of medicine powder and auxiliary materials, wherein the medicine powder comprises the following components in parts by mass: 11-23 parts of a dendrobium huoshanense extract, 17-23 parts of a polygonatum odoratum extract and 14-25 parts of a lily extract; the auxiliary materials comprise the following components: mannitol which accounts for 10-30% of the mass of the medicine powder, menthol which accounts for 1.7-2.1% of the mass of the medicine powder, povidone pyrrolidone K30 which accounts for 4.5-8.5% of the mass of the medicine powder, sucralose which accounts for 0.03-0.1% of the mass of the medicine powder, and magnesium stearate which accounts for 0.3-0.6% of the mass of the medicine powder. The composite dendrobium huoshanense lozenge disclosed by the invention has the function of improving the body immunity by conditioning the functions of the lung, the kidney, the spleen and the stomach, and can also recover internal body fluid and moisten the throat by utilizing the sweetness and the coldness of dendrobium huoshanense.
Description
Technical field
The present invention relates to a kind of compound dendrobium huoshanense buccal tablet and preparation method thereof, belong to the health food containing Herba Dendrobii and preparing technical field thereof.
Background technology
Modern society is due to the quickening of rhythm of life, the increase of operating pressure, the increasing of social communication, plus irrational diet and the stimulation of air pollution, immunity of organisms all may be caused to decline, thus reduce human body and resist the ability of disease, more likely cause throat illness, cause the disease such as dysphonia, throat discomfort, cause people to feel exhausted, high liver fire, resistance weaken, so that causing the generation of various uncomfortable even chronic disease, time serious, also affect the normal working and learning of people.
And health food of the prior art the most only has a function of enhancing immunity, or only having the function of moistening and cleaning throat, the consumer's purchase to be passed through simultaneously being required for enhancing immunity and function of moistening and cleaning throat is taken at least two product and could be met demands of individuals.Therefore, the health food having moistening and cleaning throat and enhancing immunity function concurrently is a blank on market.
Summary of the invention
The deficiency that the present invention exists for prior art just, it is provided that a kind of compound dendrobium huoshanense buccal tablet, has the function of moistening and cleaning throat and enhancing immunity simultaneously.
For solving the problems referred to above, the technical solution used in the present invention is as follows:
A kind of compound dendrobium huoshanense buccal tablet, is made up of medicated powder and adjuvant,
Described medicated powder includes the component of following mass fraction: Herba Dendrobii extract, 11 parts～23 parts；Rhizoma Polygonati Odorati extract, 17 parts～23 parts；Bulbus Lilii extract, 14 parts～25 parts；
Described adjuvant includes the component of following content: mannitol, for the 10%～30% of described medicated powder quality；Mentholum, for the 1.7%～2.1% of described medicated powder quality；Polyvidone ketopyrrolidine K30, for the 4.5%～8.5% of described medicated powder quality；Sucralose, for the 0.03%～0.1% of described medicated powder quality；Magnesium stearate, for the 0.3%～0.6% of described medicated powder quality.
Wherein, Herba Dendrobii extract, Rhizoma Polygonati Odorati extract and Bulbus Lilii extract in medicated powder component can be obtained by following manner:
Herba Dendrobii extract: for the fresh or dry stem of orchid Herba Dendrobii (Dendrobiun huoshanense C.Z.Tang et S.J.Cheng), and meet and specify under " Anhui Province's prepared slices of Chinese crude drugs concocted specification " (2005 editions) " Herba Dendrobii " item, through extracting in water, concentrate, be dried, pulverize prepared.
Rhizoma Polygonati Odorati extract: for the dry rhizome of liliaceous plant Rhizoma Polygonati Odorati (Polygonatum odoratum (Mill.) Druce), and meet " Chinese Pharmacopoeia " (2010 editions) two " Rhizoma Polygonati Odorati "
Lower regulation, through extracting in water, concentrate, be dried, pulverize prepared.
Bulbus Lilii extract: for liliaceous plant tiger lily (Lilium lancifolium
Thunb.), Bulbus Lilii (Lilium brownii
F.E.Brown var.viridulum
Or the dry meat scale leaf of Lilium tenuifolium (Lilium pumilum DC.) Baker), and meet and specify under " Chinese Pharmacopoeia " (2010 editions) " Bulbus Lilii " item, through extracting in water, concentrate, be dried, pulverize prepared.
Described adjuvant should meet the following requirements:
Mentholum should meet the requirement under " Chinese Pharmacopoeia " (2010 editions) " Mentholum " item.
Mannitol, polyvidone ketopyrrolidine K30, magnesium stearate should meet the requirement under " Chinese Pharmacopoeia " (2010 editions) two " mannitol ", " PVP K30s ", " magnesium stearate " item.
Sucralose should meet the regulation of national food safety standard GB25531.
Further preferred as technique scheme, the content of described mannitol is the 20%～30% of described medicated powder quality；The content of described Mentholum is the 1.8% of described medicated powder quality；The content of described sucralose is the 0.1% of described medicated powder quality.
Further preferred as technique scheme, content is described medicated powder quality the 8.1% of described polyvidone ketopyrrolidine K30,4.5 times of the most described Determination of menthol.
Further object is that the preparation method providing above-mentioned compound dendrobium huoshanense buccal tablet, it comprises the steps:
Pulverize: medicated powder and adjuvant cross 120 mesh sieves after pulverizing respectively, it is ensured that material powders uniform color, foreign are mixed into, without stain；
Dispensing: weigh medicated powder and adjuvant according to proportioning；
Mixing, pelletize: medicated powder except for magnesium stearate and adjuvant are thoroughly mixed and are allowed to uniform, add appropriate dehydrated alcohol, make up to hold agglomerating and one touch the most scattered, 16 mesh pelletize；
It is dried: the wet granular made is put in drying equipment and be dried under the conditions of 55 DEG C～60 DEG C, controls moisture 3%～5%；
Granulate: dried granule is put and crosses 14 mesh sieve granulate in pelletizing machine；
Total mixed: the granule made and magnesium stearate are sufficiently mixed uniformly；
Tabletting: by mould punching film-making.
Further preferred as technique scheme, in described mixing, granulation step, the mode that medicated powder except for magnesium stearate and adjuvant are thoroughly mixed is placed in groove and mixes in machine and mix 15 minutes.
Further preferred as technique scheme, in described tableting step, needing the temperature controlling job shop is 18 DEG C～26 DEG C, and humidity is 45%～65%.
Compared with prior art, the implementation result of the present invention is as follows for the present invention:
A kind of compound dendrobium huoshanense buccal tablet of the present invention, selects to have the integration of edible and medicinal herbs class helping human righteousness's function or the material combination that can be used for health food, Herba Dendrobii sweet in the mouth in side, micro-salty, be slightly cold, nontoxic, return stomach, kidney channel；Bulbus Lilii sweet in the mouth, cold in nature, GUIXIN, lung two warp；Rhizoma Polygonati Odorati nature and flavor are sweet flat, enter lung, stomach warp；By regulation lung, kidney, the function of taste, strengthen human body and resist the inherent healthy energy of exopathogen, make body keep QI and blood gentle, the steady statue of YIN and YANG in a relative equilibrium, to reach the effect of enhancing human body immunity, utilizes again the sweet cold of Herba Dendrobii simultaneously, making cloudy Tianjin reflex, throat must moisten；Bulbus Lilii nourishing YIN and moistening the lung cough-relieving, clearing away heart-fire for tranquillization, effect of invigorating the spleen and replenishing QI；Rhizoma Polygonati Odorati nourishing YIN to relieve dryness, promoting the production of body fluid to quench thirst, three is used in conjunction the cloudy Tianjin by nourishing the lung and kidney and reaches to moisten the purpose of foster throat.And combine modern medicine and threpsology to improving immunity of organisms and the achievement in research of moistening and cleaning throat, Herba Dendrobii, Bulbus Lilii, Rhizoma Polygonati Odorati all contain the activity in vivo compositions such as water-soluble polysaccharides, can increase by promoting blood middle leukocytes quantity, promotion mononuclear phagocyte function strengthens, promotion T cell quantity increases, lymphoblastic transformation, and without incompatibility between each raw material, synergism is good, safety clothes consumption is big, and health care is definite, is suitably eaten for a long time.
Accompanying drawing explanation
Fig. 1 is the schematic flow sheet of a kind of compound dendrobium huoshanense process for preparing buccal lozenge of the present invention；
Fig. 2 is the rate of moisture absorption figure of granule in granule formation technology Selection experiment；
Fig. 3 is Particles at Critical relative humidity figure in granule formation technology Selection experiment.
Detailed description of the invention
Fig. 1 is the overall flow of a kind of compound dendrobium huoshanense process for preparing buccal lozenge of the present invention, and a kind of compound dendrobium huoshanense process for preparing buccal lozenge of the present invention comprises the following steps:
Pulverize: medicated powder and adjuvant are placed in pulverizer after pulverizing respectively and cross 120 mesh sieves, it is ensured that material powders uniform color, foreign are mixed into, without stain；
Dispensing: weigh medicated powder and adjuvant according to proportioning；
Mixing, pelletize: medicated powder except for magnesium stearate and adjuvant are placed in groove mix in machine mix 15 minutes, be thoroughly mixed and be allowed to uniform, add appropriate dehydrated alcohol, make up to hold agglomerating and one touch the most scattered, 16 mesh pelletize；
It is dried: the wet granular made is put in drying equipment and be dried under the conditions of 55 DEG C～60 DEG C, controls moisture 3%～5%；
Granulate: dried granule is put and crosses 14 mesh sieve granulate in pelletizing machine；
Total mixed: the granule made to be placed in three-dimensional motion mixer with magnesium stearate and mixes 30 minutes, be allowed to mix homogeneously；
Tabletting: select the mould of suitable types, first-class punch die cleaning-sterilizing, regulate loading and pressure, it is desirable to tablet weight, outward appearance etc. conform to quality requirements；In tableting processes, claimed a tablet weight every 15 minutes, it is ensured that tablet weight variation, within the scope of ± 5%, reconnoitres slice, thin piece outward appearance at any time；During tabletting, indoor temperature to control at 18 DEG C～26 DEG C, and humidity to control 45%～65%.
Below in conjunction with process parameter optimizing test, present disclosure is described.
One, adjuvant selection
The factors such as the mouthfeel of oral buccal tablet agent and dose have large effect for the compliance being suitable for crowd, general conventional adjuvant has mannitol, sucrose and xylitol etc., they both can play the effect of filler, also the effect of correctives can be played, in view of the influence factor of day dose, therefore draft the consumption of adjuvant no more than the 50% of medicated powder amount.
As medicated powder after mixing using Herba Dendrobii extract 20 parts, Rhizoma Polygonati Odorati extract 20 parts and Bulbus Lilii extract 20 parts, selecting mannitol, sucrose, xylitol respectively is correctives, consumption is respectively the 10%～50% of medicated powder, pelletize with appropriate dehydrated alcohol for wetting agent, dried tabletting, the selection result is shown in Table 1.
The screening test (one) of table 1 adjuvant
When other value during the Herba Dendrobii extract in medicated powder takes 11 parts～23 parts, Rhizoma Polygonati Odorati extract take other value in 17 parts～23 parts, Bulbus Lilii extract take other value in 14 parts～25 parts time, result of the test is consistent with upper table 1.
Because the astringent taste of medicinal substances extract cannot be covered, and product objective is suitable in crowd containing hyperglycemia person, and sucrose application limits, and intends selecting to add Sweetener Sucralose and correctives Mentholum auxiliary reaches taste masking effect.
It is 0.15% that sucralose adds the upper limit according to the regulation of " food additive use standard " (GB 2760-2011), pelletizes with appropriate dehydrated alcohol for wetting agent, dried tabletting.
As medicated powder after mixing using Herba Dendrobii extract 20 parts, Rhizoma Polygonati Odorati extract 20 parts and Bulbus Lilii extract 20 parts, adding adjuvant according to the formula of table 2 below, screening test the results are shown in Table 2.
The screening test (two) of table 2 adjuvant
When other value during the Herba Dendrobii extract in medicated powder takes 11 parts～23 parts, Rhizoma Polygonati Odorati extract take other value in 17 parts～23 parts, Bulbus Lilii extract take other value in 14 parts～25 parts time, result of the test is consistent with upper table 2.Above-mentioned test shows, adds the mannitol of medicated powder amount 20%～30%, the sucralose of medicated powder amount 0.10%, the Mentholum of medicated powder amount 1.8%, and products taste and preparation technology are preferable.
Two, the selection of wetting agent
Using Herba Dendrobii extract 20 parts, Rhizoma Polygonati Odorati extract 20 parts and Bulbus Lilii extract 20 parts as medicated powder, using the Mentholum of mannitol, the sucralose of medicated powder amount 0.10% and the medicated powder amount 1.8% of medicated powder amount 20% as adjuvant, wetting agent made by the ethanol selecting variable concentrations, 16 mesh are pelletized, 55 DEG C are dried, 14 mesh sieve granulate, obtain granule.With granule qualification rate and on the impact of tabletting as deliberated index, select suitable wetting agent, result of the test is shown in Table 3.
Table 3 wetting agent Selection experiment
Other value in the Herba Dendrobii extract in medicated powder takes 11 parts～23 parts, Rhizoma Polygonati Odorati extract take other value in 17 parts～23 parts, Bulbus Lilii extract takes other value in 14 parts～25 parts, when the mannitol in adjuvant get it filled other value in powder amount 10%～30%, Mentholum get it filled other value in powder amount 1.7%～2.1%, sucralose get it filled other value in powder amount 0.03%～0.10% time, result of the test is consistent with upper table 3.
From above-mentioned test, material needs add certain binding agent, intend selecting polyvidone ketopyrrolidine K30(hereinafter referred to as PVP-K30), PVP-K30 is not only a kind of excellent binding agent, it also has chemical inertness, insensitive to acid, alkali, salt, it i.e. can be applied with the ethanol solution of various variable concentrations can also be directly with dry powder application.Adding PVP-K30 in this product to may act as binding agent and play the effect of stabilizer simultaneously as the cross-linking agent of Mentholum, PVP-K30 is be crosslinked thing 2～5 times as the cross-linking agent amount of generally using.
Using Herba Dendrobii extract 20 grams, Rhizoma Polygonati Odorati extract 20 grams and Bulbus Lilii extract 20 grams as medicated powder, using the Mentholum of mannitol, the sucralose of medicated powder amount 0.10% that is 0.06 gram and medicated powder amount 1.8% that is 1.08 gram of medicated powder amount 30% that is 18 gram as adjuvant, wetting agent made by the ethanol selecting different PVP-K30 usage amounts and variable concentrations, 16 mesh sieves are pelletized, the granule being dried, with granule qualification rate, mouthfeel and Mentholum stability and on the impact of tabletting as deliberated index, select suitable wetting agent and binding agent, select to the results are shown in Table 4.
Table 4 binding agent usage amount and the determination Selection experiment of wetting agent
From result of the test, adding the PVP-K30 of 4.5 times (i.e. 4.86 grams) of Herba Menthae brain volume, use dehydrated alcohol to prepare granule, result of the test is preferable.When other value during the Herba Dendrobii extract in medicated powder takes 11 grams～23 grams, Rhizoma Polygonati Odorati extract take other value in 17 grams～23 grams, Bulbus Lilii extract take other value in 14 grams～25 grams time, similarly, when PVP-K30 usage amount is 4.5 times of Herba Menthae brain volume, result of the test is preferable.
Three, hybrid parameter selects
Using Herba Dendrobii extract 20 parts, Rhizoma Polygonati Odorati extract 20 parts and Bulbus Lilii extract 20 parts as medicated powder, make with the mannitol of medicated powder amount 20%, the sucralose of medicated powder amount 0.10%, the Mentholum of medicated powder amount 1.8% and the PVP-K30 of medicated powder amount 8.1% is as adjuvant, extract is put groove with adjuvant mix machine mixes 15 minutes, observe material color, judge material mixing uniform level, observe at regular intervals once.5 minutes, 10 minutes, 15 minute period each took 5 some samples at random, was the time that index investigates material mix homogeneously with mixed material color, crude polysaccharides content, result of the test is shown in Table 5, table 6, table 7 and table 8.
Table 5 mixed material color is investigated
65 minute period of table material crude polysaccharides content investigates (g/100g)
7 10 minute period material content of table investigates (g/100g)
8 15 minute period material content of table investigates (g/100g)
Result of the test shows: during supplementary material hybrid technique, mixes 15 minutes, supplementary material mix homogeneously, and content can reach uniformity, therefore selecting incorporation time is 15 minutes.
Other value in the Herba Dendrobii extract in medicated powder takes 11 parts～23 parts, Rhizoma Polygonati Odorati extract take other value in 17 parts～23 parts, Bulbus Lilii extract takes other value in 14 parts～25 parts, when the mannitol in adjuvant get it filled other value in powder amount 10%～30%, Mentholum get it filled other value in powder amount 1.7%～2.1%, sucralose get it filled other value in powder amount 0.03%～0.10%, PVP-K30 get it filled other value in powder amount 4.5%～8.5% time, need also exist for mixing 15 minutes and just can make supplementary material mix homogeneously.
Four, granule formation technology selects
With Herba Dendrobii extract 20 parts, Rhizoma Polygonati Odorati extract 20 parts and Bulbus Lilii extract 20 parts are as medicated powder, mannitol with medicated powder amount 20%, the sucralose of medicated powder amount 0.10%, the Mentholum of medicated powder amount 1.8% is made and the PVP-K30 of medicated powder amount 8.1% is adjuvant, select to add dehydrated alcohol and cross 16 mesh granulations, 55 DEG C～60 DEG C are dried, pellet moisture is 3%～5%, 14 mesh granulate, add after magnesium stearate always mixes 30 minutes and obtain the dry granule of intermediate products, mobility of particle with made granule, granule Moisture percentage, critical relative humidity (CRH) is that index investigates granule formation technology.
(1) mobility of particle
Angle of repose measures: use fixed funnel method, 3 funnels are connected and is fixed on the graph paper of horizontal positioned at the height of 3cm, carefully granule is poured in the funnel gone up most until the granule cone tips formed on graph paper touches funnel by hopper walls, surveyed the diameter (2R) of conical base by graph paper, calculate angle of repose (tg α=H/R).
Table 9 measurement result angle of repose
Result shows: the average angle of repose of granule is 31.45 °, shows that the mobility of this granule is preferable.
(2) granule Moisture percentage
Bottom being contained the glass desicator of sodium chloride supersaturated solution and puts into the constant incubator constant weight 24 hours of 25 DEG C, now the relative humidity in exsiccator is 75 DEG C.After the particle drying for preparing to constant weight, putting into the granule of thick about 2 millimeters bottom the weighing botle of constant weight, in 25 DEG C of preservations, regularly (6,12,24,48,72 hours) weigh to put into above-mentioned glass desicator (weighing bottle cap to open), being calculated as follows hydroscopicity, result of the test is shown in Table 10.With Moisture percentage as vertical coordinate, the time (h) is abscissa mapping, and the rate of moisture absorption figure of granule is shown in Figure of description 2.
Table 10 granule Moisture percentage
Result shows: the prolongation in time of the Moisture percentage of granule is not proportional increase, and Moisture percentage gradually tends towards stability.
(3) Particles at Critical relative humidity (CRH)
After the particle drying for preparing to constant weight, the granule of thick about 2 millimeters is put into bottom the weighing botle of constant weight, (weighing bottle cap to open) it is respectively placed in the exsiccator of the supersaturated solution filling 7 kinds of variable concentrations sulphuric acid and different salt after precise, weigh after keeping 7 days in 25 DEG C of constant incubators, calculate Moisture percentage, the results are shown in Table 11.With Moisture percentage (%) as vertical coordinate, relative humidity (RH%) is abscissa mapping, and Particles at Critical relative humidity figure is shown in Figure of description 3.
Table 11
Granule Moisture percentage
The abscissa that the point of intersection of tangents at curve two ends is corresponding is critical relative humidity.This granule critical relative humidity (CRH) when 25 DEG C is about 57%, big produce in subpackage granule time, refer to this value by the humid control in workshop below 57%, affect quality to avoid moisture absorption to make the water content of product too high.
Other value in the Herba Dendrobii extract in medicated powder takes 11 parts～23 parts, Rhizoma Polygonati Odorati extract take other value in 17 parts～23 parts, Bulbus Lilii extract takes other value in 14 parts～25 parts, when the mannitol in adjuvant get it filled other value in powder amount 10%～30%, Mentholum get it filled other value in powder amount 1.7%～2.1%, sucralose get it filled other value in powder amount 0.03%～0.10%, PVP-K30 get it filled other value in powder amount 4.5%～8.5% time, Particles at Critical relative humidity (CRH) is 45%～65%.
Five, conclusion
According to above-mentioned technical study data it was determined that production technology is supplementary material size-reduced mistake 120 mesh sieve, mixing, make wetting agent with appropriate dehydrated alcohol, 16 mesh are pelletized, and 55 DEG C～60 DEG C are dried, and 14 mesh granulate add magnesium stearate and always mix 30 minutes, tabletting.Adjuvant uses rationally, and preparation process operation is feasible, and product all meets the requirements through qualitative and quantitative analysis, result, and this formula and processing technology can play raw material efficacy effect.
Above content is detailed description the most made for the present invention, it is impossible to assert that the present invention is embodied as being only limitted to these explanations.For those skilled in the art, without departing from the inventive concept of the premise, it is also possible to make some simple deduction or replace, all should be considered as belonging to the scope of protection of the invention.
Claims (3)
1. a compound dendrobium huoshanense buccal tablet, is characterized in that, is made up of medicated powder and adjuvant,
Described medicated powder includes the component of following mass fraction: Herba Dendrobii extract, 11 parts～23 parts；Rhizoma Polygonati Odorati extract, 17 parts～23 parts；Bulbus Lilii extract, 14 parts～25 parts；
Described adjuvant includes the component of following content: mannitol, for the 20%～30% of described medicated powder quality；Mentholum, for the 1.8% of described medicated powder quality；Polyvidone ketopyrrolidine K30, for the 8.1% of described medicated powder quality；Sucralose, for the 0.1% of described medicated powder quality；Magnesium stearate, for the 0.3%～0.6% of described medicated powder quality；
And preparation method comprises the following steps:
Pulverize: medicated powder and adjuvant cross 120 mesh sieves after pulverizing respectively, it is ensured that material powders uniform color, foreign are mixed into, without stain；
Dispensing: weigh medicated powder and adjuvant according to proportioning；
Mixing, pelletize: medicated powder except for magnesium stearate and adjuvant are thoroughly mixed and are allowed to uniform, add appropriate dehydrated alcohol, make up to hold agglomerating and one touch the most scattered, 16 mesh pelletize；
It is dried: the wet granular made is put in drying equipment and be dried under the conditions of 55 DEG C～60 DEG C, controls moisture 3%～5%；
Granulate: dried granule is put and crosses 14 mesh sieve granulate in pelletizing machine；
Total mixed: the granule made and magnesium stearate are sufficiently mixed uniformly；
Tabletting: by mould punching film-making.
2. compound dendrobium huoshanense buccal tablet as claimed in claim 1 a kind of, is characterized in that, in described mixing, granulation step, the mode that medicated powder except for magnesium stearate and adjuvant are thoroughly mixed is placed in groove and mixes in machine and mix 15 minutes.
3. a kind of compound dendrobium huoshanense buccal tablet as claimed in claim 1, is characterized in that, in described tableting step, needing the temperature controlling job shop is 18 DEG C～26 DEG C, and humidity is 45%～65%.
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| CN1194117A (en) * | 1997-03-21 | 1998-09-30 | 王凯 | Health care drink and its producing method |
| CN1545947A (en) * | 2003-12-15 | 2004-11-17 | 余内逊 | Preparation method for health food compounded by Asparagus sprengreri, ginseng fibrous root, lily bulb and officinal dendrobium stem |
| CN103191308A (en) * | 2013-01-18 | 2013-07-10 | 六安同济生生物科技有限公司 | Compound Dendrobium huoshanense-cistanche-glossy ganoderma buccal tablet and production process thereof |
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| CN1194117A (en) * | 1997-03-21 | 1998-09-30 | 王凯 | Health care drink and its producing method |
| CN1545947A (en) * | 2003-12-15 | 2004-11-17 | 余内逊 | Preparation method for health food compounded by Asparagus sprengreri, ginseng fibrous root, lily bulb and officinal dendrobium stem |
| CN103191308A (en) * | 2013-01-18 | 2013-07-10 | 六安同济生生物科技有限公司 | Compound Dendrobium huoshanense-cistanche-glossy ganoderma buccal tablet and production process thereof |
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