CN101292963A - Antineoplastic patches for external use of bullatacin - Google Patents
Antineoplastic patches for external use of bullatacin Download PDFInfo
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- CN101292963A CN101292963A CNA2008103013347A CN200810301334A CN101292963A CN 101292963 A CN101292963 A CN 101292963A CN A2008103013347 A CNA2008103013347 A CN A2008103013347A CN 200810301334 A CN200810301334 A CN 200810301334A CN 101292963 A CN101292963 A CN 101292963A
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- bullatacin
- patches
- antineoplastic
- external use
- mixed liquor
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Abstract
The invention discloses a Bulataxin anti-tumor external patch, which consists of a back lining, a drug storage and an anti-adhesive layer. Breathable cotton medical non-woven cloth is selected as the back lining, the drug storage takes a macromolecule gel acrylate pressure-sensitive adhesive as an adhesive, containing the mixed Bulataxin solution, a polyester film through silicone oil anti-adhesive treatment is taken as the anti-adhesive layer. The invention not only solves the shortcomings of significant toxicity and side effects of oral intake or intravenous administration of past anti-tumor drugs, but also overcomes the shortcomings of significant skin irritation and toxicity of traditional external patches and reduces the economic cost.
Description
Technical field
The present invention relates to a kind of antineoplastic topical administration formulations, is a kind of antineoplastic patches for external use agent specifically.
Background technology
Annonaceae (Annonaceae) is the torrid zone and subtropical zone one big plant population, and this section contains compositions such as alkaloid, terpenoid, flavone, kind litchi lactone, polyoxy cyclohexene and styrene lactone.Wherein back 3 compounds have anti-tumor activity, and have caused the extensive interest of various countries scholar.Annonaceous acetogenins (annonaceous acetogenins) is a class new type natural product that is found in first nineteen eighty-two in the annonaceae plant (Annonaceae).Annonaceous acetogenins has physiologically active comparatively widely, and wherein most typical is anti-tumor activity and cytotoxicity.Studies show that most of Annonaceousacetogenicompounds compounds generally have powerful cytotoxicity to the tumor cell of In vitro culture.
At present, the sickness rate of whole world tumor, cancer rises year by year, therapies such as necessary application of radiation, chemistry, medicine in its therapeutic process.Most cancer therapy drugs are to the poor selectivity of tumor cytotoxicity, and radiotherapy, the chemotherapy time is long, dosage is big, cost is high.Antitumor drug now on sale on the market is mainly based on chemosynthesis, and its administering mode is based on oral or intravenously administrable, for example antitumor drug 5-FU and vincristine etc.Wherein antitumor drug has mutagenic action mostly, finishes inhibitory action to tumor by blocking-up tumor dna replication dna; Have toxic and side effects such as leukocyte, hepatocyte injury, and reactions such as nauseating, alopecia are arranged.
Having in the technology now, the pharmaceutical dosage form that CN1460473A proposes is injection or Emulsion.But because of the problem of production technology, uncontrollable to the dosage of medicine in implementation process, safety clinically, effectiveness, controllability can not get guaranteeing, so be difficult to apply.
And main black plaster of traditional external use plaster and rubber cream.Black plaster contains a large amount of lead oxide, and toxicity is big; Rubber cream is big to skin irritation, and the anaphylaxis phenomenon is serious.In addition, use and to produce pollution clothes behind black plaster and the rubber cream, take off the medicine difficulty, uncomfortable or the like the disadvantageous aspect of skin, all directly had influence on patient's use.
Summary of the invention
Technical problem to be solved by this invention just provides a kind of antineoplastic patches for external use of bullatacin, it had both solved the shortcoming that antitumor drug is oral or the intravenously administrable toxic and side effects is big in the past, it is big and have certain toxic shortcoming to skin irritation to have overcome traditional external use plaster again, and has reduced Financial cost.
In order to address the above problem, the invention provides a kind of antineoplastic patches for external use of bullatacin, it comprises backing layer, drug-reservoir and adherent layer, drug-reservoir as adhesive, contains deployed bullatacin medicinal liquid with high-molecular gel.
The bullatacin medicinal liquid is that bullatacin part YAOJING product are dissolved in the mixed liquor of dehydrated alcohol and propylene glycol, fully stirs mix homogeneously and getting.
The dehydrated alcohol in the mixed liquor and the volume ratio of propylene glycol are 1: 1.
The elaboration of La Taxin position medicine and the weight ratio of mixed liquor are 1: 1～1: 10.
High-molecular gel is an acrylate pressure-sensitive adhesive.
Adherent layer is the polyester film through the silicone oil release treatment.
The preparation method of antineoplastic patches for external use of bullatacin, it comprises the steps:
(1) batching: the elaboration that will contain the bullatacin part medicine is dissolved in the mixed liquor that volume ratio is 1: 1 dehydrated alcohol and propylene glycol, and the weight ratio of bullatacin part YAOJING product and mixed liquor is 1: 1～1: 10, and abundant stirring makes its mix homogeneously;
(2) glue: adopt the production technology of acrylate pressure-sensitive adhesive to make pressure sensitive adhesive;
(3) coating: with the mixed liquor of bullatacin part YAOJING product, dehydrated alcohol and propylene glycol and the pressure sensitive adhesive mixing behind the heating and melting, coat on the adherent layer, cover again and go up backing layer;
(4) section: be cut into suitable dimensions (specifications such as 5 * 7cm, 7 * 10cm, 9 * 12cm); Dry cooling: effective ingredient is kept to greatest extent, strengthen drug effect; Packing: use plastic-aluminum combined film phonograph seal.
Compared with prior art, the present invention has following advantage:
(1) external use plaster of the present invention, it selects the new natural materials bullatacin that extracts in the Sirikaya plant for use is Main Ingredients and Appearance, compares with the antitumor drug of existing chemosynthesis, toxic and side effects lowers greatly.
(2) bullatacin antitumor external use plaster of the present invention little to normal cell injury, do not have to feel sick, phenomenons such as alopecia, and existing antitumor drug is obvious to degree side effect such as leukocyte, hepatocyte injury, and reactions such as nauseating, alopecia are arranged.
(3) the present invention has adopted external use plaster, has overcome the shortcoming of the oral or intravenously administrable of existing antitumor drug, greatly reduces the toxic and side effects of medicine.
(4) the present invention has reduced the dosage of medicine, has reduced the Financial cost of treatment.For example, the dosage of antitumor drug paclitaxel is 60mg, and bullatacin part YAOJING product of the present invention are 30ug only, are 1/2000 of paclitaxels; 45 days medical expense of taxol drug is 50,000 yuan, and 45 days medical expense of bullatacin only is 1.5 ten thousand yuan.
(5) the present invention is an adhesive with the novel high polymer gel, and strong to the drug loading ability, the pharmaceutical pack capacity is big, water content height, good biocompatibility, strong with skin affinity, in breathability and to aspect skin adhesion, zest, the moisture retention, all be better than traditional black plaster and rubber cream, the patch that makes with this technology, breathability is stronger, and it is comfortable that the patient pastes the aftersensation softness, and adhesiveness is suitable, taking off to pull does not have pain, and allergic phenomena is reduced to bottom line.
(6) curative effect of the present invention rapid (30 minutes～2 hours take effect), lasting medicine is steady, and controllability is strong, if need interruption of the administration, only need throw off patch and get final product, and is very convenient.It is steady also to have lasting medicine simultaneously, the drug bioavailability advantages of higher.
(7) patch of the present invention does not use gasoline and other poisonous and hazardous organic solvent aborning, has both ensured pharmaceutical production safety, has reduced the health harm to the direct labor, does not cause the pollution to environment again.
(8) the present invention uses high-molecular gel to be pharmaceutical carrier, non-woven fabrics is the external use plaster of the support of gel medicine, is diffused into patient's skin by solvent, enters corium and subcutaneous tissue, by blood capillary and lymphatic vessel medicine is delivered to therapentic part, reach the purpose of treatment.Adjustment control dosage by the administration area discharges medicine continually and steadily.Avoided medicine to liver, gastrointestinal anaphylaxis, reduced drug-induced individual variation, more convenient in the use safety.Compare with injection, greatly reduced medicine and injected the toxic and side effects that is produced behind the human body.
The specific embodiment
Embodiment 1: antineoplastic patches for external use of bullatacin of the present invention, it comprises backing layer, drug-reservoir and adherent layer, selecting ventilative good cotton medical adhesive-bonded fabric for use is backing layer, drug-reservoir with the high-molecular gel acrylate pressure-sensitive adhesive as adhesive, containing deployed bullatacin medicinal liquid, is adherent layer with the polyester film through the silicone oil release treatment.
The bullatacin medicinal liquid is that 198 gram bullatacin part YAOJING product are dissolved in the 1100ml mixed liquor that volume ratio is 1: 1 dehydrated alcohol and propylene glycol, fully stirs, and mix homogeneously is made external use plaster 20400 subsides (sizes: 7 * 10cm).
Embodiment 2: the preparation method of antineoplastic patches for external use of bullatacin, it comprises the steps: (1) batching: 198 gram bullatacin part YAOJING product are dissolved in the 1100ml mixed liquor that volume ratio is 1: 1 dehydrated alcohol and propylene glycol, fully stir, make its mix homogeneously; (2) glue: adopt the production technology of acrylate pressure-sensitive adhesive to make pressure sensitive adhesive; (3) coating: with the mixed liquor of bullatacin part YAOJING product, dehydrated alcohol and propylene glycol and the pressure sensitive adhesive mixing behind the heating and melting, coat on the adherent layer, cover again and go up backing layer; (4) section: be cut into suitable dimensions (specifications such as 5 * 7cm, 7 * 10cm, 9 * 12cm); Dry cooling, employing aluminum-plastic composite membrane pack.
Embodiment 3: following beneficial effect of further setting forth medicine of the present invention by clinical drug trial:
The viewing test of treatment tumor:
Discover that by domestic and international medical circle personage bullatacin not only has stronger antitumor action, also have the multidrug resistance effect that can reverse tumor cell.Utilize this characteristic of bullatacin, we use the bullatacin part YAOJING product that contain that extract from Sirikaya seed to make external use plaster tumor patient is carried out clinical observation test.Find that by the observation treatment of 10 examples being suffered from the various cancers patient in nearly two months this patch has bigger improvement to patient's pain, tumor cell concentration descends in the part blood samples of patients, breathes and mental symptom is clearly better.This patch of clinical proof has tangible curative effect and great using value on clinical treatment tumour.
1, experimenter's selection
(1) according to the scheme of this experiment, preferentially selects the primary lung cancer patient, accept behind the chemicotherapy more than 2 months no severe complications.7 Genus Homos among the selected crowd of this test were in accepting chemicotherapy person more than 2 months, and other 3 people did not accept chemicotherapy in the recent period, and 10 people all do not have the complication of especially severe.
(2) experimenter totally 10 people, male 8 people, women 2 people, the age, the mean age was 62.8 years old from 39 years old-79 years old, this 10 people's diagnosis is all made a definite diagnosis by CT sheet, pathology or blood testing.
2, therapeutic scheme
Usage and dosage: external, following skin of cervical region and extremity administration or follow the doctor's advice, 8 paste/time, 1 time/day, the observation period is no less than 48 days.
3, result of the test
Clinical symptoms change situation before and after the treatment
| Sequence number | Name | Sex | Age | Diagnosis | Before the medication for the first time | After the medication for the second time | The treatment natural law | Clinical setting |
| 1 | King # | The man | 76 | Lower-left pulmonary carcinoma postoperative mediastinum and intracranial shift | (08.1.14) breast CT: lymph node 3*3 (superior vena cava) | (08.2.25) breast CT: lymph node 1.5*1.5 (superior vena cava) | 40 days | Before the medication: the lower limb body inconvenient activity, muscular strength goes down |
| 2 | Week # | The man | 79 | Constitutional, lower-left leaf, central type, trachea pulmonary carcinoma | (08.1.14) breast CT: lower-left leaf pulmonary atelectasis, fibrosis | (08.3.7) breast CT: leaf pulmonary in lower-left divides multiple opening, and fibrosis alleviates | 51 days | Before the medication: after irritable cough, cough companion poor appetite, the medication of expectorant blood: cough obviously alleviates, expectorant blood disappears |
| 3 | King ## | The man | 67 | Constitutional bottom right pulmonary carcinoma | (08.1.9) right side moderate hydrops, upper right leaf disease is according to 6.5*5 | (08.2.25) the right side hydrothorax absorbs fully, 4.5*5 | 46 days | Before the medication: uncomfortable in chest, breathe hard, after the light activity postemphasis medication: cough is alleviated, the discomfort of taking care of oneself at present, stroll, slight physical training all have |
| 4 | Week ## | The man | 53 | Left side pulmonary carcinoma | (08.1.11) breast CT: upper left leaf is not opened | (08.3.8) breast CT: upper left leaf is partly opened again | 56 days | Before the medication: uncomfortable in chest, breathe hard, after the light activity postemphasis medication: conscious uncomfortable in chest, breathe hard and obviously alleviate, can step on building 3-4 floor |
| 5 | Soup ## | The man | 66 | Constitutional left side lung squamous cancer | (08.1.9) breast CT: upper left leaf segmental atelectasis | (08.3.6) breast CT: multiple the opening of upper left leaf pulmonary's branch | 59 days | Before the medication: chest and back pain, two nipples are itched after (lung shows outward) medication: chest and back pain disappears, and two nipple Pruritus are alleviated |
| 6 | What ## | The woman | 50 | Differentiation adenocarcinoma at the bottom of the right lung | (08.1.10) breast CT: upper right tumor 4*5cm, and segmental atelectasis | (08.2.26) breast CT: the tumor fragmentation is shapeless, and the lung section is opened again | 45 days | Before the medication: after uncomfortable in chest, the medication of breathing hard: uncomfortable in chest, the remarks that are clearly better of breathing hard: on November 14th, 07 to December carried out tumor by local radiotherapy 48GY on the 7th |
| 7 | To ## | The woman | 60 | Cervical cancer: leaf pulmonary carcinoma on the right side | (07.10.20) breast CT: upper right tumor, lung marking is coarse | (08.3.12) breast CT: upper right tumor, lung marking is clear | 140 days | Before the medication: right survey the inguinal lymph nodes enlargement, obviously can touch medication after: medication is after 20 days, and the right abdomen thigh enlargement ditch lymph node of surveying diminishes, and does not touch after 7 days |
| 8 | In # | The man | 39 | Primary lung cancer: lymphatic cancer: osteocarcinoma | (08.3.9) breast CT: upper right tumor: waist 3 right side vertebra ridges are prominent to be shifted | Not check temporarily | In the treatment | Before the medication: this patient made a definite diagnosis on January 20th, 2008, do not accept any treatment after making a definite diagnosis, the patient is over more than 40 day, pain, breathes hard, after the medication of can not falling asleep: from March 9th, 2008, the patient accepts the happy peaceful patch treatment of Bradley, after 24 hours, perhaps pain relief was breathed and is improved: after 48 hours, the patient can sleep about 5 hours, at present still in therapeutic process gradually every day |
| 9 | King ## | The man | 76 | Primary lung cancer: gastric cancer | December in 2007 beginning on the 3rd medication | Check on January 25th, 2008 | In the treatment | After the patient is made a definite diagnosis, except the Chinese medicine of taking steadiness, in addition, use happy peaceful subsides of Bradley, check blood in medication after 48 days, tumor cell concentration descends in the blood, and breathing and mental symptom are clearly better |
| 10 | The ## of Tang | The man | 62 | Primary brain tumor | Beginning medication on February 12nd, 2008 | In the treatment | In the treatment | This patient's medication is after more than 20 day, and the lymph node of former right side frons one enlargement begins deliquescing to be dwindled |
4, conclusion
1, in the 10 routine patients that observe, there are 2 examples just to begin agents area and skin occur and slightly scratch where it itches, 1 example can continue medication through after the antianaphylactic treatment, and 1 example does not process spontaneous remission, all the other no abnormality seens in addition.Do not find the acute and chronic toxic and side effects relevant at present as yet, so the safety of this plaster is sure with this medicine.
2, by small sample contrast, use this medicine after, patient's subjective symptom and objective indicator all have improvement in various degree.Therefore, by preliminary clinical application, the effect of this plaster agent treatment tumor is sure.
Claims (7)
1. antineoplastic patches for external use of bullatacin, it comprises backing layer, drug-reservoir and adherent layer, it is characterized in that: drug-reservoir as adhesive, contains deployed bullatacin medicinal liquid with high-molecular gel.
2. antineoplastic patches for external use of bullatacin according to claim 1 is characterized in that: the bullatacin medicinal liquid is that bullatacin part YAOJING product are dissolved in the mixed liquor of dehydrated alcohol and propylene glycol, fully stirs mix homogeneously and getting.
3. antineoplastic patches for external use of bullatacin according to claim 2 is characterized in that: the dehydrated alcohol in the mixed liquor and the volume ratio of propylene glycol are 1: 1.
4. antineoplastic patches for external use of bullatacin according to claim 2 is characterized in that: the weight ratio of bullatacin part YAOJING product and mixed liquor is 1: 1～1: 10.
5. antineoplastic patches for external use of bullatacin according to claim 1 is characterized in that: high-molecular gel is an acrylate pressure-sensitive adhesive.
6. antineoplastic patches for external use of bullatacin according to claim 1 is characterized in that: adherent layer is the polyester film through the silicone oil release treatment.
7. the preparation method of antineoplastic patches for external use of bullatacin as claimed in claim 1, it comprises the steps:
(1) batching: will contain bullatacin part YAOJING product and be dissolved in the mixed liquor that volume ratio is 1: 1 dehydrated alcohol and propylene glycol, the weight ratio of bullatacin part YAOJING product and mixed liquor is 1: 1～1: 10, and abundant stirring makes its mix homogeneously;
(2) glue: adopt the production technology of acrylate pressure-sensitive adhesive to make pressure sensitive adhesive;
(3) coating: with the mixed liquor of bullatacin part YAOJING product, dehydrated alcohol and propylene glycol and the pressure sensitive adhesive mixing behind the heating and melting, coat on the adherent layer, cover again and go up backing layer;
(4) section, dry cooling and packing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2008103013347A CN100571691C (en) | 2008-04-28 | 2008-04-28 | A kind of antineoplastic patches for external use of bullatacin |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2008103013347A CN100571691C (en) | 2008-04-28 | 2008-04-28 | A kind of antineoplastic patches for external use of bullatacin |
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| Publication Number | Publication Date |
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| CN101292963A true CN101292963A (en) | 2008-10-29 |
| CN100571691C CN100571691C (en) | 2009-12-23 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2008103013347A Expired - Fee Related CN100571691C (en) | 2008-04-28 | 2008-04-28 | A kind of antineoplastic patches for external use of bullatacin |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552147A (en) * | 2011-02-11 | 2012-07-11 | 舒泰神（北京）生物制药股份有限公司 | Bullatacin ethosome gel and preparation method thereof |
-
2008
- 2008-04-28 CN CNB2008103013347A patent/CN100571691C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552147A (en) * | 2011-02-11 | 2012-07-11 | 舒泰神（北京）生物制药股份有限公司 | Bullatacin ethosome gel and preparation method thereof |
| CN102552147B (en) * | 2011-02-11 | 2013-06-05 | 舒泰神（北京）生物制药股份有限公司 | Bullatacin ethosome gel and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN100571691C (en) | 2009-12-23 |
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Granted publication date: 20091223 Termination date: 20190428 |