CN108451923A - Metformin hydrochloride quick-release capsules and preparation method thereof - Google Patents
Metformin hydrochloride quick-release capsules and preparation method thereof Download PDFInfo
- Publication number
- CN108451923A CN108451923A CN201810547570.0A CN201810547570A CN108451923A CN 108451923 A CN108451923 A CN 108451923A CN 201810547570 A CN201810547570 A CN 201810547570A CN 108451923 A CN108451923 A CN 108451923A
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- China
- Prior art keywords
- metformin hydrochloride
- release capsules
- preparation
- quick
- wet
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Classifications
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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
-
- 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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- 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
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
Abstract
The invention discloses a kind of Metformin hydrochloride quick-release capsules and preparation method thereof, which has steps of：1. Metformin hydrochloride bulk pharmaceutical chemicals and adhesive are put into according to recipe quantity ratio in wet mixing pelletizer, wet-mixing granulation；2. being dried in vacuo to 1. wet granular that step obtains；3. whole grain；4. the lubricant of recipe quantity is added and is always mixed；5. capsule is filled；Described adhesive selects hydroxypropyl methylcellulose and/or the dosage of polyvinylpyrrolidone and adhesive to be no more than Metformin hydrochloride bulk pharmaceutical chemicals weight 0.2%；1. wet-mixing Granulation time is 1~5min to the step, and 2. middle vacuum drying time is 3~4h to the step.The present invention is by optimizing pharmaceutical formulation and technological parameter, can obtain particle uniformly, good fluidity, the Metformin hydrochloride quick-release capsules that content uniformity is smaller and impurity content is less, the Metformin hydrochloride quick-release capsules bioavilability is high, and fast, good absorbing is disintegrated in gastrointestinal tract.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of Metformin hydrochloride quick-release capsules and its preparation side
Method.
Background technology
Metformin hydrochloride is a kind of biguanide antidiabetic medicament for treating diabetes, unsatisfied for diet-treated only
Patients with NIDDM, it is especially fat and with hyperinsulinemia person, not only there is hypoglycemic effect with this medicine, it is also possible to have and subtract
The effect of light weight and hyperinsulinemia.Its main pharmacological does not promote the secretion of insulin instead of, promote tissue without
Oxygen glycolysis is made the tissues such as muscle be reinforced using the effect of glucose, while inhibiting the heteroplasia of hepatic glycogen, and the production of glycogen is reduced
It is raw, so that blood glucose is reduced.
The chemical name of Metformin hydrochloride is 1,1-Dimethylbiguanide hydrochloride, and structural formula is as follows：
。
Existing Metformin hydrochloride capsule includes mainly quick-release capsules（Namely conventional capsule）, capsulae enterosolubilis（Referring to
CN102416007A、CN103284975A）, spansule（Referring to CN103239424A, CN104922091A）And controlled release glue
Capsule（Referring to CN1742730A, CN103356661A）Several major class.
Although capsulae enterosolubilis and spansule can alleviate improvement GI irritation, effect is in contrast poorer.
Controlled release capsule can either improve GI irritation, and effect is relatively also preferable, but production cost is higher, leads to price
It is more expensive.
Main problem is existing for existing Metformin hydrochloride quick-release capsules：Particle uniformity and mobility are poor, into
And lead to that content uniformity is larger and impurity content is higher, especially newest impurity F（Namely dimethylamine）Content.
Invention content
It is an object of the invention to solve the above problems, provide a kind of particle uniformly, good fluidity, content uniformity it is smaller and
The less Metformin hydrochloride quick-release capsules and preparation method thereof of impurity content.
Realizing the technical solution of the object of the invention is：A kind of preparation method of Metformin hydrochloride quick-release capsules, have with
Lower step：
1. Metformin hydrochloride bulk pharmaceutical chemicals and adhesive are put into according to recipe quantity ratio in wet mixing pelletizer, wet-mixing
Granulation；
2. being dried in vacuo to 1. wet granular that step obtains；
3. whole grain；
4. the lubricant of recipe quantity is added and is always mixed；
5. capsule is filled.
Above-mentioned steps 1. described in Metformin hydrochloride bulk pharmaceutical chemicals must through 40~80 mesh sieve crush, preferably through 60 mesh sieve powder
It is broken.
Above-mentioned steps 1. described in adhesive type and dosage be solve above-mentioned technical problem key technological means it
One, applicant has found by many experiments：Adhesive selects hydroxypropyl methylcellulose and/or polyvinylpyrrolidone and adhesive
Dosage is no more than Metformin hydrochloride bulk pharmaceutical chemicals weight 0.2%, can effectively solve the problem that above-mentioned technical problem；It is preferred that 0.05%~
0.18%。
The hydroxypropyl methylcellulose is preferably a concentration of 10%~15% hydroxypropyl methylcellulose aqueous solution or ethanol solution.
The mark viscosity of the hydroxypropyl methylcellulose is 1~100mPas, preferably 1~20mPas, more preferably 3
~15mPas.
The hydroxypropyl methylcellulose includes but not limited to E3 PREMIUM LV1 and E5 the PREMIUM LV1 of the Dow Chemical Company,
E3 PHARM, the E5 PHARM and E6 PHARM of Ya Shilan companies, company of SHIN-ETSU HANTOTAI 603,606, SM-4, SM-15,60SH-
The product of 50 equal-specification models.
The polyvinylpyrrolidone be preferably a concentration of 5%~15% aqueous povidone solution or ethyl alcohol it is molten
Liquid.
The K values of the polyvinylpyrrolidone are 27~32, preferably 30.
Above-mentioned steps 1. in the specific method is as follows：Metformin hydrochloride bulk pharmaceutical chemicals are first added, open stirring, shearing
（15Hz）, after dry-mixed 5~15min, binder solution is added, continues to stir, sheared（30~40Hz）, wet-mixing granulation 1
~5min, you can shut down discharging.
Above-mentioned steps 2. described in vacuum drying vacuum degree≤- 0.06MPa, bath temperature is 60~70 DEG C, warm in case
Degree is 40 DEG C~60 DEG C, and drying time is 3~4h.
Above-mentioned steps 1. in wet-mixing Granulation time and above-mentioned steps 2. in drying time be to solve above-mentioned skill
Another important technical of art problem, wet-mixing Granulation time and drying time longer can cause to some extent
Grain is uneven, and caking is hardened, and then influences mobility and content uniformity, while can also make special impurities F（Dimethylamine）Slightly increase
Add.
Above-mentioned steps 3. described in the mesh size that uses of whole grain for 0.8~3.0mm, electric machine frequency is 20~30Hz.
Above-mentioned steps 4. described in lubricant be sodium stearyl fumarate, magnesium stearate, talcum powder, one kind in silica
Or it is two or more（Containing two kinds）.
The dosage of the lubricant is the 0.1%~1.0% of Metformin hydrochloride weight.
Above-mentioned steps 4. described in it is always mixed use mixed frequency for 25~30Hz, incorporation time is 5~20min.
Above-mentioned Metformin hydrochloride quick-release capsules dosage usage is：It is oral.It takes at once when dining or after the meal, adult starts
0.25g（1）, 2~3 times on the one, dosage is adjusted according to blood glucose and glucose in urine later, daily maximum dose is no more than 2.0g（8
Grain）, or follow the doctor's advice.
The good effect that the present invention has：（1）The present invention can be obtained by optimizing pharmaceutical formulation and technological parameter
Grain uniformly, good fluidity, the Metformin hydrochloride quick-release capsules that content uniformity is smaller and impurity content is less, the hydrochloride is double
Guanidine quick-release capsules bioavilability is high, and fast, good absorbing is disintegrated in gastrointestinal tract.（2）The Metformin hydrochloride quick-release capsules of the present invention
Component is less, and preparation process is relatively simple, and product quality is stably and controllable, compared to existing other capsule formulations, not only hypoglycemic
Effect is preferable, and production cost is relatively low, thus greatly reduces drug price, is more suitable for the selection of ordinary populace.
Specific implementation mode
（Embodiment 1）
The Metformin hydrochloride quick-release capsules technology preparation of the present embodiment is as follows：Metformin hydrochloride bulk pharmaceutical chemicals 75.0kg, hydroxypropyl
Methylcellulose 0.08kg；Magnesium stearate 0.5kg.
General assembly 300,000, the hydrochloric melbine of every theory are 0.25g.
The preparation method of the Metformin hydrochloride quick-release capsules has steps of：
1. first dry-mixed by Metformin hydrochloride bulk pharmaceutical chemicals input wet mixing pelletizers of the 75.0kg after 60 mesh sieve crushes
Then the hydroxypropyl methylcellulose aqueous solution of a concentration of 10wt% of 0.8kg is added in 5min（The present embodiment is using E5 PREMIUM
LV1）, continue to stir, wet-mixing granulation 3min.
2. being dried in vacuo to 1. wet granular that step obtains using vacuum drying chamber, vacuum degree≤- 0.06MPa, water
Bath temperature is 70 DEG C, and the temperature inside the box is 50 DEG C, and dry 3h, sampling surveys moisture, meets the requirements, shut down, discharge.
3. 2. dry particle that step obtains is used the sieve in the apertures 2.0mm, carries out whole grain with the electric machine frequency of 20Hz.
4. the magnesium stearate of 0.5kg is added and is always mixed, use mixed frequency for 25Hz, incorporation time 10min.
5. by step 4. always mix after particle according to recipe quantity be packed into No. 1 hard capsule case to get.
（2~embodiment of embodiment 4）
The preparation method of each embodiment is substantially the same manner as Example 1, and difference is shown in Table 1.
Table 1
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| Adhesive | Hydroxypropyl methylcellulose E5 | Hydroxypropyl methylcellulose E5 | PVP K30 | PVP K30 |
| Binder dosage | 0.8kg | 0.9kg | 0.6kg | 0.7kg |
| Binder concn | 10wt% | 13wt% | 10wt% | 12wt% |
| Wet-mixing Granulation time | 3min | 5min | 2min | 3min |
（1~comparative example of comparative example 4）
The preparation method of each comparative example is substantially the same manner as Example 1, and difference is shown in Table 2.
Table 2
| Embodiment 1 | Comparative example 1 | Comparative example 2 | Comparative example 3 | Comparative example 4 | |
| Adhesive | Hydroxypropyl methylcellulose E5 | Hydroxypropyl methylcellulose E5 | PVP K30 | Hydroxypropyl methylcellulose E5 | PVP K30 |
| Binder dosage | 0.8kg | 1.2kg | 2.0kg | 0.8kg | 0.8kg |
| Binder concn | 10wt% | 18wt% | 10wt% | 10wt% | 10wt% |
| Granulation time | 3min | 3min | 3min | 8min | 8min |
| Drying time | 3h | 3h | 3h | 5h | 5h |
（Comparative example 5）
The preparation method of this comparative example is substantially the same manner as Example 1, the difference is that：Step 1. in Metformin hydrochloride original
It is 20min that material medicine was added together, which also has 2.0kg mannitol and 1.6kg cornstarch, dry-mixed time,.
（Test case）
In the same way with standard detection Examples 1 to 4, the Metformin hydrochloride quick-release capsules preparation process of comparative example 1~5
In, step be 2. dried in vacuo after particle proterties, step 4. always mix after particle proterties, content uniformity of step when 5. filling with
And the content of impurity F, it the results are shown in Table 3.
Table 3
| Step be 2. dried in vacuo after particle proterties | Step 4. always mix after particle proterties | Content uniformity | Impurity F content | |
| Embodiment 1 | Slight caking, light pressure are loose | Particle is uniform, good fluidity | ±6.7% | 0.005% |
| Embodiment 2 | It slightly lumps, light pressure is loose | Particle is uniform, good fluidity | ±5.9% | 0.003% |
| Embodiment 3 | Slight caking, light pressure are loose | Particle is uniform, good fluidity | ±5.6% | 0.004% |
| Embodiment 4 | It slightly lumps, light pressure is loose | Particle is uniform, good fluidity | ±5.7% | 0.004% |
| Comparative example 1 | In big bulk, light pressure is not broken | Particle is harder, uneven, and mobility is general | ±8.3% | 0.011% |
| Comparative example 2 | In big bulk, light pressure is not broken | Particle is harder, uneven, and mobility is general | ±8.4% | 0.009% |
| Comparative example 3 | In big bulk, light pressure is not broken | Particle is harder, uneven, and mobility is general | ±8.2% | 0.012% |
| Comparative example 4 | In big bulk, light pressure is not broken | Particle is harder, uneven, and mobility is general | ±8.5% | 0.010% |
| Comparative example 5 | Slight caking, light pressure are loose | Particle is uniform, and mobility is general | ±7.8% | 0.016% |
As can be seen from Table 3：With the increase of binder dosage when wet granulation, the increase of wet granulation time and true
The increase of empty drying time all can cause particle uneven to some extent, and caking is hardened, and then influence mobility and loading amount are poor
It is different, while can also make special impurities F（Dimethylamine）It is slightly increased.
Claims (10)
1. a kind of preparation method of Metformin hydrochloride quick-release capsules, it is characterised in that have steps of：
1. Metformin hydrochloride bulk pharmaceutical chemicals and adhesive are put into according to recipe quantity ratio in wet mixing pelletizer, wet-mixing
Granulation；
2. being dried in vacuo to 1. wet granular that step obtains；
3. whole grain；
4. the lubricant of recipe quantity is added and is always mixed；
5. capsule is filled.
2. the preparation method of according to claim a kind of Metformin hydrochloride quick-release capsules, it is characterised in that：Above-mentioned steps
1. Metformin hydrochloride bulk pharmaceutical chemicals described in must be sieved through 40~80 mesh and be crushed.
3. the preparation method of according to claim a kind of Metformin hydrochloride quick-release capsules, it is characterised in that：Above-mentioned steps
1. adhesive described in is hydroxypropyl methylcellulose and/or polyvinylpyrrolidone；The dosage of described adhesive is no more than hydrochloric acid two
The 0.2% of first biguanides bulk pharmaceutical chemicals weight.
4. the preparation method of according to claim 3 kind of Metformin hydrochloride quick-release capsules, it is characterised in that：The bonding
The dosage of agent is the 0.05%~0.18% of Metformin hydrochloride bulk pharmaceutical chemicals weight.
5. the preparation method of according to claim 3 kind of Metformin hydrochloride quick-release capsules, it is characterised in that：The hydroxypropyl
The hydroxypropyl methylcellulose aqueous solution or ethanol solution that methylcellulose is a concentration of 10%~15%；The mark of the hydroxypropyl methylcellulose
Show that viscosity is 1~20mPas.
6. the preparation method of according to claim 3 kind of Metformin hydrochloride quick-release capsules, it is characterised in that：The poly- second
The aqueous povidone solution or ethanol solution that alkene pyrrolidone is a concentration of 5%~15%；The polyvinylpyrrolidine
The K values of ketone are 27~32.
7. the preparation method of according to claim a kind of Metformin hydrochloride quick-release capsules, it is characterised in that：Above-mentioned steps
1. in, wet-mixing Granulation time is 1~5min.
8. the preparation method of according to claim a kind of Metformin hydrochloride quick-release capsules, it is characterised in that：Above-mentioned steps
2. in, vacuum drying time is 3~4h.
9. the preparation method of according to claim a kind of Metformin hydrochloride quick-release capsules, it is characterised in that：Above-mentioned steps
Lubricant described in 4. be sodium stearyl fumarate, magnesium stearate, talcum powder, it is more than one or two kinds of in silica；Institute
The dosage for stating lubricant is the 0.1%~1.0% of Metformin hydrochloride bulk pharmaceutical chemicals weight.
10. a kind of Metformin hydrochloride quick-release capsules made from one of claim 1 to 9 preparation method.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112451511A (en) * | 2020-12-31 | 2021-03-09 | 寿光富康制药有限公司 | Metformin hydrochloride preparation and preparation method thereof |
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2018
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| US5955106A (en) * | 1994-09-14 | 1999-09-21 | Moeckel; Joern | Pharmaceutical preparation containing metformin and a process for producing it |
| CN1414852A (en) * | 1999-11-16 | 2003-04-30 | 史密斯克莱·比奇曼公司 | Novel composition and use thereof |
| CN1561980A (en) * | 2004-03-26 | 2005-01-12 | 贵州圣济堂制药有限公司 | Melbine hydrochloride enteric coatel slow-releasing preparation and its preparing method |
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| CN112451511A (en) * | 2020-12-31 | 2021-03-09 | 寿光富康制药有限公司 | Metformin hydrochloride preparation and preparation method thereof |
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