CN100362990C - Fibrauretine-amino acid fluid for transfusion and its production process - Google Patents
Fibrauretine-amino acid fluid for transfusion and its production process Download PDFInfo
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- CN100362990C CN100362990C CNB2003101107559A CN200310110755A CN100362990C CN 100362990 C CN100362990 C CN 100362990C CN B2003101107559 A CNB2003101107559 A CN B2003101107559A CN 200310110755 A CN200310110755 A CN 200310110755A CN 100362990 C CN100362990 C CN 100362990C
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- palmatine
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- amino acid
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Abstract
The present invention provides an amino acid infusion of palmatine, which is characterized in that each bottle of infusion contains the following active ingredient of medicines of 25 to 60 g of amino acids, 0.02 to 0.5 g of palmatine, 0 to 10 g of auxiliary medicines and rest amount of auxiliary materials. The present invention not only can be used as a nutritive agent for replenishing nutrition of an organism to prevent and cure various diseases, but also can input necessary anti-infection medicines having curative effects simultaneously, and have double efficiencies of support and cure to the patients of emergency severe cases and the special patients. The present invention not only is convenient for the medical care personnel to operate, but also obtains valuable time for saving the patients. An experiment proves that the product of the present invention has the advantages of high stability, no stimulation, no pain symptoms, and has the functions of antibiosis and antiphlogosis.
Description
Technical field
The present invention relates to a kind of amino acid transfusion, especially a kind of Palmatine amino acid transfusion that contains biologically active drug.
Background technology
Palmatine (claiming fibrauretin, Fibranine, hydrochloride Palmatine, Palmatine Hydrochloride, Palmatine again) is a kind of plant antibiotic that Yunnan Province excavates out from the Miao Autonomous County of Pingbian when going all out with Chinese herbal medicine in the period of 1970-1972.Crude drug---menispermaceous plants Caulis Fibraureae [Fibraureatinctoria Lour.] is among the people be used to dye cloth and trauma infection contamination and sore due to disease such as chronic ulcer.Two kinds of existing tablet of Palmatine and aqueous injection belong to heat and toxic materials clearing away medicine, have the effect that strengthens the leukocytes phagocytic ability.Be used for the treatment of gynecological inflammation, surgical infection, bacillary dysentery, enteritis, respiratory tract and urinary tract infection, eye conjunctivitis etc.The specification of tablet is two kinds of 0.1g, 0.3g at present, oral consumption a: 0.2g-0.4g, 0.6-1.2g on the one.And injection is 2ml: 20mg, intramuscular injection, a 20mg (1), 40-80mg (2-4 props up) on the one.Along with the chemical sproof increase of patient, make each dosage also have to increase, because existing injection dosage is less than normal, can only satisfy therapeutic purposes by increasing the injection number, this not only causes the waste of packaging material, return the medical personnel and bring inconvenience, even danger, heavy patient's time is rescued in influence.In addition, since nineteen twenties L-sodium glutamate began to use, people were maked rapid progress to amino acid whose utilization, and particularly over past ten years, people are to amino acid whose concern, and it is more extensive to make its product use.Pharmaceutically, aminoacid is to constitute proteinic ultimate unit, and it can participate in internal metabolism and various physiological function activity, both can be used as the nutritional supplementation that nutrient is used for human body, can be used for preventing and treating multiple disease again.Amino acid transfusion has important role to severe crisis patient and especial patient.But existing amino acid transfusion can only be as a kind of nutritional support or supplement, and the serious often the infected of severe crisis patient must import necessary anti-infective simultaneously.So that save the quality time that gives emergency treatment to a patient and make things convenient for the doctors and nurses.Therefore, be necessary prior art is improved.
Summary of the invention
The object of the present invention is to provide a kind ofly to integrate treatment and energy, nutritional supplementation, and steady quality, Palmatine amino acid transfusion evident in efficacy.
Another object of the present invention provides the production method of Palmatine amino acid transfusion.
Technical scheme of the present invention is: described every bottle of Palmatine amino acid transfusion contains following effective ingredient:
Aminoacid 25-60g
Palmatine 0.02-0.5g
Caloric agent 50-70g
Ancillary drug 0-10g
Surplus is an adjuvant.
Described aminoacid is essential amino acids L-isoleucine, L-leucine, L-lysine acetate, L-methionine, L-phenylalanine, L-threonine, L-tryptophan, L-valine etc.; semi-dispensable amino acid L-arginine, L-tyrosine, L-histidine etc.; non essential amino acid L-alanine, L-proline, L-serine, glycine, L-cystine, L-glutamic acid, L-aspartic acid etc., one or more in other aminoacid such as the taurine etc.
Described adjuvant is one or more in sorbitol, L MALIC ACID, succinic acid, maleic acid, fumarase, glucose, lecithin, cephalin, the soybean phospholipid, perhaps for sodium sulphite, sodium sulfite, pyrosulfurous acid are received, in the cysteine one or more.So that the part heat to be provided, prevent aminoacid as energy resource consumption, help improving amino acid whose utilization rate and stability simultaneously.
Described ancillary drug is vitamin riboflavin 5 '-phosphoric acid ester sodium, nicotiamide, vitamin C, B
1, among the P, inositol one or more, under the situation that does not influence transfusion and stability thereof, increase; Perhaps be in ginsenoside, Radix Panacis Quinquefolii saponin, arasaponin, the gypenoside one or more, so that improve the curative effect of medicine.
The production method of Palmatine amino acid transfusion provided by the invention comprises the following steps:
Aminoacid, Palmatine, caloric agent and other excipient substance with trace is dissolved in water for injection fully respectively;
Be diluted with water to volume required with adding injection behind their mix homogeneously;
Behind filter paper and filter membrane coarse filtration, fine straining fine straining liquid;
Sterilization after the packing of fine straining liquid is promptly got product.
Note during operation: 1, in whole process, note leading to nitrogen or under nitrogen protection, operating, in case amino-acid oxidase; 2, antioxidant adds in the later stage as far as possible; Temperature will keep even when 3, sterilizing.
Concrete operations are:
Under the condition of 10,000 grades and nitrogen protection, aminoacid with trace is dissolved in water for injection earlier, and note it is dissolved fully, Palmatine is dissolved in an amount of water for injection, and adding water for injection is diluted to volume required, adds injection aminoacid and other adjuvants again, and note it is dissolved fully, add antioxidant, regulate to wait and ooze, add water for injection to finally volume required; After the processing such as filter membrane coarse filtration of filtrate through filter paper and 0.4 μ m, under 100 grades condition, with the following membrane filtration of 0.2 μ m.Fine straining liquid is sent into racking machine, by every bottle of required ml packing, covers the butyl rubber lid, and the preparation preheating is 121 ℃ of sterilizations (15 minutes).Or, cool off gradually towards hot water with the sterilization of rotation steriliser.Shady and cool place preserves.
Palmatine amino acid transfusion provided by the invention not only can be used as the nutritional supplementation that nutrient is used for human body, in case disease is planted by Zhiduo County, and can import necessary have therapeutic effect and anti-infective medicine simultaneously, severe crisis patient and especial patient had support and treatment double effects, both made things convenient for operation of medical workers, tried to gain time precious to one for giving emergency treatment to a patient again.Palmatine transfusion with this law preparation our experiments show that:
One, stability: the Palmatine amino acid transfusion was placed 1 year at normal temperatures, and product is reliable and stable, and every index is all qualified, meets the requirement of injection fully;
Two, zest: do irritant experiment with White Rabbit, the zest of Palmatine amino acid transfusion is 0 grade, does not promptly have significant change;
Three, pain: do the pain experiment with Kunming kind white mice, behind the injection Palmatine amino acid transfusion, all are normal for white mice, no pain symptom;
Four, anti-inflammation: Palmatine amino acid transfusion and the Palmatine injection effect basically identical aspect anti-inflammation.
The specific embodiment
Embodiment 1, produces the transfusion of Palmatine eight seed amino acids, prescription (1000ml):
Palmatine 0.08g L-isoleucine 3.82g
L-leucine 5.03g L-lysine acetate 4.52g
L-methionine 2.34g L-phenylalanine 5.65g
L-threonine 2.78g L-tryptophan 1.0g
L-valine 3.98g mannitol 70g
Preparation technology: under the condition of 10,000 grades and nitrogen protection, the L-tryptophan with trace is dissolved in～20ml water for injection earlier, and notes it is dissolved fully, Palmatine is dissolved in～water for injection of 20ml, and notes it is dissolved fully.Again other aminoacid are dissolved in～500ml water for injection, add above-mentioned solvent tryptophan liquid and Palmatine liquid, add mannitol and be diluted to volume required ~ 800ml, add antioxidant with water for injection, regulate to wait and ooze, add water for injection to finally volume required.Filter, after the processing such as filter membrane coarse filtration of filtrate through filter paper and 0.4 μ m, under 100 grades condition, with the following membrane filtration of 0.2 μ m.Fine straining liquid is sent into racking machine, by every bottle of required 250ml packing, covers the butyl rubber lid, and the preparation preheating is 121 ℃ of sterilizations (15 minutes).Or, cool off gradually towards hot water with the sterilization of rotation steriliser.Shady and cool place preserves.Packing, check, the qualified finished product that gets.Can make the Palmatine eight seed amino acids transfusion finished product of the specification of 4 bottles of 250ml: 20mg.
Embodiment 2, produce 11 kinds of amino acid transfusions of Palmatine, prescription (1000ml):
Palmatine 0.20g L-isoleucine 3.72g
L-leucine 5.00g L-lysine acetate 4.32g
L-methionine 2.30g L-phenylalanine 5.60g
L-threonine 2.71g L-tryptophan 0.90g
L-valine 3.98g L-arginine hydrochloride 5.10g
L-tyrosine 0.27g L-histidine 2.10g
Sorbitol 60g
Preparation technology: with embodiment 1 (summary).Can make 11 kinds of amino acid transfusion finished products of Palmatine of the specification of 2 bottles of 500ml: 100mg.
Embodiment 3, produce the transfusion of Palmatine 18 seed amino acids, prescription (1000ml):
Palmatine 0.40g L-isoleucine 3.52g
L-leucine 4.80g L-lysine acetate 4.12g
L-methionine 2.10g L-phenylalanine 5.22g
L-threonine 2.40g L-tryptophan 0.80g
L-valine 3.63g L-arginine hydrochloride 4.90g
L-tyrosine 0.24g L-histidine 2.00g
L-alanine 1.95g L-proline 1.00g
L-serine 1.00g glycine 7.56g
L-cystine 0.10g L-glutamic acid 0.75g
L-aspartic acid 2.50g sorbitol 50.00g
Preparation technology: with embodiment 1 (summary).Can make the Palmatine 18 seed amino acids transfusion finished product of the specification of 2 bottles of 500ml: 200mg.
Embodiment 4, produce the transfusion of Palmatine 18 seed amino acid arasaponins, prescription (1000ml):
Palmatine 0.60g L-isoleucine 3.52g
L-leucine 4.80g L-lysine acetate 4.12g
L-methionine 2.10g L-phenylalanine 5.22g
L-threonine 2.40g L-tryptophan 0.80g
L-valine 3.63g L-arginine hydrochloride 4.90g
L-tyrosine 0.24g L-histidine 2.00g
L-alanine 1.95g L-proline 1.00g
L-serine 1.00g glycine 7.56g
L-cystine 0.10g L-glutamic acid 0.75g
L-aspartic acid 2.50g L MALIC ACID 4g
Arasaponin 0.80g glucose 60g
Preparation technology: with embodiment 1 (summary).Can make the Palmatine 18 seed amino acid arasaponins transfusion finished product of the specification of 2 bottles of 500ml: 300mg.
Embodiment 5, produce the transfusion of Palmatine eight seed amino acid vitamin, prescription (1000ml):
Palmatine 1.00g L-isoleucine 3.82g
L-leucine 5.03g L-lysine acetate 4.52g
L-methionine 2.34g L-phenylalanine 5.65g
L-threonine 2.78g L-tryptophan 1.0g
L-valine 3.98g riboflavin 5 '-phosphoric acid ester sodium 0.4g
Mannitol 70g
Preparation technology: with embodiment 1 (summary).Can make the Palmatine eight seed amino acid vitamin transfusion finished product of the specification of 2 bottles of 500ml: 500mg.
Embodiment 6, produce 11 kinds of amino acid transfusions of Palmatine, prescription (1000ml):
Palmatine 0.20g L-isoleucine 3.72g
L-leucine 5.00g L-lysine hydrochloride 4.32g
L-methionine 2.30g L-phenylalanine 5.60g
L-threonine 4.71g L-tryptophan 2.90g
L-valine 3.98g L-arginine hydrochloride 5.10g
L-cysteine hydrochloride 1.07g L-histidine hydrochloride 2.10g
Lecithin 1.00g fumarase 3.25g
Sorbitol 66g
Preparation technology: with embodiment 1 (summary).Can make 11 kinds of amino acid transfusion finished products of Palmatine of the specification of 10 bottles of 100ml: 20mg.
This product is through study of pharmacy and part pharmacological research, and its result is as follows:
1, the stability of Palmatine amino acid transfusion
The lucifuge keeping at room temperature of six samples of embodiment was placed 1,2,3,6,12 month, checked that on time every bottle of outward appearance is constant substantially, and effective ingredient does not change through check yet.Therefore, think that tentatively the product of infusing this Palmatine various prescriptions making all can reach the shelf-life about 1 year.
The stability test result:
Assay and discriminating etc. were with reference to " Palmatine in the Chinese pharmacopoeia in 1977 in the quality standard.The result is as follows:
| Sample | Sample size, discriminating | ||||
| January | February | March | June | December | |
| Example 1 example 2 examples 3 examples 4 examples 5 examples 6 | Qualified qualified | Qualified qualified | Qualified qualified | Qualified qualified | Qualified qualified |
The result shows the sample of this invention preparation, and through the preliminarily stabilised investigation, product quality is basicly stable, can reach more than 1 year.
2, the irritation test of Palmatine amino acid transfusion
Get 4 of healthy rabbits, W:2.0 ~ 2.2kg, male and female half and half, be divided into two groups, inject Palmatine transfusion 1ml respectively on its left and right sides lower limb quadriceps femoris, 48h puts to death rabbit behind the medicine, cuts open the inspection quadriceps femoris, vertically cut and observe injection site muscular irritation reaction, and according to the form below converses corresponding order of reaction.
Local muscular irritation order of reaction table:
| Order of reaction | Irritant reaction |
| 0 1 2 3 4 5 | No significant change mild hyperaemia, its scope are less than the hyperemia of 0.51.0cm moderate, and its scope occurs necrosis less than the hyperemia of 0.51.0cm severe with myodegeneration, has the brown degeneration popularity necrosis to occur |
The result:
The zest of Palmatine transfusion is 0 grade;
3, the antiinflammatory action of Palmatine amino acid transfusion
Use the Whttle method, 30 of mices are divided into 3 groups at random, 10 every group, 20min behind the drug administration by injection, the blue 0.2ml/ of mouse tail vein injection 0.5% ivens is the timely lumbar injection 0.7% acetic acid 0.2ml/10g in back only, puts to death mice behind the 15min, and intraperitoneal injection of saline 5ml gently rubs the back and extracts peritoneal fluid, centrifugal, supernatant is measured optical density value in the 620nm place, calculate and comparable group differences significance, the results are shown in following table:
| Group | Body weight | Dosage (mg/Kg) | Optical density value | Suppression ratio |
| The present invention of blank group aspirin | 20±1.1 20±1.1 20±1.0 | Equal-volume 200 20 | 0.28±0.05 0.12±0.02 0.21±0.04 | 62.5％ 40.4％ |
The result shows that Palmatine amino acid transfusion group has antiinflammatory action preferably.
Claims (6)
1. Palmatine amino acid transfusion is characterized in that containing in every 1000ml transfusion following effective ingredient:
Palmatine 0.08g L-isoleucine 3.82g
L-leucine 5.03g L-lysine acetate 4.52g
L-methionine 2.34g L-phenylalanine 5.65g
L-threonine 2.78g L-tryptophan 1.0g
L-valine 3.98g mannitol 70g.
2. Palmatine amino acid transfusion is characterized in that containing in every 1000ml transfusion following effective ingredient:
Palmatine 0.20g L-isoleucine 3.72g
L-leucine 5.00g L-lysine acetate 4.32g
L-methionine 2.30g L-phenylalanine 5.60g
L-threonine 2.71g L-tryptophan 0.90g
L-valine 3.98g L-arginine hydrochloride 5.10g
L-tyrosine 0.27g L-histidine 2.10g
Sorbitol 60g.
3. Palmatine amino acid transfusion is characterized in that containing in every 1000ml transfusion following effective ingredient:
Palmatine 0.40g L-isoleucine 3.52g
L-leucine 4.80g L-lysine acetate 4.12g
L-methionine 2.10g L-phenylalanine 5.22g
L-threonine 2.40g L-tryptophan 0.80g
L-valine 3.63g L-arginine hydrochloride 4.90g
L-tyrosine 0.24g L-histidine 2.00g
L-alanine 1.95g L-proline 1.00g
L-serine 1.00g glycine 7.56g
L-cystine 0.10g L-glutamic acid 0.75g
L-aspartic acid 2.50g sorbitol 50.00g.
4. Palmatine amino acid transfusion is characterized in that containing in every 1000ml transfusion following effective ingredient:
Palmatine 0.60g L-isoleucine 3.52g
L-leucine 4.80g L-lysine acetate 4.12g
L-methionine 2.10g L-phenylalanine 5.22g
L-threonine 2.40g L-tryptophan 0.80g
L-valine 3.63g L-arginine hydrochloride 4.90g
L-tyrosine 0.24g L-histidine 2.00g
L-alanine 1.95g L-proline 1.00g
L-serine 1.00g glycine 7.56g
L-cystine 0.10g L-glutamic acid 0.75g
L-aspartic acid 2.50g L MALIC ACID 4g
Arasaponin 0.80g glucose 60g.
5. Palmatine amino acid transfusion is characterized in that containing in every 1000ml transfusion following effective ingredient:
Palmatine 1.00g L-isoleucine 3.82g
L-leucine 5.03g L-lysine acetate 4.52g
L-methionine 2.34g L-phenylalanine 5.65g
L-threonine 2.78g L-tryptophan 1.0g
L-valine 3.98g riboflavin 5 '-phosphoric acid ester sodium 0.4g
Mannitol 70g
6. Palmatine amino acid transfusion is characterized in that containing in every 1000ml transfusion following effective ingredient:
Palmatine 0.20g L-isoleucine 3.72g
L-leucine 5.00g L-lysine hydrochloride 4.32g
L-methionine 2.30g L-phenylalanine 5.60g
L-threonine 4.71g L-tryptophan 2.90g
L-valine 3.98g L-arginine hydrochloride 5.10g
L-cysteine hydrochloride 1.07g L-histidine hydrochloride 2.10g
Lecithin 1.00g fumarase 3.25g
Sorbitol 66g.
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| CNB2003101107559A CN100362990C (en) | 2003-10-17 | 2003-10-17 | Fibrauretine-amino acid fluid for transfusion and its production process |
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| CN1605332A (en) * | 2003-10-08 | 2005-04-13 | 云南创立投资管理有限公司 | Fibrauretine injection for perfusion and its preparing process |
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| CN1605332A (en) * | 2003-10-08 | 2005-04-13 | 云南创立投资管理有限公司 | Fibrauretine injection for perfusion and its preparing process |
Non-Patent Citations (2)
| Title |
|---|
| 药品标准（新药转正标准第十六至二十六册）. 国家药典委员会，881-883，国家药典委员会. 2002 * |
| 黄藤素注射液的快速含量测定. 成药，第10卷第10期. * |
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