CN102319208A - Suspension composition for treating oral mucositis caused by chemoradiotherapy - Google Patents
Suspension composition for treating oral mucositis caused by chemoradiotherapy Download PDFInfo
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Abstract
The present invention discloses a suspension composition for treating oral mucositis caused by chemoradiotherapy, and relates to a new drug for treating oral mucositis. The suspension composition comprises: 1, local anesthetics; 2, histamine 1 receptor antagonists; 3, a mucosal repairing agent and a drug dispersing agent; 4, an anti-foaming agent; 5, microcrystalline cellulose; 6, unreactive assistant materials; 7, pure water. The preparation method comprises: 1, preparing a solution I; 2, preparing a solution II; 3, adding the solution I to the solution II at a stirring state, completely stirring, adjusting the pH value of the mixed solution to 6-9 to obtain the suspension composition. According to the present invention, the suspension composition provided by the present invention has characteristics of good uniformity and strong stability, is not easy to agglomerate when the suspension composition is placed for a long time; the preparation method has characteristics of simple process and low production cost; the suspension composition can be applicable for treating the oral mucositis caused by the chemoradiotherapy, and severe mouth ulcers caused by anaerobic bacteria; the suspension composition provides effects of analgesia, inflammation eliminating and mucosa repairing; the clinical efficacy of the suspension composition is obvious; the use of the suspension composition is convenient and safe.
Description
Technical field
The present invention relates to a kind of new drug of treating oral mucositis, relate in particular to a kind of suspension composition of treating oral mucositis due to the chemoradiotherapy.
Background technology
Tumor incidence significantly rises in recent decades, has become the No.1 killer who influences human health at present.The main means of treatment tumor comprise operation, radiotherapy and chemotherapy at present.And the common complication that oral mucositis is the cancer patient when accepting chemoradiotherapy is especially accepted the patient of incidence radiotherapy, its incidence rate nearly 100%.At the bottom of the cornified mucosa of the recurrent position of oral mucositis right and wrong such as lip, cheek, soft palate and the tongue and the outside of belly of tongue, mainly show as mucosa erythema, edema, ulcer, pain, eating disorders, the danger of secondary infection simultaneously increases.The generation of mucositis forces the dosage that reduces chemotherapeutics, disturbs the expection of radiotherapy to carry out, and TD finally has a negative impact to therapeutic effect owing to serious stomatitis for appreciable impact patient's quality of life even part patient.Therefore, the new drug of stomatitis has important clinic value due to the exploitation treatment chemoradiotherapy.
Serious oral ulcer due to oral mucositis due to the chemoradiotherapy or the anaerobe is not had the standard care scheme both at home and abroad at present, new Therapeutic Method still is in the exploratory development stage.At present commonly used clinically gargle the single and poor of therapeutical effect for saleratus solution or dense normal saline; Give opium kind analgesics thing or local anaesthetics gel to the pain caused patient's whole body of stomatitis, side effect is big and administration is extremely inconvenient.Has the important clinical meaning so research and develop a kind of medicine with treatment oral mucositis of analgesic antiphlogistic, reparation mucosa ulcer face, taking convenience.
In recent years, the local anaesthetics research and development made substantial progress, and the listing of a collection of fine local anesthetics of amide derivatives is like department of stomatology local anaesthetics articaine and obstetrics ropivacaine commonly used commonly used; New histamine receptor is picked up anti-agent and is also developed listing, like LEVO CITRAZINE etc.The ropivacaine safety is good, and can shrink local vascular, thereby significantly reduces general toxic reaction; Secondly ropivacaine local anesthetic action has sensation and the motion effect separates, and effect has dose dependent, and local anesthetic action is controlled.Diphenhydramine is good antihistamine effect, and has certain local anesthetic action and maincenter sedative-hypnotic effect, and is more suitable to part oral ulcer pain patients; And LEVO CITRAZINE has good antihistamine effect, but does not have the maincenter sedative-hypnotic effect, also is fit to the part patient.S-ropivacaine mesylate, articaine hydrochloride, lidocaine hydrochloride, diphhydramine hydrochloride, the clinical use of levocetirizine aqueous solution preparation all have good stability, and do not have incompatibility between each medicine for many years; By above-mentioned part medicine is principal agent; Simple with the compositions suspensoid preparation that the diffusing suspendible of magnesium hydroxide, aluminium hydroxide or Montmorillonitum forms, good uniformity, good stability; Produce simply safety easy to use.
Summary of the invention
The objective of the invention is at present the shortage of oral mucositis Therapeutic Method due to the chemoradiotherapy, a kind of suspension composition of treating oral mucositis due to the chemoradiotherapy is provided.
The objective of the invention is to realize like this:
One, the component of this suspension composition
The component of this suspension composition mass and size concentration during by clinical use (gram/every liter, g/L), comprise 1.～7.:
1. local anesthetic
S-ropivacaine mesylate 0.05～10g/L,
Or articaine hydrochloride 0.05～60g/L,
Or lidocaine hydrochloride 0.05～20g/L,
Or articaine hydrochloride associating s-ropivacaine mesylate
Articaine hydrochloride 0.02～30g/L wherein, s-ropivacaine mesylate 0.02～10g/L;
2. the histamine 1 receptor is picked up anti-agent
Diphhydramine hydrochloride 0.05～40g/L,
Or LEVO CITRAZINE 0.05～10g/L;
3. mucosa renovation agent and medicine dispersant
Aluminium hydroxide and magnesium hydroxide
Or Montmorillonitum looses
Aluminium hydroxide 1～150g/L, magnesium hydroxide 1～150g/L, the Montmorillonitum 1～150g/L that looses;
4. anti-foaming agent
Simethicone 0.1～20g/L;
5. microcrystalline Cellulose 1～10g/L;
6. nonactive adjuvant 10～50g/L;
Nonactive adjuvant comprises:
Suspending agent: hydroxyethyl-cellulose, carboxymethyl cellulose, methylcellulose or hydroxypropyl cellulose;
And correctives: saccharin sodium, citric acid, Fructus Fragariae Ananssae flavor, mint flavored or cherry-flavored flavoring agent;
And thickening agent: sucrose, mannitol;
And wetting agent: sorbitol;
And antiseptic: propyl p-hydroxybenzoate or methyl parahydroxybenzoate;
7. pure water is a solvent.
Two, the method for preparing of this suspension composition
One of method for preparing of this suspension composition comprises the following steps:
1. prepare solution I---Emulsion
Suspending agent and anti-foaming agent in microcrystalline Cellulose, the nonactive adjuvant are fully mixed, be heated to 50 ℃, add warm pure water while stirring, stir, it is subsequent use to obtain a kind of Emulsion;
2. prepare solution II---suspensoid
Correctives in the nonactive adjuvant is dissolved in water, adds mucosa renovation agent and medicine dispersant, and add suspending agent, stir fully; Add wetting agent, thickening agent and antiseptic again, add local anesthetic, add the histamine 1 receptor and pick up anti-agent, add pure water, abundant stirring and evenly mixing, it is subsequent use to obtain a kind of suspensoid;
3. solution I is added in the solution II that is stirring, fully stir, and with promptly getting this suspension composition behind dilute hydrochloric acid or tartaric acid accent pH value to 6～9.
Two of the method for preparing of this suspension composition comprises the following steps:
1. prepare solution I---Emulsion
Suspending agent and anti-foaming agent in microcrystalline Cellulose, the nonactive adjuvant are fully mixed, be heated to 50 ℃, add warm pure water while stirring, stir, it is subsequent use to obtain a kind of Emulsion;
2. prepare solution II---suspensoid
Correctives in the nonactive adjuvant is dissolved in water, adds mucosa renovation agent and medicine dispersant, and add suspending agent, stir fully; Add wetting agent, thickening agent and antiseptic again, add pure water, abundant stirring and evenly mixing, it is subsequent use to obtain a kind of suspensoid;
3. prepare solution III---suspensoid
Solution I is added in the solution II that is stirring, fully stir, and transfer pH value to 6～9 promptly to get solution III with dilute hydrochloric acid or tartaric acid;
4. face with preceding and in filling the bottle of picking up anti-agent powder by the local anesthetic and the histamine 1 receptor of clinical working concentration amount of calculation, add solution III, promptly get this suspension composition after shaking up.
2 years stability experiments of suspension composition by method for preparing one preparation meet the suspensoid medicinal standard; 3 years stability experiments of suspension composition by method for preparing two preparations meet the suspensoid medicinal standard.Suspension composition by method for preparing two preparations is stable by the suspension composition of method for preparing one preparation, but drug packaging is complicated slightly.
Three, clinical method for using
With before shaking up, get this suspension composition 5～15mL oral cavity rinsing the mouth, every day 2～4 times.
Four, the mechanism of action
Local anesthetic rapid permeability entrance cavity mucosa in this suspension composition is ulcer wound surface particularly, performance local anesthesia effect, thus significantly alleviate the pain due to the oral mucositis rapidly.
Histamine 1 receptor in this suspension composition is picked up the release that anti-agent can the inflammation-inhibiting factor, and amelioration of inflammation is red, swollen, hot, bitterly rapidly.
The fine particle that mucosa renovation agent in this suspension composition and medicine dispersant have positive charge can optionally combine with electronegative stomatocace wound surface to a certain extent well; Repair mucosa ulcer's wound surface; And fine particle is loaded with medicine and has the dispersion slow releasing function to a certain extent; Thereby make the medicine good dispersion, simultaneously the action time of prolong drug anti-inflammatory analgesic.Aluminium hydroxide, magnesium hydroxide are as local antacid, and Montmorillonitum looses as treatment diarrheal enterotoxin adsorbent, and all in clinical widely-used decades, chemical property is extremely stable, and systemic absorption is few, has extraordinary safety.
Local anesthetic in this suspension composition and histamine 1 receptor are picked up anti-agent and are all had close pharmacokinetic characteristics, all are active medicines, are not prodrugs, can directly play a role at the mucosa place; Rapid-action, and have the close elimination half-life, thus prevent accumulating of a certain composition.
In this suspension composition anti-foaming agent---Simethicone can prevent to produce bubble, patient Geng Yi is used.Simethicone treatment flatulence is widely used for many years clinical, and it eliminates bubble through reducing bubble surface tension force through pure physical action, does not relate to chemical reaction, does not have physiologically active, can not be produced general action by gastrointestinal absorption.
In a word, this suspension composition has pain relieving, antiinflammatory and the repair of ulcer mucosa simultaneously; Determined curative effect, side effect is little, and safety is good; Preparation is simple, taking convenience.For oral mucositis due to the clinical chemoradiotherapy even upper digestive tract inflammation provide good treatment to select.
The present invention has advantage and good effect:
1. good uniformity is stable strong, places prevented from caking for a long time;
2. technology is simple, low production cost;
3. can be used to treat due to the chemoradiotherapy serious oral ulcer due to the oral mucositis and anaerobe, have pain relieving, antiinflammatory and mucosa repair, clinical efficacy is definite, safety easy to use.
The specific embodiment
Below in conjunction with the practical implementation instance, further set forth the present invention.
One, the effect of key component
1, local anesthetic
1) s-ropivacaine mesylate: these article are New-type long-acting local anesthetics of amide derivatives; Be S～optically active form; Have anesthesia and analgesic dual function, high dose can produce surgical anesthesia, during low dosage then sensigenous retardance (analgesia) only block with non-the carrying out property nervus motorius that limits to; Its acting duration is longer, 4～6 hours half-life.Its pharmacological characteristic is that cardiac toxicity is humble, and the sensation retardance separates more obvious with the motion retardance, have the peripheral blood vessel contraction, delays anesthetis and gets into systemic circulation, keeps local organization concentration.Therefore this medicine is particularly useful for the anesthesia of mucosa local surfaces.
S-ropivacaine mesylate is compared with traditional local anaesthetics, has advantage:
1. curative effect effect---s-ropivacaine mesylate obviously is longer than other long effective local anesthetic action time, and the surface anesthetic effect time is grown 2 to 3 times with the bupivacaine of concentration;
2. special effect---sensation of s-ropivacaine mesylate---motion is blocked separating degree much larger than bupivacaine, and clearance rate is higher, and it is more suitable in analgesia;
3. controllability is strong---and the anaesthetic effect of s-ropivacaine mesylate is dose dependent, and the sensation of generation and motion retarding degree are measurable control;
4. toxic and side effects is humble---and s-ropivacaine mesylate does not have the bigger shortcoming of the cardiac toxicity of general long effective local anesthetic, and these article are few, and cardiac toxicity takes place, and fetus is to these article tool well tolerable property.
2) articaine hydrochloride: these article are to belong to amide type local anesthetic, can block the nerve conduction of medicine-feeding part nerve fiber, play the local anesthesia effect.Local anesthetic action is appearance in 2-3 minute after administration, and is rapid-action, sustainable about 60 minutes.The articaine hydrochloride elimination half-life is about 110 minutes; Articaine hydrochloride is mainly by liver metabolism, and the medicine of 5%-10% dosage is discharged from urine with original shape.
3) lidocaine hydrochloride: these article are local anesthetics of amide derivatives, and anesthetic potency is big, rapid-action, dispersion force is strong, when blood drug level is low, analgesia and drowsiness, threshold of pain raising occur.Medicine is eliminated approximately from the part and is needed 2～4 hours; Most of earlier through the liver particle enzymatic degradation be still have local anesthetic action take off ethyl intermediate metabolites list ethyl glycinamide glutamine xylene, through the amidase hydrolysis, discharge through urine; 10% of about consumption is discharged with original shape, appears in the bile on a small quantity.
2, the H1 receptor is picked up anti-agent
1) diphhydramine hydrochloride: these article have antihistamine effect preferably, and local anaesthesia, the town's anti-M in Tuhe～choline-like effect are also arranged.Eliminating the half-life is about 4～7h, protein binding rate 78%～99%, and 98% combines with plasma protein.
2) LEVO CITRAZINE: these article are that the selectivity histamine H1-receptor is picked up anti-agent.Zoopery shows the no obvious cholinolytic of these article and anti-5～hydroxytryptamine effect, is difficult for acting on maincenter H1 receptor through blood～cerebrospinal fluid barrier, and central inhibitory action is lighter during clinical use.About 6～10 hours of plasma half-life, LEVO CITRAZINE and plasma protein binding rate are high.
3, mucosa renovation agent and medicine dispersant
Montmorillonitum looses, aluminium hydroxide, magnesium hydroxide microgranule have positive charge, can with electronegative oral mucosa particularly ulcer wound surface well combine, help the reparation of wound surface; Simultaneously Montmorillonitum looses, aluminium hydroxide, magnesium hydroxide microgranule can well disperse s-ropivacaine mesylate and diphenhydramine isoreactivity medicine, can be carried to wound surface to active medicine, plays certain targeting, better analgesic antiphlogistic effect and side effect is little; Montmorillonitum looses, aluminium hydroxide, that the magnesium hydroxide microgranule disperses medicine is better, has improved uniformity, makes suspensoid have stability preferably.
4, anti-foaming agent
Simethicone: can prevent effectively that suspensoid from the bubble that before rocks generation, taking more convenient safety.
Two, confirmatory experiment
The various single active component that uses in this suspension composition is clinical widely-used through for many years, confirms safe and effective;
At long-time stability experiment and the animal pharmacodynamics toxicological experiment that laboratory carries out, confirm this suspension composition good stability, and to the mucosa nonirritant, therapeutic effect is definite, safety is good.
1, animal safety and effectiveness experiment
1) each effective ingredient is all got the concentration minimum
Local anesthetic, histamine 1 receptor are picked up anti-agent, mucosa renovation agent and medicine dispersant and are all got separately under the concentration range in limited time; This suspension composition preparation stabilization; Mouse animal experiment shows that this suspension composition does not all have influence to mouse core vascular system, nervous system and respiratory system; Safety is good, and the scorching model mice of digestion mucous membrane is had analgesic effect.
2) each effective ingredient is all got the concentration median
When local anesthetic, histamine 1 receptor are picked up anti-agent, mucosa renovation agent and medicine dispersant and are all got separately the concentration range median; This suspension composition preparation stabilization; Mouse animal experiment shows that the said composition suspensoid does not all have influence to mouse core vascular system, nervous system and respiratory system, does not influence the mice masticatory function, and safety is good; The scorching model mice of digestion mucous membrane is had remarkable analgesic effect, and can promote the reparation of damage mucosa.
3) each effective ingredient is all got the concentration peak
When local anesthetic, histamine 1 receptor are picked up anti-agent, mucosa renovation agent and medicine dispersant and are all got separately the concentration range peak; This suspension composition preparation preparation stabilization; Mouse animal experiment shows that the said composition suspensoid does not all have influence to mouse core vascular system, nervous system and respiratory system; Safety is good, the scorching model mice of digestion mucous membrane is had remarkable analgesic effect, and can promote the reparation of damage mucosa.
2, large-scale clinical case retrospective study
S-ropivacaine mesylate, diphhydramine hydrochloride, aluminium hydroxide and magnesium hydroxide suspensoid are used nearly 2 years as the famous tumor center of U.S. doctors experience prescription preparation, use surplus the said preparation patient 800 example time.After the case retrospective study that my research team carries out found that the patient uses, pain symptom was obviously alleviated, and oral mucositis cure time more not user shortens 4 days, and user quality of life obviously improves, and has statistical significance (P＜0.001).
3, case report
Sufferer 1: the patient, the man, 65 years old, local advanced NPC patient 3 grades of oral mucositis occurred after the row radiotherapy.Use this suspension composition, every day 3 times, each 15mL gargles, and the back oral cavity causalgia sense of gargling obviously alleviates, oral mucositis recovery from illness after 7 days.
Sufferer 2: patient, woman, 45 years old, nonsmall-cell lung cancer IIIA phase; 3 grades of esophagus mucositiss occur behind the row chemicotherapy same period, use this suspension composition, every day 3 times, each 10mL swallows; Behind the oral drugs, the esophagus causalgia is obviously alleviated, esophagus mucositis recovery from illness after 9 days.
Sufferer 3: the patient, the woman, 55 years old, the multiple transfer of three cloudy breast carcinoma brains patient, row is appeased full brain radiotherapy; 2 grades of oral mucositis occur, use this suspension composition, every day 3 times, each 10mL gargles; After gargling, the oral cavity causalgia is obviously alleviated, and can take food oral mucositis recovery from illness after 5 days.
Claims (3)
1. suspension composition of treating oral mucositis due to the chemoradiotherapy is characterized in that:
The component of this suspension composition is mass and size concentration during by clinical use,
1. local anesthetic
S-ropivacaine mesylate 0.05～10 g/L,
Or articaine hydrochloride 0.05～60 g/L,
Or lidocaine hydrochloride 0.05～20 g/L,
Or articaine hydrochloride associating s-ropivacaine mesylate,
Articaine hydrochloride 0.02～30 g/L wherein, s-ropivacaine mesylate 0.02～10 g/L;
2. histamine 1 receptor antagonist
Diphhydramine hydrochloride 0.05～40 g/L,
Or LEVO CITRAZINE 0.05～10 g/L;
mucosa renovation agent and medicine dispersant
Aluminium hydroxide and magnesium hydroxide
Or Montmorillonitum looses
Aluminium hydroxide 1～150 g/L, magnesium hydroxide 1～150 g/L, Montmorillonitum 1～150 g/L that looses;
4. anti-foaming agent
Simethicone 0.1～20 g/L;
Nonactive adjuvant comprises:
Suspending agent: hydroxyethyl-cellulose, carboxymethyl cellulose, methylcellulose or hydroxypropyl cellulose;
And correctives: saccharin sodium, citric acid, Fructus Fragariae Ananssae flavor, mint flavored or cherry-flavored flavoring agent;
And thickening agent: sucrose, mannitol;
And wetting agent: sorbitol;
And antiseptic: propyl p-hydroxybenzoate or methyl parahydroxybenzoate;
pure water is a solvent.
2. by one of described a kind of method for preparing of treating the suspension composition of oral mucositis due to the chemoradiotherapy of claim 1, it is characterized in that:
1. prepare solution I---Emulsion
Suspending agent and anti-foaming agent in microcrystalline Cellulose, the nonactive adjuvant are fully mixed, be heated to 50 ℃, add warm pure water while stirring, stir, it is subsequent use to obtain a kind of Emulsion;
2. prepare solution II---suspensoid
Correctives in the nonactive adjuvant is dissolved in water, adds mucosa renovation agent and medicine dispersant, and add suspending agent, stir fully; Add wetting agent, thickening agent and antiseptic again, add local anesthetic, add the histamine 1 receptor antagonist, add pure water, abundant stirring and evenly mixing, it is subsequent use to obtain a kind of suspensoid;
3. the solution I is added in the solution II that is stirring, fully stir, and with promptly getting this suspension composition behind dilute hydrochloric acid or tartaric acid accent pH value to 6～9.
3. by two of the described a kind of method for preparing of treating the suspension composition of oral mucositis due to the chemoradiotherapy of claim 1, it is characterized in that:
1. prepare solution I---Emulsion
Suspending agent and anti-foaming agent in microcrystalline Cellulose, the nonactive adjuvant are fully mixed, be heated to 50 ℃, add warm pure water while stirring, stir, it is subsequent use to obtain a kind of Emulsion;
2. prepare solution II---suspensoid
Correctives in the nonactive adjuvant is dissolved in water, adds mucosa renovation agent and medicine dispersant, and add suspending agent, stir fully; Add wetting agent, thickening agent and antiseptic again, add pure water, abundant stirring and evenly mixing, it is subsequent use to obtain a kind of suspensoid;
3. prepare solution III---suspensoid
The solution I is added in the solution II that is stirring, fully stir, and transfer pH value to 6～9 promptly to get the solution III with dilute hydrochloric acid or tartaric acid;
4. face with preceding and in the bottle that fills by the local anesthetic of clinical working concentration amount of calculation and histamine 1 receptor antagonist powder, add the solution III, promptly get this suspension composition after shaking up.
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| CN104173372A (en) * | 2014-09-03 | 2014-12-03 | 左克源 | Composition for treating oral mucositis, as well as preparation method and application package thereof |
| CN106474137A (en) * | 2016-08-30 | 2017-03-08 | 广东科玮生物技术股份有限公司 | One kind is containing chlorophyllous film for treating oral ulcer and preparation method thereof |
| CN109414406A (en) * | 2017-04-13 | 2019-03-01 | 辽宁大熊制药有限公司 | Suspension and its manufacturing method containing aluminium hydroxide and magnesium hydroxide |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103007253A (en) * | 2012-12-12 | 2013-04-03 | 北京化工大学 | Pharmaceutical composition containing beta-galactosylation azo ene glycol and preparation method thereof |
| CN103007253B (en) * | 2012-12-12 | 2015-06-17 | 北京化工大学 | Pharmaceutical composition containing beta-galactosylation azo ene glycol and preparation method thereof |
| CN104173372A (en) * | 2014-09-03 | 2014-12-03 | 左克源 | Composition for treating oral mucositis, as well as preparation method and application package thereof |
| CN106474137A (en) * | 2016-08-30 | 2017-03-08 | 广东科玮生物技术股份有限公司 | One kind is containing chlorophyllous film for treating oral ulcer and preparation method thereof |
| CN109414406A (en) * | 2017-04-13 | 2019-03-01 | 辽宁大熊制药有限公司 | Suspension and its manufacturing method containing aluminium hydroxide and magnesium hydroxide |
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Application publication date: 20120118 |