CN105012626A - Preparation method of kidney-strengthening oral liquid - Google Patents
Preparation method of kidney-strengthening oral liquid Download PDFInfo
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- CN105012626A CN105012626A CN201510395626.1A CN201510395626A CN105012626A CN 105012626 A CN105012626 A CN 105012626A CN 201510395626 A CN201510395626 A CN 201510395626A CN 105012626 A CN105012626 A CN 105012626A
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Abstract
The invention discloses a preparation method of a kidney-strengthening oral liquid. The method is as below: decocting ginseng, Radix Astragali, bighead atractylodes rhizome, Poria cocos, Epimedium, Chinese yam, lumbricus, safflower, fructus rosae laevigatae, Gorgon fruit and licorice with water for three times, filtering, merging the three decocted fluid, concentrating the merged decocted fluid to obtain a concentrate, cooling the concentrate to room temperature, adding ethanol, standing for 24 h, taking the supernatant, recovering ethanol, adding a simple syrup, adjusting the pH value, adding water to 1000ml, stirring, standing, filtering, and sterilizing the filtrate. The preparation method of the kidney-strengthening oral liquid employs a refining production process to improve the extraction of pharmaceutical active ingredients, ensure the stability of the formulation, and reduce treatment effect degradation and adverse reactions due to the quality difference of formulation. The oral liquid has the advantages of small dose, rapid absorption, stable quality and easiness to carry ad preserve, is especially applicable to industrial production.
Description
Technical field
The invention belongs to drug world, be specifically related to a kind of preparation method of health kidney oral liquid.
Background technology
Chronic nephritis (CGN) has the trend increased in the incidence rate of China, therefore early prevention and treatment chronic nephritis delay it and develop into chronic renal failure and be day by day subject to people's attention.Nephropathy majority belongs to sick categories such as " edema, lumbagos ".Cause of disease multiterminal are owing to attacking outside ailment said due to cold or exposure, or injury due to diet, or work and rest is unbalance, occupy for a long time caused by wetland etc.No matter diseases caused by exogenous pathogenic factor or internal injury, be the metabolism of lung spleen kidney three addle liquid not normal caused by, especially hinder based on spleen kidney, treatment should QI invigorating warming YANG, consolidates arresting seminal emission, promoting blood circulation to remove obstruction in the collateral.
One group of primary glomerulopathy that chronic glomerulonephritis is is main clinical manifestation with hematuria, albuminuria, hypertension and edema, be called for short chronic nephritis, its course of disease is long, protracted inflammation is not healed, and pathological change is various, and renal function Progressive symmetric erythrokeratodermia can be had to go down, may uremia be there is in severe patient, prognosis is widely different, is the first cause of disease of China's end stagerenaldisease, there is no special effective Therapeutic Method at present.The cause of disease of chronic nephritis and pathogenesis complexity, several factors is had to participate in, as infection, autoimmune, medicine, heredity, environment etc., wherein immunologic injury is the common link in most chronic nephritis generating process, and the Development process of nearly all chronic nephritis has the participation of amynologic mechanism.Chronic nephritis belongs to by Chinese medicine " edema, lumbago, hematuria and asthenia " category, it is dirty that its pathological changes relates to lung spleen kidney three, focuses on spleen kidney, and its pathomechanism is that with the passing of time disease prolongs, and spleen is suffered from a deficiency of the kidney damage, folder congestion of holding concurrently.Cover insufficiency of the spleen then biochemical weary source, have under one's command and have no right, then dysfunction of the kidney in storing essence of suffering from a deficiency of the kidney, purgation loses its astringency inducing and outside albumen, smart emblem is leaked in urine, so repeatedly endlessly, becomes persistent ailment eventually.
In health kidney oral liquid side with Radix Ginseng, the Radix Astragali for monarch drug, two medicines are pungent, using warming therapy product, and enter spleen kidney two warp, kidney and spleen invigorating, consolidates arresting seminal emission; The spleen invigorating such as RHIIZOMA DIOSCOREAE fr0m Henan of China, Rhizoma Atractylodis Macrocephalae spermatogenesis source is ministerial drug, focuses on benefit the foundation of acquired constitution, to help the congenital foundation; Herba Epimedii, Semen Euryales, Fructus Rosae Laevigatae warming YANG consolidate the lucid yang sending up, arresting seminal emission, precise and tinyly to leak with unlikely; Pheretima, Flos Carthami Removing Blood Stasis the meridian dredging are adjuvant drug altogether, make the network gas of spleen kidney unobstructed, can rise again gently the turbid descending; Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, can relax again all medicines sun heat and exaggerate, have the merit of qi and blood tonifying concurrently; All medicine close fit above, emphasis is intended to kidney and spleen invigorating, holds concurrently and invigorates blood circulation, making healthy energy runback, and congestion is from removing, and nephropathy must heal.Modern pharmacological research shows: in we, Radix Astragali, Radix Ginseng etc. have enhancing immune function of human body, suppresses disproportional immune, removes the effect of immune complex; And Flos Carthami, Pheretima etc. have anticoagulation, antiplatelet aggregation and antithrombotic function; The Radix Astragali, the Rhizoma Atractylodis Macrocephalae etc. also have effect of inducing diuresis to remove edema; Radix Glycyrrhizae has the effect of glucocoricoid sample, possesses the multi-efficiencies such as antiinflammatory, anti-immunity and tissue repair.
Summary of the invention
An object of the present invention is that this preparation is oral liquid formulations form, is convenient for carrying in order to provide a kind of novel effective preparation-health kidney oral liquid being used for the treatment of chronic nephritis, nephrotic syndrome, absorbs rapidly, can promote the chemical reaction of each pharmaceutically active ingredient.
The invention provides a kind of preparation method of health kidney oral liquid, get Radix Ginseng, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Poria, Herba Epimedii, Rhizoma Dioscoreae, Pheretima, Flos Carthami, Fructus Rosae Laevigatae, Semen Euryales and Radix Glycyrrhizae and decoct with water three times, after filtering, merge three decoction liquor, obtain concentrated solution by concentrated for the decoction liquor after merging, treat that described concentrated solution is cooled to room temperature, add ethanol, place 24h, get supernatant and reclaim ethanol, add simple syrup, adjust ph, add water to 1000ml again, stir evenly rear leaving standstill, filter, get filtrate sterilizing and get final product.
Further, described Radix Ginseng 150g, Radix Astragali 200g, Rhizoma Atractylodis Macrocephalae 150g, Poria 200g, Herba Epimedii 150g, Rhizoma Dioscoreae 150g, Pheretima 100g, Flos Carthami 200g, Fructus Rosae Laevigatae 200g, Semen Euryales 100g and Radix Glycyrrhizae 40g.
Further, during described concentrated solution 80 DEG C, relative density is 1.15-1.30.
Further, adding ethanol to ethanol content in described concentrated solution is 60%.
Further, described adjust ph is to 5.0-7.0.
Further, described sterilizing is 100 DEG C of sterilizing 30min.
Further, each amount of water of described decoction is 6-8 times of medical material cumulative volume, and each decocting time is 40min.
Beneficial effect of the present invention is: the preparation method of health kidney oral liquid of the present invention, by refining production technology, improve the extraction of effective ingredient, ensure that the stability of preparation, decrease therapeutic effect that the mass discrepancy due to preparation causes and reduce and the generation of untoward reaction.Oral liquid formulations form, taking dose is little, absorption is rapid, steady quality, be convenient for carrying, easily preserve, and is especially applicable to suitability for industrialized production.
Accompanying drawing explanation
Figure 1 shows that the horizontal comparison diagram of 24h urine protein quantitation before and after health kidney oral liquor embodiment 2 three groups of the present invention treatment.
Detailed description of the invention
Hereafter will describe the specific embodiment of the invention in detail in conjunction with concrete accompanying drawing.It should be noted that the combination of technical characteristic or the technical characteristic described in following embodiment should not be considered to isolated, they can mutually be combined thus be reached better technique effect.
Embodiment 1
The preparation method of health kidney oral liquid of the present invention, get Radix Ginseng 150g, Radix Astragali 200g, Rhizoma Atractylodis Macrocephalae 150g, Poria 200g, Herba Epimedii 150g, Rhizoma Dioscoreae 150g, Pheretima 100g, Flos Carthami 200g, Fructus Rosae Laevigatae 200g, Semen Euryales 100g and Radix Glycyrrhizae 40g decocts with water three times, decoct 6-8 times that each amount of water is medical material cumulative volume, each decoction 40min, three decoction liquor are merged after filtering, when decoction liquor after merging is concentrated into 80 DEG C, relative density is that 1.15-1.30 obtains concentrated solution, solution to be concentrated is cooled to room temperature, adding ethanol to ethanol content is 60%, place 24h, get supernatant and reclaim ethanol, add simple syrup, adjust ph is to 5.0-7.0, add water to 1000ml again, stir evenly rear leaving standstill, filter, get filtrate 100 DEG C of sterilizing 30min sterilizing and get final product.
Embodiment 2
The clinical research of health kidney oral liquid
One, clinical data
1, case source
In March ,-2009 in February, 2002 PLA the 152nd central hospital's inpatient, treatment group 150 example.
2, physical data
Include in patient 450 example, wherein male 281 example, women 169 example, the age 18-60 year between, 36.5 ± 11.1 years old mean age, course of disease 2-11.
3, diagnostic criteria and case inclusive criteria
3.1 Western medicine diagnose references;
3.2 Efficacy of Traditional Chinese Medicines judge " diagnosis of chronic glomerulonephritis, differentiation of symptoms and signs for classification of syndrome and the efficacy assessment standard " of taking nephropathy branch of China Association of Traditional Chinese Medicine to formulate.
3.3, voluntarily as study subject, can accept given therapeutic scheme, ensure the course for the treatment of.
4, case exclusion standard
Age is below 16 years old or the patient of over-65s; Trimester of pregnancy or women breast-feeding their children; Merge the acute complications persons such as malignant hypertension; Person is shown Cr > 256 μm of ol/L or suffers from cardiovascular and cerebrovascular disease in serious hepatic injury or the inspection of kidney merit; Pathology levies reflection positive; Other are had to cause nephritis, connective tissue disease protopathy etc.; Noncooperationist; There is Chinese medicine allergies person; Secondary cases kidney damage person.
5, case rejecting and come off
Treat less than 2 the course for the treatment of person; In the treatment because of other diseases therapy discontinued person; Do not press given therapeutic Regimen Chemotherapy, the infull person of curative effect or data cannot be judged; Follow up a case by regular visits to the person of coming off.
Two, research method
1, random packet
The patient meeting inclusion criteria is divided into treatment group (health kidney oral liquid group) 150 example by random number method, man 93 example, female 57 example, age 18-60 year, the median age 36 years old, average course of disease 3.3 ± 1.5 years, matched group 1 (benazepril group) 150 example, man 101 example, female 49 example, age 21-63 year, the median age 31 years old, average course of disease 3.7 ± 1.2 years.Matched group 2 (NIAODUQING group) 150 example, man 87 example, female 63 example, age 20-54 year, the median age 33 years old, average course of disease 3.9 ± 1.6 years.Three groups of patients comparing difference not statistically significant in sex, age, the course of disease, severity extent etc., P>0.05, all has comparability.
2, Therapeutic Method
Treatment group: low-salt high-quality low protein diet and proper use of anticoagulant etc. are suited the medicine to the illness on Supporting Therapy basis and added with health kidney oral liquid, 10ml/ time, 3 times/day.
Matched group 1: give the Comprehensive Treatment such as low-salt high-quality low protein diet and benazepril (lotensin, Novartis Co., Ltd, 10mg/ sheet 10mg/ time, 1 times/day), anticoagulant.
Matched group 2: give low-salt high-quality low protein diet and NIAODUQING KELI (Guangzhou Kang Chen Pharmaceutical, medicine composition Radix Et Rhizoma Rhei, the Radix Astragali, Cortex Mori, Radix Sophorae Flavescentis, the Rhizoma Atractylodis Macrocephalae, Poria, the Radix Paeoniae Alba, Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae, Herba Plantaginis etc., 5g/ bag, 5g/ time 3 times/day), the Comprehensive Treatment such as anticoagulant.
Treatment cycle is 2 months, and treatments period is avoided eating anything raw or cold, pungent and sour food, avoids aggravating activities and heavy physical labour, guards against to drench with rain, suffer from cold.
3, observation index
3.1 curative effect observations:
The symptom such as blood pressure, edema before and after main detection treatment, and detect 24h urine protein quantitation, routine urinalysis, serum creatinine, blood urea nitrogen situation of change.
3.2 untoward reaction observations
Main detection respiratory response, gastrointestinal reaction (as Nausea and vomiting, stomachache or diarrhoea), skin allergy and other uncertain untoward reaction.The discomfort that in drug administration process, record is irrelevant with primary symptom.After terminating the course for the treatment of, blood test, urine, stool routine examination and liver function.
3.3 efficacy assessment standard
With reference to the efficacy assessment standard of regulation in China Association of Traditional Chinese Medicine nephropathy branch " diagnosis of chronic glomerulonephritis, differentiation of symptoms and signs for classification of syndrome and efficacy assessment standard ", specific as follows:
Effective standard: ache of the spinal column; Lassitude and weak; Puffiness of the face and limbs transference cure, hematuria, albuminuria reduce more than 70%, or hematuria, albuminuria disappear, and blood pressure recovers normal, and (serum creatinine, blood urea nitrogen) declines more than 70%, or graft function is normal.
Effective standard: ache of the spinal column; Lassitude and weak; Puffiness of the face and limbs symptom alleviates, and hematuria, albuminuria reduce more than 30%, blood pressure drops more than 30%, and renal function takes a turn for the better (serum creatinine, blood urea nitrogen decline more than 30%).
Null criterion: ache of the spinal column; Lassitude and weak; Puffiness of the face and limbs symptom is without alleviating, and hematuria, albuminuria reduce less than 30%, even increase; Blood pressure drops less than 30%, or raises; Serum creatinine, blood urea nitrogen decline are less than 30%, or renal function exacerbation.
4, statistical procedures method
In the data of clinical research, measuring index adopts mean ± standard deviation to describe, and counting index adopts number of cases and percent to describe.Measurement data t inspection (as do not meet normal distribution, then use rank test), enumeration data X 2 test.All data all adopt SPSS13.0 statistical package to add up, and P<0.05 variantly has statistical significance.
5, result of study
5.1 participate in quantitative analysis
Include 450 examples in, 8 examples in matched group 1,5 examples do not enter interpretation of result because of untoward reaction in matched group 2, remainingly do not occur the case that comes off.
5.2 adverse reaction rate
Over the course for the treatment of, in matched group 1 there is dry cough at night in 6 examples, and hypotension appears in 2 examples, and in matched group 2, severe diarrhea appears in 5 examples, does not occur untoward reaction in treatment group.
5.3 curative effect of disease evaluations
This research is observed and is added with health kidney oral liquid on the basis of western medicine routine treatment, and soreness of waist and knee joint, fatigue and weakness, puffiness of the face and dropsy of the feet, anemia, the symptoms such as hypertension and sign are obviously improved.Three groups of curative effects see the following form.
Three groups of comparitive study
Note: ▼ compares chi-square value=0.399 P=0.528* and compares chi-square value=39.96P=0.000 with non-health kidney oral liquid group with matched group 2
5.4 urine protein reducing effective evaluations
As shown in Figure 1, before and after the treatment for the treatment of group, matched group 1, urine protein all has minimizing, difference has statistical significance (P < 0.05), matched group 2 treats front and back urine protein without obviously reducing (P > 0.05), wherein treatment group is compared with matched group 1, difference has statistical significance P < 0.01), show that renal venothrombi treatment chronic nephritis is better than benazepril in reduction urine protein, and NIAODUQING KELI does not demonstrate obviously reduction urine protein effect.
6, conclusion
By analyzing each data record and statistical information before and after test, can draw to draw a conclusion:
Before 6.1 liang of group patient ages, sex, the course of disease and treatments, symptom and sign integration is through the equal no significant difference of statistical analysis, illustrates to have comparability between two groups.
It is better that 6.2 treatment groups and matched group compare safety, and obvious adverse reaction does not occur.
6.3 liang of group Clinical efficacy comparisons, treatment group total effective rate is 85.3%, matched group 1 total effective rate 69.7%, matched group 2 total effective rate 71.7%, display matched group 1 curative effect compared with matched group 2 is compared close between group, no significant difference (P > 0.05), and treatment group curative effect is better than matched group, difference has statistical significance (P < 0.05), shows that comparing renal venothrombi treatment chronic nephritis effect from symptoms is better than benazepril and NIAODUQING KELI.Health kidney oral liquid also demonstrates the effect reducing urine protein preferably simultaneously.
Chronic nephritis is clinical kidney disease the most common, and be the second cause of disease causing end stagerenaldisease in world wide, its cause of disease complexity is not bright so far, is one of key subjects of research both at home and abroad.Because chronic nephritis pathogenesis is not yet completely clear, suit the medicine to the illness and support that combining the Comprehensive Treatment delaying renal hypofunction is current primary treatment strategy, wherein regular follow-up, rationally controlling of blood pressure, more than 1g patient, RAS inhibitor applied to 24 hours protein quantifications be proved effectively definite, widely promote clinical.But merging the not enough and intractable cough of kidney perfusion that hypotension (BP < 90/60mmHg) causes after ACEI class medicine Treatment of Hypertension is the main cause causing drug withdrawal, although secondly western medical treatment Be very effective, but most of patients with chronic glomerulonephritis still unavoidably advances to end stagerenaldisease, us are needed to find more efficiently new Therapeutic Method.
Chinese medicine is the important content of chronic nephritis traditional therapy, wherein NIAODUQING KELI can ventilation quality, invigorating spleen to remove dampness, blood circulation promoting and blood stasis dispelling, find in clinical practice that it can reduce serum creatinine, blood urea nitrogen, stablize renal function, delay dialysis time and reduce level of proteinuria in patients with diabetic nephropathy, being widely used in the treatment of phase chronic renal disease morning, noon and afternoon.But some patients occurs watery diarrhea after application NIAODUQING KELI, restrict its application to a certain extent.Health kidney oral liquid, for chronic nephritis (spleen kidney both deficiency type) pathogenesis, with kidney and spleen invigorating, consolidates tonify deficiency; blood stasis dispelling row water is reason prescription; have similar part with NIAODUQING KELI, the animal experiment study of preclinical phase also shows health kidney oral liquid and obviously can alleviate kidney injury, renal function protecting.Further investigation Chinese medicine to the effect of nephropathy and verify its mechanism, may for chronic kidney disease control more effective ways are provided.This clinical test results display health kidney oral liquid significantly can improve that chronic nephritis is weak, the clinical symptoms of swelling, and it is better than benazepril and NIAODUQING KELI treatment to symptom improvement rate, and in reduction urine protein, effect is remarkable, is better than benazepril.In addition, health kidney oral liquid low price, untoward reaction is rare, for treatment chronic nephritis opens the new way for the treatment of by Chinese herbs, is worthy of further application.
The preparation method of health kidney oral liquid of the present invention, by refining production technology, improves the extraction of effective ingredient, ensure that the stability of preparation, decreases therapeutic effect that the mass discrepancy due to preparation causes and reduces and the generation of untoward reaction.Oral liquid formulations form, taking dose is little, absorption is rapid, steady quality, be convenient for carrying, easily preserve, and is especially applicable to suitability for industrialized production.
Although give some embodiments of the present invention, it will be understood by those of skill in the art that without departing from the spirit of the invention herein, can change embodiment herein.Above-described embodiment is exemplary, should with the restriction of embodiment herein as interest field of the present invention.
Claims (7)
1. the preparation method of health kidney oral liquid, is characterized in that, gets Radix Ginseng, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Poria, Herba Epimedii, Rhizoma Dioscoreae, Pheretima, Flos Carthami, Fructus Rosae Laevigatae, Semen Euryales and Radix Glycyrrhizae and decocts with water three times, merge three decoction liquor after filtering, obtain concentrated solution by concentrated for the decoction liquor after merging, treat that described concentrated solution is cooled to room temperature, add ethanol, place 24h, get supernatant and reclaim ethanol, add simple syrup, adjust ph, then add water to 1000ml, stir evenly rear leaving standstill, filter, get filtrate sterilizing and get final product.
2. the preparation method of health kidney oral liquid as claimed in claim 1, it is characterized in that, described Radix Ginseng 150g, Radix Astragali 200g, Rhizoma Atractylodis Macrocephalae 150g, Poria 200g, Herba Epimedii 150g, Rhizoma Dioscoreae 150g, Pheretima 100g, Flos Carthami 200g, Fructus Rosae Laevigatae 200g, Semen Euryales 100g and Radix Glycyrrhizae 40g.
3. the preparation method of the health kidney oral liquid as described in any one of claim 1 or 2, is characterized in that, during described concentrated solution 80 DEG C, relative density is 1.15-1.30.
4. the preparation method of health kidney oral liquid as claimed in claim 3, it is characterized in that, adding ethanol to ethanol content in described concentrated solution is 60%.
5. the preparation method of health kidney oral liquid as claimed in claim 4, it is characterized in that, described adjust ph is to 5.0-7.0.
6. the preparation method of health kidney oral liquid as claimed in claim 5, it is characterized in that, described sterilizing is 100 DEG C of sterilizing 30min.
7. the preparation method of health kidney oral liquid as claimed in claim 6, is characterized in that, each amount of water of described decoction is 6-8 times of medical material cumulative volume, and each decocting time is 40min.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102068585A (en) * | 2011-01-05 | 2011-05-25 | 中国人民解放军第三七一医院 | Chinese medicinal compound preparation for treating chronic nephritis and nephrotic syndromes |
| KR20120133194A (en) * | 2011-05-30 | 2012-12-10 | 정진남 | A method for manufacturing traditional wine using bamboo |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102068585A (en) * | 2011-01-05 | 2011-05-25 | 中国人民解放军第三七一医院 | Chinese medicinal compound preparation for treating chronic nephritis and nephrotic syndromes |
| KR20120133194A (en) * | 2011-05-30 | 2012-12-10 | 정진남 | A method for manufacturing traditional wine using bamboo |
Non-Patent Citations (1)
| Title |
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| 王希东等: "康肾口服液的最佳制备工艺研究", 《河北医药》 * |
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Application publication date: 20151104 |