CN110538242A - Preparation process of compound rhodiola rosea and salvia miltiorrhiza buccal tablets - Google Patents
Preparation process of compound rhodiola rosea and salvia miltiorrhiza buccal tablets Download PDFInfo
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- CN110538242A CN110538242A CN201910915653.5A CN201910915653A CN110538242A CN 110538242 A CN110538242 A CN 110538242A CN 201910915653 A CN201910915653 A CN 201910915653A CN 110538242 A CN110538242 A CN 110538242A
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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)
- A61K36/41—Crassulaceae (Stonecrop family)
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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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
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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)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
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Abstract
The invention discloses a preparation process of a compound rhodiola rosea and salvia miltiorrhiza buccal tablet, which comprises the following steps: mixing fructus Lycii extract, radix Rhodiolae extract, Saviae Miltiorrhizae radix extract, glucose, sucrose, and polyethylene glycol 6000 at a certain proportion, granulating, drying, and grading; dissolving Mentholum in anhydrous alcohol, spraying into the above granules, mixing, and sealing; ventilating and drying at low temperature, adding magnesium stearate and polyethylene glycol 6000, mixing, and tabletting; the glass fiber is placed in an irradiation workshop for standing and storage after irradiation, and the radiation dose is more than 50 kGy. The compound rhodiola rosea and salvia miltiorrhiza buccal tablet is applied to solving the problem of buccal tablet disintegration for the first time, the irradiation dose is controlled, the disintegration time of the compound rhodiola rosea and salvia miltiorrhiza buccal tablet can be effectively prolonged, the disintegration time reaches the regulation of 10 minutes in pharmacopoeia, and the effect of preventing and treating acute altitude reaction can be improved.
Description
Technical Field
The invention relates to the field of compound rhodiola rosea and salvia miltiorrhiza buccal tablets, in particular to a preparation process of a compound rhodiola rosea and salvia miltiorrhiza buccal tablet.
background
According to the pharmacopoeia related definition: the buccal tablet is a pressed tablet which is slowly dissolved in the oral cavity to generate a lasting local effect, and the disintegration time of the buccal tablet is regulated to be not less than 10 minutes. The disintegration time means the time during which the oral solid preparation is completely disintegrated and dissolved within the examination time and passes through a mesh (except for insoluble coating material or broken capsule shell).
The existing compound rhodiola rosea and salvia miltiorrhiza tablets contain glucose and sucrose with higher proportion, and are formed and tableted by adopting a pressing (non-decocting) process, and the glucose and the sucrose exist in a small granule form, so the disintegration time after meeting water is shorter, usually about 5 minutes, and the requirement of the buccal tablets on the disintegration time cannot be met; other processes do not meet the definition of buccal tablets and have influence on effective components and effects.
Disclosure of Invention
The invention provides a preparation process of a compound rhodiola rosea and salvia miltiorrhiza buccal tablet for solving the technical problems.
The invention is realized by the following technical scheme:
A preparation process of a compound rhodiola rosea and salvia miltiorrhiza buccal tablet comprises the following steps:
A. mixing fructus Lycii extract, radix Rhodiolae extract, Saviae Miltiorrhizae radix extract, glucose, sucrose, and polyethylene glycol 6000 at a certain proportion, granulating, drying, and grading;
B. Dissolving Mentholum in anhydrous alcohol, spraying into the above granules, mixing, and sealing;
C. Ventilating and drying at low temperature, adding magnesium stearate and polyethylene glycol 6000, mixing, and tabletting;
D. the glass fiber is placed in an irradiation workshop for standing and storage after irradiation, and the radiation dose is more than 50 kGy.
The compound rhodiola rosea and salvia miltiorrhiza buccal tablet comprises a medlar extract, a rhodiola rosea extract, a salvia miltiorrhiza extract, glucose, sucrose, polyethylene glycol 6000, magnesium stearate and menthol, and adopts a common compression molding process, the average disintegration time is 5 minutes, and the related regulation of pharmacopeia is not met. The compound rhodiola rosea and salvia miltiorrhiza tablets are prepared into the buccal tablets by adopting the process, small molecular substances in effective components can be separated out by adopting a buccal mode, the small molecular substances can quickly enter blood through oral mucosa, sublingual venous plexus, pharyngeal mucosa and the like and act on target organs, so that acute altitude stress is quickly relieved, the effective components which are not absorbed through the above ways can also be absorbed by the body through the traditional absorption mode of the digestive tract after being swallowed, the quick and lasting action effect is achieved, and the action of preventing and treating the acute altitude stress is improved. The irradiation is high-energy, short-wavelength, strong-penetrability and far-range gamma rays, namely gamma rays, generated by cobalt-60 or 137Cs, and the wavelength of the gamma rays is shorter than 0.2 angstroms. Many materials can be irradiated at one time, and are generally used for irradiation sterilization in the food industry, and the method is also a common and very effective modification method. The scheme is applied to solving the problem of buccal tablet disintegration for the first time, controls the irradiation dose, can effectively improve the disintegration time of the compound rhodiola rosea and salvia miltiorrhiza buccal tablet and enables the disintegration time to reach the regulation of 10 minutes on the disintegration time of pharmacopoeia. Under the irradiation of a certain dose of gamma rays, molecular chains of substances such as glucose, cane sugar and the like can be broken, a certain amount of heat is generated at the same time, and after the substances are placed, the molecules are polymerized into long-chain molecules again, so that the disintegration time of the molecules can be greatly prolonged when the molecules are dissolved in water. And the irradiation technology adopted by the scheme can solve the problem of disintegration of the compound rhodiola rosea and salvia miltiorrhiza buccal tablet, and can realize sterilization, save sterilization operation and reduce process flow.
Preferably, the weight parts of the components in the step A are as follows: 75-85 parts of medlar extract, 25-35 parts of rhodiola rosea extract, 65-75 parts of salvia extract, 380-400 parts of glucose, 590-620 parts of sucrose and 60008-11 parts of polyethylene glycol.
Preferably, in order to improve the effect of the compound rhodiola rosea-salvia miltiorrhiza buccal tablet on preventing and treating acute altitude sickness, the components in the step A are as follows in parts by weight: 80 parts of medlar extract, 30 parts of rhodiola rosea extract, 70 parts of salvia miltiorrhiza extract, 390 parts of glucose, 610 parts of sucrose and 600010 parts of polyethylene glycol.
Preferably, during irradiation, 10 kg of tablets are placed in a polyethylene bag, placed in an irradiation box or a barrel made of kraft paper, placed in an irradiation workshop, irradiated at room temperature according to the dose of 50kGy, and stored at room temperature in a dark place.
Furthermore, in order to improve the disintegration time of the rhodiola crenulata-salvia miltiorrhiza buccal tablet, the storage time in the dark is more than or equal to 72 hours.
preferably, the radiation dose is less than 100 kGy.
Compared with the prior art, the invention has the following advantages and beneficial effects:
1. the invention is applied to solve the problem of buccal tablet disintegration for the first time, controls the irradiation dose, can effectively improve the disintegration time of the compound rhodiola rosea and salvia miltiorrhiza buccal tablet and leads the disintegration time to reach the regulation of 10 minutes on the disintegration time of pharmacopoeia.
2. The compound rhodiola rosea and salvia miltiorrhiza tablets are prepared into the buccal tablets by adopting the method, small molecular substances in the active ingredients can be separated out by adopting a buccal mode, the small molecular substances can quickly enter blood through oral mucosa, sublingual venous plexus, pharyngeal mucosa and the like and act on target organs, so that acute altitude stress is quickly relieved, the active ingredients which are not absorbed through the above ways can also be absorbed by the body through the traditional absorption mode of the digestive tract after being swallowed, the quick and lasting action effect is achieved, and the action of preventing and treating the acute altitude stress is improved.
3. The invention adopts irradiation to realize sterilization, saves sterilization operation and reduces the process flow of the rhodiola rosea and salvia miltiorrhiza buccal tablet.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to examples, and the exemplary embodiments and descriptions thereof are only used for explaining the present invention and are not used as limitations of the present invention.
Example 1
A preparation process of a compound rhodiola rosea and salvia miltiorrhiza buccal tablet comprises the following steps:
A. mixing fructus Lycii extract, radix Rhodiolae extract, Saviae Miltiorrhizae radix extract, glucose, sucrose, and polyethylene glycol 6000 at a certain proportion, granulating, drying, and grading; preferably 75-85 parts of medlar extract, 25-35 parts of rhodiola rosea extract, 65-75 parts of salvia miltiorrhiza extract, 400 parts of glucose 380-.
B. Dissolving Mentholum in anhydrous alcohol, spraying into the above granules, mixing, and sealing;
C. Ventilating and drying at low temperature, adding magnesium stearate and polyethylene glycol 6000, mixing, and tabletting;
D. the glass fiber is placed in an irradiation workshop for standing and storage after irradiation, and the radiation dose is more than 50 kGy.
example 2
based on the principles of the above embodiments, the present embodiment discloses a set of detailed implementations.
A. Uniformly mixing 80g of medlar extract, 30 g of rhodiola rosea extract, 70 g of salvia extract, 390 g of glucose, 610 g of cane sugar and 600010 g of polyethylene glycol, granulating, drying and finishing granules, wherein the conventional processes are adopted for granulating, drying and finishing granules.
B. Dissolving Mentholum in anhydrous ethanol, spraying into the above granules, mixing, and sealing for several hours.
C. Drying at low temperature under ventilation, adding magnesium stearate and polyethylene glycol 6000 with particle size of polyethylene glycol 6000 of 200 mesh, mixing, and pressing into 1000 tablets.
D. Putting the prepared tablets in a polyethylene bag per 10 kg, putting the polyethylene bag in an irradiation box or a barrel made of kraft paper, sending the polyethylene bag into an irradiation workshop of an irradiation center, irradiating at room temperature according to the dosage of 50kGy, and storing at room temperature in a dark place for more than or equal to 72 hours.
The compound rhodiola rosea and salvia miltiorrhiza buccal tablets prepared by the method of the embodiment are subjected to disintegration test determination:
an instrument device: the main structure of the existing lifting disintegration tester is a lifting metal support, a hanging basket with a screen embedded at the lower end and a baffle. The up-down moving distance of the lifting metal support is 55mm +/-2 mm, and the reciprocating frequency is 30-32 times per minute. Hanging the hanging basket on a metal support through a stainless steel shaft at the upper end, immersing the hanging basket in a 1000ml beaker, adjusting the position of the hanging basket to enable the screen to be 25mm away from the bottom of the beaker when the hanging basket descends, filling water with the temperature of 37 +/-1 ℃ in the beaker, and adjusting the height of the water level to enable the screen to be 15mm below the water surface when the hanging basket ascends. Taking 6 tablets, respectively placing the tablets in glass tubes of the hanging baskets, adding baffles, starting a disintegration tester for checking, and recording the total disintegration time of each tablet; the disintegration time can reach 12 minutes on average, and all accord with pharmacopoeia regulations. And repeating multiple tests, wherein the tests all accord with pharmacopoeia regulations.
On the basis of the present example, the inventors found that the irradiation dose is in a positive correlation with the disintegration time by increasing the irradiation dose. As in the method steps of this example, the disintegration time was 17 minutes when the irradiation dose was 100kGy, which was different from the irradiation dose alone.
tests prove that the disintegration time of the buccal tablet is also influenced by the storage time in the dark after irradiation, and the test proves that the buccal tablet is stable after 72 hours, and the detection result of 72 hours is consistent with the detection result of 12 months after 6 months of storage, so that the irradiation process stipulates that the next packaging process or quality detection is carried out after 72 hours of storage.
the above-mentioned embodiments are intended to illustrate the objects, technical solutions and advantages of the present invention in further detail, and it should be understood that the above-mentioned embodiments are merely exemplary embodiments of the present invention, and are not intended to limit the scope of the present invention, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (6)
1. A preparation process of a compound rhodiola rosea and salvia miltiorrhiza buccal tablet is characterized by comprising the following steps:
A. Mixing fructus Lycii extract, radix Rhodiolae extract, Saviae Miltiorrhizae radix extract, glucose, sucrose, and polyethylene glycol 6000 at a certain proportion, granulating, drying, and grading;
B. Dissolving Mentholum in anhydrous alcohol, spraying into the above granules, mixing, and sealing;
C. Ventilating and drying at low temperature, adding magnesium stearate and polyethylene glycol 6000, mixing, and tabletting;
D. The glass fiber is placed in an irradiation workshop for standing and storage after irradiation, and the radiation dose is more than 50 kGy.
2. The preparation process of the compound rhodiola rosea and salvia miltiorrhiza buccal tablet according to claim 1, wherein the weight parts of the components in the step A are as follows: 75-85 parts of medlar extract, 25-35 parts of rhodiola rosea extract, 65-75 parts of salvia extract, 380-400 parts of glucose, 590-620 parts of sucrose and 60008-11 parts of polyethylene glycol.
3. the preparation process of the compound rhodiola rosea and salvia miltiorrhiza buccal tablet according to claim 1, wherein the components in the step A are as follows in parts by weight: 80 parts of medlar extract, 30 parts of rhodiola rosea extract, 70 parts of salvia miltiorrhiza extract, 390 parts of glucose, 610 parts of sucrose and 600010 parts of polyethylene glycol.
4. The process for preparing the compound buccal tablet of rhodiola rosea and salvia miltiorrhiza according to claim 1, wherein during irradiation, 10 kg of tablets are placed in a polyethylene bag, placed in an irradiation box or a barrel made of kraft paper, placed in an irradiation workshop, irradiated at room temperature according to the dose of 50kGy, and stored away from light at room temperature after irradiation.
5. The preparation process of the compound rhodiola rosea and salvia miltiorrhiza buccal tablet according to claim 4, wherein the time of light-resistant storage is more than or equal to 72 hours.
6. The preparation process of the compound rhodiola rosea and salvia miltiorrhiza buccal tablet according to claim 1, wherein the radiation dose is less than 100 kGy.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910915653.5A CN110538242A (en) | 2019-09-26 | 2019-09-26 | Preparation process of compound rhodiola rosea and salvia miltiorrhiza buccal tablets |
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| CN201910915653.5A CN110538242A (en) | 2019-09-26 | 2019-09-26 | Preparation process of compound rhodiola rosea and salvia miltiorrhiza buccal tablets |
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| CN110538242A true CN110538242A (en) | 2019-12-06 |
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| CN201910915653.5A Pending CN110538242A (en) | 2019-09-26 | 2019-09-26 | Preparation process of compound rhodiola rosea and salvia miltiorrhiza buccal tablets |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1130531A (en) * | 1995-12-07 | 1996-09-11 | 青海省老年医学研究所 | Medicine for preventing and curing altitude disease |
| JP2001072202A (en) * | 1999-09-03 | 2001-03-21 | Daicel Chem Ind Ltd | Net shaped garbage bag for composting |
| CN109588720A (en) * | 2019-01-15 | 2019-04-09 | 长春中医药大学 | A kind of health food and preparation method thereof with raising anoxia endurance effect |
-
2019
- 2019-09-26 CN CN201910915653.5A patent/CN110538242A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1130531A (en) * | 1995-12-07 | 1996-09-11 | 青海省老年医学研究所 | Medicine for preventing and curing altitude disease |
| JP2001072202A (en) * | 1999-09-03 | 2001-03-21 | Daicel Chem Ind Ltd | Net shaped garbage bag for composting |
| CN109588720A (en) * | 2019-01-15 | 2019-04-09 | 长春中医药大学 | A kind of health food and preparation method thereof with raising anoxia endurance effect |
Non-Patent Citations (2)
| Title |
|---|
| M. DE KERF: "《Characterisation and disintegration properties of irradiated starch》", 《INTERNATIONAL JOURNAL OF PHARMACEUTICS》 * |
| 国家药典委员会: "《中国药典（四部）》", 30 June 2015, 中国医药科技出版社 * |
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Application publication date: 20191206 |