CN105769987A - Ganyanling injection (injection for treating hepatitis) and preparation method of injection - Google Patents
Ganyanling injection (injection for treating hepatitis) and preparation method of injection Download PDFInfo
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- CN105769987A CN105769987A CN201410772645.7A CN201410772645A CN105769987A CN 105769987 A CN105769987 A CN 105769987A CN 201410772645 A CN201410772645 A CN 201410772645A CN 105769987 A CN105769987 A CN 105769987A
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Abstract
The invention provides a Ganyanling injection (injection for treating hepatitis) and a preparation method of the injection. The Ganyanling injection is characterized in that the prescription of the injection consists of the following components in parts by weight: 1-10 parts of an extracting solution of radix sophorae subprostratae, 0.1-2 parts of (medicinal) Tween-80 and 58-98.9 parts of injection water. The Ganyanling injection disclosed by the invention is prepared by two steps, with a simple process and controllable preparation conditions; and the prepared Ganyanling injection is high in purity of active ingredients, low in side effects and nearly free from such adverse reactions as dizziness, irregular heartbeats, nausea and vomiting, allergy and the like.
Description
Technical field
The invention belongs to field of medicine preparations, be specifically related to a kind of Sophora Tankinensis and preparation method thereof.
Background technology
At present, the class diseases such as chronic, active hepatitis, liver cirrhosis, abnormal liver function account for about the 30% of normal population China patient, in many treatments in the Chinese patent medicine of the liver disease such as liver property inflammation chronic, movable, liver cirrhosis, abnormal liver function, great majority also exist prescription composition complexity, thus causing that human body is had the effect of multiple complexity, the shortcoming of even many side effect by product.
Chinese patent CN85100392B discloses a kind of method extracting treatment medicine for curing hepatitis from plant Radix Sophorae Tonkinensis.Method described in this invention includes: by Radix Sophorae Tonkinensis sheet soak by water, decoction liquor ethanol precipitates, medicinal liquid organic solvent extraction, regulate the medicinal liquid being extracted to pH1～3, cold preservation, filter precipitation, precipitating impurity in medicinal liquid with ethanol again, the alcohol content of medicinal liquid is 80～90 degree.Presently commercially available Sophora Tankinensis or title Sophora Tankinensis are the preparations containing total alkaloids of subprostrate sophora root, and 2ml is containing total alkaloids of subprostrate sophora root 50mg, and the matrine containing mark (C15H24N2O) is 35mg.This injection shows through long-term clinical application, it is possible to reduce transaminase, improves immunity of organisms, chronic active hepatitis is had good therapeutic effect.Said preparation adopts the method disclosed in patent CN85100392B to prepare.But viral hepatitis is more with mild, asymptomatic or chronic person, need long-term prescription, and life-time service Sophora Tankinensis, in addition to pain, the easy inflammation in injection site, play lump, it is difficult to adhere to for a long time, and decrement inconvenience during ALT knock-on, thus affecting therapeutic effect.After patient's intramuscular injection hepatitis medicine also reported by document, the untoward reaction such as dizziness, heart beating, nausea and vomiting and allergy occur.One Sophora Tankinensis of the present invention and preparation method thereof, can reduce transaminase, improves immunity of organisms.For chronic, active hepatitis.
Summary of the invention
It is desirable to provide a kind of principal agent active component purity is high, side effect is little, simple Sophora Tankinensis of preparation technology and preparation method thereof.
For achieving the above object, one Sophora Tankinensis of the present invention and preparation method thereof, the specific scheme is that
A kind of Sophora Tankinensis of the present invention and preparation method thereof, it is characterised in that this Sophora Tankinensis prescription parts by weight meter is made up of Radix Sophorae Tonkinensis extracting solution 1-10 part, tween 80 (medicinal) 0.1-2 part, water for injection 58-98.9 part.
A kind of Sophora Tankinensis of the present invention and preparation method thereof, main active Radix Sophorae Tonkinensis extracting solution through dissolving, regulate ph value, cross post, eluting, concentration, water precipitating, the refining acquirement of filtration, it is characterized in that this Radix Sophorae Tonkinensis extracting solution filters purification step and is: pour in treatment tank by Radix Sophorae Tonkinensis water precipitating extracting solution, medicinal charcoal is added when being warming up to 70-80 DEG C, stirring, be warming up to 80 ± 5 DEG C and be incubated 0.5-1.5 hour, sodium hydroxide solution regulates medicinal liquid pH to 6.0-6.5, titanium rod filters, and to obtain final product.
A kind of Sophora Tankinensis of the present invention and preparation method thereof, it is characterised in that the concrete preparation method of this Sophora Tankinensis is:
1) dense joining: inject water to the 80%-90% of dosage in dense preparing tank, stirring, heating adds medicinal tween 80 after boiling to medicinal liquid, be incubated 5-20 minute, is cooled to 75 ~ 80 DEG C, adds medicinal charcoal, and 80 ± 5 DEG C are incubated 0.5-1.5 hour, titanium rod filtration medicinal charcoal；
2) rare joining: step 1) gained medicinal liquid is delivered to dilute preparing tank, inject with water, stirring, sodium hydroxide solution regulates medicinal liquid pH to 6.4 ~ 7.0, and after nitrogen is passed into dilute preparing tank, accurate filter filters, embedding, steam sterilization, and leak detection, lamp inspection are packed and be get final product.
A kind of Sophora Tankinensis of the present invention and preparation method thereof, it is characterized in that this Radix Sophorae Tonkinensis extracting solution filters purification step particularly as follows: pour in treatment tank by Radix Sophorae Tonkinensis water precipitating extracting solution, medicinal charcoal is added when being warming up to 75 DEG C, stir, it is warming up to 80 DEG C and is incubated 1 hour, sodium hydroxide solution regulates medicinal liquid pH to 6.0, and titanium rod filters, and to obtain final product.
A kind of Sophora Tankinensis of the present invention and preparation method thereof, it is characterised in that the concrete preparation method of this Sophora Tankinensis is:
1) dense joining: inject water to the 85% of dosage in dense preparing tank, stirring, heating adds medicinal tween 80 after boiling to medicinal liquid, be incubated 15 minutes, is cooled to 75 DEG C, adds medicinal charcoal, and 80 DEG C are incubated 0.5 hour, titanium rod filtration medicinal charcoal；
2) rare joining: step 1) gained medicinal liquid is delivered to dilute preparing tank, inject with water, stirring, sodium hydroxide solution regulates medicinal liquid pH to 6.5, after nitrogen is passed into dilute preparing tank, and accurate filter double-filtration, embedding, steam sterilization, leak detection, lamp inspection, pack and get final product.
A kind of Sophora Tankinensis of the present invention and preparation method thereof, it is characterized in that preparation process 2) accurate filter double-filtration, the accurate filter bubble point pressure of 0.45 μm is 0.23-0.35MPa, and the accurate filter bubble point pressure of 0.22 μm is 0.35-0.45MPa.
A kind of Sophora Tankinensis of the present invention and preparation method thereof, it is characterised in that the present invention adapts to the Sophora Tankinensis preparation of all size.
The method have the benefit that
1. the present invention prepares reasonable recipe, and active component purity is high, and side effect is little；
2. preparation technology is simple, and operating condition is controlled, is suitable for industrialized production.
Detailed description of the invention
Example below, only for further illustrating the present invention, does not limit the present invention in any form.
Embodiment 1
Prescription: Radix Sophorae Tonkinensis extracting solution 17.5g(presses matrine and calculates), tween 80 (medicinal) 2.0g, water for injection adds to 1000ml, makes 500 (2ml/ props up).
Preparation method:
1) in dense preparing tank, inject water to dosage 90%, stir 5 minutes, open the heating of interlayer steam valve, after medicinal liquid boils, add medicinal tween 80, be incubated 10min, be cooled to 75 DEG C, add 0.5% medicinal charcoal (g/ml).80 DEG C are incubated 30 minutes, stop logical steam.
2) after filtering medicinal charcoal by 0.8 μm of titanium rod, medicinal liquid is delivered to dilute preparing tank, adds to the full amount of water for injection, stirring, adds NaOH solution and regulates medicinal liquid pH value to 6.5.Shut each valve, open nitrogen valve, make the filter that nitrogen passes through 0.22 μm pass into dilute preparing tank again, adopt accurate filter to filter and filtrate is filtered, the accurate filter first time of 0.45 μm filters, bubble point pressure should at 0.23-0.35MPa, and the accurate filter second time of 0.22 μm filters, and bubble point pressure should at 0.35-0.45MPa, embedding, embedding, steam sterilization, leak detection, lamp inspection, pack and get final product.
Embodiment 2
Prescription: Radix Sophorae Tonkinensis extracting solution 18g(presses matrine and calculates), tween 80 (medicinal) 1.5g, water for injection adds to 1000ml, makes 500 (2ml/ props up).
Preparation method:
1) in dense preparing tank, inject water to dosage 90%, stir 5 minutes, open the heating of interlayer steam valve, after medicinal liquid boils, add medicinal tween 80, be incubated 10min, be cooled to 75 DEG C, add 0.5% medicinal charcoal (g/ml).80 DEG C are incubated 30 minutes, stop logical steam.
2) after filtering medicinal charcoal by 0.8 μm of titanium rod, medicinal liquid is delivered to dilute preparing tank, adds to the full amount of water for injection, stirring, adds NaOH solution and regulates medicinal liquid pH value to 6.5.Shut each valve, open nitrogen valve, make the filter that nitrogen passes through 0.22 μm pass into dilute preparing tank again, adopt accurate filter to filter and filtrate is filtered, the accurate filter first time of 0.45 μm filters, bubble point pressure should at 0.23-0.35MPa, and the accurate filter second time of 0.22 μm filters, and bubble point pressure should at 0.35-0.45MPa, embedding, embedding, steam sterilization, leak detection, lamp inspection, pack and get final product.
Embodiment 3
Prescription: Radix Sophorae Tonkinensis extracting solution 18.5g(presses matrine and calculates), tween 80 (medicinal) 1.5g, water for injection adds to 1000ml, makes 500 (2ml/ props up).
Preparation method:
1) in dense preparing tank, inject water to dosage 90%, stir 5 minutes, open the heating of interlayer steam valve, after medicinal liquid boils, add medicinal tween 80, be incubated 10min, be cooled to 75 DEG C, add 0.5% medicinal charcoal (g/ml).80 DEG C are incubated 30 minutes, stop logical steam.
2) after filtering medicinal charcoal by 0.8 μm of titanium rod, medicinal liquid is delivered to dilute preparing tank, adds to the full amount of water for injection, stirring, adds NaOH solution and regulates medicinal liquid pH value to 6.5.Shut each valve, open nitrogen valve, make the filter that nitrogen passes through 0.22 μm pass into dilute preparing tank again, adopt accurate filter to filter and filtrate is filtered, the accurate filter first time of 0.45 μm filters, bubble point pressure should at 0.23-0.35MPa, and the accurate filter second time of 0.22 μm filters, and bubble point pressure should at 0.35-0.45MPa, embedding, embedding, steam sterilization, leak detection, lamp inspection, pack and get final product.
Claims (7)
1. Sophora Tankinensis and preparation method thereof, it is characterised in that this Sophora Tankinensis prescription parts by weight meter is made up of Radix Sophorae Tonkinensis extracting solution 1-10 part, tween 80 (medicinal) 0.1-2 part, water for injection 58-98.9 part.
2. a kind of Sophora Tankinensis and preparation method thereof according to claim 1, main active Radix Sophorae Tonkinensis extracting solution through dissolving, regulate ph value, cross post, eluting, concentration, water precipitating, the refining acquirement of filtration, it is characterized in that this Radix Sophorae Tonkinensis extracting solution filters purification step and is: pour in treatment tank by Radix Sophorae Tonkinensis water precipitating extracting solution, medicinal charcoal is added when being warming up to 70-80 DEG C, stir, it is warming up to 80 ± 5 DEG C and is incubated 0.5-1.5 hour, sodium hydroxide solution regulates medicinal liquid pH to 6.0-6.5, titanium rod filters, and to obtain final product.
3. a kind of Sophora Tankinensis and preparation method thereof according to claim 1, it is characterised in that the concrete preparation method of this Sophora Tankinensis is:
1) dense joining: inject water to the 80%-90% of dosage in dense preparing tank, stirring, heating adds medicinal tween 80 after boiling to medicinal liquid, be incubated 5-20 minute, is cooled to 75 ~ 80 DEG C, adds medicinal charcoal, and 80 ± 5 DEG C are incubated 0.5-1.5 hour, titanium rod filtration medicinal charcoal；
2) rare joining: step 1) gained medicinal liquid is delivered to dilute preparing tank, inject with water, stirring, sodium hydroxide solution regulates medicinal liquid pH to 6.4 ~ 7.0, and after nitrogen is passed into dilute preparing tank, accurate filter filters, embedding, steam sterilization, and leak detection, lamp inspection are packed and be get final product.
4. a kind of Sophora Tankinensis and preparation method thereof according to claim 2, it is characterized in that this Radix Sophorae Tonkinensis extracting solution filters purification step particularly as follows: pour in treatment tank by Radix Sophorae Tonkinensis water precipitating extracting solution, medicinal charcoal is added when being warming up to 75 DEG C, stir, it is warming up to 80 DEG C and is incubated 1 hour, sodium hydroxide solution regulates medicinal liquid pH to 6.0, and titanium rod filters, and to obtain final product.
5. a kind of Sophora Tankinensis and preparation method thereof according to claim 3, it is characterised in that the concrete preparation method of this Sophora Tankinensis is:
1) dense joining: inject water to the 85% of dosage in dense preparing tank, stirring, heating adds medicinal tween 80 after boiling to medicinal liquid, be incubated 15 minutes, is cooled to 75 DEG C, adds medicinal charcoal, and 80 DEG C are incubated 0.5 hour, titanium rod filtration medicinal charcoal；
2) rare joining: step 1) gained medicinal liquid is delivered to dilute preparing tank, inject with water, stirring, sodium hydroxide solution regulates medicinal liquid pH to 6.5, after nitrogen is passed into dilute preparing tank, and accurate filter double-filtration, embedding, steam sterilization, leak detection, lamp inspection, pack and get final product.
6. a kind of Sophora Tankinensis and preparation method thereof according to claim 3, it is characterized in that preparation process 2) accurate filter double-filtration, the accurate filter bubble point pressure of 0.45 μm is 0.23-0.35MPa, and the accurate filter bubble point pressure of 0.22 μm is 0.35-0.45MPa.
7. a kind of Sophora Tankinensis and preparation method thereof according to claim 1-6, it is characterised in that the present invention adapts to the Sophora Tankinensis preparation of all size.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410772645.7A CN105769987A (en) | 2014-12-16 | 2014-12-16 | Ganyanling injection (injection for treating hepatitis) and preparation method of injection |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410772645.7A CN105769987A (en) | 2014-12-16 | 2014-12-16 | Ganyanling injection (injection for treating hepatitis) and preparation method of injection |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN85100392A (en) * | 1985-04-01 | 1986-08-27 | 广西壮族自治区天然药物研究中心 | From the plant Radix Sophorae Tonkinensis, extract the method for treatment medicine for curing hepatitis |
| CN1994364A (en) * | 2006-12-30 | 2007-07-11 | 湖南康普制药有限公司 | Subprostrate soplhor root extract refining process |
| CN102293780A (en) * | 2011-08-16 | 2011-12-28 | 湖北博瑞佳医药科技有限公司 | Sodium acetate Ringer's injection and its preparation method |
-
2014
- 2014-12-16 CN CN201410772645.7A patent/CN105769987A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN85100392A (en) * | 1985-04-01 | 1986-08-27 | 广西壮族自治区天然药物研究中心 | From the plant Radix Sophorae Tonkinensis, extract the method for treatment medicine for curing hepatitis |
| CN1994364A (en) * | 2006-12-30 | 2007-07-11 | 湖南康普制药有限公司 | Subprostrate soplhor root extract refining process |
| CN102293780A (en) * | 2011-08-16 | 2011-12-28 | 湖北博瑞佳医药科技有限公司 | Sodium acetate Ringer's injection and its preparation method |
Non-Patent Citations (2)
| Title |
|---|
| 何晓艳: "肝炎灵注射液不良反应物质基础研究与品种质量提高", 《中国优秀硕士学位论文全文数据库 医药卫生科技辑》 * |
| 陈卫卫等: "《药剂学》", 31 January 2014, 西安交通大学出版社 * |
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Application publication date: 20160720 |
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