CN1883674A - 'Jiang Tang Ning' preparation for treating diabetes and preparation method thereof - Google Patents
'Jiang Tang Ning' preparation for treating diabetes and preparation method thereof Download PDFInfo
- Publication number
- CN1883674A CN1883674A CN 200610200515 CN200610200515A CN1883674A CN 1883674 A CN1883674 A CN 1883674A CN 200610200515 CN200610200515 CN 200610200515 CN 200610200515 A CN200610200515 A CN 200610200515A CN 1883674 A CN1883674 A CN 1883674A
- Authority
- CN
- China
- Prior art keywords
- gypsum
- hours
- drying
- preparation
- water
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Abstract
The invention relates to a Chinese preparation for treating diabetes and process for preparation, which is prepared from gen-seng, rhizoma dioscoreae, plaster stone, anemarrhena rhizome, astragalus root, root of Chinese trichosannthes, poria cocos, lilyturf root, dried rehmannia root, root bark of chinese wolf berry, corn stigma, cornus officinalis licorice root and right amount of auxiliary materials.
Description
Technical Field: The present invention relates to a method for treating diabetes Jiangtangning preparation method thereof, belonging to the Chinese pharmaceutical technology
Surgical fields.
BACKGROUND: Diabetes is the second killer of modern diseases, which harm the human body after cancer. In fact, glycosuria
Disease itself is not terrible, terrible complications of diabetes, diabetes harm, almost all from its complications.
In our diabetic patients, as many as 12 million with hypertension, stroke by 5,000,000, 6,000,000 coronary heart disease, loss of binocular
Ming were 450,000, uremia 500,000. Complications due to diabetes itself and its harm to people's physical and mental health is growing, due to
Here, we have developed a need to better efficacy, better quality of diabetes medicines.
The prevalence of diabetes for a long time, the treatment for a long time, need long-term medication. At present, China's pharmaceutical market cures diabetes drug
Goods only six or seven, far can not meet the market demand. Hypoglycemic Capsules can effectively increase glucose transport, accelerate Portugal
Glucose oxidation and glycolysis, and promote glycogen synthesis and storage, inhibition of gluconeogenesis and glycogenolysis and lower blood sugar, and diabetes
Caused by repeated infections, difficulty urinating, upper body obesity, pruritus, peripheral neuritis weakening or disappearance of tendon reflexes have a good
Effect. But its formulation of a single species, can not meet the needs of the majority of patients. In order to meet the needs of different types of patients, acute
Required to provide a richer and efficient preparation varieties.
...
The prevalence of diabetes for a long time, the treatment for a long time, need long-term medication. At present, China's pharmaceutical market cures diabetes drug
Goods only six or seven, far can not meet the market demand. Hypoglycemic Capsules can effectively increase glucose transport, accelerate Portugal
Glucose oxidation and glycolysis, and promote glycogen synthesis and storage, inhibition of gluconeogenesis and glycogenolysis and lower blood sugar, and diabetes
Caused by repeated infections, difficulty urinating, upper body obesity, pruritus, peripheral neuritis weakening or disappearance of tendon reflexes have a good
Effect. But its formulation of a single species, can not meet the needs of the majority of patients. In order to meet the needs of different types of patients, acute
Required to provide a richer and efficient preparation varieties.
...
The object of the present invention is to: provide a hypoglycemic agent for treating diabetes and a preparation method of the present invention to existing
The lack of technology, providing good preparation disintegration, bioavailability, absorption of fast, easy to take, but also enriched formulations
Species, applicable to different types of patients.
The present invention is so constructed: it is with ginseng 30g, Chinese yam 120g, gypsum 300g, Anemarrhena 100g, 120g astragalus
, TCS 150g, Poria 120g, Radix 120g, Rehmanniae 150g, Digupi 150g, corn 150g, 60g dogwood
, Licorice 60g and appropriate auxiliary materials.
The formulation of tablets, dispersible tablets, granules, dripping pills, micro-pills or soft capsules.
Formulations of the invention Jiangtangning preparation method: take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum remaining
And Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water
Boiling twice every 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding
The fine powder, then add the appropriate accessories made of different formulations.
The tablet formulation thus prepared: Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum and knowledge remaining
Mother, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of boiling water
Second, every 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding the above
Powder and starch 65g, microcrystalline cellulose, 24g, 38g hydroxypropylcellulose mixing, drying, grinding, granulating, adding stearic acid
Magnesium 3g, mixing, tabletting, coating, ie.
The tablet formulations thus prepared: Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum, and the remaining
Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water to cook
Boiled twice, each 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, add the
Said powder and starch 60g, other than the addition of 4.2% by weight of sodium carboxymethyl starch, mix with a concentration of 5% polyvinyl pyrrolidine
One solution for the adhesive, 40 mesh granulation, whole, plus 2.8% by weight of sodium carboxymethyl starch, magnesium stearate 1%,
1% silica powder particles in a good system, tablet, that was.
...
The tablet formulations thus prepared: Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum, and the remaining
Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water to cook
Boiled twice, each 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, add the
Said powder and starch 60g, other than the addition of 4.2% by weight of sodium carboxymethyl starch, mix with a concentration of 5% polyvinyl pyrrolidine
One solution for the adhesive, 40 mesh granulation, whole, plus 2.8% by weight of sodium carboxymethyl starch, magnesium stearate 1%,
1% silica powder particles in a good system, tablet, that was.
...
The formulations thus prepared dropping pills: take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum, and the remaining
Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water to cook
Boiled twice, each 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, add the
Said powder mix; take the mixture of a, two polyethylene glycol 4000 and polyoxyethylene monostearate S-40 a mixed
Evenly melted on a water bath, stir, drop in dimethyl silicone oil into a pill, dropping distance 5cm, drops caliber 2.5mm/2mm, mix cream
Temperature 80 ℃, the cooling liquid height 70cm, that is, too.
...
The formulations thus prepared dropping pills: take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum, and the remaining
Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water to cook
Boiled twice, each 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, add the
Said powder mix; take the mixture of a, two polyethylene glycol 4000 and polyoxyethylene monostearate S-40 a mixed
Evenly melted on a water bath, stir, drop in dimethyl silicone oil into a pill, dropping distance 5cm, drops caliber 2.5mm/2mm, mix cream
Temperature 80 ℃, the cooling liquid height 70cm, that is, too.
...
The formulation of soft capsules thus prepared: Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum remaining
And Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water
Boiling twice every 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding
The powder mix; according to the amount of drug: Base Quality = 1:1.5 added soybean oil, and mix; rubber formulations as gelatin: Glycerin:
Water: titanium dioxide = 100g: 45g: 100g: 1g, the ingredients of the gum conditions: weighing ingredients, put in plastic cans of cold soak 30 minutes
Minutes later gradually heated to 65 ± 5 ℃, stirring for 3 hours while vacuuming except bubble gum material to be evenly discharge, after filtration into
Capsule machines in plastic drums; debug pressure pill machine, gelatin box thermostat 65 ℃, spray temperature control 45 ℃, roller die speed 2.0, thick rubber
Degree 0.8mm, indoor temperature 18 ~ 25 ℃, relative humidity less than 40%, the pressure pill; drying drying and rolling tray drying stereotypes
Combining step, dried for 2 hours scroll shape, drying temperature 22 ℃, drying should be less than 40% relative humidity, the drying time at 24 ~
48 hours, that is, too.
...
The prescription, ginseng natured, sweet, bitter, with regulating qi and blood, tranquilizer puzzle, Sheng Jin cough, nourishing the body of the power
Effect. To take off for the physically weak, cold extremities pulse, Spleen eat less, lung deficiency cough, fluid and thirst, heat diabetes, chronic illness virtual lean, scared
Palpitations, insomnia, impotence, cold house, heart failure, cardiogenic shock. Yam, sweet, spleen, lung, kidney. With Spleen
Stomach, Sheng Jin Yifei, kidney Shibuya fine function. Spleen eat less, than Jiuxie, lung deficiency cough, kidney spermatorrhea, vaginal discharge
, Frequent urination and Hot diabetes. Gypsum sweet, acrid, cold, lung and stomach. Functional heat purging fire, arrests restless thirst. Use for
Exogenous fever, high fever, polydipsia, Hyperactivity cough, stomach hyperactivity, headache, toothache. Anemarrhena of bitter, sweet, cold, lung, stomach
And kidney. There is heat purging fire, nourishing yin, thirst effect. For warm disease, evil heat Kang Sheng, strong heat, thirst,
Pulse loud and other lung and stomach heat syndrome. Compatibility with gypsum synergistic effect. Astragalus and warm, sweet. With qi solid form, diuretic care drugs
, Abscess, sore myogenic function. For deficiency fatigue, eat less, loose stools, subsidence in the air, a long vent prolapse, uterine bleeding blood in the stool, table
Virtual spontaneous, Qi edema, long collapse is not grabbing, chronic nephritis, proteinuria, diabetes. Modern pharmacological shown that astragalus Spleen
, Increase immunity, strengthen physique, have lungs gas and lowering blood pressure function, suitable for the elderly or in combination of obesity with hypertension, sugar
Diabetes, kidney disease in patients. TCS slightly cold, sweet, bitter. With heat fluid, swelling and pus function.
For fever, polydipsia, Hyperactivity dry cough, heat diabetes, sore swollen poison. Poria sweet, light, flat. Heart, lung, spleen, kidney
ECONOMY. Diuretic, swelling, spleen, Water Shenshi have efficacy for the edema, oliguria, phlegm dizzy palpitate; spleen Ning heart function, with
Spleen eat less, loose stools, diarrhea, malaise, palpitation insomnia. Radix sweet, slightly bitter, slightly cold. Heart, lung and stomach.
YangYinShengJin, lungs and pure heart. For Dryness cough, asthenia, coughing, fluid and thirst, irritability, insomnia, heat diabetes, intestinal dry it
Peru, pharyngeal diphtheria. Rehmanniae is Qingreliangxue medicine, sweet, bitter, cold, into the heart, liver and kidney. Qingreliangxue, Yin Sheng
Tianjin, nourishing. For hot blood into the camp, strong heat, thirst, red tongue; blood heat hematemesis, hematuria, epistaxis, uterine bleeding; blood deficiency
, Fever subside, diabetes or irregular menstruation; hives, itchy rashes wind embolism. Digupi of sweet, light, cold, lung, liver
And kidney. Gan Hanqing Run, the main into the lung, lung fire while lowering good addition to kidney deficiency heat, and can be cooling. Made for the deficiency of the blood heat Wang Xing
Commonly used. 1, the cooling steam back Indications: Yin fever and sweat Gu Zheng; blood heat Wang Xing, hematemesis. 2, Qingxie Hyperactivity:
Suitable for Hyperactivity cough. Can also be used to heat Diabetes and false fire toothache. Corn, sweet, light, nature, into the bladder, gall bladder.
A diuretic, Xiere, Pinggan, gallbladder function. Modern medical research suggests that corn has a diuretic, lowering blood pressure, lowering blood sugar
, Gallbladder, bleeding, bacterial and enhance immunity, anti-cancer and other effects. Used to treat the following diseases: pregnancy edema, acute
Cystitis, urinary frequency Pediatric Neurology, twin postpartum abdominal pain, chronic cholecystitis, gallstones, diabetes, high blood pressure. Mountain
Cornel of tepid, Pickle, astringent. With liver and kidney tonic, astringent fine solid off function. For dizziness, tinnitus, waist and knee pain, impotence
Nocturnal emission, enuresis, frequent urination, bleeding vaginal discharge, sweating exhaustion, heat diabetes. Licorice, sweet. Spleen, stomach, heart, lung
. With Spleen Qi, detoxification, expectorant cough, urgency and pain relief, to reconcile the various drugs function. For the weak stomach, fatigue
Fatigue, palpitations, shortness of breath, cough, sputum, abdominal, limb twin acute pain, boils, ease of drug toxicity and potent. Above
Various drugs played a total of Qi, Yin, fluid effect, for diabetes is Qi and Yin. Restore function of the pancreas,
Promote normal pancreas secretes insulin; adjust the body yin and yang imbalance, smooth lower blood sugar, urine, thirst, lung and kidney tonic
, Spleen Qi, Tiaowei Lee liver, blood glucose, and its effect is significant.
...
Compared with the prior art, the present invention provides a preparation with good disintegration, bioavailability, absorption of fast, easy to take,
The resulting stable product quality, rich variety of dosage forms for a wide range of people. Its micro-pill disintegration good bioavailability
, Especially for the elderly and have difficulty swallowing tablets or capsules in patients taking; tablet taking way more, you can swallow,
Taking sublingual and sucking the same time, the agent may be water rapidly disintegrating in 3 minutes to form a uniform aqueous dispersion, a solution of
Bioavailability of active ingredients is not high; soft capsules of the drug enclosed in a soft shell, the solution of the drug in case of heat unstable
Problems, but also drugs can mask the unpleasant taste and odor, serve to increase stability, to improve the bioavailability of the role; particles
Agent of good taste, while absorbing fast bioavailability.
...
Compared with the prior art, the present invention provides a preparation with good disintegration, bioavailability, absorption of fast, easy to take,
The resulting stable product quality, rich variety of dosage forms for a wide range of people. Its micro-pill disintegration good bioavailability
, Especially for the elderly and have difficulty swallowing tablets or capsules in patients taking; tablet taking way more, you can swallow,
Taking sublingual and sucking the same time, the agent may be water rapidly disintegrating in 3 minutes to form a uniform aqueous dispersion, a solution of
Bioavailability of active ingredients is not high; soft capsules of the drug enclosed in a soft shell, the solution of the drug in case of heat unstable
Problems, but also drugs can mask the unpleasant taste and odor, serve to increase stability, to improve the bioavailability of the role; particles
Agent of good taste, while absorbing fast bioavailability.
...
I. Extraction Process
The following main study 225g gypsum and the rest Anemarrhena, astragalus and a dozen flavored boiling water craft.
1.1 Sample preparation: prescription ratio 1/10 Weigh plaster 22.5g, Anemarrhena 10g, Astragalus 10g, TCS 15g, Fu
Ling 12g, Radix 12g, Rehmannia 15g, Digupi 15g, Corn 15g, dogwood 6g, licorice 6g press table conditions
Water extraction, liquid with a 300 mesh filter cloth filtration, the filtrate was concentrated and dried under vacuum into dry extract and crushed into fine powder.
1.2 dry extract yield: Table 1 Experimental conditions for each sample obtained dry extract powder, continue drying to constant weight, placed in dry
Desiccator for 30 minutes and weighed to calculate. In each of the original ingredients by weight of dry extract weight percentage of dry extract yield, knot
Results are shown in Table 1.
Table 1 Water Tigard water yield of dry paste inspection results
| Experiment No. | 1 | 2 | 3 | 4 | 5 |
| Add water (times) | 8 | 10 | 12 | 14 | 16 |
| Dry extract yield (%) | 9.42 | 10.51 | 12.39 | 14.65 | 14.74 |
Seen from Table 1, plus 14 times the amount of water dry extract yield was the highest cost savings and production complex considering the selection of plus 14 times the amount of
Water extraction is preferred.
1.3 Determination: Astragalus containing mainly Astragaloside, so the use of quantitative indicators astragaloside visits to determine the water
The optimum conditions mentioned.
1.3.1 Instruments and Equipment
CS-9000 dual-wavelength TLC scanner (Shimadzu); UV-8 ultraviolet analyzer (Shanghai Analytical Instrument Factory), fixed
Volume capillary (USA Drummond Soientific Co) TCQ-250 ultrasonic cleaner (Beijing Medical Equipment Plant);
Silica gel G TLC plates (Qingdao Marine Chemical).
1.3.2 Preparation of standard solutions
Astragaloside take appropriate reference substance, accurately weighed, add methanol containing 1mg per 1ml of solution as the reference solution.
1.3.3 Preparation of the test solution
Weigh the product water extraction and dry extract powder 10g, shaking with chloroform extracted two times, each 30ml, points to take the upper solution
Water saturated butanol shake extraction five times, the first 30ml, rest every 20ml, combined n-butanol extracts were washed with ammonia
Solution extracted two times (100ml, 80ml), get a butanol solution, evaporated and the residue dissolved 5ml 10% ethanol by
D101 macroporous resin (diameter 1.5cm, column height 12cm), eluted with 50ml water, discard the eluent, and then 40% ethanol
30ml elution, discard the eluent, following with 70% ethanol 50ml eluate evaporated, the residue was dissolved in methanol and transferred
Go 2ml volumetric flask, add methanol to the mark, shake, as the test solution.
1.3.4 TLC scanning
Precision drawing of the test solution 4μl and 6μl, respectively, the intersection at the same point with 0.1% sodium carboxymethyl cellulose solution as bonding
Agent silica gel G TLC plate (n-butanol - ethyl acetate - water = 4:1:5 upper solution) - methanol = 10:1 as eluent
, Set the expansion tank saturated ammonia vapor, expand the exhibition from 16cm or more, removed, dried, sprayed with 10% sulfuric acid in ethanol,
Heated at 100 ℃ for about 7 minutes, until a clear spot color, let cool, cover the same size in the thin plate of glass, surrounded by
Tape securely. Thin layer chromatography (Chinese Pharmacopoeia Appendix VI B TLCS) for scanning, wavelength: λS
＝530nm，λ
R= 700nm, measured for the sample absorption integral value with the reference substance absorption integral value calculation, that is, too.
1.3.5 Linear Relation
Astragaloside precision drawing reference solution (1.0mg/ml) 1,2,3,4,5 μl absorbed by the above chromatographic conditions
Integral value to absorption integral value Y of the sample volume X (μg) linear regression, the regression equation is:
Y = 1976.2X +167.74 (r = 0.9998), indicate astragaloside 1.0 to 5.0 range with a good linear relationship, the
Linear regression equation: Y = 2022X
Linear relationship between the study results in Table 2
| The injection volume (μg) | Peak area |
| 1.0 | 2075.18 |
| 2.0 | 4162.25 |
| 3.0 | 6140.79 |
| 4.0 | 8132.91 |
| 5.0 | 9970.98 |
1.3.6 Precision Test
1.3.6.1 precision test precision drawing board with the test solution, repeated five times point on the same board, according to the chromatographic conditions
Expand, record the chromatograms, Astragaloside absorption integral value of RSD was 0.7%, see Table 3.
Table 3 with plate precision test results
| Frequency | 1 | 2 | 3 | 4 | 5 | Mean | RSD(％) |
| Absorption integral value | 4094.68 | 4014.68 | 4060.20 | 4035.02 | 4067.24 | 4054.36 | 0.7 |
1.3.6.2 iso-board precision test precision drawing above test solution, repeated five times, respectively, points in five board
Launched by chromatographic conditions, record the chromatograms, RSD was 2.18%, the calculation results are listed in Table 4.
Table 4 different plate precision test results
| Frequency | 1 | 2 | 3 | 4 | 5 | Mean | RSD(％) |
| Content (10-3％) | 6.21 | 6.05 | 6.02 | 6.23 | 6.36 | 6.17 | 2.3 |
1.3.7 Different times the amount of water extracted Jiangtangning preparation Astragalus water extract of dry extract content determination Astragaloside
Take different amounts of water were extracted Jiangtangning preparation Astragalus water extract of dry extract powder, liquid preparation according to the test method and the color
Spectral condition operation Astragaloside (concentration: 1.0mg/ml) reference 2μl, the results in Table 5.
Table 5 Effect of Water water extraction assay results
| Extraction of water | 8 times of water | 10 times of water | 12 times of water | 14 times of water | 16 times of water |
| Content (10-3％) | 5.62 | 5.99 | 6.13 | 6.48 | 6.40 |
As can be seen from Table 5, plus 14 times the amount of water extracted Jiangtangning preparation Astragalus powder dry extract water extraction astragaloside
Maximum, and extract yield results.
Second, the molding process research
(A) a tablet molding process research
1 Category Filter Accessories
Some herbs Jiangtangning piece water extraction system, plus the amount of some herbs crushed materials directly pressed tablets. Therefore, the presence of large
The amount of plant fiber, the direct presence of starch granulation tabletting loose tablets, hardness substandard issues to consider joining a good compressibility and energy
Increase the hardness of the microcrystalline cellulose and hydroxypropyl cellulose. Filter results shown in Table 6.
Table 6 Screening of excipients
| Accessories | Starch | Microcrystalline cellulose, starch + | Hydroxypropyl cellulose, starch + | + + Hydroxypropyl starch, microcrystalline cellulose, cellulose |
| Hardness | - | + | ++ | ++++ |
| Disintegration | + | ++ | ++ | +++ |
(2) the amount of filtering materials
With hardness and granulation effect as the marker, the results are shown in Table 7.
Table 7 excipients dosage screening
| Accessories | Dosage (g) | |||
| Starch | 35g | 50 | 65 | 80 |
| Microcrystalline cellulose | 34 | 29 | 24 | 19 |
| Hydroxypropylcellulose | 58 | 48 | 38 | 28 |
| Hardness | ++ | ++ | +++ | + |
| Granulation effects | + | ++ | +++ | ++ |
Visible add starch 65g, microcrystalline cellulose, 24g, 38g Jiangtangning hydroxypropyl cellulose film hardness and granulation effects are satisfactory
.
(Two) tablet molding process research
Water can be rapidly disintegrating tablet form a uniform viscous suspension, to solve the original forms of poor disintegration, dissolution slow disadvantages
, The present invention is prepared dispersible tablets at 19 ℃ ~ 21 ℃ water 3min completely disintegrated, suspension, good dispersity, bio-
Utilization is high.
1 Screening of excipients
Sodium carboxymethyl starch prescription polyvinylpyrrolidone Disintegration time / s
%% Within plus plus oxazolidinone solution (%)
1 0 7 3 6.3
2 0 7 5 5.7
3 0 7 7 6.9
4 1.4 5.6 3 3.8
5 1.4 5.6 5 3.1
6 1.4 5.6 7 4.1
7 2.8 4.2 5 2.5
8 4.2 2.8 5 3.3
9 5.6 1.4 5 4.1
10 7 0 5 6.2
The results show that, with added 4.2% sodium carboxymethyl starch, with a concentration of 5% solution of polyvinylpyrrolidone as a binder,
40 mesh granulation, whole, plus 2.8% sodium carboxymethyl starch, in the prepared particles, tablets, dispersible tablets obtained product is easy to
In disintegration.
(Three) Granules Molding Process
Taking into account applicable to more people, was to prepare sugar-free granules, so the relatively small amount of accessories. And the extract of the original product
Hygroscopic powder, not excessive amount of excipients case materials and process conditions must pass strict screening and control,
In order to solve these problems.
1 flavoring agents selected
Sweeteners feature comparison table
Sucrose, sodium cyclamate proteoglycan species Stevia
Sweetness 1 (comparative standard) 200 ~ 180 ~ 300 times 300 times 50 times
Good quality taste bitter or metallic taste similar sense of smell good
Price a (relatively standard) 30 times 80 times lower cost
Dosage unrestricted unrestricted usage is limited, the amount is limited,
Generally do not exceed 0.1% 0.01% 0.6%
Good good good good safety
After a comprehensive comparison, sugar-free granules should cyclamate or aspartame as a sweetener is excellent, but the protein sugar more expensive.
Therefore, the product selected for cyclamate flavoring agents, taste debug derived by the required amount. Screening experiment: Take extract powder four copies, one
Copies without any accessories, by weight than the other three were added to 0.01%, 0.03%, 0.05% sodium cyclamate, add the right amount of open water
Clothes, the people try, taste tasting the merits, the results below.
Cyclamate with Scale
| Test No. | 1 | 2 | 3 | 4 |
| Dosage | Without accessories | 0.01％ | 0.03％ | 0.05％ |
| Taste | Slightly bitter taste | Sweet too light | Moderate sweetness | Too sweet |
The results showed that adding 0.03% by weight of sodium cyclamate, taste is moderate, better.
2 absorbency test
Take extract powder two, one added lactose, mix, respectively, set a weighed flat, said bottle, accurately weighed, at a temperature of
25 ℃, relative humidity of 75% was measured under the conditions of moisture absorption, the results in Table:
Hygroscopic test results
| Sample | Pure extract powder | Lactose extract powder + | |
| Said bottle Numbers | 1 | 2 | |
| Material Weight (g) | 1.01 | 0.50+0.50 | |
| Between Partition Time Between Breathe Wet Hundred Minute Rate (%) | 1h | 1.37 | 1.19 |
| 2h | 3.93 | 1.83 | |
| 3h | 5.81 | 2.35 | |
| 4h | 8.30 | 3.47 | |
| 6h | 10.32 | 4.54 | |
| 8h | 12.35 | 5.59 | |
| 10h | 14.07 | 7.18 | |
| 12h | 18.55 | 9.51 | |
| 24h | 20.69 | 12.73 | |
| 36h | 25.67 | 15.11 | |
| 48h | 33.17 | 17.84 | |
| 72h | 41.89 | 20.46 | |
| 84h | 45.37 | 22.84 | |
| 96h | 47.19 | 24.97 | |
The results show that using lactose as excipients as is reasonably practicable, the effect is more ideal.
(Four) drop pills forming process research
1 matrix screening
Matrix and the integration of the main drug compared to the situation
| Drugs: Matrix | Coolant | Melting method, molding conditions and settlement | Weight variation | Disintegration test time |
| Drugs: glycerine = 1:1 | Liquid Stone Wax | Easy to mix, sticky substance precipitate and sediment Fast, pill-shaped flat, good roundness. | 14％ | 18min |
| Drugs: glycerine = 1:2 | Bean oil | Easy mixing, sedimentation rate is moderate, pill-shaped round , Not bonded. | 12％ | 25min |
| Drugs: glycerine = 1:3 | Dimethyl Silicone | Easy mixing, settling slightly faster, pill-shaped not round Whole, not forming. | 13％ | 30min |
| Drugs: polyethylene glycol -4000 = 1:1 | Liquid Stone Wax | Easy to mix, sticky substance precipitate and sediment Fast, pill-shaped flat, good roundness. | 16％ | 15mim |
| Drugs: polyethylene glycol -4000 = 1:2 | Bean oil | Easy mixing, sedimentation rate is moderate, not round-shaped pills Whole, not forming. | 12％ | 13mim |
| Drugs: polyethylene glycol -4000 = 1:3 | Dimethyl Silicone | Easy mixing, sedimentation rate is moderate, not round-shaped pills Whole, not forming, non-adhesive. | 10％ | 14mim |
| Drugs: polyethylene glycol -4000 : Polyoxyethylene monostearate S-40 = 1:2:1 | Liquid Stone Wax | Easy mixing, settling moderate, good formability , The surface smooth and compact, roundness, hardness Well, not bonded. | 5％ | 5mim |
| Drugs: polyethylene glycol -4000 : Polyoxyethylene monostearate S-40 = 1:1:1 | Bean oil | Easy mixing, settling moderate, good formability Smooth surface dense, slightly rounded tail, Hardness slightly harder. | 7％ | 7mim |
| Drugs: polyethylene glycol -4000 : Polyoxyethylene monostearate S-40 = 1:1:2 | Dimethyl Silicone | Easy mixing, settling moderate, good formability Smooth surface dense, slightly rounded tail, Hardness slightly harder. | 8％ | 8mim |
| Drugs: sodium stearate = 1:1 | Liquid Stone Wax | Energy mix, settling moderate, pill-shaped round , Not bonded. | 10％ | 14mim |
| Drugs: sodium stearate = 1:2 | Bean oil | Easy mixing, settling slightly faster, good formability , Not bonded. | 14％ | 15mim |
| Drugs: sodium stearate = 1:3 | Dimethyl Silicone | Energy mix, settling slightly faster, pill-shaped not round Whole, not forming. | 16％ | 18mim |
The results show that the composite matrix obtained pills rapid dissolution, forming the best condition and settlement, and the disintegration test time is short,
To achieve the purpose of acting. Since polyethylene glycol matrix formed by esterification, is a water-soluble base of surfactant (melting
Point of 46 ~ 51 ℃), S-40 polyethylene glycols change itself does not have an affinity ester structure and surface activity, the improvement of the
Solubility of poorly soluble drugs, is conducive to drug absorption.
2 drops away, dropping the temperature of choice: drop port is fixed to the inner diameter 2.0mm ~ 2.5mm. Evaluation: pill weight qualified
Rate according to "Chinese Pharmacopoeia" 2005 edition a difference in quality requirements: should be within ± 15%.
Category temperature / ℃ dropping distance / cm height coolant / cm pill weight yield /%
1 90 4 50 81.2
2 90 5 60 88.3
3 90 8 70 85.0
4 80 4 60 92.5
5 80 5 70 97.3
6 80 8 50 92.1
7 70 4 70 91.4
8 70 5 50 88.6
9 70 8 60 87.4
The results showed that the present invention pills optimum conditions: drops in dimethyl silicone oil into a pill, dropping distance 5cm, drop diameter
2.5mm/2mm, mix cream temperature 80 ℃, the cooling liquid height 70cm.
(Five) micro-molding of pills
Pellet diameter is less than 2.5mm, the particle properties like high bioavailability, the present applicant in the development of the present invention, the pellets,
The biggest problem is hygroscopic and poor mobility, plasticity is poor, difficult to shape. The applicant obtained by screening using micro-
Pill manufacturing technology and materials makes the product easy to disintegration, bioavailability, nature is good.
1 hygroscopicity test
Take extract powder two, one adding starch, mix, respectively, set a weighed flat, said bottle, accurately weighed, at a temperature of
25 ℃, relative humidity of 75% was measured under the conditions of moisture absorption, the results below.
Hygroscopic test results
| Sample | Pure extract powder | Extract powder + starch | |
| Said bottle Numbers | L | 2 | |
| Material Weight (g) | 0.1005 | 0.9976 | |
| Between Partition Time Between Breathe Wet Hundred Minute Rate (%) | 1h | 1.48 | 1.12 |
| 2h | 4.76 | 2.36 | |
| 3h | 6.68 | 4.69 | |
| 4h | 8.23 | 6.12 | |
| 6h | 10.09 | 7.79 | |
| 8h | 12.87 | 9.54 | |
| 10h | 15.60 | 11.25 | |
| 12h | 18.27 | 13.21 | |
| 24h | 20.69 | 17.14 | |
| 36h | 25.11 | 18.26 | |
| 48h | 34.16 | 22.38 | |
| 72h | 42.65 | 28.59 | |
| 84h | 45.39 | 37.25 | |
| 96h | 46.23 | 39.12 | |
The results show that using starch as excipients reasonable and feasible.
(2) the amount of ethanol and soybean oil inspection
Take extract powder and starch, soybean oil and the amount of ethanol using wet granulation method into a soft material, so as to reach hand into the group, pinch
The energy spread, spare; research focuses on the amount of ethanol and soybean oil on the pill's effect, the experimental results below.
Ethanol concentration investigated
| Test No. | Ethanol concentration | Made of soft wood case |
| 1 | 70% ethanol | Soft material easy to bond |
| 2 | 60% ethanol | Moderate soft material |
| 3 | 50% ethanol | Soft material viscosity is not enough |
Soybean oil consumption inspection
| Test No. | Soybean oil consumption | Pill case |
| 1 | 60% ethanol, 1% soybean oil | Soft material viscosity is not enough, no legal pill |
| 2 | 60% ethanol, 2% soybean oil | Moderate soft material, suitable Pill |
| 3 | 60% ethanol, 3% soybean oil | Soft material easy to bond, pill difficulties |
Results can be seen, the use concentration of 60% ethanol, 2% soybean oil as a binder in an amount of granulation is ideal.
(Six) soft capsules forming process research
Soft capsules fast disintegration in the gastrointestinal tract, the capsule shell burst, drugs quickly dispersed, so fast dissolution of drug release, effective rapid
High bioavailability; semi-translucent soft capsules with better packaging material can protect drugs from moisture and oxygen in the air, the light
, Thereby enhancing the stability of the volatile components; stability of the capsule and molding process is crucial technology.
1 Select the type and amount of excipients
(1) a dispersion medium (or matrix), select the filler material can be mixed with the matrix, and to smooth the input materials and the pellet
Under the premise of minimizing the amount of matrix. Through several tests to determine the amount of the drug: quality = 1:1.5 appropriate base, the experimental results
Below.
Matrix dosage visits
Amount of the drug: the base quality 1:1.0 1:1.5 1:2
Quality liquid viscosity, poor mobility viscosity, viscosity difference are better fluidity, mobility
(2) Capsule shell formulation screening ingredient proportioning the table, add 500ml filtration bottle, 65 ℃ water bath to melt, automatically
Mixing of the rubber, while vacuuming, the vacuum degree of 0.095Mpa about 3 hours after heat for 1 hour, filtered glue, take a
Determination of the viscosity of glue and some other properties, some glue on the iron plate paved with a thin layer of uniform (first wipe a layer of liquid below
Paraffin), placed on the next day for further observation rubber performance evaluation will examine each index in turn results from the good to the bad with the "+ + +"
, "+ +", "+", "-" Indicates the results below.
Rubber ingredient screening results
| Formula | Viscosity (mpa · s) | Softness | Elasticity | Toughness | Feature | Evaluation |
| 1 Gelatin: Glycerin: Water (100g: 35g: 100g) | 3.62 | - | - | + | Brittle, hard | Poor |
| 2 Gelatin: Glycerin: Water (100g: 45g: 100g) | 3.32 | + | ++ | +++ | Tough, film Sex | Well |
| 3 Gelatin: Glycerin: Water (100g: 55g: 100g) | 3.59 | + | ++ | + | Good elasticity | General |
| 4 Gelatin: Glycerin: Water (100g: 45g: 80g) | 3.73 | ++ | ++ | + | Good elasticity, Viscosity | Well |
| 5 Gelatin: Glycerin: Water (100g: 45g: 120g) | 3.11 | +++ | + | - | Too soft | Poor |
| 6 Gelatin: Glycerin: Sorbitol: Water (100g: 45g: 5g: 100g) | 3.52 | ++ | + | + | Tough | Better |
| 7 Gelatin: Glycerin: Sorbitol: Water (100g: 45g: 10g: 100g) | 3.47 | ++ | ++ | - | Soft | General |
| 8 gelatin: acacia: Glycerin: Water (100g: 25g: 35g: 100g) | 3.57 | - | - | + | Partial gray color | Poor |
| 9 gelatin: acacia: Glycerin: Water (85g: 15g: 45g: 100g) | 3.51 | - | + | + | Brittle | Poor |
After the above screening, evaluation, taking into account the characteristics of the filler material, i.e. selecting the recipe 2 Gelatin 100g: Glycerin 45g: Water
100g.
(3) Choose sunscreens
Transparent capsule shells are prone to cause instability, it takes a certain amount of sunscreen. After inspection selection titania (titanium dioxide) as
Opacifiers shading effect can be achieved effectively, and the quality is stable, not with glue and filler material chemical changes. The amount by
Visits to gelatin: Glycerin: Water: titanium dioxide = 100g: 45g: 100g: 1g appropriate, and has little effect on the quality of the rubber, knot
Fruit below.
Opacifiers selected dosage
Amount of mucilage viscosity ratio of rubber transparency Evaluation
(Mpa·S)
1 gelatin 100g: Glycerin 45g: Water 100g: 3.12 titania 0.5g translucent enough dosage
2 Gelatin 100g: Glycerin 45g: Water 100g: 3.19 titania 1g translucent good
3 gelatin 100g: Glycerin 45g: Water 100g: 3.36 titania 2g translucent viscosity
4 Gelatin 100g: Glycerin 45g: Water 100g: 3.52 titania 3g opaque viscosity
Capsules formulated with sunscreens after quality more stable.
(2) molding process conditions investigated
(A) examine the ingredients of the gum formulation that according to the above preferred gelatin: glycerol: water: titanium dioxide = 100:45:100
: 1 weighed ingredients of the gel at different temperatures, the results below.
Investigation of glue temperature
Temperature (℃) of gel time (H) rubber quality
505 General
603 good
703 good
80 2.5 bit hard
90 2.5 hard
Above table shows that, of the gel temperature of 60 ~ 70 ℃ most suitable. Therefore, the ingredients of the gum conditions: weighing ingredients, put of glue
Cans, cold soak for 30 minutes to warm gradually to 65 ± 5 ℃, stirring for 3 hours while vacuuming except bubble until after the release of the compound evenly
Material, filtration and encapsulated machine in plastic drums.
(2) pressure pills: plastic barrel with the insulation barrel medicine at room temperature to the top of the capsule machine, connected to the machine, commissioning pressure pills
Machine, gelatin box thermostat 65 ℃, spray temperature control 45 ℃, roller die speed 2.0, rubber thickness 0.8mm, indoor temperature 18 ~ 25 ℃,
Relative humidity less than 40%. Pelleting machine debugging to be adjusted after pill contents installed capacity of 400mg / tablets. Pelleting process every half hour
Measuring the amount of loading time.
(3) Drying: Drying stereotypes: After pelleting machine pressed out of the soft capsules transferred by conveyor belt to the cage, the cage while rotating while blowing
Cold, turn the setting to dry for about 2 hours. Tray Drying: After turn cold cage in a clean, dry capsules containing stainless steel trays filled
Installed, go to the temperature about 22 ℃, relative humidity of 40% or less of the drying chamber to dry for 24 to 48 hours, and constantly flip, measuring glue
Sac is below 10% moisture dried appropriate. Drying Precautions: Dry rolling stereotypes combined drying and tray drying step
, Scroll stereotypes drying the investigation to two hours is appropriate, then the surface is not smooth too long; drying temperature after visits to about 22 ℃
Appropriate, low temperature drying time is too long, although elevated temperatures can shorten the drying time, but it is easy to produce the capsule surface cracking; dry
After the inspection dry relative humidity should be less than 40%, otherwise easy to dry; drying time of about 24 to 48 hours to control the moisture
10% or less.
...
(3) Drying: Drying stereotypes: After pelleting machine pressed out of the soft capsules transferred by conveyor belt to the cage, the cage while rotating while blowing
Cold, turn the setting to dry for about 2 hours. Tray Drying: After turn cold cage in a clean, dry capsules containing stainless steel trays filled
Installed, go to the temperature about 22 ℃, relative humidity of 40% or less of the drying chamber to dry for 24 to 48 hours, and constantly flip, measuring glue
Sac is below 10% moisture dried appropriate. Drying Precautions: Dry rolling stereotypes combined drying and tray drying step
, Scroll stereotypes drying the investigation to two hours is appropriate, then the surface is not smooth too long; drying temperature after visits to about 22 ℃
Appropriate, low temperature drying time is too long, although elevated temperatures can shorten the drying time, but it is easy to produce the capsule surface cracking; dry
After the inspection dry relative humidity should be less than 40%, otherwise easy to dry; drying time of about 24 to 48 hours to control the moisture
10% or less.
...
Preparation according to preparation of the pilot product batches, each batch feeding amount of the original amount of 100 times the amount of prescriptions, made 100,000. And
Three batches of samples were used in the test stability test observation, the results are shown in Table 8.
Test data in Table 8
| Lot number | Feeding amount (kg) | Thick paste volume (kg) | Powder weight (kg) | Number of pieces | Yield (%) | |
| Theory | Get real value | |||||
| 20041101 | 163 | 42.5 | 22.28 | 100000 | 89600 | 89.6 |
| 20041102 | 163 | 43.1 | 22.35 | 100000 | 92100 | 92.1 |
| 20041103 | 163 | 42.8 | 22.30 | 100000 | 91200 | 91.0 |
Thus, three batches of pilot production sample results were stable, indicating that this process is stable.
Specific embodiments:
Example 1 of the present invention: ginseng 30g, yam 120g, gypsum 300g, altogether 100g, astragalus 120g, TCS
150g, Poria 120g, Radix 120g, Rehmanniae 150g, Digupi 150g, corn 150g, dogwood 60g, licorice 60g
Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum and Anemarrhena surplus, astragalus, TCS, Poria, wheat
Winter, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of boiling water twice, each time 1.5 hours, combined decoction
, Filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding the powder and starch 65g, microcrystalline cellulose
24g, 38g hydroxypropyl cellulose mix, drying, grinding, granulating, adding magnesium stearate 3g, mixed, pressed into a
1000, including film-coated, ie tablets. This product is taken orally, 4 to 6, 3 times a day.
Embodiment 2 of the present invention: ginseng 30g, yam 120g, gypsum 300g, altogether 100g, astragalus 120g, TCS
150g, Poria 120g, Radix 120g, Rehmanniae 150g, Digupi 150g, corn 150g, dogwood 60g, licorice 60g
Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum and Anemarrhena surplus, astragalus, TCS, Poria, wheat
Winter, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of boiling water twice, each time 1.5 hours, combined decoction
, Filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding the powder and starch 60g, the other at a weight ratio
Plus 4.2% sodium carboxymethyl starch, mix with a concentration of 5% solution of polyvinylpyrrolidone as a binder, 40 mesh granulation, the entire
Tablets, plus 2.8% by weight of sodium carboxymethyl starch, magnesium stearate 1%, 1% of silica powder particles in the prepared
, Tabletting, ie tablet. This product is a dosage: 1.6g-2.4g, three times a day.
...
Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum and Anemarrhena surplus, astragalus, TCS, Poria, wheat
Winter, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of boiling water twice, each time 1.5 hours, combined decoction
, Filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding the powder and starch 60g, the other at a weight ratio
Plus 4.2% sodium carboxymethyl starch, mix with a concentration of 5% solution of polyvinylpyrrolidone as a binder, 40 mesh granulation, the entire
Tablets, plus 2.8% by weight of sodium carboxymethyl starch, magnesium stearate 1%, 1% of silica powder particles in the prepared
, Tabletting, ie tablet. This product is a dosage: 1.6g-2.4g, three times a day.
...
Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum and Anemarrhena surplus, astragalus, TCS, Poria, wheat
Winter, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of boiling water twice, each time 1.5 hours, combined decoction
, Filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding the fine powder and sodium carboxymethyl starch 24g, milk
Sugar 60g, added another 0.03% by weight of sodium cyclamate, mix with a concentration of 70% ethanol as a wetting agent, granulation, drying
, Whole, packaging, ie granules. This product is a dosage: 1.6g-2.4g, three times a day.
% E6% 9C% AC% E5% 8F% 91% E6% 98% 8E% E7% 9A% 84% E5% AE% 9E% E6% 96% BD% E4% BE% 8B4% EF% BC% 9A% E4 % BA% BA% E5% 8F% 8230g% E3% 80% 81% E5% B1% B1% E8% 8D% AF120g% E3% 80% 81% E7% 94% 9F% E7% 9F% B3% E8% 86 % 8F300g% E3% 80% 81% E7% 9F% A5% E6% AF% 8D100g% E3% 80% 81% E9% BB% 84% E8% 8A% AA120g% E3% 80% 81% E5% A4% A9 % E8% 8A% B1% E7% B2% 89% 0A% 20% 20% 20% 20% 20% 20% 20% 20% 20% 20% 20% 20% 0A% 09% 09% 09% 09% 09150g % E3% 80% 81% E8% 8C% AF% E8% 8B% 93120g% E3% 80% 81% E9% BA% A6% E5% 86% AC120g% E3% 80% 81% E7% 94% 9F% E5 % 9C% B0% E9% BB% 84150g% E3% 80% 81% E5% 9C% B0% E9% AA% A8% E7% 9A% AE150g% E3% 80% 81% E7% 8E% 89% E7% B1 % B3% E9% A1% BB150g% E3% 80% 81% E5% B1% B1% E8% 8C% B1% E8% 90% B860g% E3% 80% 81% E7% 94% 98% E8% 8D% 8960g
Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum and Anemarrhena surplus, astragalus, TCS, Poria, wheat
Winter, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of boiling water twice, each time 1.5 hours, combined decoction
, Filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding the powder mix; take the mixture of a,
Polyethylene glycol 4000 in duplicate and polyoxyethylene monostearate S-40 A, mixing, melting on a water bath, stir, drop in
Dimethyl silicone oil into a pill, dropping distance 5cm, drops caliber 2.5mm/2mm, mix cream temperature 80 ℃, the cooling liquid height 70cm, namely
Was dropping pills. This product is a dosage: 1.6g-2.4g, three times a day.
...
Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum and Anemarrhena surplus, astragalus, TCS, Poria, wheat
Winter, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of boiling water twice, each time 1.5 hours, combined decoction
, Filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding the powder mix; take the mixture of a,
Polyethylene glycol 4000 in duplicate and polyoxyethylene monostearate S-40 A, mixing, melting on a water bath, stir, drop in
Dimethyl silicone oil into a pill, dropping distance 5cm, drops caliber 2.5mm/2mm, mix cream temperature 80 ℃, the cooling liquid height 70cm, namely
Was dropping pills. This product is a dosage: 1.6g-2.4g, three times a day.
...
Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum and Anemarrhena surplus, astragalus, TCS, Poria, wheat
Winter, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of boiling water twice, each time 1.5 hours, combined decoction
, Filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding the powder and starch 45g, with 60% ethanol
And 2% soybean oil made of soft material, soft material with the prepared pellets mechanisms pills, wet material extruded 0.8mm sieve, strip off the wet grain rounded
, 50 ~ 60 ℃ drying and forming, over 16 to 20 mesh filter pills, ie micro-pills. This product is a dosage: 1.6g-2.4g, a
Three times a day.
% E6% 9C% AC% E5% 8F% 91% E6% 98% 8E% E7% 9A% 84% E5% AE% 9E% E6% 96% BD% E4% BE% 8B6% EF% BC% 9A% E4 % BA% BA% E5% 8F% 8230g% E3% 80% 81% E5% B1% B1% E8% 8D% AF120g% E3% 80% 81% E7% 94% 9F% E7% 9F% B3% E8% 86 % 8F300g% E3% 80% 81% E7% 9F% A5% E6% AF% 8D100g% E3% 80% 81% E9% BB% 84% E8% 8A% AA120g% E3% 80% 81% E5% A4% A9 % E8% 8A% B1% E7% B2% 89% 0A% 20% 20% 20% 20% 20% 20% 20% 20% 20% 20% 20% 20150g% E3% 80% 81% E8% 8C% AF % E8% 8B% 93120g% E3% 80% 81% E9% BA% A6% E5% 86% AC120g% E3% 80% 81% E7% 94% 9F% E5% 9C% B0% E9% BB% 84150g% E3 % 80% 81% E5% 9C% B0% E9% AA% A8% E7% 9A% AE150g% E3% 80% 81% E7% 8E% 89% E7% B1% B3% E9% A1% BB150g% E3% 80 % 81% E5% B1% B1% E8% 8C% B1% E8% 90% B860g% E3% 80% 81% E7% 94% 98% E8% 8D% 8960g
Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum and Anemarrhena surplus, astragalus, TCS, Poria, wheat
Winter, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of boiling water twice, each time 1.5 hours, combined decoction
Liquid filtration, the filtrate was concentrated to 90 ℃ The relative density of 1.25 thick paste, add the powder mix; according to the amount of drug: Base Quality
= 1:1.5 adding soybean oil, and mix; rubber formulations as gelatin: glycerol: water: titanium dioxide =
100g: 45g: 100g: 1g, the ingredients of the gum conditions: weighing ingredients, put in plastic cans of cold soak for 30 minutes to warm gradually to
65 ± 5 ℃, stirring for 3 hours while vacuuming except bubble gum material to be evenly discharge, filtration and encapsulated machine plastic drums
Medium; debug pressure pill machine, gelatin box thermostat 65 ℃, spray temperature control 45 ℃, roller die speed 2.0, rubber thickness 0.8mm, indoor temperature
Degrees 18 ~ 25 ℃, relative humidity less than 40%, the pressure pill; dried rolling tray drying step of drying and styling combined rolling
Stereotypes dried for 2 hours, drying temperature 22 ℃, drying should be less than 40% relative humidity, the drying time at 24 to 48 hours, that is, too soft
Capsules. This product is a dosage: 1.6g-2.4g, three times a day.
...
Claims (9)
- Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum and Anemarrhena surplus, astragalus, TCS, Poria, wheat Winter, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of boiling water twice, each time 1.5 hours, combined decoction Liquid filtration, the filtrate was concentrated to 90 ℃ The relative density of 1.25 thick paste, add the powder mix; according to the amount of drug: Base Quality = 1:1.5 adding soybean oil, and mix; rubber formulations as gelatin: glycerol: water: titanium dioxide = 100g: 45g: 100g: 1g, the ingredients of the gum conditions: weighing ingredients, put in plastic cans of cold soak for 30 minutes to warm gradually to 65 ± 5 ℃, stirring for 3 hours while vacuuming except bubble gum material to be evenly discharge, filtration and encapsulated machine plastic drums Medium; debug pressure pill machine, gelatin box thermostat 65 ℃, spray temperature control 45 ℃, roller die speed 2.0, rubber thickness 0.8mm, indoor temperature Degrees 18 ~ 25 ℃, relative humidity less than 40%, the pressure pill; dried rolling tray drying step of drying and styling combined rolling Stereotypes dried for 2 hours, drying temperature 22 ℃, drying should be less than 40% relative humidity, the drying time at 24 to 48 hours, that is, too soft Capsules. This product is a dosage: 1.6g-2.4g, three times a day. ...
- (2) as claimed in claim 1, wherein said hypoglycemic agent for treating diabetes, wherein: said The formulation of tablets, dispersible tablets, granules, dripping pills, micro-pills or soft capsules.
- (2) as claimed in claim 1, wherein said hypoglycemic agent for treating diabetes, wherein: said The formulation of tablets, dispersible tablets, granules, dripping pills, micro-pills or soft capsules....
- 4 according to claim 3, wherein the treatment of diabetes hypoglycemic Preparation of formulations, characterized That: the preparation of tablets thus prepared: Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum, and the remaining Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water to cook Boiled twice, each 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, add the Said powder and starch 65g, microcrystalline cellulose, 24g, 38g hydroxypropyl cellulose mix, drying, grinding, granulating, adding stearyl Magnesium 3g, mixing, tabletting, coating, ie. ...
- 5 according to claim 3, wherein the treatment of diabetes hypoglycemic Preparation of formulations, characterized That: the preparation of dispersible tablets thus prepared: Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum remaining And Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water Boiling twice every 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding The fine powder and starch 60g, other than the addition of 4.2% by weight of sodium carboxymethyl starch, mix with a concentration of 5% polyvinylpyrrolidone Polyvinylpyrrolidone as a binder solution, 40 mesh granulation, whole, plus 2.8% by weight of sodium carboxymethyl starch, magnesium stearate 1% , 1% silica powder particles in a good system, tablet, that was. ...
- 6 according to claim 3, wherein the treatment of diabetes hypoglycemic Preparation of formulations, characterized In that: the preparation of the granules thus prepared: take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum remaining And Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water Boiling twice every 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding The sodium carboxymethyl starch powder and 24g, lactose 60g, added another 0.03% by weight of sodium cyclamate, mix with a concentration of 70% ethanol as wetting agents, granulation, drying, whole, packaging, ie. ...
- 7 according to claim 3, wherein the treatment of diabetes hypoglycemic Preparation of formulations, characterized That: the preparation of pills agent thus prepared: Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum remaining And Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water Boiling twice every 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding The powder mix; take the mixture of a, two polyethylene glycol 4000 and polyoxyethylene monostearate a S-40, mix Together evenly melted on a water bath, stir, drop in dimethyl silicone oil into a pill, dropping distance 5cm, drops caliber 2.5mm/2mm, mixing drugs Cream temperature 80 ℃, the cooling liquid height 70cm, that is, too. ...
- 8 according to claim 3, wherein the treatment of diabetes hypoglycemic Preparation of formulations, characterized That: the micro-pill formulation thus prepared: Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, gypsum remaining And Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of water Boiling twice every 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ relative density of 1.25 thick paste, adding The fine powder and starch 45g, with 60% ethanol and 2% soybean oil system soft material, the prepared pellets mechanism soft pill timber, wet material extruded Over 0.8mm sieve, strip off the wet grain rounded, 50 ~ 60 ℃ drying molding, over 16 to 20 mesh screening pill, that was. ...
- 9 according to claim 3, wherein the treatment of diabetes hypoglycemic Preparation of formulations, characterized That: the preparation of soft capsules thus prepared: Take ginseng, Chinese yam 75g crushed into fine powder and gypsum, and the remaining raw stone Cream and Anemarrhena, astragalus, TCS, Poria, Radix, Rehmanniae, Digupi, corn, dogwood, licorice plus 14 times the amount of Boiling water twice, each time 1.5 hours, the combined decoction, filtration, the filtrate was concentrated to 90 ℃ The relative density of 1.25 thick paste, add Into the powder mix; according to the amount of drug: Base Quality = 1:1.5 added soybean oil, and mix; rubber formulations as gelatin: Glycerin : Water: titanium dioxide = 100g: 45g: 100g: 1g, ingredients of glue conditions: weighing ingredients, put in plastic cans of cold soak 30 Minutes later gradually heated to 65 ± 5 ℃, stirring for 3 hours while vacuuming except bubble gum material to be evenly discharge, installed after filtration Into the capsule machine in plastic drums; debug pressure pill machine, gelatin box thermostat 65 ℃, spray temperature control 45 ℃, roller die speed 2.0, rubber Thickness of 0.8mm, the indoor temperature 18 ~ 25 ℃, relative humidity less than 40%, the pressure pill; drying tray drying and rolling stereotypes dry Dry step combination, scroll shape dried for 2 hours, drying temperature 22 ℃, drying should be less than 40% relative humidity, the drying time at 24 ~ 48 hours, that is, too. ...
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610200515 CN1883674A (en) | 2006-06-02 | 2006-06-02 | 'Jiang Tang Ning' preparation for treating diabetes and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610200515 CN1883674A (en) | 2006-06-02 | 2006-06-02 | 'Jiang Tang Ning' preparation for treating diabetes and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1883674A true CN1883674A (en) | 2006-12-27 |
Family
ID=37582058
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610200515 Pending CN1883674A (en) | 2006-06-02 | 2006-06-02 | 'Jiang Tang Ning' preparation for treating diabetes and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1883674A (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008153502A1 (en) * | 2007-06-08 | 2008-12-18 | Eu Yan Sang International Ltd | Compositions for prevention and/or treatment of diabetes |
| CN101062256B (en) * | 2007-05-26 | 2010-12-01 | 李丰军 | Chinese traditional combination medicine for treating diabetes |
| CN105770606A (en) * | 2016-04-06 | 2016-07-20 | 练燕媚 | Pharmaceutical composition for treating type II diabetes mellitus and complications thereof and preparation method thereof |
| CN106072639A (en) * | 2016-06-27 | 2016-11-09 | 吉林亚泰明星制药有限公司 | A kind of auxiliary hyperglycemic selenium sheet and preparation method thereof |
| CN107308352A (en) * | 2016-04-26 | 2017-11-03 | 济南比罗茨信息科技有限公司 | A kind of Chinese medicine composition for treating diabetes |
-
2006
- 2006-06-02 CN CN 200610200515 patent/CN1883674A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101062256B (en) * | 2007-05-26 | 2010-12-01 | 李丰军 | Chinese traditional combination medicine for treating diabetes |
| WO2008153502A1 (en) * | 2007-06-08 | 2008-12-18 | Eu Yan Sang International Ltd | Compositions for prevention and/or treatment of diabetes |
| CN105770606A (en) * | 2016-04-06 | 2016-07-20 | 练燕媚 | Pharmaceutical composition for treating type II diabetes mellitus and complications thereof and preparation method thereof |
| CN107308352A (en) * | 2016-04-26 | 2017-11-03 | 济南比罗茨信息科技有限公司 | A kind of Chinese medicine composition for treating diabetes |
| CN106072639A (en) * | 2016-06-27 | 2016-11-09 | 吉林亚泰明星制药有限公司 | A kind of auxiliary hyperglycemic selenium sheet and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1876139A (en) | Medicinal preparation for treating children's fastidium, its preparation process and quality control method | |
| CN1840166A (en) | Modern Chinese medicinal oral liquid of 'Wen Dan Tang' and preparation method thereof | |
| CN1883674A (en) | 'Jiang Tang Ning' preparation for treating diabetes and preparation method thereof | |
| CN1768800A (en) | Chinese medicinal formulation for treating blennorrhagia and urinary system infection, and preparation method thereof | |
| CN101049440A (en) | Preparation of Chinese traditional medicine in use for diabetes, and preparation method | |
| CN1895535A (en) | Chinese-medicinal preparation for treating gutture disease and it making method | |
| CN1709341A (en) | Medicinal composition for nourishing qi to invigorate spleen, and its preparing method and use | |
| CN1958010A (en) | Composition preparation of Chinese traditional medicine, and preparation method | |
| CN1186051C (en) | 'Huajuhong' preparation and its preparing process | |
| CN1733109A (en) | Soft capsule for treating coronary disease and process for preparing the same | |
| CN1840087A (en) | King solomonseal- and fleece-flower root-containing Chinese medicinal formulation for treating chronic fatigue syndrome and its preparation method | |
| CN1857385A (en) | Medicine composition for treating cervical spondylosis and its preparing method | |
| CN1308018C (en) | Medicine xinqin tablet for treating allergic rhintis and its prepn | |
| CN1634476A (en) | Chinese ephedra and almond containing cough stopping dripping pills and its preparing process | |
| CN1615959A (en) | Chines medicine capsule preparation for treating skin diseases | |
| CN1853670A (en) | Coronary heart Danshen root micropellets and preparation thereof | |
| CN1297254C (en) | Drop pills containing bear gall and tendril-leaved fritillary bulb and preparation method thereof | |
| CN1817359A (en) | Chinese medicinal preparation for treating gynecopathy and production thereof | |
| CN1293895C (en) | Oral disintegration tablet for laryngopathy and its preparing method | |
| CN1634478A (en) | Tendril-leaved fritillary bulb loquat drop pills and preparation method thereof | |
| CN1768794A (en) | Chinese medicinal preparation for treating respiratory diseases and its preparing process | |
| CN1872325A (en) | Composition of Chinese traditional medicine for treating cold in virulence, and preparation method | |
| CN1733272A (en) | Pulean pharmaceutical preparation for treating urinary system diseases and process for preparing the same | |
| CN1679793A (en) | Xiaoaiping preparation against cancers and its making method | |
| CN1733095A (en) | Chinese medicine preparation for treating gynecopathy and its preparation method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |