Aminoglucose hydrochloride medicinal composition
The present invention relates to a kind of pharmaceutical composition for the treatment of osteoarthritis, the active component of said composition is a glucosamine hydrochloride.
Background technology
Osteoarthritis also claims osteoarthritis, malum senile, hypertrophic arthropathy etc., is articular cartilage albumen resulting anomaly and the result of the degeneration of jointization that causes, the clinical symptoms such as arthralgia, limitation of activity and joint deformity that produce.Can involve all joints of whole body, as knee joint, hip joint, vertebra, shoulder, hands, carpal joint and ankle joint.Degeneration that it is generally acknowledged cartilage may promptly begin from 20 years old later stage, had approximately among the group crowd at 40 years old 90% on X-ray film the sign of visible cartilage degeneration, old age is particularly outstanding, therefore, osteoarthritis be influence the active most commonly encountered diseases of old people because of, the sickness rate of osteoarthritis in women crowd is far above male crowd, and substantial connection is arranged with occupation, the investigation of Lawrence shows, the osteoarthritis incidence rate of coal miner is than docker height, and the docker is again than office staff height.Kneed athletic injury accounts for the first place at each position of whole body, wherein, because of the knee joint osseous arthritis due to the long-term specialized training and change chondromalacia patella in early days and patella articular cartilage malacosis) just accounted for 40% of all motion of knee joint damages.
The earliest period pathologic basis that osteoarthritis takes place is the change of articular cartilage, and promptly because articular cartilage synthetic proteins polysaccharide reduces, and the content of the proteoglycan in the cartilage matrix descends, proteoglycan aggregates into macromolecular ability drop, loses increase.At present, the treatment osteoarthritis has pharmacotherapy, operative therapy, physical therapy, physical exercise therapy and other auxiliary treatment etc.Wherein, use at most with pharmacotherapy.General pharmacotherapy commonly used is the non-steroidal anti-inflammatory medicine, though this type of medicine is that effectively it is not the medicine at the osteoarthritis cause of disease for mitigation symptoms.The mechanism of action of non-steroidal anti-inflammatory class medicine mainly reaches antiinflammatory, analgesic activity by suppressing Cycloxygenase; yet; non-steroidal anti-inflammatory class medicine has also suppressed the biosynthesis of prostaglandin in the gastrointestinal tract simultaneously, and these prostaglandins have protective effect to gastric mucosa.Often produce the hemorrhage and ulcer that gastrointestinal side effect, especially life-time service just may produce gastrointestinal when therefore using NSAID (non-steroidal anti-inflammatory drug).Glucosamine is a kind of natural amino monosaccharide, it is a kind of material with physiologically active, can stimulate proteoglycan and collagen that chondrocyte produces normal polymer structure, it is the essential material of synthetic intraarticular proteoglycan, simultaneously, glucosamine can suppress to damage enzyme such as the collagenase and the phospholipase A of cartilage
2, and can prevent the generation of the superoxide radical of damaging cells, simultaneously, it does not suppress the biosynthesis of prostaglandin, therefore, glucosamine can be blocked the pathological process of osteoarthritis, and progress wards off disease, improve joint motion, alleviating pain, and do not have significant side effects.And non-steroidal anti-inflammatory medicine relief of symptoms does not only have the blocking-up effect to the process of osteoarthritis, and some medicine such as indomethacin have the effect that promotes destruction of joint and disturb joint repair even can the arthritic process of accelerated bone because of it.More what is interesting is, after the drug withdrawal, still sustainable several months of the effect of glucosamine, then bounce-back immediately after the drug withdrawal of non-steroidal anti-inflammatory medicine.Find that as far back as the research worker of Sweden Stockholm Karolinska institute in 1956 external adding glucosamine hydrochloride can obviously increase the synthetic of chondroitin sulfate, glucosamine glycogen (GAG) to joint tissue.After this, the research worker of institute of pharmacology, Bonn University and American I llinois university institute of pharmacology has also been reappeared above-mentioned experimental result, proves that all external adding glucosamine hydrochloride can obviously increase synthetic about 170% of glucosamine glycogen (GAG) to joint tissue.In early days on Yan Jiu the basis, scientists is recognized and can be treated osteoarthritis then by oral or injection glucosamine to stimulate synthesizing of glucosamine glycogen (GAG) and albumen glycogen (PG) in the joint.There are some researches prove that glucosamine and NSAID (non-steroidal anti-inflammatory drug) such as diclofenac, indometacin, piroxicam share can increase the effect of oozing out that the anti-carrageenin of NSAID (non-steroidal anti-inflammatory drug) causes and reach 2-2.7 doubly.US36883706 and CH525861 patent application glucosamine sulfate prepare patent, and go on the market with capsule.From 1980 to 1994, successively studied 2500 routine osteoarthritis patients, fully proved the effectiveness of glucosamine when the treatment osteoarthritis.Take the 1500mg glucosamine every day, 4-6 patient's pain relief more than 80% after week, recover to quicken, function of joint partially or completely recovers.Thereby glucosamine obtains permission as a kind of medicine in several countries of Europe, and because side effect is low, that is proposed as long-term treatment preferentially selects medicine for use.For glucosamine sulfate, the part of onset only is a glucosamine, and glucosamine sulfate should have consistent therapeutical effect with glucosamine hydrochloride.But, glucosamine sulfate has many shortcomings as a kind of medicine, draw wet, its amino very easily oxidation stain as the glucosamine sulfate height, therefore the preparation of glucosamine sulfate is had relatively high expectations, as tablet need coating, be loaded in the ampoule, capsule reply capsule shells is carried out encapsulation process, and require to keep away wet and oxygen.The ratio that contains the free amine group glucose in the glucosamine hydrochloride is higher than glucosamine sulfate (free glucosamine content is suitable with latter 250mg among the former 238mg), in order to increase the sucting wet stability of glucosamine sulfate, in the preparation of glucosamine sulfate, added equimolar sodium chloride, like this, the amount of glucosamine is suitable in the amount of the glucosamine in the 314mg glucosamine sulfate and the 238mg glucosamine hydrochloride.Glucosamine hydrochloride is compared with glucosamine sulfate, also has instability problem, places certain hour in room temperature, degraded can occur, and degraded mainly occurs under the solution state, and especially very fast variable color under alkali condition forms furfural class material.Glucosamine hydrochloride also has and certain draws moistly, and mobile relatively poor, operation easier is big when making preparation, and when filling capsule, content uniformity is bigger, influences the quality and the shelf-life of product, but slightly is inferior to glucosamine sulfate on degree.
Summary of the invention the invention provides a kind of aminoglucose hydrochloride medicinal composition, said composition comprises the active ingredient hydrochloric acid glucosamine and the medicine acceptable carrier of medicine effective quantity, after pharmaceutical composition of the present invention mixes with cellulose derivative (particularly microcrystalline Cellulose) by glucosamine hydrochloride and granulates as binding agent with the polyvidone alcoholic solution, draw moist reduction greatly, mobile increasing, stripping is rapid, and the stability of product strengthens.Pharmaceutical composition of the present invention comprises following dosage form: these pharmaceutical dosage forms can be tablet, capsule, spray, gel, gel inhalant, oral liquid, suspensoid, electuary, patch, pill, powder, injection, infusion solution, suppository, slow releasing preparation, controlled release preparation etc.Cellulose derivative of the present invention comprises: methylcellulose, ethyl cellulose, propyl cellulose, hydroxypropyl cellulose, microcrystalline Cellulose etc.Pharmaceutical composition of the present invention, wherein the amount of glucosamine hydrochloride is 1-2000mg, and cellulosic amount is 1-300mg, and the amount of polyvidone is 1-20mg.Pharmaceutical composition of the present invention, wherein the weight ratio of glucosamine hydrochloride is more than 50%.Pharmaceutical composition of the present invention, preferred prescription consists of, and the amount of glucosamine hydrochloride is 200-600mg, and the amount of microcrystalline Cellulose is 20-80mg, and it is an amount of that polyvidone is made into 3% alcoholic solution.
The specific embodiment is following to be the embodiment of this patent, but not as the restriction to this patent,
Embodiment 1 glucosamine hydrochloride capsule prescription glucosamine hydrochloride 240g microcrystalline cellulose vegetable dish 40g Pulvis Talci 1.4%3% polyvidone alcoholic solution is made 1000 in right amount altogether glucosamine hydrochloride is pulverized, cross 80 mesh sieves, get recipe quantity glucosamine hydrochloride and recipe quantity microcrystalline Cellulose mix homogeneously, add 3% polyvidone alcoholic solution system soft material, cross 18 mesh sieve system granules, 60 ℃ (the gained granule was held dried granule with hand-tight in dry 30-45 minute, hands loosens and causes granule and should not bond agglomerating, palm does not have that fine powder adheres to yet or should pulverize immediately when being twined with forefinger and thumb granule, the free from dampness sense) granulate, add Pulvis Talci, mixing, fill in No. 1 capsule, promptly get every capsule that contains the 240mq glucosamine hydrochloride.
Embodiment 2: Glucosamine hydrochloride tablet agent prescription glucosamine hydrochloride 240g microcrystalline cellulose vegetable dish 40g Pulvis Talci 1.4%3% polyvidone alcoholic solution is made 1000 in right amount altogether glucosamine hydrochloride is pulverized, cross 80 mesh sieves, get recipe quantity glucosamine hydrochloride and recipe quantity microcrystalline Cellulose mix homogeneously, add 3% polyvidone alcoholic solution system soft material, cross 18 mesh sieve system granules, 60 ℃ (the gained granule was held dried granule with hand-tight in dry 30-45 minute, hands loosens and causes granule and should not bond agglomerating, palm does not have that fine powder adheres to yet or should pulverize immediately when being twined with forefinger and thumb granule, the free from dampness sense) granulate, add Pulvis Talci, mixing, tabletting.
Embodiment 3 glucosamine hydrochloride granules prescriptions glucosamine hydrochloride 240g microcrystalline cellulose vegetable dish 40g Pulvis Talci 1.4%3% polyvidone alcoholic solution is made 500 bags in right amount altogether glucosamine hydrochloride is pulverized, cross 80 mesh sieves, get recipe quantity glucosamine hydrochloride and recipe quantity microcrystalline Cellulose mix homogeneously, add 3% polyvidone alcoholic solution system soft material, cross 18 mesh sieve system granules, 60 ℃ (the gained granule was held dried granule with hand-tight in dry 30-45 minute, hands loosens and causes granule and should not bond agglomerating, palm does not have that fine powder adheres to yet or should pulverize immediately when being twined with forefinger and thumb granule, the free from dampness sense) granulate, pack.
The glucosamine hydrochloride capsule of the method preparation of embodiment 4 usefulness embodiment 1 has carried out confirming the experiment of stability, experimental result is as follows: (annotate: the time in the table all is unit with the sky except that having indicated) (one) strong illumination test: the preliminarily stabilised result of the test of table 1 glucosamine hydrochloride capsule after the strong illumination test
| Time | Lot number | Outward appearance, character | Related substance | Weightening finish % | Indicate content % | Average dissolution % ± SD |
| 0 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | | 99.06 96.53 97.57 | 92.93±2.36 92.09±1.72 93.13±3.01 |
| 1 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 1.3 1.3 -0.6 | 98.97 100.6 96.11 | 94.83±2.95 96.11±3.59 93.30±1.39 |
| 3 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 1.0 1.4 -0.4 | 98.82 95.97 97.48 | 95.86±3.68 92.88±4.24 94.59±1.72 |
| 5 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 0.8 -0.2 -3.4 | 96.41 97.67 96.24 | 98.94±1.80 97.60±1.43 95.67±2.58 |
| 10 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 1.2 2.2 0.2 | 96.77 98.46 100.7 | 98.72±3.57 101.0±1.76 97.50±1.80 |
Above results suggest glucosamine hydrochloride capsule is stable to light, and medicament contg is constant substantially, and just because air humidity is omited the suction weightening finish, its weightening finish % changes with air humidity varies.The sealing of suggestion this product is preserved.(2) glucosamine hydrochloride capsule hot test table 2, the 3, the 4th, the preliminarily stabilised result of the test after 40,60,80 ℃ of tests of glucosamine hydrochloride capsule.Table 2 glucosamine hydrochloride capsule is placed result of the test for 40 ℃
| Time | Lot number | Outward appearance, character | Related substance | Weightening finish % | Indicate content % | Average dissolution ± SD |
| 0 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | | 99.06 96.53 97.57 | 92.93±2.36 92.09±1.72 93.13±3.01 |
| 1 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -1.2 -0.7 -1.5 | 97.48 102.9 98.46 | 96.24±2.24 97.73±2.58 95.11±2.04 |
| 3 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -0.1 1.2 -0.8 | 99.62 102.1 97.29 | 98.38±3.68 94.88±1.24 98.00±3.89 |
| 5 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -2.6 -1.8 -2.4 | 96.68 100.4 101.3 | 95.70±2.36 95.86±1.35 96.19±1.63 |
| 10 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -2.5 -2.2 -2.5 | 101.9 100.9 102.6 | 94.58±2.62 97.84±1.93 98.49±1.94 |
Table 3 glucosamine hydrochloride capsule is placed result of the test for 60 ℃
| Time | Lot number | Outward appearance, character | Related substance | Weightening finish % | Indicate content % | Average dissolution ± SD |
| 0 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | | 99.06 96.53 97.57 | 92.93±2.36 92.09±1.72 93.13±3.01 |
| 1 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -1.1 -1.0 -1.6 | 104.2 96.68 98.36 | 95.76±2.27 95.74±1.44 96.43±2.05 |
| 3 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -2.4 -1.8 -2.2 | 95.64 ?98.49 103.0 | 98.74±1.67 94.93±1.10 95.66±2.04 |
| 5 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -3.8 -4.2 -3.9 | 100.9 103.5 102.2 | 96.81±3.63 94.36±3.93 96.54±3.50 |
| 10 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -3.9 -4.0 -4.2 | 100.3 98.04 102.1 | 96.08±1.38 96.94±2.15 96.96±1.86 |
Table 4 glucosamine hydrochloride capsule is placed result of the test for 80 ℃
| Time | Lot number | Outward appearance, character | Related substance | Weightening finish % | Indicate content % | Average dissolution ± SD |
| 0 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | | 99.06 96.53 97.57 | 92.93±2.36 92.09±1.72 93.13±3.01 |
| 1 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -2.4 -2.7 -2.0 | 95.78 100.2 100.2 | 94.14±3.27 93.47±4.41 96.97±2.68 |
| 3 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -4.7 -4.7 -4.2 | 96.90 95.47 93.18 | 101.9±3.56 97.68±3.48 99.36±4.03 |
| 5 | ?98090901 ?98090902 ?98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -5.0 -3.7 -4.2 | ?98.24 ?95.79 ?97.46 | 94.74±3.10 93.11±3.00 94.94±3.30 |
| 10 | ?98090901 ?98090902 ?98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -4.3 -4.7 -5.8 | ?101.9 ?98.43 ?102.3 | 93.58±1.34 98.90±1.58 98.32±2.11 |
The explanation of above-mentioned result of the test, this product is being removed under the outer package condition, and 40 ℃, 60 ℃ and 80 ℃ when being heated, because temperature is higher, the very fast dehydration loss of weight of capsule is obvious.All other indexs do not have significant change.The storage of should being Protected from Heat of this investigation results suggest, this product.(3) high humility test: table 5,6 is respectively the steadiness that the glucosamine hydrochloride capsule is placed in room temperature in the environment of relative humidity 75%, 92.5%.Table 5 glucosamine hydrochloride capsule RH75%, room temperature are placed result of the test
| Time | Lot number | Outward appearance, character | Related substance | Weightening finish % | Indicate content % | Average dissolution ± SD |
| 0 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | | 99.06 96.53 97.57 | 92.93±2.36 92.09±1.72 93.13±3.01 |
| 1 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 0.3 0.3 0.8 | 98.04 100.3 102.8 | 97.20±1.83 96.18±1.31 95.11±3.48 |
| 3 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 1.0 1.9 1.5 | 99.27 95.47 93.18 | 99.00±4.77 97.61±5.44 98.59±4.35 |
| 5 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 1.0 1.9 1.2 | 98.92 101.3 99.48 | 95.61±2.22 93.51±1.74 94.61±1.91 |
| 10 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 2.2 3.2 2.7 | 102.1 96.72 101.9 | 96.77±1.49 96.82±1.12 95.57±1.26 |
Table 6 glucosamine hydrochloride capsule RH92.5%, room temperature are placed result of the test
| Time | Lot number | Outward appearance, character | Related substance | Weightening finish % | Indicate content % | Average dissolution ± SD |
| 0 | ?98090901 ?98090902 ?98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | | 99.06 96.53 97.57 | 92.93±2.36 92.09±1.72 93.13±3.01 |
| 1 | ?98090901 ?98090902 ?98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 0.6 0.7 0.5 | 97.66 98.24 102.1 | 97.31±1.44 97.01±2.15 95.57±1.69 |
| 3 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 1.5 1.0 1.8 | 100.8 97.19 ?99.38 | 99.91±3.67 98.41±3.63 99.30±3.44 |
| 5 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 2.5 2.4 2.9 | 98.90 100.1 98.20 | 94.54±1.93 93.75±1.83 94.15±1.80 |
| 10 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 3.2 4.1 6.6 | 101.5 99.86 96.22 | 97.90±1.86 96.88±1.45 96.82±2.18 |
Above presentation of results is removed the packing sample and is absorbed water under high humidity, deliquescing and inter-adhesive phenomenon occur.This product must be kept away wet the storage.(4) expose air test: table 7 is put airborne result of the test for the glucosamine hydrochloride capsule reveals.Table 7 glucosamine hydrochloride capsule exposes the air test result
| Time | Lot number | Outward appearance, character | Related substance | Weightening finish % | Indicate content % | Average dissolution ± SD |
| 0 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | | 99.06 96.53 97.57 | 92.93±2.36 92.09±1.72 93.13±3.01 |
| 1 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 0.9 1.9 2.0 | 99.07 99.98 102.1 | 9514±2.12 95.74±2.65 93.69±3.22 |
| 3 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 0.9 1.7 1.8 | 98.82 95.97 97.48 | 100.5±1.73 100.1±3.44 97.32±4.29 |
| 5 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 1.3 2.7 1.1 | 98.84 100.4 99.23 | 99.76±2.22 96.36±2.05 98.11±2.02 |
| 10 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -0.3 -2.0 -1.2 | 98.98 96.41 102.6 | 100.9±1.36 100.3±1.50 100.8±2.59 |
Presentation of results, glucosamine hydrochloride capsule are removed the packing sample and were placed in air 10 days, and every index does not have significant change.(5) accelerated test: table 8 is for placing trimestral stability result down relative humidity 75%, 40 ℃ under the glucosamine hydrochloride capsule simulation listing terms of packing, no matter be that outward appearance (color and luster, character), content have no significant change, chromatograph is checked three month and was not relatively had significant change on the 0th day, with reference to pertinent regulations, the useful life that can fix tentatively this product is 2 years.Place trimestral stability result down for 75%/40 ℃ at relative humidity under the table 8 glucosamine hydrochloride capsule simulation listing terms of packing
| Moon time | Lot number | Outward appearance, character | Related substance | Weightening finish % | Content is equivalent to labelled amount % | Average dissolution ± SD |
| 0 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | | 99.06 96.53 97.57 | 92.93±2.36 92.09±1.72 93.13±3.01 |
| 1 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 0.5 -0.3 0.2 | 100.3 100.2 99.36 | 97.70±1.00 96.94±1.64 98.12±2.04 |
| 2 | 98090901 98090902 98090903 | Rubber deliquescing content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 0.9 0.8 1.2 | 98.65 101.3 100.5 | 95.67±1.29 97.44±1.96 96.62±2.38 |
| 3 | 98090901 98090902 98090903 | Rubber deliquescing content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -1.0 -0.6 1.0 | 101.3 102.6 99.87 | 97.52±1.79 96.82±2.39 96.53±1.48 |
(6) room temperature reserved sample observing: table 9 is room temperature reserved sample observing result under the glucosamine hydrochloride capsule simulation listing terms of packing, because time restriction, has finished 12 months investigate at present, further observes still underway.Room temperature reserved sample observing result under the aluminum-plastic packaged condition of table 9 glucosamine hydrochloride capsule
| Moon time | Lot number | Outward appearance, character | Related substance | Weightening finish % | Content is equivalent to labelled amount % | Average dissolution ± SD |
| 0 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | | 99.06 ?96.53 ?97.57 | 92.93±2.36 92.09±1.72 93.13±3.01 |
| 1 | 98090901 98090902 98090903 | The red capsule content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | -0.5 -0.9 1.0 | 99.41 101.2 ?99.88 | 97.90±1.32 96.73±1.63 96.06±2.15 |
| 3 | 98090901 98090902 98090903 | Rubber deliquescing content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 0.8 0.1 0.9 | 100.5 101.6 101.4 | 96.45±1.33 96.67±1.85 96.44±2.03 |
| | 98090901 | The rubber deliquescing | Do not see the impurity speckle | 0.2 | 100.3 | 96.61±2.94 |
| 6 | 98090902 98090903 | Content is a white powder | Do not see that the impurity speckle do not see the impurity speckle | -0.4 0.1 | 99.88 98.12 | 95.25±1.67 96.77±2.74 |
| 12 | 98090901 98090902 98090903 | Rubber deliquescing content is a white powder | Do not see that the impurity speckle do not see that the impurity speckle do not see the impurity speckle | 0.1 0.5 0.3 | 100.4 99.45 98.77 | 97.23±1.92 97.19±2.67 97.09±2.29 |
Three lot number samples, the simulation listing is packed shading at room temperature and was stored 12 months, and the result shows that significant change does not take place every index, and prompting this product seals placement at ambient temperature, and the useful life was at least 12 months.