羥基磷灰石作為吸收劑的研究
發(fā)布時間：2019-03-04 12:56
【摘要】：如果主藥為油性藥物或主藥含揮發(fā)油成分時，此時常常加入一定量的吸收劑以便于壓片成型，提高藥物壓片成型性。吸收劑的用量往往由藥物中油性成分的含量決定，通常吸收劑用量占處方總量的10%。藥典收載的常見吸收劑對油性成分的容納量一般都不大，通常吸收劑的用量占到油性成分含量的三倍甚至更多，對油性藥物特別是主藥含量大的油性藥物的片重會有較大影響，增加病人服用藥物片數(shù)，降低了患者對藥物的順應(yīng)性，不利于藥物的市場發(fā)展。因此，新型高效的吸收劑的開發(fā)對油性藥物片劑的制備是必不可少的一項(xiàng)工作。 羥基磷灰石（Hydroxyapatite，HAP，Ca10（PO4）6(OH)2)是牙齒和骨骼的主要無機(jī)礦物成分，安全無毒，生物相容性高。羥基磷灰石同時系屬多孔性物質(zhì)，能夠吸附吸收油性藥物，使油性藥物進(jìn)入羥基磷灰石的孔道中，較藥典收載的一般的吸收劑相比，，羥基磷灰石對油性藥物的吸收容納性更強(qiáng)，容納量更高。目前，尚未有文獻(xiàn)報(bào)道羥基磷灰石在藥物吸收劑方面的應(yīng)用研究。 本文以液體油性藥物維生素E為模型藥物，研究了羥基磷灰石對油性藥物的吸收容納量及吸收劑性能的影響因素，并以羥基磷灰石為吸收劑制備了維生素E片，同時研究了維生素E片的質(zhì)量標(biāo)準(zhǔn)。實(shí)驗(yàn)結(jié)果表明：羥基磷灰石克服了藥典收載的常規(guī)吸收劑的容納量小的問題，其對油性藥物維生素E的吸收容納量比磷酸氫鈣高3.4倍、比碳酸鈣高2.6倍、比硫酸鈣高2.47倍。比表面積和孔容則可能是影響物質(zhì)吸收性能的因素。羥基磷灰石用作維生素E片的吸收劑時，制粒過程中容易過篩，壓制時不粘沖不裂片，壓出的片劑外觀光潔，顏色均勻，無色差，硬度大，片重差異小且符合藥典片重差異限度，藥片含量均一度也在藥典規(guī)定范圍值內(nèi)。與磷酸氫鈣、碳酸鈣和硫酸鈣等藥典收載的吸收劑相比，羥基磷灰石能更好解決因油性組分存在而引起聚合力差，顆粒松散易碎、顆粒流動性不良，易松片裂片、易粘沖，片子硬度過小、片重差異過大等問題。此外，研究還發(fā)現(xiàn)羥基磷灰石還能增加維生素E片的穩(wěn)定性，加速試驗(yàn)中，羥基磷灰石為吸收劑的維生素E片的保存期比磷酸氫鈣、硫酸鈣和碳酸鈣為吸收劑的維生素E片的保存期延長了1個月，長期試驗(yàn)中羥基磷灰石為吸收劑的維生素E片的保存期比磷酸氫鈣、硫酸鈣和碳酸鈣為吸收劑的維生素E片的保存期延長了3個月。 綜上：羥基磷灰石有望成為新型藥用輔料，為揮發(fā)油及油性藥物提供了一種高效的吸收劑，為吸收劑家族添加了一個新成員，同時擴(kuò)展了羥基磷灰石的應(yīng)用范圍，增加了羥基磷灰石的實(shí)用性。
[Abstract]:If the main drug is an oily drug or the main drug contains volatile oil components, at this time a certain amount of absorbent is often added in order to facilitate the molding of the tablet and improve the formability of the drug tablet. The dosage of the absorbent is usually determined by the content of the oil component in the drug, which usually accounts for 10% of the total prescription. The common absorbents contained in pharmacopoeia generally have little capacity for oil components, usually the amount of absorbents accounts for three times or more of the oil components, and it will have a great impact on the weight of oily drugs, especially those with large contents of main drugs. Increasing the number of drug tablets, reducing the patient's compliance to drugs, is not conducive to the development of the drug market. Therefore, the development of new and efficient absorbents is necessary for the preparation of oily drug tablets. Hydroxyapatite (Hydroxyapatite,HAP,Ca10 (PO4) 6 (OH) 2) is the main inorganic mineral component of teeth and bones. It is safe and non toxic and has high biocompatibility. Hydroxyapatite is also a porous substance, which can adsorb and absorb oil drugs, and make oil drugs into the pores of hydroxyapatite. Compared with the general absorbents contained in Pharmacopoeia, the absorption capacity of hydroxyapatite to oil drugs is stronger than that of the general absorbents contained in Pharmacopoeia. The capacity is higher. At present, the application of hydroxyapatite in drug absorbents has not been reported in literature. In this paper, vitamin E, a liquid oil drug, was used as the model drug to study the influence factors of hydroxyapatite on the absorption capacity and absorbent performance of the oil drug, and the vitamin E tablets were prepared by using hydroxyapatite as the absorbent. At the same time, the quality standard of vitamin E tablets was studied. The results show that hydroxyapatite overcomes the problem of low capacity of conventional absorbents contained in Pharmacopoeia, and its absorption capacity to oil drug vitamin E is 3.4 times higher than that of calcium hydrogen phosphate and 2.6 times higher than that of calcium carbonate, and the absorption capacity of hydroxyapatite is 3.4 times higher than that of calcium hydrogen phosphate and 2.6 times higher than calcium carbonate. It is 2.47 times higher than calcium sulfate. The specific surface area and pore volume may be the factors affecting the absorption performance of the material. When hydroxyapatite is used as absorbent of vitamin E tablets, it is easy to sift in the granulation process, does not stick to impingement and does not crack when pressing, and the tablet has a smooth appearance, uniform color, no color difference and high hardness, and has the advantages of smooth appearance, uniform color and high hardness. The difference of tablet weight is small and accords with the limit of weight difference of Pharmacopoeia tablets, and the contents of tablets are also within the prescribed range of Pharmacopoeia. Compared with the absorbents contained in pharmacopoeia, such as calcium hydrogen phosphate, calcium carbonate and calcium sulfate, hydroxyapatite can better solve the problem of poor coalescence due to the presence of oil components, loose and fragile particles, poor fluidity of particles, easy loosening of fragments, and easy adhesion and erosion. The hardness of the film is too small, and the difference in the weight of the film is too big and so on. In addition, the study also found that hydroxyapatite can also increase the stability of vitamin E tablets, accelerated the test, hydroxyapatite as absorbent vitamin E tablets storage life than calcium hydrogen phosphate, The shelf life of vitamin E tablets with calcium sulfate and calcium carbonate as absorbents was extended by one month. In the long-term test, the retention period of vitamin E tablets with hydroxyapatite as absorbent was higher than that of calcium hydrogen phosphate. The shelf life of vitamin E tablets with calcium sulfate and calcium carbonate as absorbers was extended by 3 months. Above all: hydroxyapatite is expected to become a new type of medicinal adjunct, providing an efficient absorbent for volatile oil and oily drugs, adding a new member to the absorbent family, and expanding the scope of application of hydroxyapatite at the same time. It increases the practicability of hydroxyapatite.
【學(xué)位授予單位】：吉林大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R943
本文編號：2434286
[Abstract]:If the main drug is an oily drug or the main drug contains volatile oil components, at this time a certain amount of absorbent is often added in order to facilitate the molding of the tablet and improve the formability of the drug tablet. The dosage of the absorbent is usually determined by the content of the oil component in the drug, which usually accounts for 10% of the total prescription. The common absorbents contained in pharmacopoeia generally have little capacity for oil components, usually the amount of absorbents accounts for three times or more of the oil components, and it will have a great impact on the weight of oily drugs, especially those with large contents of main drugs. Increasing the number of drug tablets, reducing the patient's compliance to drugs, is not conducive to the development of the drug market. Therefore, the development of new and efficient absorbents is necessary for the preparation of oily drug tablets. Hydroxyapatite (Hydroxyapatite,HAP,Ca10 (PO4) 6 (OH) 2) is the main inorganic mineral component of teeth and bones. It is safe and non toxic and has high biocompatibility. Hydroxyapatite is also a porous substance, which can adsorb and absorb oil drugs, and make oil drugs into the pores of hydroxyapatite. Compared with the general absorbents contained in Pharmacopoeia, the absorption capacity of hydroxyapatite to oil drugs is stronger than that of the general absorbents contained in Pharmacopoeia. The capacity is higher. At present, the application of hydroxyapatite in drug absorbents has not been reported in literature. In this paper, vitamin E, a liquid oil drug, was used as the model drug to study the influence factors of hydroxyapatite on the absorption capacity and absorbent performance of the oil drug, and the vitamin E tablets were prepared by using hydroxyapatite as the absorbent. At the same time, the quality standard of vitamin E tablets was studied. The results show that hydroxyapatite overcomes the problem of low capacity of conventional absorbents contained in Pharmacopoeia, and its absorption capacity to oil drug vitamin E is 3.4 times higher than that of calcium hydrogen phosphate and 2.6 times higher than that of calcium carbonate, and the absorption capacity of hydroxyapatite is 3.4 times higher than that of calcium hydrogen phosphate and 2.6 times higher than calcium carbonate. It is 2.47 times higher than calcium sulfate. The specific surface area and pore volume may be the factors affecting the absorption performance of the material. When hydroxyapatite is used as absorbent of vitamin E tablets, it is easy to sift in the granulation process, does not stick to impingement and does not crack when pressing, and the tablet has a smooth appearance, uniform color, no color difference and high hardness, and has the advantages of smooth appearance, uniform color and high hardness. The difference of tablet weight is small and accords with the limit of weight difference of Pharmacopoeia tablets, and the contents of tablets are also within the prescribed range of Pharmacopoeia. Compared with the absorbents contained in pharmacopoeia, such as calcium hydrogen phosphate, calcium carbonate and calcium sulfate, hydroxyapatite can better solve the problem of poor coalescence due to the presence of oil components, loose and fragile particles, poor fluidity of particles, easy loosening of fragments, and easy adhesion and erosion. The hardness of the film is too small, and the difference in the weight of the film is too big and so on. In addition, the study also found that hydroxyapatite can also increase the stability of vitamin E tablets, accelerated the test, hydroxyapatite as absorbent vitamin E tablets storage life than calcium hydrogen phosphate, The shelf life of vitamin E tablets with calcium sulfate and calcium carbonate as absorbents was extended by one month. In the long-term test, the retention period of vitamin E tablets with hydroxyapatite as absorbent was higher than that of calcium hydrogen phosphate. The shelf life of vitamin E tablets with calcium sulfate and calcium carbonate as absorbers was extended by 3 months. Above all: hydroxyapatite is expected to become a new type of medicinal adjunct, providing an efficient absorbent for volatile oil and oily drugs, adding a new member to the absorbent family, and expanding the scope of application of hydroxyapatite at the same time. It increases the practicability of hydroxyapatite.
【學(xué)位授予單位】：吉林大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R943
【參考文獻(xiàn)】
相關(guān)期刊論文 前10條
1 代晶;朱軍;趙淼;楊萬清;;HPLC法測定維生素E片含量[J];成都醫(yī)學(xué)院學(xué)報(bào);2007年01期
2 林開利;成榮明;常江;;超聲化學(xué)法合成納米羥基磷灰石粉體的研究[J];材料導(dǎo)報(bào);2006年S2期
3 竇妍;李東旭;曹豐;李延報(bào);;聚乙烯吡咯烷酮對羥基磷灰石結(jié)晶和形貌的影響[J];材料導(dǎo)報(bào);2011年20期
4 宋江鳳;劉詠;張瑩;;水熱法合成不同形貌羥基磷灰石[J];粉末冶金材料科學(xué)與工程;2010年05期
5 王海斌;赫淑倩;趙冬梅;孫康寧;劉愛紅;;羧甲基殼聚糖/納米羥基磷灰石復(fù)合支架材料的制備及生物安全性[J];復(fù)合材料學(xué)報(bào);2008年06期
6 汪華明;薛幼江;;羥基磷灰石對水溶液中鋅離子的吸附動力學(xué)研究[J];廣東化工;2011年05期
7 高翔;光善儀;徐洪耀;沈衛(wèi)華;顧莉琴;巨安奇;;聚乙烯醇模板中原位水熱法羥基磷灰石納米顆粒的控制制備及表征[J];功能材料;2009年06期
8 王英,靳正國,華縝,程志捷;超聲處理對羥基磷灰石納米針狀晶形成的影響[J];硅酸鹽通報(bào);2003年06期
9 陳明源,邱莉;水解磷酸氫鈣制備羥基磷灰石粉末的研究——活性生物陶瓷研究之一[J];廣西大學(xué)學(xué)報(bào)(自然科學(xué)版);1999年04期
10 王欣宇,韓穎超,李世普,閆玉華;自燃燒法制備納米羥基磷灰石粉的機(jī)理探討及影響因素[J];硅酸鹽學(xué)報(bào);2002年05期
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