CN102525888A - Ferrous sulfate sustained release gel, preparation method thereof and application of ferrous sulfate sustained release gel to preparation of spleen-invigorating blood-enriching granules - Google Patents
Ferrous sulfate sustained release gel, preparation method thereof and application of ferrous sulfate sustained release gel to preparation of spleen-invigorating blood-enriching granules Download PDFInfo
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Abstract
The invention discloses a ferrous sulfate sustained release gel. The gel consists of ferrous sulfate, sodium alginate and vitamin C in a mass ratio of 1:(0.1-2):(0.002-0.1). The invention also discloses a preparation method for the ferrous sulfate sustained release gel and application of the ferrous sulfate sustained release gel to the preparation of spleen-invigorating blood-enriching granules. The release rate of ferrous iron in the ferrous sulfate sustained release gel in hot water is low, so the probability that Fe<2+> and teeth are subjected to side reaction when a ferrous sulfate preparation is orally taken is reduced, the rust smell is covered, and the administration compliance is improved; and meanwhile, the ferrous sulfate sustained release gel has the advantages of high medicine loading capacity, low production cost and the like, and can be widely applied to ferrous sulfate-containing preparations.
Description
Technical field
The invention belongs to the pharmaceutics field, relate to a kind of sustained-release gel, particularly relate to ferrous sulfate sustained-release gel and preparation method thereof and the application in preparation spleen invigorating blood generation promoting granule.
Background technology
Ferrum element is the indispensable trace element of health, and the content of ferrum element is about 3g～5g in the human body of growing up, and wherein 2/3 concentrates in the hemoglobin.Ferrum is the important composition composition of hemoglobin in the human body, if iron ion lacks and just can make hemoglobin reduction, causes anemia, i.e. iron deficiency anemia, and human beings'health in serious threat.Ferrous sulfate is one of common medicine of treating now iron deficiency anemia, yet, long-term oral ferrous sulfate, Fe
2+Meeting and tooth generation side reaction, the cause teeth blackening has a strong impact on attractive in appearance.And ferrous sulfate has bigger rust flavor, the mouthfeel extreme difference, and the patient is difficult to accept.
Sodium alginate is the cell membrane constituent of Brown algae, has good water-solubility and biocompatibility, is a kind of important natural macromolecule amylose, in medicine, food and day chemical industry, all has extensive use.At present, as the adjuvant commonly used in a kind of medicament, mainly as suspending agent, thickening agent, emulsifying agent, microcapsule capsule material and disintegrating agent etc.Because sodium alginate has good bioadhesive; Form hydrogel easily with the metal ion effect, can prolong drug and time of contact of intestinal mucosa, also help and improve the partial drug level of intestinal; Therefore be suitable as oral slow controlled release carrier (Journal of Controlled Release; 2006,114,1-14).What wherein, research was maximum is the hydrogel of calcium ion and sodium alginate cross-linking.It is generally acknowledged that 2 GG unit form coordination compound, i.e. " Egg-box " structures through 4 coordinate bonds in 1 calcium ion and the sodium alginate molecular structure.
The spleen invigorating blood generation promoting granule is the herbal species that Wuhan JianMin Pharmaceutical Group Co., Ltd produces, and is the granule of being processed by 13 flavor Chinese medicines such as Radix Codonopsis, Poria and ferrous sulfate, and instructions of taking is that warm water is taken after mixing it with water.These article are national essential drugs, OTC medicine, secondary Chinese medicine protection kind, and Chinese Medical Association confirms prevents and treats the anemia drug of first choice, is recorded by teaching materials such as " Pediatrics of Chinese Medicine ".Because the side reaction of ferrous sulfate and rust are distinguished the flavor of, influenced safety and patient's medication compliance of the clinical uses of these article.
Summary of the invention
First purpose of the present invention is in order to overcome the deficiency of prior art, a kind of ferrous sulfate sustained-release gel to be provided, and through ferrous sulfate being combined form hydrogel with sodium alginate, thereby delays Fe
2+Rate of release, reduce side reaction and also cover bad smell.
Second purpose of the present invention provides the method for preparing of ferrous sulfate sustained-release gel.
The 3rd purpose of the present invention provided the application of ferrous sulfate sustained-release gel in preparation spleen invigorating blood generation promoting granule.
The objective of the invention is to realize through following technical scheme:
A kind of ferrous sulfate sustained-release gel is characterized in that being made up of ferrous sulfate, sodium alginate and vitamin C, and said ferrous sulfate, sodium alginate and ascorbic mass ratio are 1: 0.1-2: 0.002-0.1.
The preferred ferrous sulfate of the present invention, sodium alginate and ascorbic mass ratio are 1: 0.6-1.2: 0.005-0.01.
Ferrous sulfate, sodium alginate and ascorbic mass ratio that the present invention is best are 1: 0.8: 0.006.
A kind of method for preparing of ferrous sulfate sustained-release gel is characterized in that may further comprise the steps:
(1) takes by weighing ferrous sulfate, sodium alginate and vitamin C by above-mentioned mass ratio;
(2) sodium alginate is soluble in water, process mass concentration and be 0.5～5% sodium alginate soln, ferrous sulfate is soluble in water, process mass concentration and be 1～10% copperas solution;
(3) sodium alginate soln is slowly splashed under stirring condition in the copperas solution, stir and it was fully reacted in 2.5-4.5 hour and generate deposition;
(4) filter, will precipitate and use water washing, refilter, be deposited in 60-100 ℃ of drying down, be ground into fine powder.
The present invention is preferably soluble in water with sodium alginate in the step (2), processes mass concentration and be 3% sodium alginate soln, and ferrous sulfate is soluble in water, processes mass concentration and be 5% copperas solution.
Mixing time in the preferred step of the present invention (3) is 3 hours.
The present invention further provides the application of ferrous sulfate sustained-release gel in preparation spleen invigorating blood generation promoting granule.
Beneficial effect of the present invention:
(1) ferrous sulfate sustained-release gel of the present invention, ferrous rate of release in hot water reduces, Fe when effectively having reduced oral Feosol
2+With the probability of tooth generation side reaction, covered the rust flavor simultaneously, improved the compliance of taking medicine.
(2) the present invention effectively reduces ferrous sulfate at the intravital rate of release of people, the discomfort that the rust flavor that has reduced to discharge in the gastrointestinal tract brings human body.
(3) in the process of preparation ferrous sulfate sustained-release gel, added vitamin C, reduced the oxidation of ferrous ion in cross-linking process in the water, improved the drug loading of gel as antioxidant.
(4) method for preparing of the present invention is simple, and is with low cost, effectively reduces the side reaction of the ferrous preparation of sulfur acid, improved the compliance of taking medicine of the ferrous preparation of sulfur acid.
Description of drawings
Fig. 1 shows the influence of the rate of charge of sodium alginate and ferrous sulfate to the hydrogel drug loading.
Fig. 2 shows the influence of crosslinking time to the hydrogel drug loading.
Fig. 3 is the infrared spectrogram of ferrous sulfate sustained-release gel of the present invention.
The specific embodiment
Below in conjunction with specific embodiment and accompanying drawing the present invention is further specified.
Embodiment 1
The Study on Preparation of ferrous sulfate sustained-release gel
1.1 the rate of charge of sodium alginate and ferrous sulfate is to the influence of gel drug loading
Respectively according to sodium alginate: ferrous sulfate=1.2: 1,0.6: 1,0.3: 1 mass ratio prepare the ferrous sulfate sustained-release gel, survey the Fe in the gel
2+Content, the result is as shown in Figure 1: the drug loading of gel reduces along with the increase of rate of charge gradually.When sodium alginate had just joined in the copperas solution, the surface of gel was crosslinked at first, along with rate of charge increases; Be that copperas solution concentration increases, then gel surface is crosslinked rapid more, causes the surface fine and close more; Thereby slow down and stoped the infiltration of iron ion item gel inside; Therefore, then can reduce at internally crosslinked iron ion of unit interval, drug loading reduces.
1.2 crosslinking time is to the influence of gel drug loading
The result is as shown in Figure 2: along with the prolongation of crosslinking time, the drug loading of hydrogel increases earlier, after slightly reduce, be to locate in 3 hours in the response time, drug loading is maximum.Crosslinked initialization phase, iron ion is along with crosslinking time prolongs gradually and sodium alginate cross-linking, and drug loading increases.Yet in the preparation process of gel, the ferrous meeting of part is oxidized to ferric ion, and along with the prolongation of crosslinking time, oxidized iron ion can increase.Because carboxyl is more than ferrous in the bonded sodium alginate molecular structure of ferric ion; Be the unit mass sodium alginate can maximum bonded ferric ions be less than ferrous, so, prolong crosslinking time; The bonded ferric ion of sodium alginate increases, and then total iron ion content can reduce.
1.3 the assay method of drug loading
Adopt soak with hydrochloric acid and ultransonic method to measure.Take by weighing a certain amount of medicine carrying gel, it earlier with behind the soak with hydrochloric acid certain hour, is carried out supersound process again, destroy the interaction between iron ion and the sodium alginate fully, cause iron ion to discharge fully through strong acid and ultransonic effect.The content of iron ion adopts first derivative method and standard curve method to measure respectively.
The assay method of iron ion content is:
(1) preparation of reference substance solution: get ferrous sulfate (FeSO
4) the about 50mg of reference substance, accurate claim surely, place the 100ml volumetric flask, add dilute sulfuric acid 5ml, shake up, add sulfuric acid solution (3-1000) again and dissolve and be diluted to scale, shake up, promptly get the ferrous (FeSO of sulfur acid among every 1ml
4) reference substance solution of 0.5mg.
(2) preparation of need testing solution: get the gel under these article content uniformity item, porphyrize, precision takes by weighing in right amount and [is equivalent to ferrous sulfate (FeSO approximately
4) 50mg], place the 100ml volumetric flask, process need testing solution by the method for preparing under the item of reference substance solution.
(3) algoscopy: precision takes by weighing reference substance solution and each 2ml of need testing solution, places the 50ml volumetric flask respectively, adds 4% Potassium Hydrogen Phthalate solution 10ml and 0.3% orthophenanthroline solution (is got orthophenanthroline 0.3g; Add dilute sulfuric acid 2ml; Add water again and make and be dissolved into 100ml, shake up, promptly get) 20ml; Thin up shakes up to scale.According to spectrophotography (appendix VA of Chinese Pharmacopoeia version in 2005) test, in wavelength is 600～400nm scope, record the first derivative amplitude respectively, adopt peak-paddy method to calculate, promptly get.
Standard curve method is: in 6 25mL volumetric flasks, add 0.00,0.10,0.20,0.30,0.40 respectively with pipette, 0.50mL ferrum standard solution (iron content 0.1gL
-1), add 1mL100gL respectively
-1Oxammonium hydrochloride. solution shakes up the back and places 2min, respectively adds 1mL1.5gL again
-1Orthophenanthroline solution, 2.5mL1.0molL
-1Sodium acetate solution is diluted to scale with water, shakes up.With the blank reagent solution is reference, under the 510nm wavelength of setting, measures each development criteria solution absorbency.Concentration with ferrum is abscissa, and corresponding absorbance is a vertical coordinate, the drawing standard curve.
Drug loading calculates by formula 1:
A kind of ferrous sulfate sustained-release gel is made up of ferrous sulfate, sodium alginate and vitamin C, and said ferrous sulfate, sodium alginate and ascorbic mass ratio are 1: 0.8: 0.006.
Method for preparing is:
(1) takes by weighing ferrous sulfate 10g, sodium alginate 8g, vitamin C 0.06g;
(2) sodium alginate is soluble in water, process mass concentration and be 3% sodium alginate soln, ferrous sulfate and vitamin C is soluble in water, process mass concentration and be 5% copperas solution;
(3) sodium alginate soln is slowly splashed under stirring condition in the copperas solution, stir and it was fully reacted in 3 hours and generate deposition;
(4) filter, will precipitate and use water washing, refilter, be deposited in 60-100 ℃ of drying down, be ground into fine powder.
Table 3
Can find out from table 3, ferrous sulfate is processed gel after, ferrous in hot water 5 minutes cumulative release 0.59% only, generally speaking, medicine can not be detained in the oral cavity 5 minutes during oral Feosol, so little release degree effectively reduces Fe
2+With the probability of tooth generation side reaction, covered the rust flavor simultaneously.It can also be seen that from last table; Ferrously in the simulation simulated gastric fluid, just discharged 50.68% in 125 minutes; And in the simulation simulated intestinal fluid, just discharged 51.46% in 245 minutes; It is thus clear that the present invention effectively reduces ferrous sulfate at the intravital rate of release of people, the discomfort that the rust flavor that has reduced to discharge in the gastrointestinal tract brings human body.
A kind of ferrous sulfate sustained-release gel is made up of ferrous sulfate, sodium alginate and vitamin C, and said ferrous sulfate, sodium alginate and ascorbic mass ratio are 1: 0.1: 0.002.
Method for preparing is:
(1) takes by weighing ferrous sulfate 10g, sodium alginate 1g, vitamin C 0.02g;
(2) sodium alginate is soluble in water, process mass concentration and be 0.5% sodium alginate soln, ferrous sulfate and vitamin C is soluble in water, process mass concentration and be 1% copperas solution;
(3) sodium alginate soln is slowly splashed under stirring condition in the copperas solution, stir and it was fully reacted in 2.5 hours and generate deposition;
(4) filter, will precipitate and use water washing, refilter, be deposited in 60-100 ℃ of drying down, be ground into fine powder.
A kind of ferrous sulfate sustained-release gel is made up of ferrous sulfate, sodium alginate and vitamin C, and said ferrous sulfate, sodium alginate and ascorbic mass ratio are 1: 2: 0.1.
Method for preparing is:
(1) takes by weighing ferrous sulfate 10g, sodium alginate 20g, vitamin C 1g;
(2) sodium alginate is soluble in water, process mass concentration and be 5% sodium alginate soln, ferrous sulfate and vitamin C is soluble in water, process mass concentration and be 10% copperas solution;
(3) sodium alginate soln is slowly splashed under stirring condition in the copperas solution, stir and it was fully reacted in 4.5 hours and generate deposition;
(4) filter, will precipitate and use water washing, refilter, be deposited in 60-100 ℃ of drying down, be ground into fine powder.
A kind of ferrous sulfate sustained-release gel is made up of ferrous sulfate, sodium alginate and vitamin C, and said ferrous sulfate, sodium alginate and ascorbic mass ratio are 1: 0.6: 0.005.
Method for preparing is:
(1) takes by weighing ferrous sulfate 10g, sodium alginate 6g, vitamin C 0.05g;
(2) sodium alginate is soluble in water, process mass concentration and be 1% sodium alginate soln, ferrous sulfate and vitamin C is soluble in water, process mass concentration and be 5% copperas solution;
(3) sodium alginate soln is slowly splashed under stirring condition in the copperas solution, stir and it was fully reacted in 4 hours and generate deposition;
(4) filter, will precipitate and use water washing, refilter, be deposited in 60-100 ℃ of drying down, be ground into fine powder.
Embodiment 6
A kind of ferrous sulfate sustained-release gel is made up of ferrous sulfate, sodium alginate and vitamin C, and said ferrous sulfate, sodium alginate and ascorbic mass ratio are 1: 1.2: 0.01.
Method for preparing is:
(1) takes by weighing ferrous sulfate 10g, sodium alginate 12g, vitamin C 0.1g;
(2) sodium alginate is soluble in water, process mass concentration and be 1% sodium alginate soln, ferrous sulfate and vitamin C is soluble in water, process mass concentration and be 5% copperas solution;
(3) sodium alginate soln is slowly splashed under stirring condition in the copperas solution, stir and it was fully reacted in 4 hours and generate deposition;
(4) filter, will precipitate and use water washing, refilter, be deposited in 60-100 ℃ of drying down, be ground into fine powder.
Ferrous sulfate sustained-release gel to embodiment 2-6 carries out infrared spectrum measurement, and it is as shown in Figure 3 to measure the result.The result shows: in the infrared spectrum of sodium alginate, the absworption peak at about 1600cm-1 and 1410cm-1 place belongs to respectively-and antisymmetric stretching vibration and the symmetrical stretching vibration of COO-, the broad peak at 3400cm-1 place belongs to the hydroxyl absworption peak of sodium alginate.And in the infrared spectrum of hydrogel, the antisymmetric stretching vibration of-COO-and symmetrical stretching vibration absworption peak have taken place respectively to move, and show between carboxyl and the iron ion in the sodium alginate interaction has taken place.-CH2 obviously weakens in the absworption peak at 2920cm-1 place, and this is because cross-linked structure makes the vibration of group be suppressed.To sum up visible, among the embodiment 2-6, ferrous sulfate and sodium alginate are all through having formed cross-linked structure with ionization.
Embodiment 7
The application of ferrous sulfate sustained-release gel in preparation spleen invigorating blood generation promoting granule.
7.1 the prescription of spleen invigorating blood generation promoting granule
7.2 the method for preparing of spleen invigorating blood generation promoting granule
(1) above 14 flavors, except that sulphuric acid is ferrous, Os Draconis, Concha Ostreae, Carapax Et Plastrum Testudinis, Endothelium Corneum Gigeriae Galli decocte with water secondary, each 4 hours, collecting decoction filtered, and filtrating is left standstill, and it is subsequent use to get supernatant; Nine flavors such as all the other Radixs Astragali, decocte with water three times, each 2 hours, collecting decoction filtered, and filtrating is left standstill, and gets supernatant and above-mentioned subsequent use supernatant merging, filters, and filtrating is concentrated into the clear paste that relative density is 1.30 (55～65 ℃), and is subsequent use.
(2) take by weighing ferrous sulfate 20g, sodium alginate 16g, vitamin C 0.12g, sodium alginate is soluble in water, process mass concentration and be 3% sodium alginate soln; Ferrous sulfate and vitamin C is soluble in water, process mass concentration and be 5% copperas solution, under stirring condition, slowly splash in the copperas solution sodium alginate soln; Stir and it was fully reacted in 3 hours and generate deposition, filter, will precipitate and use water washing; Refilter; Be deposited in 60-100 ℃ of drying down, be ground into fine powder, subsequent use.
(3) get above-mentioned clear paste and fine powder, add an amount of cane sugar powder, mixing is processed granule, promptly gets.
The instructions of taking of these article is: takes after mixing it with hot water after meal, and one-year-old with interior one time 2.5 gram, one to three years old one time 5 gram; Three to five years old one time 7.5 gram; Five to 12 years old one time 10 gram; One time 15 gram of being grown up; 3 times on the one or follow the doctor's advice is a course of treatment all around.These article are owing to used ferrous sulfate sustained-release gel of the present invention, and ferrous release in hot water significantly reduces, and has reduced Fe
2+With the probability of tooth generation side reaction, covered the rust flavor simultaneously, and the rust that has reduced to discharge in gastrointestinal tract flavor discomfort that human body is brought.
Claims (7)
1. a ferrous sulfate sustained-release gel is characterized in that being made up of ferrous sulfate, sodium alginate and vitamin C, and said ferrous sulfate, sodium alginate and ascorbic mass ratio are 1: 0.1-2: 0.002-0.1.
2. ferrous sulfate sustained-release gel as claimed in claim 1 is characterized in that said ferrous sulfate, sodium alginate and ascorbic mass ratio are 1: 0.6-1.2: 0.005-0.01.
3. ferrous sulfate sustained-release gel as claimed in claim 1 is characterized in that said ferrous sulfate, sodium alginate and ascorbic mass ratio are 1: 0.8: 0.006.
4. like the method for preparing of any one described ferrous sulfate sustained-release gel of claim 1-3, it is characterized in that may further comprise the steps:
(1) takes by weighing ferrous sulfate, sodium alginate and vitamin C by said mass ratio;
(2) sodium alginate is soluble in water, process mass concentration and be 0.5～5% sodium alginate soln, ferrous sulfate and vitamin C is soluble in water, process mass concentration and be 1～10% copperas solution;
(3) sodium alginate soln is slowly splashed under stirring condition in the copperas solution, stir and it was fully reacted in 2.5-4.5 hour and generate deposition;
(4) filter, will precipitate and use water washing, refilter, be deposited in 60-100 ℃ of drying down, be ground into fine powder.
5. the method for preparing of ferrous sulfate sustained-release gel as claimed in claim 4; It is characterized in that in the step (2) sodium alginate is soluble in water; Process mass concentration and be 3% sodium alginate soln, ferrous sulfate and vitamin C is soluble in water, process mass concentration and be 5% copperas solution.
6. the method for preparing of ferrous sulfate sustained-release gel as claimed in claim 4 is characterized in that mixing time is 3 hours described in the step (3).
7. the application of ferrous sulfate sustained-release gel in preparation spleen invigorating blood generation promoting granule.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107467672A (en) * | 2017-06-27 | 2017-12-15 | 福格森（武汉）生物科技股份有限公司 | A kind of preparation method of ferrous composite gel microsphere |
| CN112891314A (en) * | 2021-01-27 | 2021-06-04 | 陕西思瑰瑞食品科技有限公司 | Vitamin C and ferrous sulfate sustained and controlled release tablet and preparation method thereof |
| CN114027507A (en) * | 2021-11-18 | 2022-02-11 | 中国农业大学 | Oral gel iron supplement and preparation method thereof |
| CN114796266A (en) * | 2022-04-25 | 2022-07-29 | 陕西科技大学 | Application of ferrous ions in preparation of product for treating bacterial infection |
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| CN1686244A (en) * | 2005-04-13 | 2005-10-26 | 刘进波 | Preparation method of child blood generating gel |
| CN1771930A (en) * | 2005-10-19 | 2006-05-17 | 浙江杭康海洋生物药业有限公司 | Externally applied compound amino acid prepn for promoting wound healing and its prepn and application |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686244A (en) * | 2005-04-13 | 2005-10-26 | 刘进波 | Preparation method of child blood generating gel |
| CN1771930A (en) * | 2005-10-19 | 2006-05-17 | 浙江杭康海洋生物药业有限公司 | Externally applied compound amino acid prepn for promoting wound healing and its prepn and application |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107467672A (en) * | 2017-06-27 | 2017-12-15 | 福格森（武汉）生物科技股份有限公司 | A kind of preparation method of ferrous composite gel microsphere |
| CN107467672B (en) * | 2017-06-27 | 2020-11-13 | 福格森（武汉）生物科技股份有限公司 | Preparation method of ferrous composite gel microspheres |
| CN112891314A (en) * | 2021-01-27 | 2021-06-04 | 陕西思瑰瑞食品科技有限公司 | Vitamin C and ferrous sulfate sustained and controlled release tablet and preparation method thereof |
| CN114027507A (en) * | 2021-11-18 | 2022-02-11 | 中国农业大学 | Oral gel iron supplement and preparation method thereof |
| CN114796266A (en) * | 2022-04-25 | 2022-07-29 | 陕西科技大学 | Application of ferrous ions in preparation of product for treating bacterial infection |
| US20230338418A1 (en) * | 2022-04-25 | 2023-10-26 | Shaanxi University Of Science & Technology | Application of a hydrogel in the preparation of products for the treatment of bacterial infections |
| US11957712B2 (en) | 2022-04-25 | 2024-04-16 | Shaanxi University Of Science & Technology | Application of a hydrogel in the preparation of products for the treatment of bacterial infections |
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Address after: 430052, 484 parrot Avenue, Hanyang District, Hubei, Wuhan Patentee after: JIANMIN PHARMACEUTICAL GROUPS CORP., LTD. Address before: 430052, 484 parrot Avenue, Hanyang District, Hubei, Wuhan Patentee before: Wuhan Jianmin Pharmaceutical Group Co., Ltd. |