CN103054793A - Propranolol hydrochloride cream used for treating infantile hemangioma, and preparation method thereof - Google Patents
Propranolol hydrochloride cream used for treating infantile hemangioma, and preparation method thereof Download PDFInfo
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- CN103054793A CN103054793A CN2013100039115A CN201310003911A CN103054793A CN 103054793 A CN103054793 A CN 103054793A CN 2013100039115 A CN2013100039115 A CN 2013100039115A CN 201310003911 A CN201310003911 A CN 201310003911A CN 103054793 A CN103054793 A CN 103054793A
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Abstract
The invention discloses a propranolol hydrochloride cream used for treating infantile hemangioma, and a preparation method thereof. The cream comprises the components of, by weight, 0.8-1.2% of propranolol hydrochloride, 5.5-8% of octadecanol, 5.5-8% of glycerol monostearate, 5.5-8% of stearic acid, 7.5-10.5% of liquid paraffin, 7.5-10.5% of glycerol, 7.5-10.5% of propylene glycol, 1.5-2.5% of an emulsifier, 0.4-0.6% of a penetration enhancer, 0.08-0.12% of a preservative, and balance of water. The propranolol hydrochloride cream provided by the invention has good stability, and an effective duration of at least 24 months. The cream can directly act upon an infection site, such that local medicine concentration is high, and adverse reactions caused by oral administration or intravenous administration can be avoided. With the cream, medicine effect can be maximized, and medicine side effect can be reduced. The cream has a definite effect, and is suitable for industrialized large-scale productions. The cream is used for treating hemangioma and is especially suitable for treating infantile hemangioma.
Description
Technical field
The present invention relates to a kind of propranolol hydrochloride emulsifiable paste that is used for the treatment of infant hemangioma and preparation method thereof.
Background technology
Infant hemangioma (infantile hemangioma) is a kind of congenital dysplasia that occurs in period of embryo's vascularization process, is more common in after when birth or the birth soon, and be infant modal benign tumor in period.But 85～90% hemangioma spontaneous regression need not special treatment, but part-blood tuberculation growth site may threat to life, affect body function or destruction appearance, then need active treatment.Therapeutic Method comprises excision, cold therapy, radiation and radio nuclide therapy, laser therapy, Drug therapy etc., and Drug therapy is the most frequently used therapeutic modality.The traditional treatment medicine comprises glucocorticoid, interferon, antitumor drug etc.Above medicine respectively has pluses and minuses, but all has untoward reaction in various degree.
The Propranolol toleration is good, after reported first treatment infant hemangioma in 2008 is achieved success, causes powerful repercussion in the doctors such as department of pediatrics, plastic surgery, Oral and Maxillofacial Surgery and department of dermatologry, becomes the angiomatous new selection of Drug therapy.A large amount of clinical practices confirm that the propranolol in treatment hemangioma is rapid-action, determined curative effect, and individual variation is little, and in the normal dose scope, the Propranolol untoward reaction is few.Potential untoward reaction has bradycardia, hypotension, bronchospasm, drowsiness or insomnia, dream dimple, appetite depression, diaphoresis, hypoglycemia.The premature infant, less than 3 months babies and take medicine night and long-time fasting more is prone to hypoglycemia.
Mainly be by oral Propranolol sheet treatment hemangioma at present clinically, but for infant, the Propranolol tablet will be divided into 1/3～1/4 part of use, this split-run control dosage is very difficult, thereby infant dosage just can't accurately grasp, therefore the bad control of tablet dose is taken also inconvenient, there is clinical expert to consider medicine dissolution in liquid in the North America, uses the Propranolol oral administration solution and treat.On the other hand, the oral first pass effect of hepar of Propranolol is strong, and approximately 30～40% medicine original shapes enter the body circulation behind liver metabolism, and bioavailability is low, and individual variation is larger, and easy and other drug interacts.And the half-life is short, and blood concentration fluctuation is larger, needs repeat administration.For addressing this problem, someone has proposed Propranolol topical treatment hemangioma.Foreign study shows, the Propranolol Topical therapy is effective, and untoward reaction is little, can use separately or be used in conjunction with other therapies, and topical administration obviously has better safety.But systemic Absorption reduces because local concentration is high, and it may have preferably application prospect in the angiomatous curative effect of shallow.
This research proposes first preparation propranolol hydrochloride emulsifiable paste and is used for the treatment of infant hemangioma, though former studies has the research of propranolol hydrochloride transdermal delivery system, its research all is to be used for the treatment of hypertension; Also have at present propranolol hydrochloride is prepared into patch, because the infant hemangioma treatment cycle reaches half a year, therefore the patch significant discomfort is used for the infant hemangioma treatment.
Summary of the invention
The object of the present invention is to provide a kind of propranolol hydrochloride emulsifiable paste that is used for the treatment of infant hemangioma and preparation method thereof.
For addressing the above problem, the technical solution used in the present invention is:
A kind of propranolol hydrochloride emulsifiable paste that is used for the treatment of infant hemangioma, the component of the percentage by weight of described emulsifiable paste: propranolol hydrochloride 0.8～1.2%, octadecanol 5.5～8%, glyceryl monostearate 5.5～8%, stearic acid 5.5～8%, liquid Paraffin 7.5～10.5%, glycerol 7.5～10.5%, propylene glycol 7.5～10.5%, emulsifying agent 1.5～2.5%, penetration enhancer 0.4～0.6%, antiseptic 0.08～0.12%, surplus are water.
Preferably, described emulsifiable paste is comprised of the component of following percentage by weight: propranolol hydrochloride 1%, octadecanol 6.5%, glyceryl monostearate 6.5%, stearic acid 6.5%, liquid Paraffin 9%, glycerol 9%, propylene glycol 9%, emulsifying agent 2%, penetration enhancer 0.5%, antiseptic 0.1%, surplus are water.
Preferably, emulsifying agent is sodium lauryl sulphate.
Preferably, penetration enhancer is azone.
Preferably, antiseptic is ethyl hydroxybenzoate.
The preparation method of above-mentioned propranolol hydrochloride emulsifiable paste may further comprise the steps:
1) octadecanol, glyceryl monostearate, stearic acid, liquid Paraffin are mixed, be heated to melting after, water-soluble control temperature gets oil phase at 60～80 ℃;
2) the part water boil is mixed with antiseptic, be stirred to fully dissolving, add residue water, glycerol, propylene glycol, emulsifying agent, penetration enhancer, propranolol hydrochloride, water-bath control temperature gets water at 60～80 ℃;
3) oil phase is joined aqueous phase, stir, cooling namely gets the propranolol hydrochloride emulsifiable paste.
The usage of propranolol hydrochloride emulsifiable paste of the present invention: external is coated in patient vessel's tumor surface, every day 1～2 time.
The invention has the beneficial effects as follows:
Propranolol hydrochloride stability of cream of the present invention is good, the effect duration of emulsifiable paste is 24 months at least, emulsifiable paste can directly act on infection site, make local drug concentration high, avoided the untoward reaction due to oral administration or the intravenously administrable, emulsifiable paste of the present invention can be brought into play drug effect to greatest extent, reduces again drug side effect.
Emulsifiable paste determined curative effect of the present invention is suitable for large-scale industrialization production, is used for the treatment of hemangioma, is particularly useful for the treatment of infant hemangioma.
Description of drawings
Fig. 1 is the high-efficient liquid phase chromatogram of propranolol hydrochloride emulsifiable paste;
Fig. 2 is the high-efficient liquid phase chromatogram of propranolol hydrochloride;
Fig. 3 be the blank emulsifiable paste high-efficient liquid phase chromatogram;
Fig. 4 facial hemangioma infant patients is used emulsifiable paste of the present invention front and back contrast effect figure;
The hemangioma infant patient of Fig. 5 ear uses emulsifiable paste of the present invention front and back contrast effect figure.
The specific embodiment
The present invention is further illustrated below in conjunction with specific embodiment, but do not limit to so.
Embodiment 1
A kind of propranolol hydrochloride emulsifiable paste that is used for the treatment of infant hemangioma, component by following percentage by weight forms: propranolol hydrochloride 1%, octadecanol 6.5%, glyceryl monostearate 6.5%, stearic acid 6.5%, liquid Paraffin 9%, glycerol 9%, propylene glycol 9%, sodium lauryl sulphate 2%, azone 0.5%, ethyl hydroxybenzoate 0.1%, surplus are water.
The preparation method of above-mentioned propranolol hydrochloride emulsifiable paste may further comprise the steps:
1) octadecanol, glyceryl monostearate, stearic acid, liquid Paraffin are mixed, be heated to melting after, water-soluble control temperature gets oil phase at 70 ℃;
2) the part water boil is mixed with ethyl hydroxybenzoate, be stirred to fully dissolving, add residue water, glycerol, propylene glycol, sodium lauryl sulphate, azone, propranolol hydrochloride, water-bath control temperature gets water at 70 ℃;
3) oil phase is joined aqueous phase, stir, be cooled to 25～30 ℃, get final product.
The high-efficient liquid phase chromatogram of gained propranolol hydrochloride emulsifiable paste is seen Fig. 1, the appearance time of its first peak is 11.218min, the appearance time at the second peak is 15.033min, the high-efficient liquid phase chromatogram of propranolol hydrochloride is seen Fig. 2, the appearance time of its first peak is 15.048min, the blank emulsifiable paste high-efficient liquid phase chromatogram see Fig. 3, the appearance time of its first peak is 11.246min, the blank emulsifiable paste also is by above-mentioned prescription and preparation method preparation, does not just add propranolol hydrochloride in the prescription.As seen from the figure, the appearance time in the propranolol hydrochloride emulsifiable paste of the present invention and Fig. 2 and Fig. 3 coincide, and the propranolol hydrochloride stable components is constant in the emulsifiable paste.
A kind of propranolol hydrochloride emulsifiable paste that is used for the treatment of infant hemangioma, component by following percentage by weight forms: propranolol hydrochloride 0.8%, octadecanol 8%, glyceryl monostearate 8%, stearic acid 5.5%, liquid Paraffin 7.5%, glycerol 10.5%, propylene glycol 7.5%, sodium lauryl sulphate 2.5%, azone 0.4%, ethyl hydroxybenzoate 0.08%, surplus are water.
The preparation method of above-mentioned propranolol hydrochloride emulsifiable paste may further comprise the steps:
1) octadecanol, glyceryl monostearate, stearic acid, liquid Paraffin are mixed, be heated to melting after, water-soluble control temperature gets oil phase at 60 ℃;
2) the part water boil is mixed with ethyl hydroxybenzoate, be stirred to fully dissolving, add residue water, glycerol, propylene glycol, sodium lauryl sulphate, azone, propranolol hydrochloride, water-bath control temperature gets water at 60 ℃;
3) oil phase is joined aqueous phase, stir, be cooled to 25～30 ℃, get final product.
Embodiment 3
A kind of propranolol hydrochloride emulsifiable paste that is used for the treatment of infant hemangioma, component by following percentage by weight forms: propranolol hydrochloride 1.2%, octadecanol 5.5%, glyceryl monostearate 5.5%, stearic acid 8%, liquid Paraffin 10.5%, glycerol 7.5%, propylene glycol 10.5%, sodium lauryl sulphate 1.5%, azone 0.6%, ethyl hydroxybenzoate 0.12%, surplus are water.
The preparation method of above-mentioned propranolol hydrochloride emulsifiable paste may further comprise the steps:
1) octadecanol, glyceryl monostearate, stearic acid, liquid Paraffin are mixed, be heated to melting after, water-soluble control temperature gets oil phase at 80 ℃;
2) the part water boil is mixed with ethyl hydroxybenzoate, be stirred to fully dissolving, add residue water, glycerol, propylene glycol, lauryl sulphate acid, azone, propranolol hydrochloride, water-bath control temperature gets water at 80 ℃;
3) oil phase is joined aqueous phase, stir, be cooled to 25～30 ℃, get final product.
Stability experiment:
The study on the stability method is: 1) centrifugal layering experiment: with the emulsifiable paste centrifuge tube of packing into, 3000rmin
-1, centrifugal 15min, the profit layering result of observation emulsifiable paste; 2) cold-resistant experiment: be under-15 ℃ in temperature, emulsifiable paste is placed 24h, the profit layering result of observation emulsifiable paste; 3) heat-resistant experiment: 2h is placed in the emulsifiable paste water-bath, and bath temperature is 55 ℃, observes the profit layering result of emulsifiable paste;
Adopt said method that the propranolol hydrochloride emulsifiable paste of all embodiment is carried out stability experiment.The performance test results sees Table 1, and as seen from table, the stability of emulsifiable paste of the present invention is better, and the profit of emulsifiable paste is not stratified, and emulsifiable paste is cold-resistant, heat-resisting.
Accelerated stability test:
Press pertinent regulations among Chinese Pharmacopoeia version appendix in 2010 XIXC it " crude drug and pharmaceutical preparation stability test guideline ", get the propranolol hydrochloride emulsifiable paste of embodiment 1, put temperature: 30 ± 2 ℃, relative humidity: 65 ± 5% times placements 6 months.Sampling in 1,2,3,6 month, according to quality standard, detect respectively this product character, lamination, microbial limit, assay index, replication 3 times respectively.The sampling of propranolol hydrochloride emulsifiable paste different time detects according to quality standard, and each index all meets the requirements, and investigates and the results are shown in Table 2.
As shown in Table 2, propranolol hydrochloride emulsifiable paste of the present invention was placed 6 months under acceleration environment, and after testing, each index all meets the requirement of propranolol hydrochloride emulsifiable paste quality standard, so at least 24 months lower effect duration of propranolol hydrochloride emulsifiable paste room temperature of the present invention.
Efficacy experiment:
Adopt face of propranolol hydrochloride cream for treating of embodiment 1 that angiomatous 6 months large babies are arranged, see the left figure of Fig. 4 before the treatment, use the effect of emulsifiable paste of the present invention after 4 months to see the right figure of Fig. 4, the redness of contrast visible vessels tumor shoals, and the surface that hemangioma is outstanding also disappears flat, contrasts as seen, and hemangioma is clearly better, and have no side effect, visible emulsifiable paste of the present invention has good therapeutic effect to infant hemangioma.
Adopt auris dextra of propranolol hydrochloride cream for treating of embodiment 1 to suffer from angiomatous 14 months large infant, before the treatment, the left figure among Fig. 5 is seen in the affected part of this infant, use the effect of emulsifiable paste of the present invention after 4 months to see right figure among Fig. 5, contrast as seen, the hemangioma that the baby suffers from take a favorable turn, and have no side effect, as seen, do not take the propranolol hydrochloride tablets agent, emulsifiable paste of the present invention also reaches the effect of effectively treating infant hemangioma.
Claims (6)
1. propranolol hydrochloride emulsifiable paste that is used for the treatment of infant hemangioma, the component of the percentage by weight of described emulsifiable paste: propranolol hydrochloride 0.8～1.2%, octadecanol 5.5～8%, glyceryl monostearate 5.5～8%, stearic acid 5.5～8%, liquid Paraffin 7.5～10.5%, glycerol 7.5～10.5%, propylene glycol 7.5～10.5%, emulsifying agent 1.5～2.5%, penetration enhancer 0.4～0.6%, antiseptic 0.08～0.12%, surplus are water.
2. propranolol hydrochloride emulsifiable paste according to claim 1, it is characterized in that: described emulsifiable paste is comprised of the component of following percentage by weight: propranolol hydrochloride 1%, octadecanol 6.5%, glyceryl monostearate 6.5%, stearic acid 6.5%, liquid Paraffin 9%, glycerol 9%, propylene glycol 9%, emulsifying agent 2%, penetration enhancer 0.5%, antiseptic 0.1%, surplus are water.
3. propranolol hydrochloride emulsifiable paste according to claim 1 and 2, it is characterized in that: emulsifying agent is sodium lauryl sulphate.
4. propranolol hydrochloride emulsifiable paste according to claim 1 and 2, it is characterized in that: penetration enhancer is azone.
5. propranolol hydrochloride emulsifiable paste according to claim 1 and 2, it is characterized in that: antiseptic is ethyl hydroxybenzoate.
6. the preparation method of claim 1 or 2 described propranolol hydrochloride emulsifiable pastes may further comprise the steps:
1) octadecanol, glyceryl monostearate, stearic acid, liquid Paraffin are mixed, be heated to melting after, water-soluble control temperature gets oil phase at 60～80 ℃;
2) the part water boil is mixed with antiseptic, be stirred to fully dissolving, add residue water, glycerol, propylene glycol, emulsifying agent, penetration enhancer, propranolol hydrochloride, water-bath control temperature gets water at 60～80 ℃;
3) oil phase is joined aqueous phase, stir, cooling namely gets the propranolol hydrochloride emulsifiable paste.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103239405A (en) * | 2013-05-24 | 2013-08-14 | 南京市妇幼保健院 | Preparation method of propranolol stealth liposome modified by vascular endothelial growth factor receptor-2 (VEGFR-2) monoclonal antibody and casein phosphopeptides (CPP) jointly, and products thereof |
| CN105106105A (en) * | 2015-08-14 | 2015-12-02 | 天津市聚星康华医药科技有限公司 | Application of external timolol preparations in treating infantile hemangioma and preparation method thereof |
| CN106176582A (en) * | 2016-08-25 | 2016-12-07 | 赣南医学院 | A kind of for atenolol emulsifiable paste treating infant hemangioma and preparation method thereof |
| CN106474061A (en) * | 2016-12-08 | 2017-03-08 | 黑龙江童医生儿童生物制药有限公司 | A kind of propranolol hydrochloride Orally taken emulsion and preparation method thereof |
| CN110314154A (en) * | 2018-03-28 | 2019-10-11 | 武汉恒信源药业有限公司 | Application of the left-handed Propranolol in preparation treatment vascular lesion drug |
| CN110464774A (en) * | 2019-09-17 | 2019-11-19 | 河南百年康鑫药业有限公司 | A kind of compound hydrochloric acid Propranolol oral solution for treating infantile hemangioma |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103239405A (en) * | 2013-05-24 | 2013-08-14 | 南京市妇幼保健院 | Preparation method of propranolol stealth liposome modified by vascular endothelial growth factor receptor-2 (VEGFR-2) monoclonal antibody and casein phosphopeptides (CPP) jointly, and products thereof |
| CN103239405B (en) * | 2013-05-24 | 2014-07-30 | 南京市妇幼保健院 | Preparation method of propranolol stealth liposome modified by vascular endothelial growth factor receptor-2 (VEGFR-2) monoclonal antibody and casein phosphopeptides (CPP) jointly, and products thereof |
| CN105106105A (en) * | 2015-08-14 | 2015-12-02 | 天津市聚星康华医药科技有限公司 | Application of external timolol preparations in treating infantile hemangioma and preparation method thereof |
| CN106176582A (en) * | 2016-08-25 | 2016-12-07 | 赣南医学院 | A kind of for atenolol emulsifiable paste treating infant hemangioma and preparation method thereof |
| CN106474061A (en) * | 2016-12-08 | 2017-03-08 | 黑龙江童医生儿童生物制药有限公司 | A kind of propranolol hydrochloride Orally taken emulsion and preparation method thereof |
| CN106474061B (en) * | 2016-12-08 | 2019-01-22 | 黑龙江童医生儿童生物制药有限公司 | A kind of Propranolol Hydrochloride Orally taken emulsion and preparation method thereof |
| CN110314154A (en) * | 2018-03-28 | 2019-10-11 | 武汉恒信源药业有限公司 | Application of the left-handed Propranolol in preparation treatment vascular lesion drug |
| CN110464774A (en) * | 2019-09-17 | 2019-11-19 | 河南百年康鑫药业有限公司 | A kind of compound hydrochloric acid Propranolol oral solution for treating infantile hemangioma |
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