CN1233315C - Sibutramine hydrochloride guttate pill - Google Patents
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- CN1233315C CN1233315C CN 200410037846 CN200410037846A CN1233315C CN 1233315 C CN1233315 C CN 1233315C CN 200410037846 CN200410037846 CN 200410037846 CN 200410037846 A CN200410037846 A CN 200410037846A CN 1233315 C CN1233315 C CN 1233315C
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Abstract
The present invention discloses a pharmaceutical composition for curing obesity, especially a pharmaceutical composition oral administration dropping pills formulation containing sibutramine hydrochloride as an activity component. The objective in accordance with the present invention is to compensate for the insufficiency in prior arts, to provide hydrochloride dropping pills to patients and medical service workers sibutramine, wherein the sibutramine hydrochloride dropping pills have large drug loading amount, can release drugs and exhibits effects quickly, are high in bioavailability and low in price, and has small toxic and side effects. Said pharmaceutical composition is prepared through the following steps: selecting sibutramine hydrochloride as raw material, adding therein groundsubstances such as polyethyleneglycol surfactant, heating them until a melt water and/or emulsion and/or turbid liquor of the pharmaceutical composition containing sibutramine hydrochloride and groundsubstances therein is obtained, putting them into a pill dropping machine, droping them into a condensation agent for shrinkage shaping, taking them out and drying them by wiping them.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of obesity, particularly a kind of is the drug composition oral dropping pill formulation of active component with the Sibutramine hydrochloride.
Background technology
Current, along with China people's living standard raising, the incidence rate of obesity progressively raises, and nineteen eighty-two, 1989 and 1992 National urban incidence rate overweight and obesity is respectively 9.7%, 12.0% and 14.9%, is progressively trend of rising.Because obesity itself and close with it concurrent hypertension, blood fat disorder, type ii diabetes, coronary heart disease and part tumor etc. have had a strong impact on people's the quality of life and the life-span of shortening.Generally acknowledge that at present body weight reduces by 5%～10% and just can obviously improve the above-mentioned risk factor relevant with obesity, to through keep on a diet and add sharp movement and lose weight effect inadequately significantly the patient need short-term to add to use effective medicine
[1]
According to " Chinese clinical pharmacology and therapeutics " publication king paint, the research article introduction of Chen Bin: obesity is a kind of serious health problem, and in the past decade prevalence has increased by 30%, and about 1/3rd suffer from this disease in U.S. adult.The prevalence of Chinese obesity is now still lacked the Epidemiological study data of accurate large sample, from Shanghai, some data promptings of Hong Kong have the tendency of increasing.Many strong evidence promptings, ameliorate body Beijing South Maxpower Technology Co. Ltd reduces fat harm.The evidence that proposed in NIH technology assessment meeting in 1992 shows, pass through in diet, exercise or the slimming individuality of behavior therapy success in major part, about 1/3～2/3 after 1 year body weight can rebound, and nearly all people can return to original body weight after 5 years.To the physiopathologic further understanding of obesity, can promote everybody and further seek fat new treatment.
Obesity is a kind of chronic disease, and is similar with hypertension concerning many patients, also is a kind of chronic disease that needs long-term treatment, still do not have medicine at present and can cure.The target of Bariatric is to alleviate unnecessary body weight, and suitably loss of weight is good for one's health really, how to seek a kind of not only not only good, the side effect of economy, toleration but also few medicine effectively not only, is the problem of numerous medical personnels' joint research.
Sibutramine is a kind of new reduction appetite, the medicine of increase satiety, and it is the uptake inhibitor of 5-hydroxy tryptamine and norepinephrine.Sibutramine in 1998 through drugs approved by FDA listing, now in America and Europe and the listing of part Asian countries and be applied to clinical.
Data shows that sibutramine is taken medicine once every day, can alleviate the body weight of adiposis patient, improves lipid metabolism.In a research that schedules to last 24w, to observe for 10mg or more heavy dose of, average weight descends and surpasses placebo group 5%～8%.Under these dosage, in the administration stage of 24w, the decline of body weight is detected in the initial 12w of treatment, keeps stable later on, and is consistent with this group conclusion.In the research of rat, sibutramine reduces food intake, the order of being satiated with food in the preservation behavior, and can increase energy expenditure, these synergism can be explained observed result in this group data.The effect of this group data in 3 groups of different weight patients shows that drug effect becomes positive correlation with initial body weight, thereby predicts the ability of reacting in the future for the different weight patient.In addition, this group data also shows weight loss in the initial 2w＜1.5kg person's Low Response in future, this consistent and more saving of conclusion of predicting the ability of reaction in the future and predict the respond in future with 4w in 2w in other researchs.Predict the ability of reaction in the future according to the reaction of different weight and initial 2wk, can prevent nonresponder's long-term treatment, thereby increase sibutramine benefit, i.e. relative risk and cost effectiveness ratio.In loss of weight research,, it is important to estimate the benefit chance of patient in loss of weight research except estimating the average fall of body weight.The decline of body weight 5%～10% can make the clinical meaning of metabolic risk factors reduce.Serum TC H decline 1% can make the coronary heart disease incidence rate reduce 2%.The every 10mgL of serum hdl
-1Increase can make the coronary heart disease incidence rate reduce 2%～3%.The patient of sibutramine-treated has weight loss can cause expected blood fat and improving, but there is no the change of blood pressure.The minimizing of the increase of serum hdl and serum TG, TCH is relevant with the weight loss amplitude in this data, and the benefit of patient on blood fat that those weight loss in sibutramine-treated are maximum is also maximum.
In a word, sibutramine has lost weight more than 5%～10% most of adiposis patients, and the improvement of blood fat is arranged simultaneously, side effect is slight, blood pressure, changes in heart rate are little, and sibutramine can be tolerated well by patient once a day, and uncomplicated patient can lose weight safely and effectively to obesity
[2]
About sibutramine to the mechanism of action of human body and pharmacodynamics, pharmacokinetics, and the research data of the fat-reducing effect data that sees reference
[3,4,5]
The Sibutramine hydrochloride tablet that commonly used clinically is makes with its hydrochlorate " Sibutramine hydrochloride ", capsule etc.Because the characteristics that conventional tablet, capsule fabricating technology are had, make this class oral formulations have that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, bioavailability is lower, problems such as liver sausage first pass effect easily take place, thereby influence giving full play to of drug effect.Conventional simultaneously tablet, capsule supplementary product consumption are big, and relative cost is also higher, thereby has increased the certain economic burden to the patient.
Summary of the invention
Purpose of the present invention is to remedy the deficiencies in the prior art, provides a kind of drug loading big to extensive patients and medical personnel, release fast, and quick produce effects, the bioavailability height, toxic and side effects is little, cheap Sibuqumin hydrochloride drip pill.
Can obtain Sibuqumin hydrochloride drip pill involved in the present invention by following preparation method.
With the Sibutramine hydrochloride is raw material, mixes according to matrix phases such as certain ratio and surfactant polyethylenes, forms through specific prepared again.Specific as follows:
1. fill a prescription:
Sibutramine hydrochloride---English name SibutramineHydrochloride;
Another name---Qu Mei, Ao Lina, Reductil Aolina, Reductil;
Chemical structural formula---(±) N-{1-(1-4-chlorphenyl) cyclobutyl }-the 3-methyl butyl }-N, the N dimethylamine hydrochloride monohydrate
Molecular formula: C
12H
26ClN.HCl.H
2O; Molecular weight: 334.33;
Character: white or off-white powder.
Substrate---polyoxyethylene stearate 40 esters.
Proportioning---according to the weight portion meter (g, kg), Sibutramine hydrochloride: substrate=1: 1～1: 8;
More preferred proportioning is: Sibutramine hydrochloride: substrate=1: 3～1: 6;
Best proportioning is: Sibutramine hydrochloride: substrate=1: 5.
2. preparation method
(1) according to weight portion meter (g, kg), with 1: the ratio of (1～8), accurately take by weighing Sibutramine hydrochloride raw material and substrate, mix homogeneously, place in the heating container heating while stirring, standby until the pharmaceutical composition fused solution that obtains containing Sibutramine hydrochloride and substrate and/or emulsion and/or suspension;
(2) adopt self-control or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper storage tank temperature heating of drop pill machine and remain on (60～100) ℃, error＜2%; The temperature of condensing agent cooling and remain on (40～-15) ℃, error＜5% in the condensation column;
(3) treating that the temperature of condensing agent in the storage tank of dropping-pill machine head and the condensation column is stable respectively is in above second step during desired state of temperature, to contain the pharmaceutical composition fused solution of Sibutramine hydrochloride and substrate and/or emulsion and/or suspension and under the state of insulation, insert in the water dropper storage tank of drop pill machine, and splash into by water dropper with suitable speed and shrink shaping in the condensing agent naturally;
Condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
(4) drop pill that will shrink molding by the outlet of drop pill machine takes out, and removes the surface condensation agent, is drying to obtain.
Beneficial effect
Obesity is a chronic disease that sickness rate raises year by year, and common hypertension, diabetes, dyslipidemia etc. are all relevant with obesity, and above-mentioned cardiovascular risk factor has the tendency of gathering in the obese patient.Based on the conventional non-pharmaceutical intervention of diet control and motion, it is limited to reach the long-lasting effect that loses weight, and therefore, weight reduction with drugs remains an important supplementary means.
Existing be used for clinical sibutramine preparation Sibutramine hydrochloride tablet and Sibutramine hydrochloride capsule are arranged, because the influence of factors such as the characteristics of conventional oral formulations itself and preparation technology, make that the oral formulations of most drug often exists in actual taking that dissolve scattered time limit is long, dissolution is low, problem such as absorption difference, bioavailability are lower, GI irritation and liver sausage first pass effect, thereby influence the performance of drug effect, also directly affect the effect of treatment.
Conventional in addition oral formulations uses a large amount of adjuvants, and medicament contg is reduced, and volume increases, and has improved cost accordingly, has increased patient's financial burden.
Sibuqumin hydrochloride drip pill involved in the present invention utilizes polyoxyethylene stearate 40 esters as substrate, makes solid dispersion with Sibutramine hydrochloride, makes medicine be molecule, colloid or microcrystalline state and is dispersed in the substrate, and the total surface area of medicine is increased.And substrate is hydrophilic, and medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby makes the dissolving of medicine and absorb and accelerate, thereby has improved bioavailability, has brought into play efficient, quick-acting effects.Compare with other conventional oral formulations of Sibutramine hydrochloride, Sibuqumin hydrochloride drip pill involved in the present invention has following beneficial effect:
1. the drop pill that utilizes the solid dispersion technology preparation and get can adopt sublingual administration, and effective ingredient is fully contacted with mucomembranous surface, absorbs by mucomembranous epithelial cell, directly enters blood circulation.Especially sublingual administration administration contacts promptly with saliva and to dissolve rapidly, is absorbed by oral mucosa, directly enters blood circulation without gastrointestinal tract and liver, not only avoided the liver sausage first pass effect, and it is rapid to have brought into play onset, bioavailability height, the advantage that side effect is little.
2. Sibuqumin hydrochloride drip pill production technology, equipment involved in the present invention are simple, and the cycle is short, the automaticity height, and the production efficiency height, production cost can reduce patient's drug cost greatly with below 50% of kind tablet usually.With present commercially available bent U.S. capsule is example, take 288 yuan of month needs according to statistics, the cost of taking medicine of average every day is more than 9 yuan, and Sibuqumin hydrochloride drip pill involved in the present invention, with a specific embodiment products obtained therefrom is foundation, calculate according to identical dosage, according to forecasting of cost and economic analysis, the cost of taking medicine of every day only needs 2 yuan, be 22% of capsule, greatly reduce patient's financial burden, make Most patients all have the ability to use this up to now by universally acknowledged effective slimming medicine.
3. this preparation is by after solid drugs and substrate heating, being melt into liquid state, splash in the not miscible condensed fluid and make, and the stability of drug height, not facile hydrolysis, oxidation is not subject to the influence of crystal formation, thereby guaranteed drug quality, increased stability.
4. Sibuqumin hydrochloride drip pill involved in the present invention, main production process is all carried out under liquid state, and no dust pollution helps labor protection and environmental protection.
The specific embodiment
Below in conjunction with the experiment of two groups of specific embodiments, the preparation process and the experimental result of Sibuqumin hydrochloride drip pill involved in the present invention is described further.
Embodiment tests the prescription experiment of a Sibutramine hydrochloride and different substrates
Experimental design: select the influence of different substrates for use in order to observe, respectively with Polyethylene Glycol to Sibuqumin hydrochloride drip pill involved in the present invention
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000Polyoxyethylene stearate 40 esters, Lac, the polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium, any one is a substrate in the pharmaceutic adjuvants such as sodium lauryl sulphate, Sibutramine hydrochloride and above substrate are carried out prescription respectively with 1: 5 ratio, and according to the step of stipulating in the preparation method, place the heating container internal heating until the pharmaceutical composition fused solution and/or emulsion and/or the suspension that obtain containing Sibutramine hydrochloride and substrate respectively each group prepared materials, adopt homemade drop pill machine, regulating its temperature control system makes and satisfies preparation method second requirement in step, with the methyl-silicone oil is condensing agent, can obtain the prescription experiment of 9 Sibutramine hydrochloride and different substrates, and obtain 9 groups of different experimental results and see Table 1.
The prescription experiment of table 1 Sibutramine hydrochloride and different substrates
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 4000 | 25.0 | 96 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 95 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 66 | ＜30 | ＞10 | + |
| Lac | 25.0 | 38 | ＞30 | ＞10 | - |
| The polyoxyethylene monostearate | 25.0 | 88 | ＜30 | ＜10 | ++ |
| Polyethers | 25.0 | 82 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium | 25.0 | 78 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 25.0 | 72 | ＜30 | ＞10 | ++ |
Result by table 1 can find out: in an embodiment, when selecting different substrate, indexs such as, dissolve scattered time limit different to rounding rate, the ball method of double differences and hardness all have comparatively significantly influence.
Embodiment tests the experiment of two hydrochloric acid sibutramine and the different proportionings of substrate
Experimental design: carry out the influence of prescription in varing proportions in order to observe Sibutramine hydrochloride and substrate, select Polyethylene Glycol for use to Sibuqumin hydrochloride drip pill involved in the present invention
4000As substrate, respectively with 1: 1/1: 2/1: 3/1: 4/1: 5/1: 6/1: 7/1: 8 ratio is with Sibutramine hydrochloride and Polyethylene Glycol
4000Mix homogeneously, and according to defined terms in the preparation method and step, the mixed material that each assembly is made places the heating container internal heating respectively, until obtaining containing Sibutramine hydrochloride and Polyethylene Glycol
4000Pharmaceutical composition fused solution and/or emulsion and/or suspension, adopt homemade drop pill machine, regulate its temperature control system and make the requirement of satisfying second step in the preparation method, with the methyl-silicone oil is condensing agent, can obtain the test of 8 Sibutramine hydrochloride and the different proportionings of substrate, and obtain 8 groups of different result of the tests and see Table 2.
The experiment of table 2 sibutramine and the different proportionings of substrate
| Sibutramine: substrate | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| 1∶1 | 50.0 | 41 | ＜30 | ＞10 | + |
| 1∶2 | 33.3 | 73 | ＜30 | ＞10 | ++ |
| 1∶3 | 25.0 | 96 | ＜30 | ＜10 | +++ |
| 1∶4 | 20.0 | 96 | ＜30 | ＜10 | +++ |
| 1∶5 | 16.7 | 97 | ＜30 | ＜10 | +++ |
| 1∶6 | 14.3 | 95 | ＜30 | ＜10 | +++ |
| 1∶7 | 12.5 | 94 | ＜30 | ＜10 | +++ |
| 1∶8 | 11.1 | 95 | ＜30 | ＜10 | +++ |
Can be found out by table 2 result: in an embodiment, when the mixed proportion of Sibutramine hydrochloride raw material and substrate reached 1: 3, every index all entered a comparatively ideal state.
The partial reference data is as follows:
1. history ferrum cyclophanes, Pan Changyu, Guangwei LI etc. curative effect and the safety analysis of sibutramine in Chinese obese patient. Chinese endocrine metabolism magazine 2002; 18 (1): 70-74
2. the king paints, Chen Bin. and sibutramine is to different overweight peoples' loss of weight effect. Chinese clinical pharmacology and therapeutics 2002; 7 (4): 327-330
3. Zou advances greatly, Wang Zhuo. food inhibition type appetrol sibutramine. and Chinese Journal of New Drugs 2002; 11 (3): 200-203
4. spring, Da Hongyuan are known in a left side. appetrol of new generation---sibutramine .Chin J Clin Pharmacol2000; 16 (2): 155-157
5. Zhao Yong Fructus Citri tangerinae, Wang Xiaowei, Yan Zhongde etc. the comparative study of Sibutramine hydrochloride treatment Simple Obesity. Chinese Journal of Preventive Medicine 2001; 9-35 (5): 329-332
6. literary composition is heavy far away, Gao Yubin, Gan Peizhen. and sibutramine is to the observation of curative effect of Simple Obesity loss of weight. clinical department of internal medicine magazine 2002; 19 (3): 219-220
Claims (3)
1. Sibuqumin hydrochloride drip pill that is used for the treatment of obesity, by the active constituents of medicine Sibutramine hydrochloride with form as the surfactant of substrate, wherein:
Sibutramine hydrochloride---English name SibutramineHydrochloride,
Chemical structural formula: (±) N-{1-(1-4-chlorphenyl) cyclobutyl }-the 3-methyl butyl }-N, N dimethylamine hydrochloride monohydrate, substrate---polyoxyethylene stearate 40 esters;
The proportioning of Sibutramine hydrochloride and described substrate, with g or kg be unit of weight count 1: 1～1: 8.
2. Sibuqumin hydrochloride drip pill as claimed in claim 1 is characterized in that: the proportioning of Sibutramine hydrochloride and described substrate is 1: 3～1: 6.
3. Sibuqumin hydrochloride drip pill as claimed in claim 1 is characterized in that: the proportioning of Sibutramine hydrochloride and described substrate is 1: 5.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410037846 CN1233315C (en) | 2003-10-29 | 2004-05-12 | Sibutramine hydrochloride guttate pill |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200310102240.4 | 2003-10-29 | ||
| CN200310102240 | 2003-10-29 | ||
| CN 200410037846 CN1233315C (en) | 2003-10-29 | 2004-05-12 | Sibutramine hydrochloride guttate pill |
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| Publication Number | Publication Date |
|---|---|
| CN1543936A CN1543936A (en) | 2004-11-10 |
| CN1233315C true CN1233315C (en) | 2005-12-28 |
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|---|---|---|---|
| CN 200410037846 Expired - Fee Related CN1233315C (en) | 2003-10-29 | 2004-05-12 | Sibutramine hydrochloride guttate pill |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2024178428A1 (en) * | 2023-02-24 | 2024-08-29 | Glanbia Nutritionals, Inc. | Shelf stable organic nucleotide compositions and methods of manufacturing the same |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1327832C (en) * | 2006-04-05 | 2007-07-25 | 赵伟庆 | Sibuqumin hydrochloride drip pill |
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2004
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2024178428A1 (en) * | 2023-02-24 | 2024-08-29 | Glanbia Nutritionals, Inc. | Shelf stable organic nucleotide compositions and methods of manufacturing the same |
| US20240285541A1 (en) * | 2023-02-24 | 2024-08-29 | Glanbia Nutritionals, Inc. | Shelf stable organic nucleotide compositions and methods of manufacturing the same |
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| Publication number | Publication date |
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| CN1543936A (en) | 2004-11-10 |
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Effective date of registration: 20090123 Address after: No. 9, HANKOOK North Road, Jiangsu, Huaian Patentee after: Jiangsu Chiatai Qingjiang Pharmaceutical Co., Ltd. Address before: Beijing economic and Technological Development Zone Hongda North Road, 12 innovation building, block B, two floor Patentee before: Beijing Zhengda Oasis Medicine Technology Co., Ltd. |
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Owner name: JIANGSU ZHENGDA QINGJIANG PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: ZHENGDA-LUZHOU MEDICINE SCIENCE-TECHNOLOGY CO., LTD., BEIJING Effective date: 20090123 |
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