CN103877004A - Compound risperidone subcutaneous embedded sustained-release preparation and preparation method thereof - Google Patents
Compound risperidone subcutaneous embedded sustained-release preparation and preparation method thereof Download PDFInfo
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- CN103877004A CN103877004A CN201410119335.5A CN201410119335A CN103877004A CN 103877004 A CN103877004 A CN 103877004A CN 201410119335 A CN201410119335 A CN 201410119335A CN 103877004 A CN103877004 A CN 103877004A
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Abstract
The invention relates to a compound risperidone subcutaneous embedded sustained-release preparation and a preparation method thereof. The sustained-release preparation is prepared from the following raw materials in parts by weight: 100 parts of risperidone and 0.00247 part of propionic acid sustained-release preparation. The preparation method comprises the following step of uniformly mixing risperidone and the propionic acid sustained-release preparation into granules which are wrapped in a plurality of medical silicon rubber tubes. The compound risperidone subcutaneous embedded sustained-release preparation provided by the invention can be guided and embedded in a loose part of the subcutaneous tissue of the inferior abdominal wall of a patient by means of a small incision with a sleeve needle after getting a satisfactory effect of acute treatment of the patient, and 8-10 subcutaneous embedded sustained-release preparations can be embedded at one time. The subcutaneous embedded sustained-release preparation is lasting in curative effect and economical and practical, and the one-time embedding curative effect is controlled within about 1 year. Medicines guided by the sustained-release preparation are slowly and uniformly released through a medical silica gel thin film wall to ensure stable and effective blood concentration so as to realize the purpose of maintaining treatment. The subcutaneous embedded sustained-release preparation provided by the invention is suitable for patients with various schizophrenia, mood disorders, multiple Tourette syndrome and other risperidone treatment indications.
Description
Technical field
The present invention relates to psychosis medical medicine technical field, relate in particular to a kind of compound recipe risperidone subcutaneous implantable sustained-release agent and preparation method thereof.
Background technology
In psychologic medicine field, schizophrenia, mood disorders, multiple convulsion-obscene words syndrome etc. all belong to chronic mental sickness, have the feature of outbreak repeatedly, or even lifelong participation disease.At present, these diseases are all take various psychotropic therapy as main.Press conventional treatment, acute treatment after date, for reaching the object of consolidating curative effect, prevention of recurrence, also needs long term maintenance to take medicine.Due to reasons such as disease, economic condition, time-histories are long, cause patient to maintain treatment compliance poor, often active break medication in a short time of patient, shows effect disease repeatedly, is even the relieved state that is difficult to of persistence.In order to improve the compliance of this type of patient's long term maintenance treatment, exploitation, development a drug remain effectively long-time, and slight, the economical and practical antipsychotic agent dosage form of toxicity, are that Present Global psychiatric department expert is badly in need of the key subjects that solve.
Summary of the invention
For solving the problems of the technologies described above, the invention provides a kind of compound recipe risperidone subcutaneous implantable sustained-release agent simple in structure, easy to use, preparation method is simple, and cost is low, and a drug maintains duration of action and reaches 1 year, economical and practical, convenient drug administration.
Compound recipe risperidone subcutaneous implantable sustained-release of the present invention agent, is made up of the raw material that comprises following parts by weight: risperidone 100, propanoic acid controlled release agent 0.00247; Granulation shape after risperidone and propanoic acid controlled release agent mix homogeneously is wrapped in multiple medical silicone tubes.
The preparation method of compound recipe risperidone subcutaneous implantable sustained-release of the present invention agent, comprises the following steps:
1) raw-material preparation: required multiple medical silicone tubes, risperidone, propanoic acid controlled release agent, adhesive of medical are carried out to quality determination, and carry out necessary disinfecting;
2) compound medicine preparation: in order to make risperidone and the full and uniform mixing of interior sour controlled release agent, 100 parts of risperidones are put into container with 0.00247 part of propanoic acid, add again there is sterilization, volatile, the medical lytic agent that dissolves each other with controlled release agent, under room temperature, normal pressure, fully stir, make mixture become even suspension, under room temperature, condition of normal pressure, make afterwards medical lytic agent volatilize completely, obtain the piece that hardens of compound recipe risperidone, under aseptic, normal temperature condition, the piece that hardens of compound recipe risperidone is ground into 400 order powderies for subsequent use;
3) compound medicine fill: under room temperature, normal pressure and aseptic condition, through step 2) powder that makes is filled in multiple medical silicone tubes;
4) sealing after fill: medical silicone tube two ends adhesive of medical sealing good fill, obtain compound recipe risperidone subcutaneous implantable sustained-release agent manufactured goods;
5) manufactured goods quality inspection: sampling is carried out the quality testing of totally four aspects of sealing, active constituent content, microbiology index, releasing effect to above-mentioned manufactured goods;
6) packing of manufactured goods: the manufactured goods that reach designing requirement for detection require to carry out finished product packing according to drug packaging, every 2 is one group.
In the preparation method of above-mentioned compound recipe risperidone subcutaneous implantable sustained-release agent, described medical lytic agent is the ethanol of mass concentration 75%,
In the preparation method of above-mentioned compound recipe risperidone subcutaneous implantable sustained-release agent, described adhesive of medical is acrylic acid orthopaedics cement.
The application process of compound recipe risperidone subcutaneous implantable sustained-release of the present invention agent: suitable patient, take lower abdominal wall subcutaneous embedding, according to dosage requirement, it is ampoule that each patient 8-10 props up this patent preparation, annual use once.
Compound recipe risperidone subcutaneous implantable sustained-release of the present invention agent is wall thickness 0.4mm with medical silica-gel thin film, length 52mm, the tubular capsule of internal diameter 1.6mm.
Compared with prior art beneficial effect of the present invention is: compound recipe risperidone subcutaneous implantable sustained-release of the present invention agent can be used for the Acute Stage treatment and obtains after satisfactory effect, comparatively porous spot of stomach wall subcutaneous tissue under patient, adopt little otch to add trocar guiding heeling-in wherein, once can heeling-in 8-10 prop up skin of the present invention and bury slow releasing agent; Skin of the present invention buries slow releasing agent simple structure, making, easy to use, and curative effect is lasting, economical and practical, and one time heeling-in curative effect can be controlled in about 1 year; Medicine by medical silica-gel membrane wall slowly, at the uniform velocity discharge, guarantees stable, effective blood drug level under the guiding of controlled release agent, reaches the object that maintains treatment; Skin of the present invention buries slow releasing agent and is applicable to various schizophrenia, mood disorders, multiple convulsion-obscene words syndrome and other risperidone treatment eligible patients.
The specific embodiment
Below in conjunction with embodiment, the specific embodiment of the present invention is described in further detail.Following examples are used for illustrating the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
The agent of a kind of compound recipe risperidone subcutaneous implantable sustained-release, by comprise following weight (gram) raw material make: risperidone 100, propanoic acid controlled release agent 0.00247; Granulation shape after risperidone and propanoic acid controlled release agent mix homogeneously is wrapped in multiple medical silicone tubes.
The preparation method of the compound recipe risperidone subcutaneous implantable sustained-release agent of the present embodiment, comprises the following steps:
1) raw-material preparation: required multiple medical silicone tubes, risperidone, propanoic acid controlled release agent, adhesive of medical are carried out to quality determination, and carry out necessary disinfecting;
2) compound medicine preparation: in order to make risperidone and the full and uniform mixing of propanoic acid controlled release agent, 100 grams of risperidones are put into container crowd with 0.00247 gram of propanoic acid, add again there is sterilization, volatile, the medical lytic agent that dissolves each other with controlled release agent, under room temperature, normal pressure, fully stir, make mixture become even suspension, under room temperature, condition of normal pressure, make afterwards medical lytic agent volatilize completely, obtain the piece that hardens of compound recipe risperidone, under aseptic, normal temperature condition, the piece that hardens of compound recipe risperidone is ground into 400 order powderies for subsequent use;
3) compound medicine fill: under room temperature, normal pressure and aseptic condition, through step 2) powder that makes is filled in multiple medical silicone tubes, and each medical silicone tube packs 110 milligrams of powder into;
4) sealing after fill: medical silicone tube two ends adhesive of medical sealing good fill, obtain compound recipe risperidone subcutaneous implantable sustained-release agent manufactured goods;
5) manufactured goods quality inspection: sampling is carried out the quality testing of totally four aspects of sealing, active constituent content, microbiology index, releasing effect to above-mentioned manufactured goods;
6) packing of manufactured goods: the manufactured goods that reach designing requirement for detection require to carry out finished product packing according to drug packaging, every 2 is one group.
In the preparation method of above-mentioned compound recipe risperidone subcutaneous implantable sustained-release agent, described medical lytic agent is the ethanol of mass concentration 75%,
In the preparation method of above-mentioned compound recipe risperidone subcutaneous implantable sustained-release agent, described adhesive of medical is acrylic acid orthopaedics cement.
Embodiment 2
The agent of a kind of compound recipe risperidone subcutaneous implantable sustained-release, by comprise following weight (gram) raw material make: risperidone 1000, propanoic acid controlled release agent 0.0247; Granulation shape after risperidone and propanoic acid controlled release agent mix homogeneously is wrapped in multiple medical silicone tubes.
The preparation method of the compound recipe risperidone subcutaneous implantable sustained-release agent of the present embodiment is with embodiment 1.
Embodiment 3
The agent of a kind of compound recipe risperidone subcutaneous implantable sustained-release, by comprise following weight (gram) raw material make: risperidone 10000, propanoic acid controlled release agent 0.247; Granulation shape after risperidone and propanoic acid controlled release agent mix homogeneously is wrapped in multiple medical silicone tubes.
The preparation method of the compound recipe risperidone subcutaneous implantable sustained-release agent of the present embodiment is with embodiment 1.
The application process of compound recipe risperidone subcutaneous implantable sustained-release of the present invention agent: suitable patient, take lower abdominal wall subcutaneous embedding, according to dosage requirement, it is ampoule that each patient 8-10 props up this patent preparation, annual use once.
Compound recipe risperidone subcutaneous implantable sustained-release of the present invention agent is wall thickness 0.4mm with medical silica-gel thin film, length 52mm, the tubular capsule of internal diameter 1.6mm.
Compound recipe risperidone subcutaneous implantable sustained-release of the present invention agent can be used for the Acute Stage treatment and obtains after satisfactory effect, comparatively porous spot of stomach wall subcutaneous tissue under patient, adopt little otch to add trocar guiding heeling-in wherein, once can heeling-in 8-10 prop up skin of the present invention and bury slow releasing agent; Skin of the present invention buries slow releasing agent simple structure, making, easy to use, and curative effect is lasting, economical and practical, and one time heeling-in curative effect can be controlled in about 1 year; Medicine by medical silica-gel membrane wall slowly, at the uniform velocity discharge, guarantees stable, effective blood drug level under the guiding of controlled release agent, reaches the object that maintains treatment; Skin of the present invention buries slow releasing agent and is applicable to various schizophrenia, mood disorders, multiple convulsion-obscene words syndrome and other risperidone treatment eligible patients.
The present invention selects raw material and each component to meet pharmaceutical control law regulation, utilize the micro-control release action that sees through characteristic and propanoic acid controlled release agent of antipsycholic action, medical silica-gel thin film of risperidone, various schizophrenia, mood disorders, multiple convulsion-obscene words syndrome and other risperidone treatment eligible patients are played to effective, safe, the stable therapeutical effect that maintains; The present invention is slight to human body toxic and side effects, and foreign body zest is small, and application is convenient, and drug release is reliable.The present invention was through clinical observation in 3 years, select 30 cases, with safety, curative effect, the toxic and side effects indifference of other risperidone preparations of current clinical use, medicine of the present invention can be widely used in various schizophrenia, mood disorders, multiple convulsion-obscene words syndrome and other risperidone treatment eligible patients and maintain treatment.
The above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, do not departing under the prerequisite of the technology of the present invention principle; can also make some improvement and modification, these improve and modification also should be considered as protection scope of the present invention.
Claims (4)
1. a compound recipe risperidone subcutaneous implantable sustained-release agent, is characterized in that, is made up of the raw material that comprises following parts by weight: risperidone 100, propanoic acid controlled release agent 0.00247; Granulation shape after risperidone and propanoic acid controlled release agent mix homogeneously is wrapped in multiple medical silicone tubes.
2. a preparation method for compound recipe risperidone subcutaneous implantable sustained-release agent, is characterized in that, comprises the following steps:
1) raw-material preparation: required multiple medical silicone tubes, risperidone, propanoic acid controlled release agent, adhesive of medical are carried out to quality determination, and carry out necessary disinfecting;
2) compound medicine preparation: in order to make risperidone and the full and uniform mixing of propanoic acid controlled release agent, 100 parts of risperidones are put into container crowd with 0.00247 part of propanoic acid, add again there is sterilization, volatile, the medical lytic agent that dissolves each other with controlled release agent, under room temperature, normal pressure, fully stir, make mixture become even suspension, under room temperature, condition of normal pressure, make afterwards medical lytic agent volatilize completely, obtain the piece that hardens of compound recipe risperidone, under aseptic, normal temperature condition, the piece that hardens of compound recipe risperidone is ground into 400 order powderies for subsequent use;
3) compound medicine fill: under room temperature, normal pressure and aseptic condition, through step 2) powder that makes is filled in multiple medical silicone tubes;
4) sealing after fill: medical silicone tube two ends adhesive of medical sealing good fill, obtain compound recipe risperidone subcutaneous implantable sustained-release agent manufactured goods;
5) manufactured goods quality inspection: sampling is carried out the quality testing of totally four aspects of sealing, active constituent content, microbiology index, releasing effect to above-mentioned manufactured goods;
6) packing of manufactured goods: the manufactured goods that reach designing requirement for detection require to carry out finished product packing according to drug packaging, every 2 is one group.
3. the preparation method of compound recipe risperidone subcutaneous implantable sustained-release according to claim 2 agent, is characterized in that: described medical lytic agent is the ethanol of mass concentration 75%.
4. according to the preparation method of the compound recipe risperidone subcutaneous implantable sustained-release agent described in claim 2 or 3, it is characterized in that: in the preparation method of above-mentioned compound recipe risperidone subcutaneous implantable sustained-release agent, described adhesive of medical is acrylic acid orthopaedics cement.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410119335.5A CN103877004A (en) | 2014-03-26 | 2014-03-26 | Compound risperidone subcutaneous embedded sustained-release preparation and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410119335.5A CN103877004A (en) | 2014-03-26 | 2014-03-26 | Compound risperidone subcutaneous embedded sustained-release preparation and preparation method thereof |
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| CN201410119335.5A Pending CN103877004A (en) | 2014-03-26 | 2014-03-26 | Compound risperidone subcutaneous embedded sustained-release preparation and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107753418A (en) * | 2017-11-20 | 2018-03-06 | 中国农业科学院北京畜牧兽医研究所 | Medicament slow release implants and heeling-in device |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2712349Y (en) * | 2004-07-12 | 2005-07-27 | 郑士全 | Subcutaneous implantable sustained-release silica gel rod for antipsychotics |
| CN102764229A (en) * | 2012-07-24 | 2012-11-07 | 孟宪礼 | Compound haloperidol subcutaneously-implanted sustained-release agent and preparation and use methods thereof |
-
2014
- 2014-03-26 CN CN201410119335.5A patent/CN103877004A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2712349Y (en) * | 2004-07-12 | 2005-07-27 | 郑士全 | Subcutaneous implantable sustained-release silica gel rod for antipsychotics |
| CN102764229A (en) * | 2012-07-24 | 2012-11-07 | 孟宪礼 | Compound haloperidol subcutaneously-implanted sustained-release agent and preparation and use methods thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107753418A (en) * | 2017-11-20 | 2018-03-06 | 中国农业科学院北京畜牧兽医研究所 | Medicament slow release implants and heeling-in device |
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Application publication date: 20140625 |