CN101979048B - A kind of pharmaceutical composition of Flos Lonicerae and method for making thereof - Google Patents

A kind of pharmaceutical composition of Flos Lonicerae and method for making thereof Download PDF

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CN101979048B
CN101979048B CN201010517668.5A CN201010517668A CN101979048B CN 101979048 B CN101979048 B CN 101979048B CN 201010517668 A CN201010517668 A CN 201010517668A CN 101979048 B CN101979048 B CN 101979048B
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pharmaceutical composition
flos lonicerae
volatile oil
radix
water
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CN101979048A (en
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谢顺国
邓娟
孙善娇
何芳
郭敏
廖妮英
邓春玲
蒋怀林
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HUNAN JINGHETANG PHARMACEUTICAL CO Ltd
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Abstract

The present invention relates to a kind of pharmaceutical composition and method for making thereof of Flos Lonicerae.Said composition makes acceptable dosage form on pharmaceutics by Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Herba Menthae, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizae, Borneolum Syntheticum; This pharmaceutical composition has effect of clearing away heat-fire removing toxic substances, YIN nourishing tonifying the lung, is mainly used in the diseases such as the laryngopharynx swelling and pain that acute/chronic pharyngitis and cold, fever cause.The present invention also comprises the preparation method of described pharmaceutical composition.Buccal tablet prepared by pharmaceutical composition of the present invention, treatment acute pharyngitis total effective rate reaches 95%.

Description

A kind of pharmaceutical composition of Flos Lonicerae and method for making thereof
Technical field
The present invention relates to a kind of pharmaceutical composition and method for making thereof, especially relate to a kind of pharmaceutical composition and method for making thereof of Flos Lonicerae.
Background technology
Acute, chronic pharyngitis is common clinical, frequently-occurring disease, for respiratory tract common acute one of catches.The environmental pollutions such as industrial waste gas, dust, chemistry cause this sick sickness rate to raise, and about in urbanite, sickness rate accounts for 10% to 20% of laryngopharyngeal diseases, male's sickness rate is comparatively more than women.Clinical main manifestations is: pharyngeal discomfort, has foreign body sensation, the sense of expectorant viscous, always feel pharyngeal have pharynx not under thing that can not tell again, block, swell, scorching hot, dry, itch, irritative cough, micro-ly have pharyngalgia etc.Because its course of disease is long, symptom is obstinate, and short-term difficulty is shown in effective, therefore not easily cures, and has a strong impact on mankind's health and work and study.Western medical treatment pharyngitis generally focuses on local application, as: rinse medicine, with 2% canopy acid solution, 3% saline and 1: 5000 furacilin solution rinse repeatedly, or with 2% iodine glycerol, 5% protargol liquid way in pharynx wall, or to be contained in oral cavity etc. with tabellae iodi gurgitis, oradol, Herba Menthae etc., there is the function of certain relief of symptoms, but cannot effect a radical cure; The kind for the treatment of by Chinese herbs pharyngitis has: Qingyanlihou granules, liyan jiedu granule, fall ball, JINSANGZIHOUBAO, Herba Pileae Scriptae Tabellae, watermelon crystal etc. clearly, all lays particular emphasis on clearing away heat-fire removing toxic substances.And the present invention is on the basis of the clearing away heat-fire removing toxic substances such as Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, is accompanied by middle Radix Ophiopogonis, Fructus Crataegi, takes into account YIN nourishing tonifying the lung, sour sweet stomach function regulating, be intended to effect a permanent cure, be aided with Herba Menthae, Borneolum Syntheticum also increase heat clearing away effect while regulating mouthfeel simultaneously.
Summary of the invention
The object of the invention is to: provide one to treat acute, chronic pharyngitis, the Flos Lonicerae pharmaceutical composition of upper respiratory tract infection and method for making thereof.
The present invention is achieved in that calculation by weight, and the raw material making this pharmaceutical composition effective ingredient is: Flos Lonicerae 30 ~ 100g, Flos Chrysanthemi 15 ~ 50g, Radix Platycodonis 15 ~ 50g, Herba Menthae 15 ~ 50g, Radix Ophiopogonis 15 ~ 50g, Fructus Crataegi 15 ~ 50g, Radix Glycyrrhizae 3g ~ 10g, Borneolum Syntheticum 0.6 ~ 1.5g.
Flos Lonicerae pharmaceutical composition of the present invention can be made acceptable dosage form on pharmaceutics, comprise agent, granule, tablet, capsule, oral liquid, drop pill, slow releasing preparation or controlled release preparation etc., preferred particulates agent, capsule, tablet, particularly preferably buccal tablet.
Flos Lonicerae medicament composition granule agent preparation method of the present invention: Herba Menthae adds water distillation, extracts volatile oil for subsequent use, and the another device of debris is collected, volatile oil, Borneolum Syntheticum ethanol are made into saturated solution, slowly add in beta-schardinger dextrin-saturated aqueous solution and prepare Benexate Hydrochloride, dry, for subsequent use; All the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizae etc. decoct with water, and filter, then are added by the medicinal residues after extracting volatile oil, decoct with water, filter, merging filtrate and above-mentioned debris, concentrating under reduced pressure becomes extractum, add appropriate amount of auxiliary materials, granulate, dry, mix with Benexate Hydrochloride, subpackage, to obtain final product.
Flos Lonicerae medicament composition capsule agent preparation method of the present invention: Herba Menthae adds water distillation, extracts volatile oil for subsequent use, and the another device of debris is collected, volatile oil, Borneolum Syntheticum ethanol are made into saturated solution, slowly add in beta-schardinger dextrin-saturated aqueous solution and prepare Benexate Hydrochloride, dry, for subsequent use; All the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizae etc. decoct with water, and filter, then are added by the medicinal residues after extracting volatile oil, decoct with water, filter, merging filtrate and above-mentioned debris, concentrating under reduced pressure becomes extractum, add appropriate amount of auxiliary materials, granulate, dry, mix with Benexate Hydrochloride, encapsulated, to obtain final product.
Flos Lonicerae medicinal composition tablets preparation method of the present invention: Herba Menthae adds water distillation, extracts volatile oil for subsequent use, and the another device of debris is collected, volatile oil, Borneolum Syntheticum ethanol are made into saturated solution, slowly add in beta-schardinger dextrin-saturated aqueous solution and prepare Benexate Hydrochloride, dry, for subsequent use; All the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizae etc. decoct with water, and filter, then are added by the medicinal residues after extracting volatile oil, decoct with water, filter, merging filtrate and above-mentioned debris, concentrating under reduced pressure becomes extractum, adds appropriate amount of auxiliary materials and Benexate Hydrochloride, mixing, granulate, drying, adds appropriate magnesium stearate, mixing, tabletted, to obtain final product.
Flos Lonicerae pharmaceutical composition buccal tablet preparation method of the present invention: Herba Menthae adds 14 times of water gagings and distills 6 hours, extracts volatile oil for subsequent use, and the another device of debris is collected, get volatile oil and Borneolum Syntheticum ethanol is made into saturated solution, slowly add in beta-schardinger dextrin-saturated aqueous solution, cryogenic thermostat stirs 2 hours, refrigerated overnight, sucking filtration, and 40 DEG C dry, pulverize, are prepared into Benexate Hydrochloride for subsequent use, all the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizaes etc. decoct with water three times, 2 hours first times, second time 1.5 hours, add water and two be respectively 10 times amount and 8 times amount, merging filtrate, filter, medicinal residues and the medicinal residues after extracting volatile oil merge, add water 6 times amount again, decoct 1 hour, filter, merging filtrate and above-mentioned debris, when being evaporated to 60 DEG C, relative density is 1.20 ~ 1.30, above-mentioned extractum and Benexate Hydrochloride add appropriate amount of starch, dextrin, mannitol, sucrose (1: 1: 2: 2), mixing, granulate, less than 40 DEG C dry, granulate, add appropriate magnesium stearate, mixing, tabletted, obtains buccal tablet.
The traditional Chinese medical science think pharyngitis endogenous cause of ill mostly be lung, spleen, stomach function unbalance, exopathogenic factor mostly is wind heat and invades (or wind and cold strongly fragrant and heat-transformation), and pyretic toxicity follows through upper heap soil or fertilizer over and around the roots, venation numbness resistance and falling ill.This composition prescription detoxifies as monarch drug with Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis clearing away heat-fire; With YIN nourishing tonifying the lung Radix Ophiopogonis, treatment minor symptom is ministerial drug; Up with Herba Menthae, Borneolum Syntheticum heat-clearing and toxic substances removing, priming, be adjuvant drug altogether; Fructus Crataegi, the sweet stomach function regulating of glycyrrhizic acid concoct all medicines for making medicine.For the treatment of the disease such as laryngopharynx swelling and pain of acute/chronic pharyngitis and flu engine.
We have carried out pharmacodynamics and clinical research with Flos Lonicerae pharmaceutical composition buccal tablet of the present invention, and its main Review Study is as follows.
1, pharmacodynamic study result shows: this product can alleviate rat granuloma and to swell weight; Reduce the acetic acid twisting number of times of mice; Alleviate toes swelling degree caused by rat Ovum Gallus domesticus album and mice auricle swelling degree.Illustrate the present composition not only can inflammation-inhibiting occur in early days ooze out, swell and ache, the granulation tissue hyperplasia in later stage, can also reduce inflammation and ease pain.Extracorporeal bacteria inhibitor test, show that concentration of the present invention is that the solution of 2.0g/ml is to the minimal bactericidal concentration (MBC of common respiratory tract pathogenic bacterium staphylococcus aureus, escherichia coli, group B streptococcus, streptococcus pneumoniae, %) be 10.0, show that the present invention has obvious bacteriostasis.
2, clinical test results shows: case selection standard, observation index, efficacy assessment standard, all with reference to " guideline of clinical investigations of new Chinese medicine treatment acute pharyngitis ".Include anemopyretic acute pharyngitis patient 60 example in, be divided into treatment group 40 example according to the ratio randomized, double-blind for the treatment of group and matched group 2:1, matched group 20 example.Treatment group takes pharmaceutical composition buccal tablet of the present invention, each 1,6 times on the one; Matched group takes FUFANG CAOSHANHU HANPIAN, each 2,2 hours 1,6 times on the one, be 7 days the course for the treatment of.Viewing duration, two groups of cases all not to take treatment acute pharyngitis other in, western drug.Result shows: treatment group and matched group are through statistical analysis on sex, age, integration of illness, the course of disease distribute, and difference that there are no significant (P > 0.05), illustrates two groups of distributing equilibriums, have comparability.Treatment group cure rate reaches 62%, and total effective rate reaches 95%; Symptoms such as comparing there was no significant difference (P > 0.05) with matched group, two groups of medicines are scorching hot, thirsty to pharyngalgia, dry pharynx, cough, pharyngeal mucous membrane are congested is all significantly improved effect.In observation process, do not find obvious adverse reaction.
Detailed description of the invention
Embodiments of the invention 1: Flos Lonicerae 30g, Flos Chrysanthemi 15g, Radix Platycodonis 15g, Herba Menthae 15g, Radix Ophiopogonis 15g, Fructus Crataegi 15g, Radix Glycyrrhizae 3g, Borneolum Syntheticum 0.6g.
Herba Menthae adds 14 times of water gagings and distills 6 hours, extracts volatile oil for subsequent use, and the another device of debris is collected, get volatile oil and Borneolum Syntheticum ethanol is made into saturated solution, slowly add in 6 times amount beta-schardinger dextrin-saturated aqueous solutions, 50 DEG C of constant temperature enclose 2 hours, refrigerated overnight, sucking filtration, 40 DEG C dry, pulverize, are prepared into Benexate Hydrochloride for subsequent use, all the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizaes etc. decoct with water three times, 2 hours first times, second time 1.5 hours, add water and two be respectively 10 times amount and 8 times amount, merging filtrate, filter, medicinal residues and the medicinal residues after extracting volatile oil merge, add water 6 times amount again, decoct 1 hour, filter, merging filtrate and above-mentioned debris, concentrating under reduced pressure (-0.08MPa) to relative density is 1.20 ~ 1.30 (60 DEG C), above-mentioned extractum adds 2 times amount sucrose, 1 times amount dextrin, 1 times amount starch and appropriate amount of ethanol, granulate, dry (60 ~ 80 DEG C), mix with Benexate Hydrochloride, make 1000 grams, subpackage, obtain granule.
Embodiments of the invention 2: Flos Lonicerae 100g, Flos Chrysanthemi 50g, Radix Platycodonis 50g, Herba Menthae 50g, Radix Ophiopogonis 50g, Fructus Crataegi 50g, Radix Glycyrrhizae 10g, Borneolum Syntheticum 1.5g.
Herba Menthae adds 14 times of water gagings and distills 6 hours, extracts volatile oil for subsequent use, and the another device of debris is collected, get volatile oil and Borneolum Syntheticum ethanol is made into saturated solution, slowly add in 6 times amount beta-schardinger dextrin-saturated aqueous solutions, 50 DEG C of constant temperature enclose 2 hours, refrigerated overnight, sucking filtration, 40 DEG C dry, pulverize, are prepared into Benexate Hydrochloride for subsequent use, all the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizaes etc. decoct with water three times, 2 hours first times, second time 1.5 hours, add water and two be respectively 10 times amount and 8 times amount, merging filtrate, filter, medicinal residues and the medicinal residues after extracting volatile oil merge, add water 6 times amount again, decoct 1 hour, filter, merging filtrate and above-mentioned debris, concentrating under reduced pressure (-0.08MPa) to relative density is 1.20 ~ 1.30 (60 DEG C), above-mentioned extractum adds 2 times amount sucrose, 1 times amount dextrin and appropriate amount of ethanol, granulate, dry (60 ~ 80 DEG C), mix with Benexate Hydrochloride, make 1000, subpackage, obtain capsule.
Embodiments of the invention 3: Flos Lonicerae 80g, Flos Chrysanthemi 40g, Radix Platycodonis 40g, Herba Menthae 40g, Radix Ophiopogonis 40g, Fructus Crataegi 40g, Radix Glycyrrhizae 5g, Borneolum Syntheticum 1g.
Herba Menthae adds 14 times of water gagings and distills 6 hours, extracts volatile oil for subsequent use, and the another device of debris is collected, get volatile oil and Borneolum Syntheticum ethanol is made into saturated solution, slowly add in 6 times amount beta-schardinger dextrin-saturated aqueous solutions, 40 DEG C of constant temperature enclose 2 hours, refrigerated overnight, sucking filtration, 40 DEG C dry, pulverize, are prepared into Benexate Hydrochloride for subsequent use, all the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizaes etc. decoct with water three times, 2 hours first times, second time 1.5 hours, add water and two be respectively 10 times amount and 8 times amount, merging filtrate, filter, medicinal residues and the medicinal residues after extracting volatile oil merge, add water 6 times amount again, decoct 1 hour, filter, merging filtrate and above-mentioned debris, concentrating under reduced pressure (-0.08MPa) to relative density is 1.20 ~ 1.30 (60 DEG C), above-mentioned extractum and Benexate Hydrochloride add 2 times amount sucrose, 1 times amount dextrin and appropriate amount of ethanol, mixing, granulate, less than 40 DEG C dry, granulate, add 1% magnesium stearate, mixing, is pressed into 1000, obtains tablet.
Embodiments of the invention 4: Flos Lonicerae 60g, Flos Chrysanthemi 30g, Radix Platycodonis 30g, Herba Menthae 30g, Radix Ophiopogonis 30g, Fructus Crataegi 30g, Radix Glycyrrhizae 6g, Borneolum Syntheticum 0.9g.
Herba Menthae adds 14 times of water gagings and distills 6 hours, extracts volatile oil for subsequent use, and the another device of debris is collected, get volatile oil and Borneolum Syntheticum ethanol is made into saturated solution, slowly add in 6 times amount beta-schardinger dextrin-saturated aqueous solutions, 40 DEG C of constant temperature enclose 2 hours, refrigerated overnight, sucking filtration, 40 DEG C dry, pulverize, are prepared into Benexate Hydrochloride for subsequent use, all the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizaes etc. decoct with water three times, 2 hours first times, second time 1.5 hours, add water and two be respectively 10 times amount and 8 times amount, merging filtrate, filter, medicinal residues and the medicinal residues after extracting volatile oil merge, add water 6 times amount again, decoct 1 hour, filter, merging filtrate and above-mentioned debris, concentrating under reduced pressure (-0.08MPa) to relative density is 1.20 ~ 1.30 (60 DEG C), above-mentioned extractum and Benexate Hydrochloride add appropriate amount of starch, dextrin, mannitol, sucrose (1: 1: 2: 2), mixing, granulate, less than 40 DEG C dry, granulate, add 1% magnesium stearate, mixing, is pressed into 1000, obtains buccal tablet.

Claims (10)

1. the pharmaceutical composition of a Flos Lonicerae, it is characterized in that calculation by weight, the raw material making this pharmaceutical composition effective ingredient is: Flos Lonicerae 60 ~ 100g, Flos Chrysanthemi 15 ~ 50g, Radix Platycodonis 15 ~ 50g, Herba Menthae 15 ~ 50g, Radix Ophiopogonis 15 ~ 50g, Fructus Crataegi 15 ~ 50g, Radix Glycyrrhizae 3g ~ 10g, Borneolum Syntheticum 0.6 ~ 1.5g.
2. a pharmaceutical composition for Flos Lonicerae, is characterized in that calculation by weight, and the raw material making this pharmaceutical composition effective ingredient is: Flos Lonicerae 60g, Flos Chrysanthemi 30g, Radix Platycodonis 30g, Herba Menthae 30g, Radix Ophiopogonis 30g, Fructus Crataegi 30g, Radix Glycyrrhizae 6g, Borneolum Syntheticum 0.9g.
3. the pharmaceutical composition of Flos Lonicerae as claimed in claim 1 or 2, is characterized in that: described pharmaceutical composition makes pill, granule, tablet, capsule, oral liquid.
4. the pharmaceutical composition of Flos Lonicerae as claimed in claim 3, is characterized in that the dosage form that described pharmaceutical composition is made is: granule, capsule, tablet.
5. the pharmaceutical composition of Flos Lonicerae as claimed in claim 4, is characterized in that the dosage form that described pharmaceutical composition is made is buccal tablet.
6. the preparation method of the pharmaceutical composition of Flos Lonicerae as claimed in claim 4, it is characterized in that: Herba Menthae adds water distillation, extraction volatile oil is for subsequent use, the another device of debris is collected, volatile oil, Borneolum Syntheticum ethanol are made into saturated solution, slowly add in beta-schardinger dextrin-saturated aqueous solution and prepare Benexate Hydrochloride, dry, for subsequent use; All the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizae etc. decoct with water, and filter, then are added by the medicinal residues after extracting volatile oil, decoct with water, filter, merging filtrate and above-mentioned debris, concentrating under reduced pressure becomes extractum, add appropriate amount of auxiliary materials, granulate, dry, mix with Benexate Hydrochloride, subpackage, obtains granule.
7. the preparation method of the pharmaceutical composition of Flos Lonicerae as claimed in claim 4, it is characterized in that: Herba Menthae adds water distillation, extraction volatile oil is for subsequent use, the another device of debris is collected, volatile oil, Borneolum Syntheticum ethanol are made into saturated solution, slowly add in beta-schardinger dextrin-saturated aqueous solution and prepare Benexate Hydrochloride, dry, for subsequent use; All the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizae etc. decoct with water, and filter, then are added by the medicinal residues after extracting volatile oil, decoct with water, filter, merging filtrate and above-mentioned debris, concentrating under reduced pressure becomes extractum, add appropriate amount of auxiliary materials, granulate, dry, mix with Benexate Hydrochloride, encapsulated, obtain capsule.
8. the preparation method of the pharmaceutical composition of Flos Lonicerae as claimed in claim 4, it is characterized in that: Herba Menthae adds water distillation, extraction volatile oil is for subsequent use, the another device of debris is collected, volatile oil, Borneolum Syntheticum ethanol are made into saturated solution, slowly add in beta-schardinger dextrin-saturated aqueous solution and prepare Benexate Hydrochloride, dry, for subsequent use; All the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizae etc. decoct with water, and filter, then are added by the medicinal residues after extracting volatile oil, decoct with water, filter, merging filtrate and above-mentioned debris, concentrating under reduced pressure becomes extractum, and extractum and Benexate Hydrochloride add appropriate amount of auxiliary materials, mixing, granulate, drying, adds appropriate magnesium stearate, mixing, tabletted, obtains tablet.
9. the preparation method of the pharmaceutical composition of Flos Lonicerae as claimed in claim 8, is characterized in that: Herba Menthae adds 14 times of water gagings and distills 6 hours, extracts volatile oil for subsequent use, and the another device of debris is collected; Get volatile oil and Borneolum Syntheticum ethanol is made into saturated solution, slowly add in beta-schardinger dextrin-saturated aqueous solution, cryogenic thermostat stirs 2 hours, refrigerated overnight, sucking filtration, and 40 DEG C dry, pulverize, are prepared into Benexate Hydrochloride for subsequent use; All the other Flos Lonicerae, Flos Chrysanthemi, Radix Platycodonis, Radix Ophiopogonis, Fructus Crataegi, Radix Glycyrrhizae etc. decoct with water three times, 2 hours first times, second time 1.5 hours, add water and two be respectively 10 times amount and 8 times amount, merging filtrate, filters, and medicinal residues and the medicinal residues after extracting volatile oil merge, add water 6 times amount again, decoct 1 hour, filter, merging filtrate and above-mentioned debris, when being evaporated to 60 DEG C, relative density is 1.20 ~ 1.30, above-mentioned extractum and Benexate Hydrochloride add appropriate amount of starch, dextrin, mannitol, sucrose, mixing, granulate, less than 40 DEG C dry, granulate; Add appropriate magnesium stearate, mixing, tabletted, obtains buccal tablet.
10. the preparation method of the pharmaceutical composition of Flos Lonicerae as claimed in claim 9, is characterized in that: supplementary product starch, dextrin, mannitol, sucrose are calculated as by weight ratio: starch 1 part, 1 part, dextrin, 2 parts, mannitol, sucrose 2 parts.
CN201010517668.5A 2010-10-25 2010-10-25 A kind of pharmaceutical composition of Flos Lonicerae and method for making thereof Expired - Fee Related CN101979048B (en)

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