CN110075321B - Tibetan medicine Anerning granular placebo and preparation method thereof - Google Patents
Tibetan medicine Anerning granular placebo and preparation method thereof Download PDFInfo
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- CN110075321B CN110075321B CN201910416951.XA CN201910416951A CN110075321B CN 110075321 B CN110075321 B CN 110075321B CN 201910416951 A CN201910416951 A CN 201910416951A CN 110075321 B CN110075321 B CN 110075321B
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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
Abstract
The invention relates to a Tibetan medicine placebo of an' erning granule and a preparation method thereof, wherein the Tibetan medicine placebo mainly comprises the following components in parts by weight: 10-15 parts of powdered sugar, 0.1-0.15 part of caramel color, 0.1-0.15 part of lemon yellow or sunset yellow, 0.001-0.004 part of bittering agent and 0.5-1.5 parts of dextrin or starch, and the placebo and the Chinese medicinal granule basically keep consistent particle size, taste, color and appearance, thereby avoiding blindness in clinical tests.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a Tibetan medicine Anerning granular placebo and a preparation method thereof.
Background
Placebo is a "simulated drug" whose physical properties such as appearance, size, color, dosage form, weight, taste and odor are as similar as possible to the test drug, but does not contain the active ingredient of the test drug. With the rise of evidence-based medicine, the importance of placebo is higher and higher, and the clinical trial design mostly follows four major principles of random, contrast, blind method and repetition. The placebo for the clinical test of the western medicine is generally called blank control, and the western medicine is relatively single in shape, color and taste after being treated by the auxiliary materials and is easy to prepare. The traditional Chinese medicine has complex components, the types and the proportions of active ingredients are more varied, one of the basic characteristics is that the traditional Chinese medicine has the cold, hot, warm and cool four natures and the five flavors of sour, bitter, sweet, pungent and salty, the appearance, the characters, the efficacies and the sense of taste of each medicine (especially Tibetan medicines) are completely different and unique, so that the preparation of the placebo cannot be fixed and unified into a mode, and the specific selection and the proportion of each different variety are continuously discussed and researched in the research. Therefore, the preparation and evaluation of traditional Chinese medicine placebo are common problems facing the traditional Chinese medicine industry. In the process of implementing the blinding principle, the placebo used as a control is required to be kept consistent with the therapeutic in appearance, smell and color. Because the traditional Chinese medicine is used as the peculiar smell, taste and color of the natural medicine, the artificial simulation of preparing the placebo which is similar to the appearance, the smell and the taste of the natural medicine is difficult to certain extent. How to carry out preparation process research and quality evaluation on the placebo of the traditional Chinese medicine is a difficult problem at present,
the invention mainly aims at a classic Tibetan medicine variety Anerning granule, researches a corresponding placebo, a preparation method and quality evaluation thereof for exploration, and researches and determines a reasonable and practicable formula and quality evaluation method.
Disclosure of Invention
The invention aims to provide a Tibetan medicine Anerning particle placebo and a preparation method thereof. The placebo and the 'an' ning granules basically keep consistent particle size, taste, color and appearance, and avoid blindness of clinical tests.
The invention relates to a Tibetan medicine 'Anerning' granular placebo which mainly comprises the following components in parts by weight: 10 to 15 parts of powdered sugar, 0.1 to 0.15 part of caramel color, 0.1 to 0.15 part of lemon yellow or sunset yellow, 0.001 to 0.004 part of bittering agent and 0.5 to 1.5 parts of dextrin or starch.
The placebo of the invention, preferably, the placebo of the invention, mainly comprises the following components in parts by weight: 15.00 parts of sucrose powder, 0.15 part of caramel color, 0.1 part of sunset yellow, 0.002 part of bittering agent and 1.0 part of starch.
The placebo of the invention is preferably mainly composed of the following components in parts by weight, namely 15.00 parts of sucrose powder, 0.15 part of caramel color, 0.15 part of lemon yellow, 0.002 part of bittering agent and 1.0 part of dextrin.
The above placebo of the present invention, wherein the sugar powder is selected from sucrose, glucose, fructose, maltose and mannitol.
The bitterants described herein are also known as bitter or denatonium benzoate.
The invention also provides a method for preparing the Tibetan medicine Anerning particle placebo, which comprises the following steps:
1) mixing caramel color, sunset yellow and bittering agent, and dissolving in water to obtain solution;
2) mixing the powdered sugar and the starch, putting into a mixer, adding the solution obtained in the step 1), stirring, preparing into a soft material, granulating, sieving with a 10-mesh sieve, drying, and sieving the dried granules with a 10-mesh sieve and a 40-mesh sieve to obtain an intermediate product;
3) and uniformly mixing the whole intermediate product particles, and packaging into granules with the same weight as the Anerning particles to obtain the placebo.
In the method, the amount of water used in the step 1) is 18-22 times of the total weight of the formula materials, and preferably 20 times of the weight of the formula materials.
In the method, the drying in the step 2) is carried out under the conditions that the drying temperature is 40-45 ℃ and the drying time is 25-30 minutes; and (3) holding the soft material in the step 2) by hand to form a cluster, and dispersing the cluster by light pressure.
In a specific embodiment, the placebo of the ' an ' ning granule ' of the invention consists of the following components in parts by weight: 10 to 15 parts of powdered sugar, 0.1 to 0.15 part of caramel color, 0.1 to 0.15 part of lemon yellow or sunset yellow, 0.001 to 0.004 part of bittering agent and 0.5 to 1.5 parts of dextrin or starch.
Wherein said powdered sugar is selected from sucrose, glucose, fructose, maltose, mannitol, etc.
The invention relates to a preparation method of an' erning granule placebo, which comprises the following steps:
1) placing caramel color, sunset yellow and bittering agent in a suitable container, mixing well, adding appropriate amount of water (prescription material: 20 parts of water: 1 weight ratio), stirring evenly, adding water to dissolve into solution;
2) preparing a soft material: putting sucrose powder and dextrin into a groove type mixer, starting the mixer, uniformly mixing, adding the solution to prepare a soft material, stirring while adding, finally, holding the soft material by hand to form a dough, and dispersing under light pressure;
3) and (3) granulating: taking out the soft material from the mixer, conveying to a swing granulator, and granulating by using a 10-mesh stainless steel sieve sheet;
4) and (3) drying: drying the wet particles in a fluidized bed dryer at the air inlet temperature of 40-45 ℃ for 25-30 minutes;
5) powder sieving: sieving the dried granules with 10 mesh and 40 mesh sieves, wherein the intermediate product is qualified product;
6) mixing: adding all the particles into a mixer, mixing for 8-12 minutes, and sealing the uniformly mixed particles for later use after mixing;
7) packaging: and (3) performing quality evaluation (characters, granularity, dissolubility and the like) on the uniformly mixed granules, subpackaging the qualified granules until the weight of the granules is consistent with that of the Anerning granules, and carrying out internal packaging and external packaging to obtain the placebo.
Table 1: anerning granules and placebo detection standard thereof
Note: 1. the quality requirement meets the regulation, which means the quality standard of an ' erning granule recorded in p874 of the ' Chinese pharmacopoeia ' 2015 edition.
The technical effects are as follows:
the placebo of the present invention, through the studies of the present inventors, proposes a solution to the problem. The placebo is prepared by adding a flavoring agent, a coloring agent and auxiliary materials into the auxiliary materials of the formula, mixing the flavoring agent, the coloring agent and the auxiliary materials, preparing the mixture into granules, and finally preparing the granules into qualified granules through the working procedures of drying, finishing granules, packaging and the like. The method has simple preparation process, and the prepared placebo and the test drugs have little difference in aspects of appearance, properties, granularity, dissolubility, smell, taste and the like, so that clinical patients are difficult to distinguish, the defect of blindness breaking from the aspect of drugs is thoroughly overcome, and the accuracy and the consistency of clinical tests are ensured.
Detailed Description
The present invention is further illustrated by the following examples to help understand the nature of the invention. However, the scope of the invention is not limited thereto.
Example 1 placebo prescription:
sucrose powder: 15.00 parts by weight; lemon yellow: 0.15 part by weight
Caramel color: 0.15 part by weight; bitter agent: 0.002 parts by weight of
Dextrin: 1.0 part by weight
The preparation process comprises the following steps:
a) placing caramel color, lemon yellow and bitter agent in a suitable container, adding water (prescription material: 20 parts of water: 1 weight ratio) and stirring evenly to obtain solution;
b) adding sucrose powder and dextrin powder into a groove type mixer, mixing uniformly, adding the solution obtained in the previous step to prepare a soft material, stirring while adding, finally enabling the soft material to be held by a hand to form a mass, and dispersing by slight pressure;
c) taking out the soft material from the mixer, transporting to a swing type granulator, and granulating by using a 10-mesh stainless steel sieve; drying the wet particles in a fluidized bed dryer at the drying temperature and the air inlet temperature of 40-45 ℃ for 25-30 minutes; and (4) sieving the dried granules with a 10-mesh sieve and a 40-mesh sieve, wherein the intermediate product is a qualified product.
d) And (3) uniformly mixing the intermediate product particles, performing quality evaluation (character, granularity, dissolubility and the like), packaging the intermediate product particles into granules with the same weight as the Anerning particles after the intermediate product particles are inspected to be qualified, and packaging the granules inside and outside the granules to obtain the Anerning particle placebo.
Example 2 placebo prescription
Sucrose powder: 15.00 parts by weight; caramel color: 0.15 part by weight;
sunset yellow: 0.10 parts by weight of bittering agent: 0.002 parts by weight of
Starch: 1.0 part by weight
a) Putting caramel color, sunset yellow and bittering agent into a suitable container, mixing well, adding water (prescription material: 20 parts of water: 1 weight ratio) and stirring into a uniform solution;
b) adding sucrose powder and starch into a groove type mixer, mixing uniformly, adding the mixture into the aqueous solution obtained in the previous step to prepare a soft material, stirring while adding, finally enabling the soft material to be held by a hand to form a mass, and dispersing under light pressure;
c) taking out the soft material from the mixer, conveying to a swing type granulator, and granulating by using a 10-mesh stainless steel sieve; drying the wet particles in a fluidized bed dryer at the drying temperature and the air inlet temperature of 40-45 ℃ for 25-30 minutes; and (4) sieving the dried particles with a 10-mesh sieve and a 40-mesh sieve, wherein the intermediate product is a qualified product.
c) And (3) uniformly mixing the intermediate product particles, performing quality evaluation (character, granularity, dissolubility and the like), packaging the intermediate product particles into granules with the same weight as the Anerning particles after the intermediate product particles are inspected to be qualified, and packaging the granules inside and outside the granules to obtain the Anerning particle placebo.
Example 3 placebo and comparative placebo
The formulation is shown in Table 2.
TABLE 2 placebo formulation of example 3 and comparative examples 1-3 (unit: parts by weight)
The process for the preparation of the placebo in the above table is seen in the method of example 1.
Example 4 Effect test
The placebo of examples 1-3 and comparative examples 1-4 were compared with an infant granule as a reference, each placebo tested with 5 healthy volunteers (normal taste and vision) for color, granule, taste, at least two bags of placebo and two bags of an infant granule per test, the consistency of the placebo with the infant granule was compared and a score was scored for the comparison of the consistency, and additionally, the solubility of the placebo and the infant granule was tested. And the consistency comparison of each test index is graded one by one, each index is subjected to the average value of 5 grades, and then 6 indexes are summed and subjected to the average value.
1. The reference substance used for the evaluation is ' an ' erning granule ' meeting the standard requirements of ' Chinese pharmacopoeia ';
2. grading standard:
basically consistent for 95-100 minutes
Basically similar to 90 to 95 minutes
Has a visual difference of 85 to 90 points
Are not similar for 80 to 85 minutes
Totally different from 75 to 80 minutes
3. And (3) final grading: the comprehensive score is more than 95 points, and the product meets the requirements.
TABLE 2 evaluation of the scores of placebo-to-infant granules for examples 1-3 and comparative examples 1-4
As with the results of table 2 above, the placebo-to-infant granules of examples 1-3 and comparative examples 1-4 were scored for their comparative consistency, the placebo-to-infant granules of examples 1-3 were substantially identical, particularly examples 1 and 2 were substantially identical to the infant granules (the consistency score was greater than 99 points), the placebo-to-infant granules of comparative examples 1-4 were not similar to, not identical to, and particularly comparative example 4 was not identical.
It can be seen that the placebo of the present invention substantially corresponds to the Aner granules in terms of taste, granule size, granule color, solution color after dissolution, solubility, appearance, etc., and meets quality standards.
The above embodiments are described in detail, and it should be noted that the above embodiments are only for illustrating the spirit of the present invention. Numerous alternatives and modifications can be devised by those skilled in the art without departing from the spirit and scope of the invention, which should be understood to be within the scope of the invention.
Claims (7)
1. A Tibetan medicine Anerning granular placebo mainly comprises the following components in parts by weight: 15.00 parts of sucrose powder, 0.15 part of caramel color, 0.1 part of sunset yellow, 0.002 part of bittering agent and 1.0 part of starch.
2. A Tibetan medicine Anerning granular placebo mainly comprises the following components in parts by weight: 15.00 parts of sucrose powder, 0.15 part of caramel color, 0.15 part of lemon yellow, 0.002 part of bittering agent and 1.0 part of dextrin.
3. A process for the preparation of a placebo according to claim 1 or 2 comprising the steps of:
1) mixing caramel color, sunset yellow or lemon yellow with bittering agent, and dissolving in water to obtain solution;
2) mixing sucrose powder with starch or dextrin, adding into a mixer, adding the solution obtained in step 1), stirring, making into soft material, granulating, sieving with 10 mesh sieve, drying, and sieving with 10 mesh and 40 mesh sieves to obtain intermediate product;
3) and uniformly mixing the whole intermediate product particles, and packaging into granules with the same weight as the Anerning particles to obtain the placebo.
4. The method of claim 3, wherein the amount of water used in step 1) is 18 to 22 times the total weight of the formulation.
5. The method of claim 4, wherein the amount of water used in step 1) is 20 times the weight of the formulation.
6. The method according to claim 3, wherein the drying in step 2) is carried out at a drying temperature of 40 to 45 ℃ for 25 to 30 minutes.
7. The method according to claim 3, wherein the soft material in step 2) is held by hand to form a mass, and the mass is dispersed by light pressure.
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| 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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| WO2015187736A1 (en) * | 2014-06-02 | 2015-12-10 | Allergen Research Corporation | Placebo formulations and uses thereof |
| CN104034841B (en) * | 2014-06-23 | 2016-08-24 | 金诃藏药股份有限公司 | A kind of discrimination method pacifying the peaceful particle of youngster |
| CN106267242B (en) * | 2016-07-27 | 2019-07-26 | 四川新绿色药业科技发展有限公司 | A kind of manufacture craft of compound traditional Chinese medicine formula particle placebo |
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