CN103417475B - Barusiban injection and preparation method thereof - Google Patents
Barusiban injection and preparation method thereof Download PDFInfo
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- CN103417475B CN103417475B CN201310263023.7A CN201310263023A CN103417475B CN 103417475 B CN103417475 B CN 103417475B CN 201310263023 A CN201310263023 A CN 201310263023A CN 103417475 B CN103417475 B CN 103417475B
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Abstract
The invention relates to the technical field of medicine and discloses a barusiban injection and a preparation method thereof. The barusiban injection has the pH value of 4-6 and comprises acetic acid barusiban, mannitol, a pH modifier and injection water, wherein in the 265 mL injection, the mass ratio of acetic acid barusiban and mannitol is 1: (5-25), and the balance is the pH modifier and the injection water. As the mannitol and the specific pH modifier are added into the barusiban injection to serve as components for maintaining the stability of acetic acid barusiban, the injection is kept in the pH of 4-6, the stability of the injection in the extreme environment is maintained, the quality is stable, the probability of drug degradation is low, the drug safety and effectiveness are improved and long-term storage is facilitated.
Description
Technical field
The present invention relates to medical art, be specifically related to a kind of Barusiban injection and preparation method thereof.
Background technology
The western class of Baruch (barusiban) is the polypeptide compound of synthetic after transformation on the basis of oxytocin structure, and be the competitive antagonist of myometrium and decidua, fetal membrane upper annular peptide oxytocin receptor, structural formula is as follows:
Clinical research confirmation, sickness rate, the mortality rate of premature infant are closely related with pregnant age, and with the increase in pregnant age, the incidence and mortality relevant to premature labor obviously reduces.The premature infant that pregnant age is less than 28 weeks, often postpone the neonate of birth in 1 day, its survival rate can improve 3%.In 2,000 ten thousand neonates that China is born every year, premature infant reaches 2,000,000, in the U.S., 4,000,000 neonates are had to be born every year, wherein have the anemia of pregnant woman of 500,000 ~ 1,000,000 to need with the premature labor of anti-premature labor chemoprophylaxis, in Europe, nearly 8,000,000 neonates are born every year, estimate that the anemia of pregnant woman of 2,000,000 ~ 3,000,000 needs to adopt the treatment of anti-premature labor medicine, the treatment of premature labor is the focus of world health medical research always.At present, the anti-premature labor medicine the most often used is tocolytic agent, mainly comprises magnesium sulfate, calcium antagonist (common medicine: nifedipine), beta-2 adrenoceptor agonist (common medicine: ritodrine), oxytocin receptor antagonists (atosiban).Current clinical medicine research shows, with magnesium sulfate, calcium antagonist, beta-2 adrenoceptor agonist is compared, and oxytocin receptor antagonists atosiban significantly can reduce early productive rate, and side effect is less, can prolong pregnancy week 48h better, has higher female tire safety,
The western class of Baruch is the second filial generation oxytocin antagonist of Ferring company exploitation, for the treatment of prevention of preterm birth and infertility.Preclinical study proves, compared with first generation oxytocin antagonist atosiban, with 3 ~ 4 times that the affinity of oxytocin receptor is atosiban, there is better selectivity and stronger anti-uterine contraction activity, the uterine contraction inhibitory action of the western class of Baruch continues more for a long time (being greater than 13 ~ 15h), and atosiban is 1 ~ 3h, and uterine contraction inhibitory action is reversible, therefore, this medical instrument has very high clinical practice and market prospect.
The domestic and international commercialized product without this medicine at present, generally all Israel and Palestine western Shandong class acetate form injecting drug use clinically, but the less stable of the western class of acetic acid Baruch, places for a long time or is in extreme environment, and purity can drop to less than 90%, solution turned cloudy, the regulation of total impurities content more than 10%, therefore, needs to develop the good Barusiban injection of a kind of stability, to improve safety and the effectiveness of its medication, be convenient to long term storage.
Summary of the invention
In view of this, the object of the present invention is to provide a kind of Barusiban injection and preparation method thereof, make the Barusiban injection stability prepared by the present invention, be mainly manifested in solution clarity, pharmaceutical purity and total impurities content aspect.
For achieving the above object, the invention provides following technical scheme:
A kind of Barusiban injection, pH value is 4-6, comprises the western class of acetic acid Baruch, mannitol, pH adjusting agent and water for injection, wherein, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-25, and surplus is pH adjusting agent and water for injection.
For the problem of acetic acid Baruch western class less stable, the present invention selectively with the western class of acetic acid Baruch, mannitol, pH adjusting agent and water for injection for injection component, and be 4-6 by pH adjusting agent maintenance injection pH value, reach the stable object maintaining the western class of acetic acid Baruch.
Barusiban injection of the present invention is by determining that pH value is the consumption that 4-6 determines pH value regulator.Meanwhile, those skilled in the art in the expansion of the injection basis equal percentage of 265mL specification or can reduce the consumption changing each component, and this belongs to core technology category of the present invention equally.
As preferably, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-20, and surplus is pH adjusting agent and water for injection.Wherein, in some embodiments of the present invention, in every 265mL injection, Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol, pH adjusting agent mass ratio be 1:5-16.67:0.008-0.213, surplus is water for injection.
More preferably, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-10, and surplus is pH adjusting agent and water for injection.Wherein, in some embodiments of the present invention, in every 265mL injection, Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol, pH adjusting agent mass ratio be 1:5-16.67:0.016-0.04, surplus is water for injection.
Preferably, described pH adjusting agent is one or more in phosphoric acid, citric acid, sodium hydrogen phosphate, acetic acid, hydrochloric acid and sodium acetate.Follow preferably, described pH adjusting agent is the one in phosphoric acid, citric acid, acetate and hydrochloride, or is the buffer of phosphoric acid and sodium hydrogen phosphate, or is the buffer of acetic acid and sodium acetate.Wherein, the mass ratio of described phosphoric acid and sodium hydrogen phosphate is 57:65, and the mass ratio of described acetic acid and sodium acetate is 13:19.
In addition, the present invention also provides a kind of preparation method of Barusiban injection, gets mannitol and is dissolved in 200mL water for injection, then add the mixing of acetic acid Baruch western class, then add pH adjusting agent, adjustment pH is 4-6, add water for injection to 265mL, filtration sterilization, to obtain final product;
Wherein, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-25, and surplus is pH adjusting agent and water for injection.
As preferably, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-20, and surplus is pH adjusting agent and water for injection.Wherein, in some embodiments of the present invention, in every 265mL injection, Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol, pH adjusting agent mass ratio be 1:5-16.67:0.008-0.213, surplus is water for injection.
More preferably, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-10, and surplus is pH adjusting agent and water for injection.Wherein, in some embodiments of the present invention, in every 265mL injection, Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol, pH adjusting agent mass ratio be 1:5-16.67:0.016-0.04, surplus is water for injection.
Preferably, described pH adjusting agent is one or more in phosphoric acid, citric acid, sodium hydrogen phosphate, acetic acid, hydrochloric acid and sodium acetate.Follow preferably, described pH adjusting agent is the one in phosphoric acid, citric acid, acetate and hydrochloride, or is the buffer of phosphoric acid and sodium hydrogen phosphate, or is the buffer of acetic acid and sodium acetate.Wherein, the mass ratio of described phosphoric acid and sodium hydrogen phosphate is 57:65, and the mass ratio of described acetic acid and sodium acetate is 13:19.
Barusiban injection the present invention prepared carries out Detection of Stability respectively under hot and humid condition, result shows, under the high temperature conditions, place the regulation of total impurities more than 10% after 10 days, and medicine labelled amount is more than 90%, clarity of injection declines slightly, and stability in the large is higher.Under high humidity environment, total impurities is not more than 3%, and medicine labelled amount is more than 98%, and clarity of injection is clear still, and stability is higher.Show that Barusiban injection provided by the invention can, safe be applied in clinical treatment more more stable than the existing western class of acetic acid Baruch.
From above technical scheme, Barusiban injection interpolation mannitol of the present invention and specific pH adjusting agent are as the component maintaining acetic acid Baruch western class stability, and keep injection to be in pH4-6, maintain injection stability in extreme circumstances, steady quality, medicine is not easily degraded, and improves safety and the effectiveness of its medication, is convenient to long term storage.
Detailed description of the invention
The invention discloses a kind of Barusiban injection and preparation method thereof, those skilled in the art can use for reference present disclosure, and suitable improving technique parameter realizes.Special needs to be pointed out is, all similar replacements and change apparent to those skilled in the art, they are all deemed to be included in the present invention.Product of the present invention and method are described by preferred embodiment, related personnel obviously can not depart from content of the present invention, spirit and scope compound as herein described and preparation method are changed or suitably change with combination, realize and apply the technology of the present invention.
The phosphoric acid that the pH adjusting agent added in Barusiban injection actual disposition process of the present invention adopts is 85% phosphoric acid, and hydrochloric acid is 10% dilute hydrochloric acid, and acetic acid is 100% acetic acid, but all needs to be converted into 100% phosphoric acid, 100% hydrochloric acid and 100% acetic acid according to proportioning of the present invention.
Below in conjunction with embodiment, set forth the present invention further.
Embodiment 1: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 2500mg mannitol, after adding 200mL water for injection stirring and dissolving, take the western class of 150mg acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds phosphoric acid, the pH value regulating solution is 4 ~ 6, supplements the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 50.
Embodiment 2: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 2500mg mannitol, after adding 200mL water for injection stirring and dissolving, take the western class of 250mg acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds hydrochloric acid, the pH value regulating solution is 4 ~ 6, supplements the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 50.
Embodiment 3: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 2500mg mannitol, after adding 200mL water for injection stirring and dissolving, take the western class of 375mg acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds hydrochloric acid, the pH value regulating solution is 4 ~ 6, supplements the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 50.
Embodiment 4: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 2500mg mannitol, after adding 200mL water for injection stirring and dissolving, take the western class of 500mg acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds hydrochloric acid, the pH value regulating solution is 4 ~ 6, supplements the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 50.
Embodiment 5: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 2500mg mannitol, after adding 200mL water for injection stirring and dissolving, take the western class of 150mg acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds hydrochloric acid, the pH value regulating solution is 4 ~ 6, supplements the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 50.
Embodiment 6: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 2500mg mannitol, after adding 200mL water for injection stirring and dissolving, take the western class of 375mg acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds acetic acid, the pH value regulating solution is 4 ~ 6, supplements the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 50.
Embodiment 7: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 2500mg mannitol, after adding 200mL water for injection stirring and dissolving, take the western class of 375mg acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds the acid of stubborn lemon, the pH value regulating solution is 4 ~ 6, supplements the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 50.
Embodiment 8: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 2500mg mannitol, after adding 200mL water for injection stirring and dissolving, take the western class of 375mg acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds Acetic acid-sodium acetate buffer, and the pH value regulating solution is 4 ~ 6, supplement the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 50.
Embodiment 9: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 2500mg mannitol, after adding 200mL water for injection stirring and dissolving, take the western class of 375mg acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds phosphoric acid-sodium hydrogen phosphate buffer, and the pH value regulating solution is 4 ~ 6, supplement the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 50.
Embodiment 10: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 500g mannitol, after adding 40L water for injection stirring and dissolving, take the western class of 75g acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds hydrochloric acid, the pH value regulating solution is 4 ~ 6, supplements the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 10000
Embodiment 11: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 500g mannitol, after adding 40L water for injection stirring and dissolving, take the western class of 100g acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds hydrochloric acid, the pH value regulating solution is 4 ~ 6, supplements the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 10000.
Embodiment 12: the preparation of acetic acid Barusiban injection
Hundred-grade super-clean workbench in ten thousand grades of toilets and in toilet carries out, and gets each component:
Take 500g mannitol, after adding 40L water for injection stirring and dissolving, take the western class of 50g acetic acid Baruch (Israel and Palestine western Shandong class meter), add in solution, stirring and dissolving is clarified to solution, adds hydrochloric acid, the pH value regulating solution is 4 ~ 6, supplements the residue injection water yield, filtration sterilization; Divide and be filled to 7ml cillin bottle, every bottle of 5.3ml, jumps a queue, and rolls lid, totally 10000.
Embodiment 13: hot test
By acetic acid Barusiban injection obtained for the embodiment of the present invention 1 ~ 12 respectively under the high temperature conditions 40 DEG C place 0 day, 5 days and 10 days, then sample respectively, investigate its purity (labelled amount) change, solution clarity and total impurities situation, the results are shown in Table 1.
Table 1 hot test result
As shown in Table 1, in the acetic acid Barusiban injection that the embodiment of the present invention 2 ~ 4 and embodiment 11 provide, the decrease speed of acetic acid Baruch western class sign content is slow, remain on more than 90%, impurity increases few, do not exceed 10% of regulation, and solution clarity just declines, not muddy, stability in the large is higher.The result of the test of other embodiments of the invention and table 1 have the data of equal extent.
Embodiment 14: high wet test
Get acetic acid Barusiban injection that the embodiment of the present invention 2, embodiment 11 and embodiment 12 provide 2-8 DEG C of temperature, relative humidity is under the high humidity holding conditions of 60%, the long-time stability of further investigation acetic acid Barusiban injection provided by the invention, solution clarity change and purity situation of change, the results are shown in Table 2.
Table 2 high humidity result of the test
As seen from the results in Table 2, acetic acid Barusiban injection provided by the invention is all qualified at purity, clarity and total impurities after 12 months in storage, steady quality.The result of the test of other embodiments of the invention and table 1 have the data of equal extent.
The above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, under the premise without departing from the principles of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (9)
1. a Barusiban injection, it is characterized in that, pH value is 4-6, comprise the western class of acetic acid Baruch, mannitol, pH adjusting agent and water for injection, wherein, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-25, surplus is pH adjusting agent and water for injection, and described pH adjusting agent is one or more in phosphoric acid, citric acid, sodium hydrogen phosphate, acetic acid, hydrochloric acid and sodium acetate.
2. Barusiban injection according to claim 1, is characterized in that, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-20, and surplus is pH adjusting agent and water for injection.
3. Barusiban injection according to claim 2, is characterized in that, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-10, and surplus is pH adjusting agent and water for injection.
4. Barusiban injection according to claim 1, it is characterized in that, described pH adjusting agent is the one in phosphoric acid, citric acid, acetate and hydrochloride, or is the buffer of phosphoric acid and sodium hydrogen phosphate, or is the buffer of acetic acid and sodium acetate.
5. a preparation method for Barusiban injection, is characterized in that, gets mannitol and is dissolved in 200mL water for injection, and then add the mixing of acetic acid Baruch western class, then add pH adjusting agent, adjustment pH is 4-6, adds water for injection to 265mL, filtration sterilization, to obtain final product;
Wherein, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-25, and surplus is pH adjusting agent and water for injection.
6. preparation method according to claim 5, is characterized in that, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-20, and surplus is pH adjusting agent and water for injection.
7. preparation method according to claim 6, is characterized in that, in every 265mL injection, the mass ratio of Israel and Palestine western Shandong class of described acetic acid Baruch western class meter and mannitol is 1:5-10, and surplus is pH adjusting agent and water for injection.
8. preparation method according to claim 5-7 any one, is characterized in that, described pH adjusting agent is one or more in phosphoric acid, citric acid, sodium hydrogen phosphate, acetic acid, hydrochloric acid and sodium acetate.
9. preparation method according to claim 8, it is characterized in that, described pH adjusting agent is the one in phosphoric acid, citric acid, acetate and hydrochloride, or is the buffer of phosphoric acid and sodium hydrogen phosphate, or is the buffer of acetic acid and sodium acetate.
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| CN201310263023.7A CN103417475B (en) | 2013-06-27 | 2013-06-27 | Barusiban injection and preparation method thereof |
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| CN201310263023.7A CN103417475B (en) | 2013-06-27 | 2013-06-27 | Barusiban injection and preparation method thereof |
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| CN103417475B true CN103417475B (en) | 2015-06-17 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1913953A1 (en) * | 2004-01-19 | 2008-04-23 | Ferring BV | Use of substances having oxytocin antagonistic properties for the preparation of a medicament for treating hypertension |
| CN102146121A (en) * | 2010-11-19 | 2011-08-10 | 深圳市健元医药科技有限公司 | Process for producing antagonist medicament containing OXT (oxytocin) |
| CN102145162A (en) * | 2010-11-12 | 2011-08-10 | 深圳市健元医药科技有限公司 | Injection of medicine for treating premature delivery |
| CN102875650A (en) * | 2012-09-26 | 2013-01-16 | 深圳翰宇药业股份有限公司 | Preparation method of barusiban |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX2007014022A (en) * | 2005-05-10 | 2008-02-07 | Ferring Int Ct Sa | Use of antagonists of oxytocin and/or vasopressin in assisted reproduction. |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1913953A1 (en) * | 2004-01-19 | 2008-04-23 | Ferring BV | Use of substances having oxytocin antagonistic properties for the preparation of a medicament for treating hypertension |
| CN102145162A (en) * | 2010-11-12 | 2011-08-10 | 深圳市健元医药科技有限公司 | Injection of medicine for treating premature delivery |
| CN102146121A (en) * | 2010-11-19 | 2011-08-10 | 深圳市健元医药科技有限公司 | Process for producing antagonist medicament containing OXT (oxytocin) |
| CN102875650A (en) * | 2012-09-26 | 2013-01-16 | 深圳翰宇药业股份有限公司 | Preparation method of barusiban |
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