CN1264519C - Notoginseng total saponin amino acid transfusion liquid and its producing method - Google Patents
Notoginseng total saponin amino acid transfusion liquid and its producing method Download PDFInfo
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- CN1264519C CN1264519C CN 200310110968 CN200310110968A CN1264519C CN 1264519 C CN1264519 C CN 1264519C CN 200310110968 CN200310110968 CN 200310110968 CN 200310110968 A CN200310110968 A CN 200310110968A CN 1264519 C CN1264519 C CN 1264519C
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Abstract
The present invention provides an amino acid infusion of panax notoginseng saponins, which is characterized in that each bottle of infusion contains 0.10 to 1.00 g of panax notoginseng saponins, amino acids providing nutrition and energy, and pharmaceutical excipient. The present invention has the advantages of stable quality, no stimulation and good curative effect, and also has the double efficiencies of promoting blood circulation to remove blood stasis and replenishing nutrition and support components simultaneously. The present invention can obtain valuable time for saving patients of emergency severe cases, simplify the operation of medical care personnel and reduce the labor intensity, and the present invention has very important significance for rescuing cardio-cerebrovascular patients with emergency severe cases and special patients in time.
Description
Technical field
The present invention relates to a kind of amino acid transfusion, especially a kind of have therapeutic type Radix Notoginseng total arasaponins amino acid transfusion and a production method thereof that blood circulation promoting and blood stasis dispelling and nutrition and energy supplement combine.
Background technology
Radix Notoginseng is the famous special product in Yunnan, also is the important member among the Panax.Medicinal historical remote of Radix Notoginseng, it is invigorated blood circulation and the characteristics of congestion not, makes it become the traumatology key medicine.At the seventies in last century, scientific research personnel's separation and Extraction from Radix Notoginseng goes out Radix Notoginseng total arasaponins, Radix Notoginseng total arasaponins is developed as injection with small volume (general XUESAITONG by name) again.Now the product that with the Radix Notoginseng total arasaponins is raw material has been developed much, as tablet, capsule, granule, soft capsule, drop pill, injectable powder etc.According to clinical needs, the people is also arranged at research and development XUESAITONG infusion solution.But because the unstable chemcial property of arasaponin, add the reasons such as working condition harshness of common transfusion, XUESAITONG this product with better clinical demand of infusing fails to develop so far.Be still now injection or injectable powder are added in the transfusion in a large number facing the time spent.The problem that this usage exists is: both strengthened nurse's workload, time-consuming and be unfavorable for severe crisis patient's rescue increasing the chance of polluting simultaneously again, it is many unfavorable to bring to curing patient.Since the L-sodium glutamate began to use, people were maked rapid progress to amino acid whose utilization, and particularly over past ten years, the aminoacid product enjoys people's attention, and its application is more extensive.Aspect medical, aminoacid is to constitute proteinic ultimate unit, participates in internal metabolism and various physiological function activity, both can be used as the nutritional supplementation that nutrient is used for human body, can increase the resistance and the immunity of human body again, in case multiple disease.Amino acid transfusion is exactly the serious achievement in the contemporary field of medicaments, is extremely important for severe crisis patient and especial patient.But amino acid transfusion can only be as a kind of nutritional support or supplement, and, often are starved of when in time giving activating blood and removing stasis drug input nutritional supplementation or proppant for the severe crisis patient who suffers from cardiovascular and cerebrovascular disease.Through the research and development of more than ten years, the inventor has invented with Radix Notoginseng total arasaponins (XUESAITONG) and aminoacid etc., the large capacity transfusion agent that co-production curative effect-type (blood circulation promoting and blood stasis dispelling) combines with nutritional support.
Summary of the invention
The purpose of this invention is to provide a kind of steady quality, eutherapeutic Radix Notoginseng total arasaponins amino acid transfusion, try to gain time precious to one, simplify operation of medical workers simultaneously for giving emergency treatment to a patient.
According to clinical pathology, in early stage 1～48 hour of morbidity, must suit the medicine to the illness stage by stage and individualized treatment, need after 48 hours to replenish enough nutrition and proppant, in order to patient's rehabilitation to patient.Early stage some aminoacid of morbidity (as arginine etc.), vitamin C etc., all use in conjunction and obtains effect preferably in different phase in clinical practice.For patients with cerebral apoplexy, because its cerebral edema is serious, so need with dehydrant (as mannitol, glycerol etc.) dehydration.And for cardiac-cerebral ischemia with irritate equal patient again, owing to can cause serious damage to heart and brain, so will directly or indirectly treat disease with arasaponin, because of it can excite the enzyme activity of the SOD that removes free radical, opposing ischemic injuries and reperfusion injury, improve blood circulation and hemodynamics, prevent thrombosis etc.On human body normal demand, aminoacids complex can be kept normal acid-base balance in the health, replenishes best energy, corrects negative nitrogen balance in the body, keeps the human body positive nitrogen balance.From composition of prescription, single with regard to Radix Notoginseng total arasaponins, its less stable in regular solution.But in the Freamine with multiple comprehensive functions such as complexation, antioxidation, shieldings, Radix Notoginseng total arasaponins can very stable (as in former plant).Strictness control (as nitrogen protection operation down) by production technology under the process conditions of gentle relatively (rotation steriliser sterilization etc.), has ensured the stability of product.So the present invention can provide a scheme that has strong specific aim and can be applicable to the ischemic cardiovascular and cerebral vascular disease patient.
Solution of the present invention is: every bottle of Radix Notoginseng total arasaponins amino acid transfusion contains Radix Notoginseng total arasaponins 0.10g～1.00g, and aminoacid and pharmaceutic adjuvant that nutrition and energy can be provided.
Described aminoacid is one or more in essential amino acids L-isoleucine, L-leucine, L-lysine acetate, L-methionine, L-phenylalanine, L-threonine, L-tryptophan, the L-valine; perhaps be in semi-dispensable amino acid L-arginine, L-tyrosine, the L-histidine one or more; perhaps being in non essential amino acid L-alanine, L-proline, L-serine, glycine, L-cystine, L-glutamic acid, the L-aspartic acid one or more, perhaps is the taurine in other aminoacid.
Described pharmaceutic adjuvant is in sorbitol that energy is provided, L MALIC ACID, succinic acid, maleic acid, fumarase, glucose, lecithin, cephalin, the soybean phospholipid one or more, so that the part heat is provided, prevent aminoacid as energy resource consumption, help improving amino acid whose utilization rate simultaneously; Perhaps for not influencing vitamin riboflavin 5 '-phosphoric acid ester sodium, nicotiamide, glycerol, vitamin C, the B of transfusion and stability thereof
1, among the P, inositol one or more; Perhaps for do not influence transfusion and can improve that its stable sodium sulphite, sodium sulfite, pyrosulfurous acid are received, in the cysteine one or more.
The production method of described Radix Notoginseng total arasaponins amino acid transfusion is finished by following process steps:
1, the aminoacid of the trace in will writing out a prescription earlier is dissolved in water for injection, and notes it is dissolved fully;
2, in Radix Notoginseng total arasaponins, add an amount of water for injection again, add above-mentioned injection aminoacid and other adjuvants again, and note it is dissolved fully;
3, add antioxidant, regulate to wait and ooze, add water for injection to finally volume required;
4, through coarse filtration, behind the fine straining, fine straining liquid is carried out packing, by every bottle of required ml packing, cover lid, the preparation preheating in 121 ℃ of sterilizations (15 minutes), or with the sterilization of rotation steriliser, is cooled off towards hot water gradually, gets product, and shady and cool place preserves.
Operation notice:
1, in whole process, notes 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; the aminoacid of trace is dissolved in water for injection in will writing out a prescription earlier; and it is dissolved fully; in Radix Notoginseng total arasaponins, add an amount of water for injection; add 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 filter membrane coarse filtration of solution through filter paper and 0.4 μ m, under 100 grades condition, with the following filter membrane fine straining of 0.2 μ m; fine straining liquid is sent into racking machine; by every bottle of required ml packing, cover the butyl rubber lid and carry out preheating, in 121 ℃ of sterilizations (15 minutes).Or, after cooling off gradually towards hot water, promptly get the Radix Notoginseng total arasaponins amino acid transfusion with rotating the steriliser sterilization.Shady and cool place preserves.
Radix Notoginseng total arasaponins amino acid transfusion with the present invention's preparation our experiments show that:
One, stability: the transfusion of Radix Notoginseng total arasaponins base acid was at normal temperatures placed 1 year, 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 Radix Notoginseng total arasaponins (XUESAITONG) amino acid transfusion is 0 grade, does not promptly have significant change;
Three, blood circulation promoting and blood stasis dispelling: Radix Notoginseng total arasaponins (XUESAITONG) amino acid transfusion and the XUESAITONG ZHUSHEYE effect basically identical aspect blood circulation promoting and blood stasis dispelling.
Embodiment 1
Preparation Radix Notoginseng total arasaponins and the transfusion of eight seed amino acids, prescription (1000ml):
Radix Notoginseng total arasaponins 0.40g L-isoleucine 3.82g
L-leucine 5.03g L-lysine acetic acid 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, and is stand-by; In Radix Notoginseng total arasaponins, add the dissolving of 20ml water for injection, and note it is dissolved fully, filter, stand-by; Again other aminoacid are dissolved in 500ml water for injection, add above-mentioned solvent tryptophan liquid and Radix Notoginseng total arasaponins liquid, add mannitol and be diluted to 800ml volume required with water for injection, add antioxidant, regulate to wait and ooze, add water for injection, filter to final volume required 1000ml; After the filter membrane coarse filtration of filtrate through filter paper and 04 μ m, under 100 grades condition, with the following filter membrane fine straining 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 preparation is carried out preheating, and 121 ℃ of sterilizations 15 minutes, shady and cool place preserved; Packing, check, qualified, the Radix Notoginseng total arasaponins (XUESAITONG) of specification and the eight seed amino acids transfusion finished product of 4 bottles of 250ml: 100mg.
Embodiment 2
Preparation Radix Notoginseng total arasaponins and 11 kinds of amino acid transfusions, prescription (1000ml):
Radix Notoginseng total arasaponins 0.40g 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 gets 11 kinds of amino acid transfusion finished products of Radix Notoginseng total arasaponins (XUESAITONG) of the specification of 2 bottles of 500ml: 200mg with embodiment 1.
Embodiment 3
Preparation Radix Notoginseng total arasaponins and the transfusion of 18 seed amino acids, prescription (1000ml):
Radix Notoginseng total arasaponins 0.80g 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 gets Radix Notoginseng total arasaponins (XUESAITONG) the 18 seed amino acids transfusion finished product of the specification of 2 bottles of 500ml: 400mg with embodiment 1.
Embodiment 4
Preparation Radix Notoginseng total arasaponins and the transfusion of 18 seed amino acids, prescription (1000ml):
Radix Notoginseng total arasaponins 1.20g 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 grape sugar 60g
Preparation technology gets Radix Notoginseng total arasaponins (XUESAITONG) the 18 seed amino acids transfusion finished product of the specification of 2 bottles of 500ml: 600mg with embodiment 1.
Embodiment 5
Preparation Radix Notoginseng total arasaponins and aminoacid, vitamin transfusion, prescription (1000ml):
Radix Notoginseng total arasaponins 8.0g L-Potassium Magnesium Aspartata 20g
Riboflavin 5 '-phosphoric acid ester sodium 0.4g mannitol 70g
Preparation technology gets a kind of amino acid, vitamine transfusion of Radix Notoginseng total arasaponins (XUESAITONG) finished product of the specification of 10 bottles of 100ml: 800mg with embodiment 1.
Embodiment 6
Preparation Radix Notoginseng total arasaponins and the transfusion of two seed amino acids, prescription (1000ml):
Radix Notoginseng total arasaponins 2.0g L-lysine hydrochloride 4.32g
L-cysteine hydrochloride 1.07g lecithin 1.00g
Fumarase 3.25g sorbitol 66g
Preparation technology makes Radix Notoginseng total arasaponins (XUESAITONG) the two seed amino acids transfusion finished product of the specification of 2 bottles of 500ml: 1g with embodiment 1.
Radix Notoginseng total arasaponins amino acid transfusion provided by the invention is through study of pharmacy and part pharmacological research, and its result is reported as follows:
1, the stability of Radix Notoginseng total arasaponins (XUESAITONG) 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 product that the various prescriptions of this Radix Notoginseng total arasaponins (XUESAITONG) transfusion make all can reach the shelf-life about 1 year.
The stability test result:
Assay and discriminating etc. are with reference to existing GB 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 Radix Notoginseng total arasaponins (XUESAITONG) 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 breviscapine infusion 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 is less than the hyperemia of 0.51.0cm moderate, its scope is less than the hyperemia of 0.51.0cm severe, necrosis occurs with myodegeneration, have the brown degeneration popularity necrosis to occur |
The result:
The zest of Radix Notoginseng total arasaponins (XUESAITONG) transfusion is 0 grade;
3, the function of promoting blood circulation to disperse blood clots of Radix Notoginseng total arasaponins (XUESAITONG) amino acid transfusion
1 experiment material
1.1 medicine and reagent
Adopt the sample of embodiment 6.XUESAITONG ZHUSHEYE, Yunnan Province's plant pharmaceutical factory is produced, lot number 021015; The adrenalin hydrochloride injection, Yongkang, Beijing pharmaceutcal corporation, Ltd, lot number 20020129.Carrageenin (Type 1, C1013), and Sigma company; ADP-2N
a, import packing, the extensive and profound in meaning biochemical reagents in Shanghai company, lot number 2001024; TT, PT, APTT and FIB measure test kit, and Sichuan steps gram science and technology limited Company, lot number 020926,030108,021016,030120.
1.2 laboratory animal
Male SD rat, cleaning level, available from unming Medical College's Animal House, the quality certification number: No. the 2001034th, the real moving card in Yunnan.Kunming mouse, regular grade, male and female half and half are provided by Kunming Institute of Zoology, Chinese Academy of Sciences's Animal House, the quality certification number: No. 9710, the moving pipe of cloud.
1.3 instrument
MCVS-2010 type cerebrovascular detection system, Chongqing Tianhai Medical Equipment Co., Ltd.; C2000-4 type high-performance magnetic bead method four-way coagulo meter and LBY-NS type four-way platelet aggregation instrument, Beijing Puli gives birth to group; The LDZ-0.8 medical centrifuge, Beijing Medical Centrifugal Machine Factory.
1.4 statistical method
The normal distribution data are checked with t, and the skewness distributed data is checked with sum of ranks (u).
2 methods and result
2.1 influence to rat blood viscosity
60 of male SD rats, body weight 320～360g is divided into 3 groups at random, 12 every group.The normal control group gives 0.5%CMC-N
a10ml/kg, positive control give XUESAITONG ZHUSHEYE 0.4ml/kg (20mg/kg) and use 0.5%CMC-N
aDilution causes 10ml/kg.The sample of embodiment 6 give each treated animal of 10ml/kg (20mg/kg) according to dosage every day gastric infusion once, continuous 6 days, the administration volume was 10ml/kg.1h after the last administration, lumbar injection 40mg/kg pentobarbital sodium anesthetized animal, carotid artery is got blood, and with 2.7% EDTA anticoagulant, whole blood is 9: 1 with the ratio of anticoagulant volume.Partly anticoagulation is used to measure whole blood viscosity, partly measures plasma viscosity with the centrifugal back of 2000rpm separated plasma.
Experimental result shows: rat gives sample or reference substance all can significantly reduce 200-30S
-1Whole blood viscosity under the shear rate and whole blood reduced viscosity, and can obviously shorten erythrocyte electrophoretic time, but packed cell volume and plasma viscosity are not had obvious influence.
2.2 influence to rat blood clotting and platelet aggregation
75 of male SD rats, 295～360g is divided into 3 groups at random, 15 every group.Dosage grouping and medication are the same.1h after the last administration, after the lumbar injection pentobarbital sodium 40mg/kg anesthesia, the carotid artery intubate is got blood, and with 3.8% sodium citrate anticoagulant, whole blood is 9: 1 with the ratio of anticoagulant volume.The centrifugal 5min of 1000rpm prepares platelet rich plasma (PRP), and the centrifugal 10min of 3500rpm prepares platelet poor plasma (PPP).By turbidimetry for Determination ADP-2N
aInductive platelet aggregation rate, the final concentration of ADP are 6mol/l;
Measure TT, PT, APTT and FIB respectively by kit method.
Experimental result shows: sample or reference substance can obviously prolong TT and APTT time; To by the inductive platelet aggregation of ADP, has obvious inhibitory action.
2.3 influence to the mouse experiment microcirculation disturbance
Get 60 of 18.5～24.5g mices, male and female half and half are divided into 3 groups at random by sex and body weight, 10 every group.Laboratory temperature remains on 25 ± 1 ℃.Each treated animal every day according to dosage gastric infusion once, for three days on end.After the last administration 30 minutes, with 10% urethane 0.15ml/10g body weight intraperitoneal injection of anesthesia animal, fixing auricle, place under the micro-circulation scanning tunnelling microscope that amplifies 240 times, (artery and vein is parallel with suitable blood capillary, be third level branch) be the object of observation, dosage by 0.1mg/kg causes experimental microcirculation disturbance to mouse peritoneal injection adrenalin hydrochloride, before gathering moulding respectively, the image of 5,10,15 and 20 timesharing after the moulding, measure following four indexs: 1. (fluidised form is divided 5 grades to the blood fluidised form; Stagnation is 0 minute; Grain stream is 1 minute; The grain linear flow is 2 minutes; Line grain stream is 3 minutes; Linear flow is 4 minutes); 2. arteriole caliber (A
3); 3. venule caliber (V
3); 4. capillary network is counted.Observe and write down the situation of change of every index, organize a u-test with the changing value before and after each group administration.
Experimental result shows, sample or reference substance can obviously increase arteriole and the venule caliber of experimental microcirculation disturbance mice due to the adrenalin hydrochloride, show that it has the effect of obvious microcirculation improvement.
The result shows: Radix Notoginseng total arasaponins (XUESAITONG) amino acid transfusion is the same with XUESAITONG ZHUSHEYE to have good blood circulation invigorating efficacies.
Claims (1)
1, a kind of Radix Notoginseng total arasaponins amino acid transfusion is characterized in that every bottle of transfusion contains Radix Notoginseng total arasaponins 0.10～1.00g and sorbitol, L MALIC ACID, succinic acid, maleic acid, fumarase, glucose, lecithin, cephalin, soybean phospholipid, vitamin riboflavin 5 '-phosphoric acid ester sodium, nicotiamide, glycerol, vitamin C, B
1P; inositol; sodium sulphite; sodium sulfite; pyrosulfurous acid is received; one or more pharmaceutic adjuvants in the cysteine; with the L-isoleucine; the L-leucine; the L-lysine acetate; the L-methionine; the L-phenylalanine; the L-threonine; the L-tryptophan; one or more essential amino acids in the L-valine; and/or L-arginine; L-tyrosine; one or more semi-dispensable amino acids in the L-histidine; and/or L-alanine; the L-proline; the L-serine; glycine; the L-cystine; L-glutamic acid; one or more non essential amino acid in the L-aspartic acid, and/or taurine.
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| CN104784234A (en) * | 2015-04-18 | 2015-07-22 | 云南一尧科技开发有限公司 | Panax plant oral liquid and preparation process thereof |
| CN107441134A (en) * | 2017-08-11 | 2017-12-08 | 南京圣诺生物科技实业有限公司 | It is a kind of to contain 1,6 diphosphofructoses, the health products and preparation method thereof of pseudo-ginseng |
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