CN103083470A - Balsam pear and kudzu root slice with functions of decreasing blood sugar - Google Patents
Balsam pear and kudzu root slice with functions of decreasing blood sugar Download PDFInfo
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- CN103083470A CN103083470A CN2013100329902A CN201310032990A CN103083470A CN 103083470 A CN103083470 A CN 103083470A CN 2013100329902 A CN2013100329902 A CN 2013100329902A CN 201310032990 A CN201310032990 A CN 201310032990A CN 103083470 A CN103083470 A CN 103083470A
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Abstract
The invention relates to a balsam pear and kudzu root slice with a function of decreasing blood sugar and a preparation method thereof. A conventional western medicine for decreasing blood sugar has side effects; and furthermore, some traditional Chinese medicines are low in degree of enrichment for effective components and are not ideal in therapeutic effect. Therefore, the balsam pear and kudzu root slice with a functions of decreasing blood sugar disclosed by the invention is prepared from balsam pear extract, kudzu root extract, cortex lycii radicis extract, notoginseng extract, folium mori extract, milk vetch extract, lactose starch, polyvinylpolypyrrolidone, D-mannite, silicon dioxide, magnesium stearate and film coating agent, wherein the film coating agent consists of hydroxypropyl methylcellulose, talcum powder and glycerol triacetate. The invention further relates to a preparation method of the balsam pear and kudzu root slice. The balsam pear and kudzu root slice disclosed by the invention has no side effect, and can avoid various complicating diseases caused by taking of western medicine; and moreover, the balsam pear and kudzu root slice is high in degree of enrichment for effective components and has an obvious assisting effect of decreasing of blood sugar and a better therapeutic effect.
Description
Technical field
The present invention relates to Fructus Momordicae charantiae Gegen tablets of a kind of auxiliary hyperglycemic and preparation method thereof.
Background technology
At present, if the drug main oral hypoglycemic of conventional therapy diabetes and prolonged application insulin.Wherein, the orally-taken blood sugar reducing drug main will for sulphanylureas, biguanides, a glycosidase inhibitor, novel insulin sensitizer etc., be mainly chemical synthetic drug.Although these medicines help the diabetes patient to control blood sugar level with the different mechanism of action, but these medicines also have weak point: model of action approach single, side reaction is in various degree all arranged, it is more obvious that taking dose is taken greatly or for a long time side effect, also drug resistance can appear, and dispenser is limited, the life taste that can not adapt to present allegro life requirement and constantly promote is so seek that blood sugar reducing function is lasting and poison is secondary little, taking convenience, easily store and portable buccal tablet dosage form seems necessary.
In addition, in long-term medical practice, China's Chinese medicine has also accumulated the invaluable experience of preventing and treating diabetes, has summed up simple and easy to do Therapeutic Method such as Chinese herbal treatment, acupuncture and moxibustion therapy, Diet Therapy, physical exercise therapy, the qigong, massage etc.These methods reduce blood glucose, blood fat to improving the diabetes clinical symptoms, and improving the sick control of microcirculation and diabetes chronic all has certain effect.The side effect of Diabetes Mellitus Treated With Traditional Chinese Medicine is less, and can reach certain blood sugar lowering control sugar effect, thereby is that more diabetics is selected.Although the Chinese medicine of present available treatment diabetes also has much, the active ingredient enrichment degree is not high, and therapeutic effect is not very good.
Summary of the invention
The technical problem to be solved in the present invention is the defects that how to overcome prior art, and a kind of Fructus Momordicae charantiae Gegen tablets of auxiliary hyperglycemic is provided.
For solving the problems of the technologies described above, the Fructus Momordicae charantiae Gegen tablets of this auxiliary hyperglycemic, made by Fructus Momordicae charantiae extract, Radix Puerariae extract, Cortex Lycii extract, Radix Notoginseng extract, Folium Mori extract, Radix Astragali extract, lactose starch, polyvinylpolypyrrolidone, D-mannital, silicon dioxide, magnesium stearate and film coating agent, described film coating agent is comprised of hypromellose, Pulvis Talci and glyceryl triacetate.
So design, without any side effects, can avoid taking the multiple complications that Western medicine causes; Secondly, have taking convenience, easily store and portable advantage, and bioavailability is than the obvious improve of ordinary preparation, for the life taste that adapts to present allegro life requirement and constantly promote provides again a route of administration easily; In addition, the active ingredient enrichment degree is high, and the assisting in reducing blood sugar mechanism of action is clear and definite, and is efficient, economical and practical.
in addition, Fructus Momordicae charantiae extract has heat-clearing and toxic substances removing and obvious hypoglycemic activity, isoflavonoid puerarin in Radix Puerariae extract, can be to adrenolytic blood glucose increasing effect, has certain blood sugar decreasing effect, Cortex Lycii extract has blood sugar lowering, removing heat from blood is except steaming, the effect of lung heat clearing pathogenic fire reducing, Radix Notoginseng extract has blood sugar lowering, blood fat reducing, reduce blood pressure, the liver protecting, also can improve immunocompetence, flavonoid composition in Folium Mori extract, play a part antioxidant, reduce the destruction of radical pair health, protection blood circulation and pancreas, and may certain repair be arranged to pancreatic function, the Radix Astragali extract instinct promotes to improve the vigor of body antioxidase and oxidation preventive content, the collaborative antioxidation that strengthens Folium Mori extract, and has the enhancing human body immunity function, promote to strengthen the physiological function of whole health, thereby also indirectly promoting pancreatic function.
Six kinds of extracts are complementary short mutually; synergism; both fundamentally strengthen whole body function, promoted pancreatic function, and promoted the secretion of insulin in body; reduce again the absorption to sugar; accelerate glucose metabolism, thereby control, reduce blood sugar level, protect simultaneously, improve blood circulation; improve gastrointestinal movement, prevent other concurrent diseases of diabetes.
As optimization, its label formula is:
The film coating agent prescription:
Hypromellose 8-12 weight portion
Pulvis Talci 2.8-3.5 weight portion
Glyceryl triacetate 1.3-1.8 weight portion.
The preparation method of the Fructus Momordicae charantiae Gegen tablets of auxiliary hyperglycemic of the present invention comprises the steps:
Step 1: sieve
Fructus Momordicae charantiae extract, Radix Puerariae extract, Cortex Lycii extract, Radix Notoginseng extract, Folium Mori extract, Radix Astragali extract, lactose starch, polyvinylpolypyrrolidone, D-mannital are crossed respectively the 40-60 mesh sieve, standby;
Step 2: mix
Fructus Momordicae charantiae extract, Radix Puerariae extract, Cortex Lycii extract, Radix Notoginseng extract, Folium Mori extract, Radix Astragali extract, lactose starch, polyvinylpolypyrrolidone, D-mannital after step 1 is sieved, and silicon dioxide, magnesium stearate add in mixer by inventory, mixed 30~70 minutes, and obtained mixture;
Step 3: tabletting
Adopt the fully automatic high-speed tablet machine to carry out tabletting in the mixture of the final preparation of step 2;
Step 4: coating
The preparation of syrup: take coating material by described coating materials formula, add in the with slurry pot, stirred 45 ~ 75 minutes, the preparation coating material; Open the coating pan door, adjust the distance between spray gun and sheet bed, adjust atomizing pressure, inlet temperature, temperature of outgoing air, sheet bed tempertaure, coating pan rotating speed and carry out coating until syrup has been sprayed, discharging after the temperature-reducing tablet bed tempertaure finally obtains the Fructus Momordicae charantiae Gegen tablets of auxiliary hyperglycemic of the present invention.
The Fructus Momordicae charantiae Gegen tablets of auxiliary hyperglycemic of the present invention, without any side effects, can avoid taking the multiple complications that Western medicine causes; Secondly, have taking convenience, easily store and portable advantage, and bioavailability is than the obvious improve of ordinary preparation, for the life taste that adapts to present allegro life requirement and constantly promote provides again a route of administration easily; In addition, the active ingredient enrichment degree is high, and the assisting in reducing blood sugar mechanism of action is clear and definite, and is efficient, economical and practical.
Description of drawings
Be described further below in conjunction with the Fructus Momordicae charantiae Gegen tablets of accompanying drawing to auxiliary hyperglycemic of the present invention:
Fig. 1 is the preparation method flow chart of the Fructus Momordicae charantiae Gegen tablets of this auxiliary hyperglycemic.
Annotate: be 100,000 grades of clean areas in dotted line in Fig. 1.
The specific embodiment
Embodiment 1: as shown in Figure 1, the Fructus Momordicae charantiae Gegen tablets of this auxiliary hyperglycemic, made by Fructus Momordicae charantiae extract, Radix Puerariae extract, Cortex Lycii extract, Radix Notoginseng extract, Folium Mori extract, Radix Astragali extract, lactose starch, polyvinylpolypyrrolidone, D-mannital, silicon dioxide, magnesium stearate and film coating agent, described film coating agent is comprised of hypromellose, Pulvis Talci and glyceryl triacetate.
Its label formula is:
The film coating agent prescription:
Hypromellose 10.5kg
Pulvis Talci 3kg
Glyceryl triacetate 1.5kg.
The preparation method of the Fructus Momordicae charantiae Gegen tablets of this auxiliary hyperglycemic comprises the steps:
Step 1: sieve
Fructus Momordicae charantiae extract, Radix Puerariae extract, Cortex Lycii extract, Radix Notoginseng extract, Folium Mori extract, Radix Astragali extract, lactose starch, polyvinylpolypyrrolidone, D-mannital are crossed respectively the 40-60 mesh sieve, standby;
Step 2: mix
Fructus Momordicae charantiae extract, Radix Puerariae extract, Cortex Lycii extract, Radix Notoginseng extract, Folium Mori extract, Radix Astragali extract, lactose starch, polyvinylpolypyrrolidone, D-mannital after step 1 is sieved, and silicon dioxide, magnesium stearate add in mixer by inventory, mixed 30~70 minutes, and obtained mixture;
Step 3: tabletting
Adopt the fully automatic high-speed tablet machine to carry out tabletting in the mixture of the final preparation of step 2;
Step 4: coating
1) preparation of syrup
Take coating material by described coating materials formula, add in the with slurry pot, stirred 45 ~ 75 minutes, the preparation coating material; 3) open the coating pan door, adjust the distance between spray gun and sheet bed, adjust atomizing pressure, inlet temperature, temperature of outgoing air, sheet bed tempertaure, coating pan rotating speed and carry out coating until syrup has been sprayed, discharging after the temperature-reducing tablet bed tempertaure finally obtains the Fructus Momordicae charantiae Gegen tablets A of auxiliary hyperglycemic.
Embodiment 2: the label formula changes into:
The film coating agent prescription changes into:
Hypromellose 8kg
Pulvis Talci 3.5kg
Glyceryl triacetate 1.3kg.
Repeat the described preparation method of embodiment 1, get the Fructus Momordicae charantiae Gegen tablets B of auxiliary hyperglycemic of the present invention.
Embodiment 3:
The label formula changes into:
The film coating agent prescription changes into:
Hypromellose 12kg
Pulvis Talci 2.8kg
Glyceryl triacetate 1.8kg.
Repeat the described preparation method of embodiment 1, get the Fructus Momordicae charantiae Gegen tablets C of auxiliary hyperglycemic of the present invention.
The auxiliary hyperglycemic function human feeding trial
1 materials and methods
1.1 Fructus Momordicae charantiae Gegen tablets A and the placebo of sample copy invention auxiliary hyperglycemic, both outward appearances, taste are basic identical, and the human oral recommended dose is every day 3 times, each 2.
1.2 the experimenter selects
1.2.1 inclusive criteria: age 18-65 year, selection state of an illness after diet control or oral antidiabetic drug treatment is more stable, do not need to change types of drugs and dosage, only take the adult type ii diabetes patient of maintenance dose, fasting glucose 〉=7.8mmol/L (140mg/dl) or 2h-plasma glucose 〉=11.1mmol/L (200mg/dl); Also can select the hyperglycemia population of 7.8mmol/L 〉=fasting glucose 〉=6.7mmol/L (120mg/dl) or 11.1mmol/L 〉=2h-plasma glucose 〉=7.8mmol/L.
1.2.2 experimenter's exclusion standard: type i diabetes (insulin-dependent) patient; Age is at under-18s or over-65s, gestation or noncooperationist (referring to diet control person in accordance with regulations); The complication such as severe cardiac, liver, kidney are arranged through B ultrasonic, Chest X-rays and Electrocardioscopy, serious gastroenteropathy, or be associated with other serious primary disease person, the psychotic; Diabetic ketosis, ketoacidosis and the infected were arranged in nearly three months; Take pol matter hormone and affect blood glucose medicine person with other; Take in a short time the article relevant with tested function, have influence on judgement person as a result; Do not meet inclusive criteria, eat in accordance with regulations given the test agent, can't judge effect or data not umbra sound effect or safety judgement person.
1.3 experimental design and grouping
The double blind random grouping is adopted in this test, between group and self two kinds of control design.According to above-mentioned Standard Selection volunteer, according to experimenter's blood sugar level, be divided at random test-meal group and matched group, consider to affect as far as possible factor such as the course of disease of result, the kind of taking medicine (sulphanylureas, biguanides etc.), sex, age etc.Carry out the harmony check, with the comparability between the assurance group.
1.4 test method
Test is front presses sex, age, different labor intensity, ideal body weight to each experimenter, and with reference to the corresponding diet of original living habit regulation, duration of test is respectively organized and adhered to diet control, and is former constant with medicament categories mediating recipe amount.The experimenter takes sample by product description every day, takes continuously 45 days.Duration of test does not change original dietary habit.
2 observation index
Each measures once every observation index when test-meal on-test and end.
2.1 safety indexes
2.1.1 general physical examination: inquire and understands in detail experimenter's the situations such as spirit, sleep, diet, defecation before test, and mensuration body weight, blood pressure, heart rate etc.
2.1.2 routine blood test: red blood cell count(RBC), numeration of leukocyte and classification, content of hemoglobin mensuration etc.
2.1.3 routine urinalysis: pH value, leukocyte, glucose in urine, urine ketoboidies etc.
2.1.4 stool for routine.
2.1.5 blood parameters check: drop of blood total protein (TP), albumin (ALB), glutamate pyruvate transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), blood urea nitrogen (BUN), creatinine (Cr), blood glucose (GLU), total gallbladder return alcohol (TC), triglyceride (TG) and HDL-C (HDL-C) and measure.
2.1.6 Chest X-rays, electrocardiogram, ultrasound diagnosis (measuring once before test)
2.1.7 untoward reaction is observed
2.2 observation index:
2.2.1 observation of symptoms: detailed medical history-taking, understand patient's diet situation, medicining condition, activity, observe the main clinic symptoms such as thirsty polydipsia, polyuria, polyorexia, fatigue and weakness, by mild symptoms multiple integral (serious symptom 3 minutes, middle disease 2 minutes, light disease 1 minute) statistics integrated value before and after test-meal, and improve (each doing well,improving is effectively more than 1 minute) with regard to its cardinal symptom, the improvement rate observes the symptoms.
2.2.2 blood sugar detection: the unified steamed bread of making for the l00g fine powder of test-meal thing, survey on an empty stomach and 2 hours blood glucoses after the meal.
2.2.3 glucose in urine, urine ketoboidies detect: urina sanguinis is qualitative on an empty stomach, by-, ± ,+, ++, +++, ++ ++ respectively long-pending O, 0.5, l, 2,3,4 minutes, statistics integrated value before and after test-meal.Urinating ketoboidies detects.
3. result is judged
Effectively: fundamental symptoms obviously improves, and self relatively reaches between group before and after test-meal group fasting glucose or 2h-plasma glucose test and compares, and difference has significance; And descend 〉=10% before the test.
Invalid: as not reach above-mentioned condition person.
4. statistical procedures
The data result represents with mean ± standard deviation, self paired data adopts paired t-test, between test-meal group and matched group under the prerequisite of homogeneity of variance, mean relatively adopts t check in groups, otherwise adopt the t check after carrying out satisfying homogeneity of variance after variable transforms, if variance is still uneven, adopt rank test.Effective percentage is pressed X
2Check.
5. double-blind method observe to finish to make known as a result: take No. 1 person for the Fructus Momordicae charantiae Gegen tablets A of auxiliary hyperglycemic of the present invention, take No. 2 persons and be placebo.
5.l ordinary circumstance: test-meal group 52 examples, matched group 52 examples.The front two groups of equal no significant differences of subject age, the course of disease and medicining condition of test-meal have comparability.
Situation as table l test-meal is last
5.2 functional observation
5.2.1 observation of symptoms: see Table 2,3, took tested material 45 days, reach matched group relatively before test-meal group clinical symptoms integration and self test, difference all has significance (P<0.05).Test-meal group clinical observation total effective rate is (82.69%), with matched group (17.31%) comparing difference, significance (P<0.05) is arranged.
Annotate: relatively P<O.05# and matched group comparison P<O.05 before * and test-meal
Table 3 clinical symptoms is improved situation
Annotate: # and the contrast l of class be P<O.05 relatively
5.2.2 fasting glucose
See Table 4, before test-meal, test-meal group fasting glucose and matched group compare, and no significant difference (P〉O.05).After the matched group test-meal before fasting glucose and test-meal comparing difference without significance (P〉0.05).Self relatively reach before fasting glucose and test-meal after the test-meal of test-meal group with the matched group test-meal after relatively, difference all has significance (P<0.05), after test-meal, test-meal group fasting glucose fall is 0.77mmol/L, compare (0.08mmol/L) with matched group, difference has significance (P<0.05).After the test-meal of test-meal group, fasting glucose descends 10.24%.
Fasting glucose variation before and after table 4 test-meal (mmol/L,
)
Annotate: compare P<0.05 before * and test-meal; # and matched group be P<0.05 relatively
5.2.3 post-prandial glycemia
See Table 5, before test-meal, test-meal group post-prandial glycemia and matched group compare, no significant difference (P〉0.05).After the matched group test-meal before post-prandial glycemia and test-meal comparing difference without significance (P〉0.05).Self relatively reach before post-prandial glycemia and test-meal after the test-meal of test-meal group with the matched group test-meal after relatively, difference all has significance (P<0.05), after test-meal, test-meal group post-prandial glycemia fall is 0.69mmol/L, compare (0.06mmol/L) with matched group, difference has significance (P<0.05).After the test-meal of test-meal group, post-prandial glycemia descends 6.26%.
The variation of post-prandial glycemia before and after table 5 test-meal (mmol/L,
)
Annotate: compare P<0.05 before * and test-meal; # with to matched group P<0.05 relatively
5.2.4 glucose in urine and urine ketoboidies
See Table 6, self relatively reach more equal no significant difference between group (P〉0.05) before and after glucose in urine test, the prompting sample has no significant effect glucose in urine.Before and after test-meal, the urine ketoboidies has no and detects.
Glucose in urine before and after table 6 test-meal, urine ketoboidies situation (integrated value,
)
5.3 security inspection: body weight, blood pressure, heart rate, routine blood test, routine urinalysis (except glucose in urine), stool routine examination, biochemical indicator and untoward reaction observation etc.
By as seen from Table 7, eat tested material 45 days, two groups of body weight, blood pressure, hearts rate are showed no obvious abnormalities change, and routine blood test, routine urinalysis (except glucose in urine), stool routine examination and biochemical indicator detect all within normal range.Do not find obvious adverse reaction during test-meal.The prompting sample to body health without obvious damage.
Body weight, blood pressure, heart rate, routine blood test, routine urinalysis, stool routine examination and changes of biochemical indexes situation before and after table 7 test-meal
5.4 take off the mistake rate
After test in 45 days, matched group has l example experimenter to take because of interruption can't be screened out by determine effect by test product; The test-meal group has l example experimenter to take because of interruption can't be screened out by determine effect by test product.Last efficiency test crowd matched group 51 examples, test-meal group 51 examples.
The mistake rate is taken off in table 8 test
6. brief summary
Adopt counter point between own control and group, select the volunteer who meets experimental condition to take tested material 45 days, during adhere to diet control, former treatment Rezulin species mediating recipe amount is constant.Result shows: the Fructus Momordicae charantiae Gegen tablets A of auxiliary hyperglycemic is improved effect to the diabetes main clinic symptoms, and total effective rate is 82.69% (matched group is 17.31%); Self relatively reach before and after the test-meal of test-meal group fasting glucose with the matched group test-meal after relatively, difference all has significance (P<0.05), test-meal group fasting glucose fall and matched group are relatively, difference has significance (P<0.05), and after the test-meal of fasting glucose test-meal group than descending 10.24% before test-meal; Self relatively reach before and after the test-meal of test-meal group post-prandial glycemia with the matched group test-meal after relatively, difference all has significance (P<0.05), test-meal group post-prandial glycemia fall and matched group are relatively, difference has significance (P<0.05), after the test-meal of test-meal group post-prandial glycemia than descending 6.26% before test-meal; The Fructus Momordicae charantiae Gegen tablets A of prompting auxiliary hyperglycemic has auxiliary hyperglycemic function.After test-meal, body weight, blood pressure, heart rate are showed no obvious abnormalities change, and routine blood test, routine urinalysis (except glucose in urine), stool routine examination and biochemical indicator detection all within normal range, are not found obvious adverse reaction during test-meal.
Replace respectively the Fructus Momordicae charantiae Gegen tablets A of auxiliary hyperglycemic of the present invention with the Fructus Momordicae charantiae Gegen tablets C of the Fructus Momordicae charantiae Gegen tablets B of auxiliary hyperglycemic of the present invention, auxiliary hyperglycemic of the present invention, repeat above-mentioned human experiment experiment, acquired results is without essential difference, slightly.
The present invention includes but be not limited to above-mentioned embodiment, any product, method that meets the description of these claims is within all falling into protection scope of the present invention.
Claims (3)
1. the Fructus Momordicae charantiae Gegen tablets of an auxiliary hyperglycemic, made by Fructus Momordicae charantiae extract, Radix Puerariae extract, Cortex Lycii extract, Radix Notoginseng extract, Folium Mori extract, Radix Astragali extract, lactose starch, polyvinylpolypyrrolidone, D-mannital, silicon dioxide, magnesium stearate and film coating agent, described film coating agent is comprised of hypromellose, Pulvis Talci and glyceryl triacetate.
2. the Fructus Momordicae charantiae Gegen tablets of auxiliary hyperglycemic according to claim 1, it is characterized in that: its label formula is:
The film coating agent prescription:
Hypromellose 8-12 weight portion
Pulvis Talci 2.8-3.5 weight portion
Glyceryl triacetate 1.3-1.8 weight portion.
3. the preparation method of the Fructus Momordicae charantiae Gegen tablets of an auxiliary hyperglycemic, comprise the steps:
Step 1: sieve
Fructus Momordicae charantiae extract, Radix Puerariae extract, Cortex Lycii extract, Radix Notoginseng extract, Folium Mori extract, Radix Astragali extract, lactose starch, polyvinylpolypyrrolidone, D-mannital are crossed respectively the 40-60 mesh sieve, standby;
Step 2: mix
Fructus Momordicae charantiae extract, Radix Puerariae extract, Cortex Lycii extract, Radix Notoginseng extract, Folium Mori extract, Radix Astragali extract, lactose starch, polyvinylpolypyrrolidone, D-mannital after step 1 is sieved, and silicon dioxide, magnesium stearate add in mixer by inventory, mixed 30~70 minutes, and obtained mixture;
Step 3: tabletting
Adopt the fully automatic high-speed tablet machine to carry out tabletting in the mixture of the final preparation of step 2;
Step 4: coating
The preparation of syrup: take coating material by described coating materials formula, add in the with slurry pot, stirred 45 ~ 75 minutes, the preparation coating material; Open the coating pan door, adjust the distance between spray gun and sheet bed, adjust atomizing pressure, inlet temperature, temperature of outgoing air, sheet bed tempertaure, coating pan rotating speed and carry out coating until syrup has been sprayed, discharging after the temperature-reducing tablet bed tempertaure finally obtains the Fructus Momordicae charantiae Gegen tablets of auxiliary hyperglycemic of the present invention.
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CN104840690A (en) * | 2015-04-30 | 2015-08-19 | 云南天美天康生物科技有限公司 | Combination with auxiliary blood sugar and blood fat reduction effect |
CN106266230A (en) * | 2016-08-09 | 2017-01-04 | 南京中医药大学 | A kind of Chinese medicinal components compatibility optimization method based on uniform Design and artificial neural network |
CN107898914A (en) * | 2018-01-09 | 2018-04-13 | 王道繁 | A kind of tea bag for prophylactic treatment diabetes and preparation method thereof |
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