CN110075321A - A kind of Tibetan medicine peace peaceful particle placebo of youngster and preparation method thereof - Google Patents
A kind of Tibetan medicine peace peaceful particle placebo of youngster and preparation method thereof Download PDFInfo
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- CN110075321A CN110075321A CN201910416951.XA CN201910416951A CN110075321A CN 110075321 A CN110075321 A CN 110075321A CN 201910416951 A CN201910416951 A CN 201910416951A CN 110075321 A CN110075321 A CN 110075321A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/0004—Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—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
- A61K9/1611—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—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
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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Abstract
A kind of Tibetan medicine peace peaceful particle placebo of youngster of the present invention and preparation method thereof; the Tibetan medicine placebo is mainly composed of the following components in parts by weight: 10~15 parts by weight of Icing Sugar, 0.5~1.5 parts by weight of 0.1~0.15 parts by weight of 0.1~0.15 parts by weight of burnt sugar coloring, lemon yellow or sunset yellow, 0.001~0.004 parts by weight of bitters and dextrin or starch; grain diameter size, taste, color, the appearance that the placebo and the peace peaceful particle of youngster are consistent substantially, to avoid clinical test unblinding.
Description
Technical field
The invention belongs to tcm fields, and in particular to a kind of Tibetan medicine peace peaceful particle placebo of youngster and preparation method thereof.
Background technique
Placebo is a kind of " aids drug ", and physical characteristic such as appearance, size, color, dosage form, weight, taste is gentle
Taste will be as identical as trial drug as possible, but cannot contain the effective ingredient of investigational agent.With the rise of evidence-based medicine EBM, comfort
The attention degree of agent is higher and higher, and clinical trial design follows random, control more, blind, repeats four big principles.The examination of Western medicine clinic
The placebo tested is commonly referred to as blank control, and since Western medicine is relatively simple, shape, color and taste are opposite after auxiliary material is handled
Single, placebo is easy preparation.Traditional Chinese medicine ingredients are complicated, and effective component type and ratio are even more ever-changing, essential characteristic it
First is that be divided into cold, hot, warm, cool four gas and acid, hardship, sweet, pungent, the salty five tastes, each its appearance of drug (especially Tibetan medicine), character,
Effect and its from sense organ to the sense of taste it is all entirely different, and have uniqueness, therefore, the production of placebo is impossible to fixation and is unified for
One mode, specific sorting and proportion for each different kind also constantly will be inquired into and grope under study for action.Cause
This, the preparation and evaluation of traditional Chinese medicine placebo are the common problems that traditional Chinese medicine industry faces.During implementing blind principle, make
For the placebo requirement of control, the Bao Te in appearance, smell, color is consistent with medicine.Due to Chinese medicine as natural drug from
Smell, taste specific to body and color, manual simulation make placebo similar with its appearance, smell and taste and truly have centainly
Difficulty.How Study on Preparation is carried out to the placebo of Chinese medicine and quality evaluation is a current problem,
Present invention is generally directed to a kind of classical Tibetan medicine kinds to pacify the peaceful particle of youngster, develop corresponding placebo, and its
Preparation method and quality evaluation are explored, and determine reasonable, enforceable formula and quality evaluating method.
Summary of the invention
The purpose of the present invention is providing a kind of Tibetan medicine peace peaceful particle placebo of youngster and preparation method thereof.Peace youngster of the invention is peaceful
Particle placebo and the peace peaceful particle of youngster are kept substantially consistent grain diameter size, taste, color, appearance, avoid clinical examination
Test unblinding.
A kind of Tibetan medicine of the invention pacifies the peaceful particle placebo of youngster, is mainly composed of the following components in parts by weight: Icing Sugar 10~
15 parts by weight, 0.1~0.15 parts by weight of 0.1~0.15 parts by weight of burnt sugar coloring, lemon yellow or sunset yellow, bitters 0.001~
0.5~1.5 parts by weight of 0.004 parts by weight and dextrin or starch.
The placebo of foregoing invention, it is preferred that placebo of the invention is mainly composed of the following components in parts by weight: sugarcane
15.00 parts of Icing Sugar, 0.15 part of burnt sugar coloring, 0.1 part of sunset yellow, 0.002 part of bitters and 1.0 parts of starch.
The placebo of foregoing invention, it is preferred that placebo of the invention is mainly composed of the following components in parts by weight, sucrose
15.00 parts of powder, 0.15 part of burnt sugar coloring, 0.15 part of lemon yellow, 0.002 part of bitters and 1.0 parts of dextrin.
The placebo of aforementioned present invention, the Icing Sugar are selected from sucrose, glucose, fructose, barley-sugar and mannitol.
Bitters as described herein is also referred to as bitter or denatonium benzoate.
The present invention also provides a kind of methods for preparing the Tibetan medicine peace peaceful particle placebo of youngster, comprising the following steps:
1) after mixing burnt sugar coloring, sunset yellow and bitters, it is dissolved in water into solution；
2) it is put into mixing machine after Icing Sugar is mixed with starch, the solution of step 1) is added, stirs, softwood is made, pelletized, mistake
10 meshes, it is dry, the particle after drying is crossed into 10 mesh and 40 meshes to get intermediate products；
3) the intermediate products particle after whole grain is uniformly mixed, subpackage dress up with the identical weight of the peace peaceful particle of youngster to get
Placebo.
The method of aforementioned present invention, the dosage of water is 18~22 times of prescription material total weight in step 1), is preferably located
20 times of square weight of material.
The method of aforementioned present invention, the drying in step 2), condition be drying temperature be 40~45 for DEG C, drying time
It is 25~30 minutes；Softwood in step 2), holding is agglomerating, and light pressure dissipates.
In a particular embodiment, the peaceful particle placebo of peace youngster of the invention, is grouped as: Icing Sugar by the group of following parts by weight
10~15 parts by weight, 0.1~0.15 parts by weight of 0.1~0.15 parts by weight of burnt sugar coloring, lemon yellow or sunset yellow, bitters 0.001
0.5~1.5 parts by weight of~0.004 parts by weight and dextrin or starch.
Wherein, the Icing Sugar can be selected from sucrose, glucose, fructose, barley-sugar and mannitol etc..
The present invention relates to the preparation methods of the peace peaceful particle placebo of youngster, include the following steps:
1) burnt sugar coloring, sunset yellow and bitters are set in suitable container, is uniformly mixed, adds suitable quantity of water (prescription material: water
=20:1 weight ratio) dissolution, it stirs evenly, is dissolved in water into solution；
2) softwood processed: by cane sugar powder and dextrin investment trough-type mixture machine, start mixing machine, after mixing, in addition
Solution softwood is stated, it is stirring while adding, finally hold softwood agglomerating, light pressure dissipates；
3) it pelletizes: softwood being taken out from mixing machine, is transported at oscillating granulator, pelletized with 10 mesh stainless steel sieves；
4) dry: wet granular to be dried in boiling drier, 40~45 DEG C of drying temperature inlet air temperature, the time 25
~30 minutes；
5) it sieves powder: 10 mesh of the particle after drying and 40 mesh is sieved, in-between product is qualified product；
6) it mixes: all particles being added to the mixer and start to mix, incorporation time is 8~12 minutes, after mixing
It is granule sealed by what is be uniformly mixed, it is spare；
7) it packs: above-mentioned uniformly mixed particle is subjected to quality evaluation (character, granularity, melting etc.), it is qualified laggard
Row packing, weight is consistent with the peace weight of the peaceful particle of youngster, and first inner packing, again outer packing are up to placebo.
Table 1: the peaceful particle of peace youngster and its placebo examination criteria
Note: 1, * quality requirement meets regulation and refers to the peaceful particle matter of peace youngster that " Chinese Pharmacopoeia " 2015 editions p874 are recorded
Amount standard.
Technical effect:
Placebo of the invention proposes a kind of solution to the problem by the research of the present inventor.Peace of the invention
Console agent and particle is made by the way that corrigent is added in the auxiliary material of formula, rectifys after toner is mixed with auxiliary material, through drying, whole grain, packaging
Etc. processes be finally made qualified particle.This method preparation process is simple, manufactured placebo and investigational agent appearance, character,
There are few difference, clinical patients are difficult to differentiate for granularity, melting, smell, the sense of taste etc., thoroughly solve from drug-layer side unblinding
The drawbacks of, guarantee the accuracy and consistency of clinical test.
Specific embodiment
The present invention will be further described by the following examples, to help to understand essence of the invention.But not with this
It limits the scope of the invention.
1 placebo prescription of embodiment:
Cane sugar powder: 15.00 parts by weight；Lemon yellow: 0.15 parts by weight
Burnt sugar coloring: 0.15 parts by weight；Bitters: 0.002 parts by weight
Dextrin: 1.0 parts by weight
Preparation process:
A) it by burnt sugar coloring, lemon yellow, bitters, sets in suitable container, adds water (prescription material: water=20:1 weight ratio)
Dissolution, is stirred into solution；
B) it by cane sugar powder and dextrine powder investment trough-type mixture machine, is uniformly mixed, the solution softwood walked is then added,
It is stirring while adding, finally hold softwood agglomerating, light pressure dissipates；
C) softwood is taken out from mixing machine, is transported to oscillating granulator, sieved and pelletized with 10 mesh stainless steels；Wet granular is existed
Boiling drier is dried, and drying temperature and inlet air temperature are 40~45 DEG C, and drying time is 25~30 minutes；After dry
Particle cross 10 mesh and 40 meshes, in-between product is qualified product.
D) intermediate products particle is uniformly mixed, is carried out quality evaluation (character, granularity, melting etc.), after the assay was approved,
Subpackage is dressed up pacifies the peaceful particle placebo of youngster with the peace peaceful particle identical weight of youngster, identical exterior and interior packing to obtain the final product.
2 placebo prescription of embodiment
Cane sugar powder: 15.00 parts by weight；Burnt sugar coloring: 0.15 parts by weight；
Sunset yellow: 0.10 parts by weight bitters: 0.002 parts by weight
Starch: 1.0 parts by weight
A) burnt sugar coloring, sunset yellow, bitters are placed in suitable container, be uniformly mixed, add water (prescription material: water=
20:1 weight ratio) dissolution, stir into homogeneous solution；
B) cane sugar powder and starch investment trough-type mixture machine are uniformly mixed, are then added and walk softwood processed in aqueous solution, side
Edged stirring finally holds softwood agglomerating, and light pressure dissipates；
C) softwood is taken out from mixing machine, is transported at oscillating granulator, sieved and pelletized with 10 mesh stainless steels；By wet granular
It is dried in boiling drier, drying temperature and inlet air temperature are 40~45 DEG C, and drying time is 25~30 minutes；It will dry
Particle afterwards crosses 10 mesh and 40 meshes, and in-between product is qualified product.
C) intermediate products particle is uniformly mixed, is carried out quality evaluation (character, granularity, melting etc.), after the assay was approved,
Subpackage is dressed up pacifies the peaceful particle placebo of youngster with the peace peaceful particle identical weight of youngster, identical exterior and interior packing to obtain the final product.
3 placebo of embodiment and comparative example placebo
Its formula is shown in Table 2.
The formula (unit: parts by weight) of 2 embodiment 3 of table and comparative example 1-3 placebo
The preparation process of placebo in upper table referring to embodiment 1 method.
4 measure of merit of embodiment
The placebo of embodiment 1-3 and comparative example 1-4 are compared with peace youngster's particle as object of reference, tested, every kind
Placebo is respectively tested with 5 healthy premenopausal volunteers (sense of taste and vision are normal), observation color, particle, trial test taste, and every
Tester's at least two bags of placebos and two bags of peaceful particles of peace youngster, comparison placebo and the consistency for pacifying the peaceful particle of youngster, and to comparing
The consistency of the two is compared marking, in addition, the dissolubility of test placebo and the peace peaceful particle of youngster.And each single item test is referred to
The comparison of target consistency is given a mark one by one, and each index acquires the average value of 5 people marking, then is averaging to 6 indexs are total
Value.
1, above evaluation object of reference used is " the peace peaceful particle of youngster " for meeting " Chinese Pharmacopoeia " standard requirements；
2, standards of grading:
Almost the same 95~100 points
Substantially 90~95 points similar
There are 85~90 points of vision difference
It is 80~85 points dissimilar
Entirely different 75~80 points
3, final scoring: comprehensive score is at 95 points or more, to meet the requirements.
The placebo and peace youngster's particle comparative evaluation marking result of table 2 embodiment 1-3 and comparative example 1-4
Ibid table 2 as a result, the placebo of embodiment 1-3 and comparative example 1-4 and peace youngster's particle comparison Conformance Assessment beat
Point as a result, embodiment 1-3 placebo and peace youngster's particle it is almost the same, especially Examples 1 and 2 with pacify youngster's particle substantially completely
Unanimously (consistency give a mark up to 99 points or more), the placebo of comparative example 1-4 and peace youngster's particle are dissimilar, inconsistent, especially pair
Ratio 4 is not completely identical.
As it can be seen that placebo of the invention taste, granular size, particle color, dissolved solution color, melting,
Appearance etc. causes substantially with peace youngster's particle, meets the quality standard.
The above embodiments are described in detail the present invention, it should be noted that above embodiment is just to lifting
Example illustrates Spirit Essence of the invention.Under the premise of without departing from the spirit and essence of invention, those skilled in the art can
To design a variety of alternatives and improvement project of the invention, should be understood within protection scope of the present invention.
Claims (9)
1. a kind of Tibetan medicine pacifies the peaceful particle placebo of youngster, mainly it is composed of the following components in parts by weight: 10~15 parts of Icing Sugar, burnt sugar coloring
0.1~0.15 part of 0.1~0.15 part, lemon yellow or sunset yellow, 0.001~0.004 part of bitters and dextrin or starch 0.5~
1.5 part.
2. placebo as claimed in claim 1, is mainly composed of the following components in parts by weight: 15.00 parts of cane sugar powder, burnt sugar coloring 0.15
Part, 0.1 part of sunset yellow, 0.002 part of bitters and 1.0 parts of starch.
3. placebo as described in claim 1, is mainly composed of the following components in parts by weight, 15.00 parts of cane sugar powder, burnt sugar coloring
0.15 part, 0.15 part of lemon yellow, 0.002 part of bitters and 1.0 parts of dextrin.
4. placebo as described in claim 1, the Icing Sugar selects sucrose, lactose and glucose.
5. a kind of method of the standby placebo of claim 1 processed, comprising the following steps:
1) after mixing burnt sugar coloring, sunset yellow and bitters, it is dissolved in water into solution；
2) it is put into mixing machine after Icing Sugar is mixed with starch, the solution of step 1) is added, stirs, softwood is made, pelletized, cross 10 mesh
Sieve, it is dry, the particle after drying is crossed into 10 mesh and 40 meshes to get intermediate products；
3) the intermediate products particle after whole grain is uniformly mixed, subpackage dresses up weight identical with the peace peaceful particle of youngster to get comfort
Agent.
6. method as claimed in claim 5, the dosage of water is 18~22 times of prescription material total weight in step 1).
7. method as claimed in claim 6, the dosage of water is 20 times of prescription weight of material in step 1).
8. method as claimed in claim 5, drying described in step 2), drying temperature are 40~45 DEG C, drying time
It is 25~30 minutes.
9. method as claimed in claim 5, softwood in step 2) is held agglomerating, and light pressure dissipates.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910416951.XA CN110075321B (en) | 2019-05-20 | 2019-05-20 | Tibetan medicine Anerning granular placebo and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910416951.XA CN110075321B (en) | 2019-05-20 | 2019-05-20 | Tibetan medicine Anerning granular placebo and preparation method thereof |
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| CN110075321A true CN110075321A (en) | 2019-08-02 |
| CN110075321B CN110075321B (en) | 2021-11-09 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112089850A (en) * | 2020-10-10 | 2020-12-18 | 深圳市中医院 | Placebo of white tiger ginseng granules and preparation method thereof |
| CN116893086A (en) * | 2023-04-28 | 2023-10-17 | 江苏艾力斯生物医药有限公司 | Simulation tablet of targeted drug-mesylate vomertinib tablet and preparation method thereof |
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| CN104034841A (en) * | 2014-06-23 | 2014-09-10 | 山东阿如拉药物研究开发有限公司 | Identification method of AnErning particles |
| US20150343075A1 (en) * | 2014-06-02 | 2015-12-03 | Aimmune Therapeutics | Placebo formulations and uses thereof |
| CN106267242A (en) * | 2016-07-27 | 2017-01-04 | 四川新绿色药业科技发展股份有限公司 | A kind of processing technology of compound traditional Chinese medicine formula granule placebo |
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2019
- 2019-05-20 CN CN201910416951.XA patent/CN110075321B/en active Active
Patent Citations (3)
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|---|---|---|---|---|
| US20150343075A1 (en) * | 2014-06-02 | 2015-12-03 | Aimmune Therapeutics | Placebo formulations and uses thereof |
| CN104034841A (en) * | 2014-06-23 | 2014-09-10 | 山东阿如拉药物研究开发有限公司 | Identification method of AnErning particles |
| CN106267242A (en) * | 2016-07-27 | 2017-01-04 | 四川新绿色药业科技发展股份有限公司 | A kind of processing technology of compound traditional Chinese medicine formula granule placebo |
Non-Patent Citations (1)
| Title |
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| 吴飞 等: "临床试验用中药安慰剂设计和质量控制研究进展", 《中国新药杂志》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112089850A (en) * | 2020-10-10 | 2020-12-18 | 深圳市中医院 | Placebo of white tiger ginseng granules and preparation method thereof |
| CN116893086A (en) * | 2023-04-28 | 2023-10-17 | 江苏艾力斯生物医药有限公司 | Simulation tablet of targeted drug-mesylate vomertinib tablet and preparation method thereof |
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| CN110075321B (en) | 2021-11-09 |
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