CN107308129A - A kind of preparation method of the ossified alcohol soft capasules of Ai Er - Google Patents
A kind of preparation method of the ossified alcohol soft capasules of Ai Er Download PDFInfo
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- CN107308129A CN107308129A CN201710376920.7A CN201710376920A CN107308129A CN 107308129 A CN107308129 A CN 107308129A CN 201710376920 A CN201710376920 A CN 201710376920A CN 107308129 A CN107308129 A CN 107308129A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/592—9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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Abstract
The invention discloses a kind of preparation method of the ossified alcohol soft capasules of Ai Er, comprise the following steps：The preparation of capsule skin, the preparation of content and compacting soft capsule, wherein, prepared by content comprises the following steps：Ai Er ostelins are taken, absolute ethyl alcohol is added, uses glass bar stirring and dissolving；Add median chain triglyceride oil, vitamin E, electric stirring 12 hours；Solution is transferred to Rotary Evaporators, 40 60 DEG C of temperature, 0.08 0.1Mpa, revolving, and detection limit residual is less than 0.5%；Solution is transferred to agitator tank, median chain triglyceride oil, stirring is added；Adjust loading amount and pelleting.The present invention by controlling the temperature of rotary evaporation, pressure, time, is controlled the residual of absolute ethyl alcohol, removes absolute ethyl alcohol by lot of experiments.The ossified alcohol soft capasules of the Ai Er without ethanol, can be such that this product is preferably treated by for more patients, especially alcohol intolerance crowd.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, the preparation method of the ossified alcohol soft capasules of more particularly to a kind of Ai Er.
Background technology
Ai Er ossify alcohol soft capasule for development of drugs in treating primary osteoporosis, and Japanese health ministry is in January, 2011 approval Japan
Outer Pharmaceutical Co., Ltd production listing, its active principle Ai Er ostelins are new to be used to treat bone after another after Alfacalcidol
The activity of vitamin d3 derivative of matter osteoporosis.One III phase for lasting 3 years participated in by 1054 patients with osteoporosis faces
Bed data display, Ai Er ostelins curative effect is better than Alfacalcidol, and security is similar to Alfacalcidol, is answered with preferable
Use prospect.
Chinese name：Ai Er ostelins
Structural formula：
Molecular formula：C30H50O5
Molecular weight：490.72
This product active component Ai Er ostelins, it is readily soluble in N, dinethylformamide and absolute ethyl alcohol, in chloroform
With slightly molten in acetic acid, the slightly soluble in acetonitrile, it is almost insoluble in water.Nothing draws moist.
This product specification is only 0.75 microgram, and soft capsule content is about 100mg/, and major solute is the acid of medium chain triglyceride three
Ester.Ai Er ostelins account for smaller in composition, if being dissolved by conventional mechanical agitation, it is more difficult to which active component is uniform
Be dissolved in solute, the low and uneven consequence of the content easily caused.
The patent of invention of Japanese Choongwae Pharmacutical Corp's application, ED-71 preparations, Authorization Notice No. CN1938034B,
In embodiment, absolute ethyl alcohol 1.30mg/ is contained in core formula of liquid.Crowd is known in the industry, and vitamine D3 class derives
Thing, the characteristics of having indissoluble, oxidizable, heat, meet water unstable.Ai Er ostelins are readily soluble in absolute ethyl alcohol, and absolute ethyl alcohol exists
The hydrotropy effect to active component is only played in formula, to clinical practice without any therapeutic action, or even easily for alcohol mistake
Quick crowd produces side reaction.If after Ai Er ostelins are pre-dissolved with absolute ethyl alcohol first, transferring in median chain triglyceride oil
Stirring and dissolving, can perfectly solve the indissoluble sex chromosome mosaicism of Ai Er ostelins.It is disadvantageous that inevitable in preparation compositions
Introduce organic solvent absolute ethyl alcohol, this is one big sorry to alcohol intolerance patient.
The content of the invention
The technical problems to be solved by the invention are to provide a kind of Ai Er and ossify the preparation method of alcohol soft capasule, and it can be by
The absolute ethyl alcohol introduced in preparation technology is removed by way of rotary evaporation, so that finished product is free of ethanol.
The technical problems to be solved by the invention are achieved through the following technical solutions：
A kind of preparation method of the ossified alcohol soft capasules of Ai Er, comprises the following steps：1) preparation of capsule skin, 2) content
Prepare and 3) suppress soft capsule, wherein, prepared by the content comprises the following steps：
21) the Ai Er ostelins of formula ratio are taken, absolute ethyl alcohol are added, with glass bar stirring and dissolving to clear；
22) 20% median chain triglyceride oil, the vitamin E of formula ratio are added into above-mentioned solution, electric stirring 1-2 is small
When；
23) above-mentioned solution is transferred in Rotary Evaporators, 40-60 DEG C of temperature is set, keep vacuum 0.08-
0.1Mpa, rotates out ethanol, and detection limit residual is less than 0.5%；
24) above-mentioned solution is transferred in agitator tank, adds the median chain triglyceride oil of formula ratio 80%, stirring is equal
It is even；And
25) adjustment loading amount and pelleting.
Preferably, in above-mentioned technical proposal, the step 1) preparation of capsule skin comprises the following steps：
11) purified water of formula ratio is weighed, 80 DEG C -90 DEG C are heated to；
12) sorbierite, glycerine stirring and dissolving are sequentially added, titanium dioxide is added and is evenly stirred until no particulate matter；
13) gelatin is added, is sufficiently stirred for 2 hours；And
14) vavuum pump is opened, bubble-free is evacuated to, and 10 hours are incubated at 50 DEG C -60 DEG C.
Preferably, in above-mentioned technical proposal, the step 3) compacting soft capsule includes：
31) wet capsule skin is controlled in 0.75mm-0.85mm, control loading amount compacting soft capsule；
32) soft capsule of compacting is synchronously transferred in drying rotating cage, round as a ball sizing.
Preferably, in above-mentioned technical proposal, the preparation method of the ossified alcohol soft capasules of the Ai Er also includes：4) polishing is chosen
Pick, 5) pack.
Preferably, in above-mentioned technical proposal, the step 2) content preparation, the formula ratio of content is comprising following heavy
Measure part component：Ai Er ostelins 0.00075, vitamin E 0.02 and median chain triglyceride oil 100.
Preferably, in above-mentioned technical proposal, the formula ratio of the content also includes absolute ethyl alcohol, the Ai Er ostelins
Solid-to-liquid ratio with the absolute ethyl alcohol is 0.00075:1.
Preferably, in above-mentioned technical proposal, the step 23) in, the temperature 50 C of the rotary evaporation keeps vacuum
0.09Mpa, rotates out ethanol, and detection limit residual 0.1%.
Preferably, in above-mentioned technical proposal, the step 1) capsule skin preparation in, the formula ratio of capsule skin is comprising following
Parts by weight of component：Gelatin 79.42, glycerine 19.86, sorbierite 9.93, titanium dioxide 0.79 and purified water 79.42.
Above-mentioned technical proposal of the present invention, has the advantages that：
The preparation method of the ossified alcohol soft capasules of Ai Er proposed by the present invention, by lot of experiments, is ensureing this quality
While amount, in preparation process, by controlling the temperature of rotary evaporation, pressure, time, final control absolute ethyl alcohol
Residual, removes absolute ethyl alcohol, finished product is free of ethanol.This without ethanol Ai Er ossify alcohol soft capasule, can make this product by
Can preferably it be treated for more patients, especially alcohol intolerance crowd.
Embodiment
The specific embodiment of the present invention is described in detail below, in order to further understand the present invention.
All experimental methods used are conventional method unless otherwise specified in following examples.In following examples
Material, reagent used etc., unless otherwise specified, can be obtained by commercial sources.
Embodiment 1
Formula composition：
Production technology：
(1) capsule leather is standby：
11st, the purified water of recipe quantity is weighed, 80 DEG C~90 DEG C are heated to；
12nd, sorbierite, glycerine stirring and dissolving one by one are sequentially added, titanium dioxide is added and is evenly stirred until no particulate matter；
13rd, gelatin is added, is sufficiently stirred for about 2 hours；
14th, vavuum pump is opened, bubble-free is evacuated to, and about 10 hours are incubated at 50 DEG C~60 DEG C.
(2) prepared by content：
21st, the Ai Er ostelins of formula ratio are taken, adds into absolute ethyl alcohol, transparence is stirred to clarify with glass bar, i.e.,
All dissolvings；
22nd, the median chain triglyceride oil of total amount 20% will be formulated, is transferred in above-mentioned solution, and adds vitamin E, is used
Electric mixer, mixing speed is tried one's best quick but can not be involved in large quantity of air, is stirred 1-2 hours；
23rd, above-mentioned solution is transferred in Rotary Evaporators, 40 DEG C of temperature is set, keep vacuum 0.08-0.1Mpa it
Between, most ethanol are rotated out, and detection limit residual is less than 0.5%；
24th, by above-mentioned solution, it is transferred in agitator tank, adds into the median chain triglyceride oil of surplus, and stir
Uniformly；
25th, adjustment loading amount and pelleting.
(3) soft capsule is suppressed：
31st, control wet capsule skin about in 0.8mm ± 0.05mm, control loading amount compacting soft capsule；
32nd, the soft capsule of compacting is synchronously transferred in drying rotating cage, round as a ball sizing；
(4) by the soft capsule after drying, it is processed by shot blasting, and picks；
(5) pack.
Embodiment 2：
Formula composition：
Production technology：
(1) capsule leather is standby：
11st, the purified water of formula ratio is weighed, 80 DEG C~90 DEG C are heated to；
12nd, sorbierite, glycerine stirring and dissolving one by one are sequentially added, titanium dioxide is added and is evenly stirred until no particulate matter；
13rd, gelatin is added, is sufficiently stirred for about 2 hours；
14th, vavuum pump is opened, bubble-free is evacuated to, and about 10 hours are incubated at 50 DEG C~60 DEG C.
(2) prepared by content：
21st, the Ai Er ostelins of formula ratio are taken, adds into absolute ethyl alcohol, transparence is stirred to clarify with glass bar, i.e.,
All dissolvings；
22nd, the median chain triglyceride oil of total amount 20% will be formulated, is transferred in above-mentioned solution, and adds vitamin E, is used
Electric mixer, mixing speed is tried one's best quick but can not be involved in large quantity of air, is stirred 1-2 hours；
23rd, above-mentioned solution is transferred in Rotary Evaporators, temperature 50 C is set, keep vacuum 0.08-0.1Mpa it
Between, most ethanol are rotated out, and detection limit residual is less than 0.5%；
24th, by above-mentioned solution, it is transferred in agitator tank, adds into the median chain triglyceride oil of surplus, and stir
Uniformly；
25th, adjustment loading amount and pelleting.
(3) soft capsule is suppressed：
31st, control wet capsule skin about in 0.8mm ± 0.05mm, control loading amount compacting soft capsule；
32nd, the soft capsule of compacting is synchronously transferred in drying rotating cage, round as a ball sizing；
(4) by the soft capsule after drying, it is processed by shot blasting, and picks；
(5) pack.
Embodiment 3：
Formula composition：
Production technology：
(1) capsule leather is standby：
11st, the purified water of formula ratio is weighed, 80 DEG C~90 DEG C are heated to；
12nd, sorbierite, glycerine stirring and dissolving one by one are sequentially added, titanium dioxide is added and is evenly stirred until no particulate matter；
13rd, gelatin is added, is sufficiently stirred for about 2 hours；
14th, vavuum pump is opened, bubble-free is evacuated to, and about 10 hours are incubated at 50 DEG C~60 DEG C.
(2) prepared by content：
21st, the Ai Er ostelins of formula ratio are taken, adds into absolute ethyl alcohol, transparence is stirred to clarify with glass bar, i.e.,
All dissolvings；
22nd, the median chain triglyceride oil of total amount 20% will be formulated, is transferred in above-mentioned solution, and adds vitamin E, is used
Electric mixer, mixing speed is tried one's best quick but can not be involved in large quantity of air, is stirred 1-2 hours；
23rd, above-mentioned solution is transferred in Rotary Evaporators, temperature 60 C is set, keep vacuum 0.08-0.1Mpa it
Between, most ethanol are rotated out, and detection limit residual is less than 0.5%；
24th, by above-mentioned solution, it is transferred in agitator tank, adds into the median chain triglyceride oil of surplus, and stir
Uniformly；
25th, adjustment loading amount and pelleting.
(3) soft capsule is suppressed：
1st, control wet capsule skin about in 0.8mm ± 0.05mm, control loading amount compacting soft capsule；
2nd, the soft capsule of compacting is synchronously transferred in drying rotating cage, round as a ball sizing；
4. by the soft capsule after drying, it is processed by shot blasting, and picks；
5. pack.
Experimental example
(1) different temperatures is set to carry out rotary evaporation, it is terminal to be similar to 0 with ethanol residue, and detects relevant material.
(2) absolute ethyl alcohol detection method：This product about 1.0g is taken, it is accurately weighed, put in 10ml measuring bottles, be dissolved in water and dilute
To scale, shake up, precision is measured in 2ml, top set empty bottle, seal, be used as need testing solution；Ethanol 500mg is taken respectively, and precision claims
It is fixed, put in 100ml measuring bottles, be diluted with water to scale, shake up, be used as control storing solution；Precision measures control storing solution 1ml, puts
In 10ml measuring bottles, scale is diluted with water to, is shaken up, precision is measured in 2ml, top set empty bottle, seals, is used as contrast solution.According to residual
Solvent determination method (three 0,861 second methods of Chinese Pharmacopoeia version in 2015) is stayed to determine, with (6%) cyanogen propyl group phenyl-(94%) diformazan
Based polysiloxane (or polarity is close) is that the capillary column of fixer (30m × 0.53mm × 3.0 μm) is chromatographic column；Initial temperature
For 45 DEG C, kept for 5 minutes, then 130 DEG C are risen to 20 DEG C/min speed, kept for 5 minutes；250 DEG C of detector temperature, injection port
150 DEG C of temperature；80 DEG C of ml headspace bottle equilibrium temperature (85 DEG C of clack box, 90 DEG C of pipeline), equilibration time 20 minutes.
(3) relevant substance detecting method：
1) chromatographic condition
Chromatographic column：Kromasil 100-5SIL 250×4.6mm
Mobile phase：N-hexane：Ethyl acetate：Chloroform：Methanol (35：55：10：4)
Detection wavelength：265nm, flow velocity：1.0ml/min, column temperature：Room temperature
2) prepared by solution
Need testing solution：Precision weighs two parts of this product content appropriate (being approximately equivalent to μ g of Ai Er ostelins 6), puts two
In 2ml measuring bottles, plus flow phased soln and be diluted to scale, shake up, be used as need testing solution.
Reference substance solution：Precision measures need testing solution 5ml, puts in 100ml measuring bottles, plus mobile phase is diluted to scale, shakes
It is even, it is used as contrast solution.
(4) experimental result：As shown in table 1.
Table 1
As a result show：With the increase of temperature, relevant material is also becoming big therewith, to ensure quality and improving efficiency,
Revolving temperature is set to 40-60 DEG C, preferably 50 DEG C.
The present invention is by lot of experiments, while this quality is ensured, in preparation process, passes through control
The temperature of rotary evaporation, pressure, time, the residual of final control absolute ethyl alcohol remove absolute ethyl alcohol, finished product is free of second
Alcohol.The ossified alcohol soft capasules of the Ai Er without ethanol, can make this product by for more patients, especially alcohol intolerance people
Group can preferably be treated.
Although the present invention is disclosed as above with embodiment, so it is not intended to limit the present invention, any people in the art
Member, without departing from the spirit and scope of the present invention, can make a variety of selections and modification, therefore the protection model of the present invention
Enclose and limited by claims and its equivalents.
Claims (8)
- The preparation method of alcohol soft capasule 1. a kind of Ai Er ossify, it is characterised in that comprise the following steps：1) preparation of capsule skin, 2) preparation of content and 3) compacting soft capsule, wherein, prepared by the content comprises the following steps：21) the Ai Er ostelins of formula ratio are taken, absolute ethyl alcohol are added, with glass bar stirring and dissolving to clear；22) 20% median chain triglyceride oil, the vitamin E of formula ratio, electric stirring 1-2 hours are added into above-mentioned solution；23) above-mentioned solution is transferred in Rotary Evaporators, 40-60 DEG C of temperature is set, keep vacuum 0.08-0.1Mpa, rotation Ethanol is steamed, and detection limit residual is less than 0.5%；24) above-mentioned solution is transferred in agitator tank, adds the median chain triglyceride oil of formula ratio 80%, stir；With And25) adjustment loading amount and pelleting.
- The preparation method of alcohol soft capasule 2. a kind of Ai Er according to claim 1 ossify, it is characterised in that the step 1) The preparation of capsule skin comprises the following steps：11) purified water of formula ratio is weighed, 80 DEG C -90 DEG C are heated to；12) sorbierite, glycerine stirring and dissolving are sequentially added, titanium dioxide is added and is evenly stirred until no particulate matter；13) gelatin is added, is sufficiently stirred for 2 hours；And14) vavuum pump is opened, bubble-free is evacuated to, and 10 hours are incubated at 50 DEG C -60 DEG C.
- The preparation method of alcohol soft capasule 3. a kind of Ai Er according to claim 1 ossify, it is characterised in that the step 3) Compacting soft capsule includes：31) wet capsule skin is controlled in 0.75mm-0.85mm, control loading amount compacting soft capsule；32) soft capsule of compacting is synchronously transferred in drying rotating cage, round as a ball sizing.
- The preparation method of alcohol soft capasule 4. Ai Er according to claim 1 ossify, it is characterised in that the Ai Er ostelins The preparation method of soft capsule also includes：4) polishing is picked, 5) packed.
- The preparation method of alcohol soft capasule 5. Ai Er according to claim 1 ossify, it is characterised in that the step 2) content The preparation of thing, the formula ratio of content includes following parts by weight of component：Ai Er ostelins 0.00075, vitamin E 0.02 and Median chain triglyceride oil 100.
- The preparation method of alcohol soft capasule 6. Ai Er according to claim 5 ossify, it is characterised in that the content is matched somebody with somebody Side, which is measured, also includes absolute ethyl alcohol, and the solid-to-liquid ratio of the Ai Er ostelins and the absolute ethyl alcohol is 0.00075:1.
- The preparation method of alcohol soft capasule 7. Ai Er according to claim 1 ossify, it is characterised in that the step 23) in, The temperature 50 C of the rotary evaporation, keeps vacuum 0.09Mpa, rotates out ethanol, and detection limit residual 0.1%.
- The preparation method of alcohol soft capasule 8. Ai Er according to claim 2 ossify, it is characterised in that the step 1) capsule In the preparation of skin, the formula ratio of capsule skin includes following parts by weight of component：Gelatin 79.42, glycerine 19.86, sorbierite 9.93, two Titanium oxide 0.79 and purified water 79.42.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109481414A (en) * | 2018-11-27 | 2019-03-19 | 正大制药（青岛）有限公司 | A kind of Chinese mugwort ground ossification alcohol soft capasule |
| CN110934847A (en) * | 2019-12-11 | 2020-03-31 | 正大制药（青岛）有限公司 | Preparation method of eldecalcitol soft capsule |
| JP2021024845A (en) * | 2019-08-09 | 2021-02-22 | 日医工株式会社 | Eldecalcitol gelatin agent |
| CN114685337A (en) * | 2022-04-24 | 2022-07-01 | 浙江花园生物高科股份有限公司 | Preparation method of eldecalcitol |
| CN115887407A (en) * | 2022-12-29 | 2023-04-04 | 深圳市泰力生物医药有限公司 | Sirolimus soft capsule and preparation method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109481414A (en) * | 2018-11-27 | 2019-03-19 | 正大制药（青岛）有限公司 | A kind of Chinese mugwort ground ossification alcohol soft capasule |
| CN109481414B (en) * | 2018-11-27 | 2021-05-04 | 正大制药（青岛）有限公司 | Adeladol soft capsule |
| JP2021024845A (en) * | 2019-08-09 | 2021-02-22 | 日医工株式会社 | Eldecalcitol gelatin agent |
| CN110934847A (en) * | 2019-12-11 | 2020-03-31 | 正大制药（青岛）有限公司 | Preparation method of eldecalcitol soft capsule |
| CN114685337A (en) * | 2022-04-24 | 2022-07-01 | 浙江花园生物高科股份有限公司 | Preparation method of eldecalcitol |
| CN114685337B (en) * | 2022-04-24 | 2023-08-29 | 浙江花园生物高科股份有限公司 | Preparation method of idecalcitol |
| CN115887407A (en) * | 2022-12-29 | 2023-04-04 | 深圳市泰力生物医药有限公司 | Sirolimus soft capsule and preparation method thereof |
| CN115887407B (en) * | 2022-12-29 | 2023-08-18 | 深圳市泰力生物医药有限公司 | Sirolimus soft capsule and preparation method thereof |
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