CN1190006A - Compound red sage injecta and its preparation - Google Patents
Compound red sage injecta and its preparation Download PDFInfo
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- CN1190006A CN1190006A CN97101352A CN97101352A CN1190006A CN 1190006 A CN1190006 A CN 1190006A CN 97101352 A CN97101352 A CN 97101352A CN 97101352 A CN97101352 A CN 97101352A CN 1190006 A CN1190006 A CN 1190006A
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- refined liquid
- fufang danshen
- danshen zhusheye
- lignum dalbergiae
- radix salviae
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Abstract
The present invention aims at providing easy-to-use compound red sage injecta with reliable effect for direct intravenous instillation. The injecta is prepared by adding penetrant, buffering agent and normal saline into the mixture of red sage extract liquid and Lignum Dalbergiae Odoriferae extract liquid, and it is packed into instillation bottle or bag. The present invention is used in instillation directly and the use of the said inkecta can prevent cross infection.
Description
The invention belongs to medical science, particularly, belong to medical drugs and compound method thereof with the Chinese crude drug preparation.
FUFANG DANSHEN ZHUSHEYE is a kind of medicine of important treatment cardiovascular disease, has blood vessel dilating, increases the effect of coronary artery amount, has been widely used in the clinical treatment of diseases such as coronary heart disease, angina pectoris, myocardial infarction.The compound red sage root preparation that uses only has the injection of every 2ml at present, and the production technology of another injectable powder is documented among the CN1051301 patent application.During practical application, need that this more than ground of injection peace cut is got liquid and mix, add the dilution of 100～500ml glucose injection again and just can be used for intravenous drip.Obviously, this using method has three shortcomings, and the one, formality is loaded down with trivial details, uses trouble; The 2nd, in the mixed diluting process, the easy oxidation of medicine produces negative consequence; The 3rd, in the pollution that this process Chinese medicine is caused by environment, apparatus or misoperation etc. easily, can cause user to produce have a fever, feel cold, tachycardia or cross and wait infusion reaction slowly, go back entail dangers to patient's life in the time of seriously.
The object of the present invention is to provide a kind of FUFANG DANSHEN ZHUSHEYE, it is more easy to use, reliable for effect than existing injection, can be directly used in intravenous drip, and its method for making is provided.
The contained main component of FUFANG DANSHEN ZHUSHEYE provided by the invention is Radix Salviae Miltiorrhizae and Lignum Dalbergiae Odoriferae, and its packing of product is above large transfusion bottle of 50ml or bag; It is to be primary raw material with Radix Salviae Miltiorrhizae refined liquid and Lignum Dalbergiae Odoriferae refined liquid, and it is made to add pharmaceutical carriers such as an amount of isotonic agent, buffer agent and water for injection.
In FUFANG DANSHEN ZHUSHEYE, the content of Radix Salviae Miltiorrhizae refined liquid and Lignum Dalbergiae Odoriferae refined liquid can be arbitrary proportion, but wherein a kind of can not lacking.The total amount of these two kinds of refined liquid and pharmaceutical carrier amount also can be arbitrary proportion, but pharmaceutical carrier can be with also can.
The effect of pharmaceutical carrier is osmotic pressure and a pH value of regulating inside of human body, suitably adds isotonic agent and buffer agent, helps the absorption of human body to medicine.In FUFANG DANSHEN ZHUSHEYE, can among the dextran of sodium chloride, magnesium chloride, calcium chloride, sodium lactate, glucose, xylitol, sorbitol, glycerol or various molecular weight one or more as the isotonic agent of pharmaceutical carrier.As the buffer agent of pharmaceutical carrier can be acids such as hydrochloric acid, acetic acid, lactic acid, or among the bases such as sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium hydroxide one or more.Isotonic agent and buffer agent can use simultaneously, also can be only with wherein a kind of; Under the comparatively suitable situation of dosage, even can.But generally, to use an amount of isotonic agent to be advisable.
The method for making of the FUFANG DANSHEN ZHUSHEYE that the inventor provides comprises: (1) prepares the Lignum Dalbergiae Odoriferae refined liquid with the way of distillation earlier; (2) prepare the Radix Salviae Miltiorrhizae refined liquid with decocting, filter, distill concentration method; (3) preparation isotonic agent concentrated solution; (4) in proportion aforesaid liquid is merged, add an amount of water for injection dilution and heating for dissolving, use decolorizing with activated carbon, remove pyrogen, filtering rear filtrate is 6.0～7.0 with sodium hydroxide or hydrochloric acid adjusting pH value; Benefit adds to the full amount of water for injection, and after mensuration content is qualified, packs behind the microporous filter membrane fine straining, obtains the FUFANG DANSHEN ZHUSHEYE finished product again after sterilization, lamp inspection, the quality inspection of routine are qualified.Its packing is undertaken by the relevant requirements of infusion solutions.
FUFANG DANSHEN ZHUSHEYE provided by the invention directly is used as the infusion solutions of various requirements in the time of can be for the various cardiovascular disease of clinical treatment, not only easy to use, also avoid cross infection, improved the clinical practice level and the safety of FUFANG DANSHEN ZHUSHEYE, helped the normal performance of drug effect.
FUFANG DANSHEN ZHUSHEYE of the present invention can be by following index test:
The name of an article: FUFANG DANSHEN ZHUSHEYE
Performance: yellowish-brown or brown clear liquid
Differentiate: show positive reaction
pH：3.5～8.5
Glucose content is labelled amount %:90～110
Other: meet requirement under the injection item
Sterility test: qualified
Pyrogen testing: qualified
Embodiment 1: preparation contains the FUFANG DANSHEN ZHUSHEYE of glucose, carries out according to the following steps:
(1) preparation Lignum Dalbergiae Odoriferae refined liquid: get Lignum Dalbergiae Odoriferae 1000g and dig flakiness, with the water for injection of 15 times of amounts of water adding commonly used, distillate 2000ml is collected in distillation, cooling, cold preservation is 24 hours under 0～4 ℃ of condition, removes oil reservoir, the water layer redistillation is collected distillate 5000ml, and cold preservation is stand-by.
(2) preparation Radix Salviae Miltiorrhizae refined liquid: get Radix Salviae Miltiorrhizae 1000g, behind water commonly used, distilled water flushing, the water for injection with 12 times, 8 times, 8 times amounts decocts respectively, and 2 hours for the first time, for the second time, decocted each 1.5 hours for the third time; Merge three liquid of boiling medicine and be concentrated into 1000ml, add 95% ethanol 4610ml, placed 36 hours down in 1 ℃; Remove by filter post precipitation, it is 350ml that filtrate is concentrated, removes ethanol to medicinal liquid; Adding 95% ethanol 3500ml placed 48 hours down in 1 ℃; Remove by filter precipitation, filtrate is concentrated, removing ethanol to medicinal liquid is 500ml, adds the 10g activated carbon decolorizing again, and heated and boiled is removed pyrogen, and cold slightly after-filtration is stand-by after the cold preservation.
(3) preparation glucose concentrated wiring liquid: get glucose for injection 3125g, add water for injection 9500ml, boiled 5 minutes, add active carbon, stand-by after the sand rod filters.
(4) preparation FUFANG DANSHEN ZHUSHEYE: the Lignum Dalbergiae Odoriferae refined liquid of step (1) gained, the Radix Salviae Miltiorrhizae refined liquid of step (2) gained and the glucose concentrated wiring liquid of step (3) gained are merged, add the injection water to 30000ml, add the 9g activated carbon decolorizing, remove pyrogen, with sand rod elimination active carbon, regulating pH value with 0.1N sodium hydroxide or 0.1N hydrochloric acid is 6.0～6.9, adds water for injection to 31250ml.Detect its content, when qualified, through 0.4 μ hole filter membrane fine straining, fill was sterilized 30 minutes down at 121 ℃ with saturated vapor in infusion bottle of cleaning or transfusion bag, cooled off laggard portable lighter inspection, again through after the assay was approved, obtained the FUFANG DANSHEN ZHUSHEYE finished product.
Embodiment 2: the FUFANG DANSHEN ZHUSHEYE of preparation sodium chloride-containing, its each step only replace glucose to make as isotonic agent with sodium chloride in step (3) all with embodiment 1.
Embodiment 3: preparation contains the FUFANG DANSHEN ZHUSHEYE of xylitol, and its each step only replaces glucose to make as isotonic agent with xylitol in step (3) all with embodiment 1.
Embodiment 4: preparation contains the FUFANG DANSHEN ZHUSHEYE of dextran, and its each step only replaces glucose to make as isotonic agent with dextran in step (3) all with embodiment 1.
Embodiment 5: the FUFANG DANSHEN ZHUSHEYE of preparation sodium chloride-containing, potassium chloride, calcium chloride, its each step only replace glucose to make as isotonic agent with sodium chloride, potassium chloride, calcium chloride in step (3) all with embodiment 1.
Embodiment 6: preparation contains the FUFANG DANSHEN ZHUSHEYE of sodium lactate, potassium chloride, calcium chloride, and its each step only replaces glucose to make as isotonic agent with sodium lactate, potassium chloride, calcium chloride in step (3) all with embodiment 1.
Embodiment 7: preparation contains the FUFANG DANSHEN ZHUSHEYE of glucose, sodium chloride, and its each step is all with embodiment 1, and only replacing partly with sodium chloride in step (3), glucose makes as isotonic agent.
Embodiment 8: preparation compound recipe glucose FUFANG DANSHEN ZHUSHEYE, its each step are all with embodiment 1, and only replacing partly with dextran in step (3), glucose makes as isotonic agent.
Embodiment 9: preparation does not contain the FUFANG DANSHEN ZHUSHEYE of isotonic agent, and its step (1), (2), (4) are with embodiment 1, but does not have step (3).Lignum Dalbergiae Odoriferae, each 100ml of Radix Salviae Miltiorrhizae refined liquid of taking step (1) and (2) preparation add water for injection and are diluted to 10000ml, and (4) make again set by step.
Claims (4)
1 one kinds is the FUFANG DANSHEN ZHUSHEYE of primary raw material with Radix Salviae Miltiorrhizae and Lignum Dalbergiae Odoriferae, it is characterized in that it is to add an amount of isotonic agent or pharmaceutical carriers such as buffer agent and water for injection are formed in Radix Salviae Miltiorrhizae refined liquid and Lignum Dalbergiae Odoriferae refined liquid, its packing of product be the above large transfusion bottle of 50ml or bag.
2 FUFANG DANSHEN ZHUSHEYE as claimed in claim 1 is characterized in that the content of Radix Salviae Miltiorrhizae refined liquid and Lignum Dalbergiae Odoriferae refined liquid can be arbitrary proportion, but wherein a kind of can not lacking.The total amount of these two kinds of refined liquid and pharmaceutical carrier amount also can be arbitrary proportion, but pharmaceutical carrier can be with also can.
3 FUFANG DANSHEN ZHUSHEYE as claimed in claim 1 is characterized in that isotonic agent as pharmaceutical carrier can be one or more among the dextran of sodium chloride, magnesium chloride, calcium chloride, sodium lactate, glucose, xylitol, sorbitol, glycerol or various molecular weight.As the buffer agent of pharmaceutical carrier can be acids such as hydrochloric acid, acetic acid, lactic acid, or among the bases such as sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium hydroxide one or more.Isotonic agent and buffer agent can use simultaneously, also can be only with wherein a kind of; Under the comparatively suitable situation of dosage, even can.
The method for making of 4 FUFANG DANSHEN ZHUSHEYE as claimed in claim 1, its feature comprises: (1) prepares the Lignum Dalbergiae Odoriferae refined liquid with the way of distillation earlier; (2) prepare the Radix Salviae Miltiorrhizae refined liquid with decocting, filter, distill concentration method; (3) preparation isotonic agent concentrated solution; (4) in proportion aforesaid liquid is merged, add an amount of water for injection dilution and heating for dissolving, use decolorizing with activated carbon, remove pyrogen, filtering rear filtrate is 6.0～7.0 with sodium hydroxide or hydrochloric acid adjusting pH value; Benefit adds to the full amount of water for injection, and after mensuration content is qualified, packs behind the microporous filter membrane fine straining, obtains the FUFANG DANSHEN ZHUSHEYE finished product again after sterilization, lamp inspection, the quality inspection of routine are qualified.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97101352A CN1190006A (en) | 1997-02-05 | 1997-02-05 | Compound red sage injecta and its preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97101352A CN1190006A (en) | 1997-02-05 | 1997-02-05 | Compound red sage injecta and its preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1190006A true CN1190006A (en) | 1998-08-12 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN97101352A Pending CN1190006A (en) | 1997-02-05 | 1997-02-05 | Compound red sage injecta and its preparation |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1297287C (en) * | 2003-12-31 | 2007-01-31 | 昆明紫健生物技术有限公司 | Compound red sage root and amino acid infusion and its preparing method |
| CN1778346B (en) * | 2004-11-26 | 2010-05-12 | 天津天士力制药股份有限公司 | Medicine for treating coronary heart disease |
| CN1778353B (en) * | 2004-11-26 | 2010-09-08 | 天津天士力制药股份有限公司 | Chinese medicine dropping ball for treating cardiovascular disease |
| CN1778352B (en) * | 2004-11-26 | 2010-11-10 | 天津天士力制药股份有限公司 | Chinese medicine composition for treating cardiovascular disease |
-
1997
- 1997-02-05 CN CN97101352A patent/CN1190006A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1297287C (en) * | 2003-12-31 | 2007-01-31 | 昆明紫健生物技术有限公司 | Compound red sage root and amino acid infusion and its preparing method |
| CN1778346B (en) * | 2004-11-26 | 2010-05-12 | 天津天士力制药股份有限公司 | Medicine for treating coronary heart disease |
| CN1778353B (en) * | 2004-11-26 | 2010-09-08 | 天津天士力制药股份有限公司 | Chinese medicine dropping ball for treating cardiovascular disease |
| CN1778352B (en) * | 2004-11-26 | 2010-11-10 | 天津天士力制药股份有限公司 | Chinese medicine composition for treating cardiovascular disease |
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