CN104415289A - Consciousness-restoring intravenous injection liquid and preparation method thereof - Google Patents
Consciousness-restoring intravenous injection liquid and preparation method thereof Download PDFInfo
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- CN104415289A CN104415289A CN201310377007.0A CN201310377007A CN104415289A CN 104415289 A CN104415289 A CN 104415289A CN 201310377007 A CN201310377007 A CN 201310377007A CN 104415289 A CN104415289 A CN 104415289A
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- consciousness
- restoring
- intravenous injection
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/55—Glands not provided for in groups A61K35/22 - A61K35/545, e.g. thyroids, parathyroids or pineal glands
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/74—Rubiaceae (Madder family)
- A61K36/744—Gardenia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
Abstract
The invention discloses a consciousness-restoring intravenous injection liquid and a preparation method thereof, wherein the consciousness-restoring intravenous injection liquid is composed of 7.5 g of musk, 30 g of curcuma aromatica, 1.0 g of borneol, 30.0 g of fructus gardenia, 5.0 g-10.0 g of HS-15, 8.0 g of sodium chloride for injection, and water for injection. The preparation method of the consciousness-restoring intravenous injection liquid comprises the steps: respectively taking 30.0 g of curcuma aromatica and 30.0 g of fructus gardenia, adding about 1500 ml of water, distilling, and collecting 1000 ml of distilled liquid; adding 7.5 g of musk into the above distilled liquid, adding 250 ml of distilled water, distilling, and collecting 1000 ml of a distilled liquid for standby application; taking 1.0 g of borneol, adding 5.0 g-10.0 g of the HS-15, grinding uniformly, adding into the distilled liquid, mixing uniformly, adding 8.0 g of sodium chloride for injection, stirring to dissolve, mixing uniformly, and placing; and refrigerating overnight, adjusting the pH value to 5.0-7.0, filtering, filling and sealing, and thus obtaining the product. The whole process is carried out under aseptic conditions, and the non-terminal sterilization process is adopted. Compared with a commercially available consciousness-restoring intravenous injection liquid, the consciousness-restoring intravenous injection liquid adopts the new prescription and process, the prepared product conforms to the standard of the Pharmacopoeia, and the consciousness-restoring intravenous injection liquid has an outstanding advantage of greatly improving the clinical medication safety of the consciousness-restoring intravenous injection liquid.
Description
Technical field
The present invention relates to pharmaceutical preparation technology field, particularly a kind of XINGNAOJING ZHUSHEYE and preparation method thereof.
Background technology
XINGNAOJING ZHUSHEYE is the Chinese medicine preparation containing Radix Salviae Miltiorrhizae and Rhizoma Chuanxiong effective extract, has clearing away heat-fire, removing pathogenic heat from blood and toxic substance from the body, inducing resuscitation.Clinically for epidemic encephalitis type B, hepatic coma, heat enters nutrient blood, and cave in pericardium, and high heat is irritated, unconsciousness and delirium, crimson tongue rapid pulse.
XINGNAOJING ZHUSHEYE is one of clinical commonly used drug, on August 30th, 2010 Hangzhou medicine and medical apparatus and instruments adverse reaction monitoring center issue and pay close attention to XINGNAOJING ZHUSHEYE untoward reaction.Think that the clinical manifestation of untoward reaction caused by XINGNAOJING ZHUSHEYE is comparatively single, main manifestations is allergy (accounting for 87.5%), as erythra (face or whole skin flushing, there is the welt sample erythra companion pruritus that differs in size, then occur that breast is vexed, tachypnea, dyspnea etc.), anaphylactic shock (blood pressure drops, breast is vexed, dyspnea, increased heart rate, feel sick, vomiting, stomachache obviously, whole skin is congested, itch, red and swollen, dysphoria, dripping sweat, extremity tip is sent out cool), (bottleneck throat is itched in general anaphylaxis, dyspnea, shiver with cold fear is cold, breast is vexed, cardiopalmus, flushed face, rubella, asthma, numb limbs and tense tendons, face and die Blausucht, dripping sweat, dizzy, headache, feel sick, blood pressure drops but not to the level of suffering a shock) and mental symptom (eyes are stared, staring spells, delirium, photis hallucination, both hands carphology, dermal sensation is irritated, manic) and drug fever (fear cold, heating is to 39.7 DEG C, companioned with headache).The untoward reaction of the patient of 62.5% occurs in medication same day, and continuous use more than the 2 days persons of appearance account for 37.5%.The fastest person of untoward reaction occurring within 2 minutes, namely occur for using first, is that continuous use occurs to the 15th talent at the latest.Wherein medication within 30 minutes the person of appearance account for 56.3%, medication does not occur that person accounts for 37.5% later in 30 minutes.Caused by prompting XINGNAOJING ZHUSHEYE, untoward reaction has anaphylactic type and delayed type two kinds.Wherein anaphylaxis is the untoward reaction that XINGNAOJING is given prominence to the most, and the clinical allergies person of having forbids this medicine.Through investigation, its solubilizing agent of Existing commercial Xingnaojing injection is poly-three pear esters 80 (tween 80), relevant pharmacological research finds: 2% tween 80 is to occurring after Cavia porcellus 1m l/ intravenous injection that raw health is crooked, the manifest symptom such as drowsiness, 5% tween 80 Cavia porcellus all occurs that ear is blue, instability of gait, health are crooked, lies on one's side, the obviously symptom such as drowsiness; Beagle dog vein slow injection tween 80, dosage is reduced to 0.02% tween 80, when giving with 4ml/ volume, animal still there will be very aobvious symptoms of allergic (Sun Li, Liu Xiaomeng etc., J Toxicol August 2007 Vo1.21 No.4), other documents and materials also definitely prove that tween 80 is the main cause that untoward reaction (anaphylaxis) occurs when causing its clinical application.
Its untoward reaction given prominence to all the more (anaphylaxis) of XINGNAOJING ZHUSHEYE seriously governs XINGNAOJING ZHUSHEYE large-area applications clinically, therefore the 'Xing Nao Jing ' injection developing safety high becomes the task of top priority.
Summary of the invention
The object of the invention is to provide the XINGNAOJING ZHUSHEYE of a kind of brand-new prescription and preparation technology, make XINGNAOJING ZHUSHEYE not only steady quality but also have higher clinical drug safety.In order to reach upper above-mentioned purpose, the present invention adopts following technical scheme: get Moschus 7.5g Radix Curcumae 30g Borneolum Syntheticum 1.0g Fructus Gardeniae 30.0g, 5.0g-10.0gHS-15,8.0g sodium chloride for injection and water for injection composition.
Xing Nao Jing ' injection liquid and preparation method thereof, respectively gets 30.0g Radix Curcumae, the Fructus Gardeniae about 1500ml that adds water distills, collect distillate 1000ml; 7.5g Moschus is added in above-mentioned distillate, and adding distil water 250ml distills, collect distillate 1000ml, for subsequent use; Get Borneolum Syntheticum 1.0g, add 5.0g-10.0gHS-15, grind well, add in distillate, mixing, add note and thank and use sodium chloride 8.0g, be stirred to dissolve, mixing, placement; Refrigerated overnight, tune pH value is 5.0-7.0, and filter, embedding, to obtain final product.
Preparation method overall process in the present invention is aseptically carried out, and adopts non-final sterilization process.Safety experiment proves: the present invention's (anaphylaxis) in safety is obviously better than commercially available XINGNAOJING ZHUSHEYE.
Detailed description of the invention
embodiment 1xINGNAOJING ZHUSHEYE, by Moschus 7.5g Radix Curcumae 30g Borneolum Syntheticum 1.0g Fructus Gardeniae 30.0g, 5.0g HS-15,8.0g sodium chloride for injection and water for injection composition.
Embodiment 1 XINGNAOJING ZHUSHEYE prepares product method, respectively gets 30.0g Radix Curcumae, the Fructus Gardeniae about 1500ml that adds water distills, collect distillate 1000ml; 7.5g Moschus is added in above-mentioned distillate, and adding distil water 250ml distills, collect distillate 1000ml, for subsequent use; Get Borneolum Syntheticum 1.0g, add 5.0gHS-15, grind well, add in distillate, mixing, add note and thank and use sodium chloride 8.0g, be stirred to dissolve, mixing, placement; Refrigerated overnight, adjusts pH value to be 5.8, and filter, embedding, to obtain final product.
embodiment 2xINGNAOJING ZHUSHEYE, by Moschus 7.5g Radix Curcumae 30g Borneolum Syntheticum 1.0g Fructus Gardeniae 30.0g, 8.0g HS-15,8.0g sodium chloride for injection and water for injection composition.
Embodiment 2 XINGNAOJING ZHUSHEYE prepares product method, respectively gets 30.0g Radix Curcumae, the Fructus Gardeniae about 1500ml that adds water distills, collect distillate 1000ml; 7.5g Moschus is added in above-mentioned distillate, and adding distil water 250ml distills, collect distillate 1000ml, for subsequent use; Get Borneolum Syntheticum 1.0g, add 8.0g HS-15, grind well, add in distillate, mixing, add note and thank and use sodium chloride 8.0g, be stirred to dissolve, mixing, placement; Refrigerated overnight, adjusts pH value to be 6.3, and filter, embedding, to obtain final product.
embodiment 3xINGNAOJING ZHUSHEYE, by Moschus 7.5g Radix Curcumae 30g Borneolum Syntheticum 1.0g Fructus Gardeniae 30.0g, 10.0gHS-15,8.0g sodium chloride for injection and water for injection composition.
Embodiment 3 XINGNAOJING ZHUSHEYE prepares product method, respectively gets 30.0g Radix Curcumae, the Fructus Gardeniae about 1500ml that adds water distills, collect distillate 1000ml; 7.5g Moschus is added in above-mentioned distillate, and adding distil water 250ml distills, collect distillate 1000ml, for subsequent use; Get Borneolum Syntheticum 1.0g, add 10.0gHS-15, grind well, add in distillate, mixing, add note and thank and use sodium chloride 8.0g, be stirred to dissolve, mixing, placement; Refrigerated overnight, adjusts pH value to be 6.8, and filter, embedding, to obtain final product.
Claims (4)
1. an XINGNAOJING ZHUSHEYE, distilled activity extract, solubilizing agent, sodium chloride and water for injection formed by Moschus, Radix Curcumae, Borneolum Syntheticum, Fructus Gardeniae four taste Chinese medicine, pH value is 5.0-7.0.
2. XINGNAOJING ZHUSHEYE as claimed in claim 1, is characterized in that solubilizing agent adopts HS-15(15-hydroxy stearic acid macrogol ester).
3. the XINGNAOJING ZHUSHEYE as described in claim 1-2, it is characterized in that by Moschus 7.5g Radix Curcumae 30g Borneolum Syntheticum 1.0g Fructus Gardeniae 30.0g, 5.0g-10.0gHS-15,8.0g sodium chloride for injection and water for injection composition, pH value is 5.0-7.0, be filtered to the qualified rear embedding of clarity, overall process is aseptically carried out, and adopts non-final sterilization process.
4. the XINGNAOJING ZHUSHEYE as described in claim 1-3, is characterized in that adopting following preparation technology:
A. respectively get 30.0g Radix Curcumae, the Fructus Gardeniae about 1500ml that adds water distills, collect distillate 1000ml;
B. 7.5g Moschus is added in above-mentioned distillate, and adding distil water 250ml distills, collect distillate 1000ml, for subsequent use;
C. get Borneolum Syntheticum 1.0g, add 5.0g-10.0gHS-15, grind well, add in distillate, mixing, add note and thank and use sodium chloride 8.0g, be stirred to dissolve, mixing, placement;
D. refrigerated overnight, tune pH value is 5.0-7.0, and filter, embedding, to obtain final product, and this product overall process is aseptically carried out, and adopts non-final sterilization process.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310377007.0A CN104415289A (en) | 2013-08-27 | 2013-08-27 | Consciousness-restoring intravenous injection liquid and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310377007.0A CN104415289A (en) | 2013-08-27 | 2013-08-27 | Consciousness-restoring intravenous injection liquid and preparation method thereof |
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| CN104415289A true CN104415289A (en) | 2015-03-18 |
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| CN201310377007.0A Pending CN104415289A (en) | 2013-08-27 | 2013-08-27 | Consciousness-restoring intravenous injection liquid and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110755573A (en) * | 2018-07-09 | 2020-02-07 | 盈科瑞（横琴）药物研究院有限公司 | A refreshing solution for inhalation and its preparation method |
| CN112641904A (en) * | 2020-12-25 | 2021-04-13 | 无锡济煜山禾药业股份有限公司 | A medicinal injection for treating disturbance of consciousness and hyperpyrexia, and its preparation method |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101884658A (en) * | 2010-07-08 | 2010-11-17 | 四川升和制药有限公司 | Compound angelica medicament injection preparation containing polyethylene glycol 12-hydroxystearate and preparation method thereof |
-
2013
- 2013-08-27 CN CN201310377007.0A patent/CN104415289A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101884658A (en) * | 2010-07-08 | 2010-11-17 | 四川升和制药有限公司 | Compound angelica medicament injection preparation containing polyethylene glycol 12-hydroxystearate and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 赵新先: "《中药注射剂学》", 31 October 2000, 广东科技出版社 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110755573A (en) * | 2018-07-09 | 2020-02-07 | 盈科瑞（横琴）药物研究院有限公司 | A refreshing solution for inhalation and its preparation method |
| CN110755573B (en) * | 2018-07-09 | 2022-06-10 | 盈科瑞（横琴）药物研究院有限公司 | A refreshing solution for inhalation and its preparation method |
| CN112641904A (en) * | 2020-12-25 | 2021-04-13 | 无锡济煜山禾药业股份有限公司 | A medicinal injection for treating disturbance of consciousness and hyperpyrexia, and its preparation method |
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Application publication date: 20150318 |