本文選題：克咳口服液 + 制備工藝�。� 參考：《北京中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】："克咳口服液"是針對貴州益佰制藥股份有限公司已經(jīng)上市產(chǎn)品"克咳膠囊"進(jìn)行二次開發(fā)的品種。具有止咳、定喘、祛痰的功效,在治療各種咳嗽、急慢性支氣管炎、支氣管哮喘、老年咳喘具有顯著療效。適用于上呼吸道感染引起的咳嗽、支氣管哮喘、急慢性支氣管炎、咽喉炎、抽煙過量引起的咳嗽、老年咳喘等癥狀,對急癥重病、頑固頻繁咳嗽尤為適用。膠囊劑型雖然有其服用量小,便于攜帶,能掩飾不良?xì)馕兜葍?yōu)點(diǎn),可是對于食道較狹小、胃腸道功能較弱的兒童和老人而言,有服用不便、療效發(fā)揮較慢等缺點(diǎn)。于是在療效不變的基礎(chǔ)上,對原處方進(jìn)行了二次開發(fā),根據(jù)處方中各藥的理化性質(zhì)和企業(yè)生產(chǎn)條件,對克咳口服液的制備工藝進(jìn)行了研究,并基于中試產(chǎn)品對其質(zhì)量標(biāo)準(zhǔn)進(jìn)行了初步研究。在制備工藝方面,以麻黃中的鹽酸麻黃堿、罌粟殼中的嗎啡,甘草中的甘草酸等指標(biāo)性成分與出膏率相結(jié)合,采用正交實(shí)驗(yàn)法,對處方中罌粟殼、麻黃,甘草、萊菔子、桔梗、石膏、苦杏仁的提取工藝分別進(jìn)行了考察最終獲得最優(yōu)提取工藝為:罌粟殼粉碎成粗顆粒,麻黃切段,加入10倍量的酸性水溶液(用10%鹽酸溶液調(diào)pH值至3左右)浸泡1.5小時(shí)后,煎煮兩次,每次煎煮1.5小時(shí)�？嘈尤手兴目嘈尤饰羲馍傻臍淝杷�,具有止咳平喘作用,但苦杏仁苷易被本身所含的苦杏仁酶分解,在煎煮之前蒸30分鐘的方法,最方便實(shí)用、而且滅酶效果較好。傳統(tǒng)的石膏煎煮方法為先煎,據(jù)資料考證石膏先煎并不科學(xué),因?yàn)榧逯髸r(shí)間的長短并不能影響石膏的溶度積,煎煮時(shí)間過長,石膏會(huì)糊于其他藥材表面,影響其他成分溶出,故采用石膏用300目的濾布包裹與其它藥材合煎的方法。以甘草酸含量、出膏率為指標(biāo)考察甘草等藥材的最佳提取方法為:甘草、桔梗切片與萊菔子、石膏一起加8倍量水浸泡1.5小時(shí),苦杏仁蒸30分鐘后,與上述浸泡好的藥材再加水至10倍量,煎煮兩次,每次1.5小時(shí)�？疾炝舜汲凉に嚄l件,其最佳條件為:藥液混合,于60～70℃減壓濃縮至相對密度為1.10(60℃測),放冷,加乙醇至含醇量為60%,靜置18小時(shí),濾過。濾液回收乙醇后,加入蒸餾水,產(chǎn)生大量的沉淀,經(jīng)多次過濾,所得口服液依然不澄明,于是采用水沉法,并考察了水沉條件,結(jié)果最佳條件為:濾液回收乙醇,繼續(xù)濃縮至相對密度為1.25(60℃測)的稠膏,加水至總量的60%,(4℃～8℃)冷藏72h,濾過。所得口服液較澄明,久置有輕搖即散沉淀。對所加入的輔料及用量進(jìn)行了考察,確定含糖量為20%,防腐劑為苯甲酸鈉加入的量為0.3%�？诜旱膒H是影響其穩(wěn)定性的一個(gè)重要因素,當(dāng)pH在4.50～5.50之間時(shí),口服液相對穩(wěn)定。最終確定了 "克咳口服液"的工藝參數(shù),該方法方便、穩(wěn)定、可行。在上述研究基礎(chǔ)上,進(jìn)行了三批中試放大研究,實(shí)驗(yàn)結(jié)果顯示,工藝穩(wěn)定可行。在質(zhì)量標(biāo)準(zhǔn)研究方面,課題建立了口服液中麻黃、罌粟殼、甘草的薄層鑒別方法和鹽酸麻黃堿和嗎啡的HPLC檢測方法,參照《中國藥典》2010版制劑通則合劑項(xiàng)下規(guī)定建立了"克咳口服液"質(zhì)量標(biāo)準(zhǔn)草案。綜上所述,課題成功制備了"克咳口服液",并對其質(zhì)量標(biāo)準(zhǔn)進(jìn)行了初步研究。研制成為口服液,為該癥患者帶來了新的用藥選擇,為推廣長期臨床用藥提供了科學(xué)依據(jù),為下一步產(chǎn)品的申報(bào)奠定了基礎(chǔ)。
[Abstract]:"Kusk oral liquid" is the two development of the "Keke capsule", which has been listed in the Limited by Share Ltd Limited by Share Ltd. It has the efficacy of relieving cough, asthma and expectorant. It is effective in treating various cough, acute and chronic bronchitis, bronchial asthma and senile cough and asthma. It is suitable for cough and bronchitis caused by upper respiratory tract infection. Guan Xiaochuan, acute and chronic bronchitis, pharyngitis, smoking excessive cough, senile cough, asthma and other symptoms, especially for acute severe disease, stubborn and frequent coughing. Although the capsule dosage form has its advantages of small dosage, easy to carry, can mask bad odor, but for children and elderly people with a smaller diet, weak gastrointestinal function, and the elderly, there are On the basis of the constant curative effect, the original prescription was developed for two times. Based on the physicochemical properties and production conditions of each prescription, the preparation technology of kought oral liquid was studied. Based on the pilot product, the quality standard was preliminarily studied. With ephedrine hydrochloride, morphine in the poppy shell and glycyrrhizic acid in licorice, the extraction technology of Papaver shell, ephedra, licorice, radish, Platycodon, plaster and bitter almond was finally obtained by orthogonal experiment. The optimum extraction technology was obtained, which was the crushing of poppy shell into coarse grain. Grain, ephedra cut section, add 10 times the amount of acid water solution (with 10% hydrochloric acid solution pH value to about 3) soak for 1.5 hours, decoct two times and decoct for 1.5 hours each time. The bitter almond in bitter almond is hydrolyzed with hydrocyanic acid, which has antitussive and antiasthmatic action, but bitter amygdalin is easily decomposed by its own bitter almond enzyme and steamed 30 before decocting. The method of minute is most convenient and practical, and the effect of enzyme extinguishing is better. The traditional method of plaster decocting is first decocted. According to the data, it is not scientific to decoct the gypsum first, because the length of the decocting time can not affect the solubility product of the gypsum, the time of decocting is too long. The gypsum will paste on the other medicinal materials and influence other ingredients to dissolve, so 300 orders of gypsum are used. The best extraction methods of Radix Glycyrrhizae, including glycyrrhizic acid content and extract rate, are as follows: Glycyrrhiza, Platycodon grandiflorum sliced with Raphani, gypsum with 8 times the water for 1.5 hours, after 30 minutes of bitter almond steaming, and then 10 times of water, two times and 1.5 small decocts. The optimum conditions of alcohol precipitation were investigated. The optimum conditions were as follows: mixture of liquid and liquid, concentrated at 60~70 C to 1.10 (60 degrees C), cooling, adding alcohol to alcohol content 60%, stating for 18 hours, filtration. After the filtrate was reclaimed, distilled water was added to a large amount of precipitation, and the oral liquid was still not clear, and the oral liquid was still not clear. The oral liquid was still not clear, so the oral liquid was still not clear, thereupon the oral solution was still not clear, thereupon the oral liquid was still not clear, thereupon the oral solution was still not clear, thereupon the oral solution was still not clear, thereupon the oral solution was still not clear, thereupon the oral solution was still not clear, thereupon the oral solution was still not clear, thereupon the oral solution was still not clear, thereupon the oral solution is still not clear, thereupon the oral solution is still not clear, thereupon the oral solution is still not clear, thereupon the oral solution is still not clear, thereupon the oral solution is still not clear, thereupon the oral solution is still not The water sedimentation method and the condition of water sedimentation were investigated. The optimum conditions were as follows: the filtrate reclaimed ethanol and continued to concentrate to the thickening ointment with relative density of 1.25 (60 degrees centigrade), adding water to 60% of the total amount, (4 ~ 8 c) refrigerated 72h, filtration. The oral liquid was clear, and the long set was scattered and precipitated. 20%, the amount of antiseptic to sodium benzoate as the amount of pH of 0.3%. oral liquid is an important factor affecting its stability. When pH is between 4.50 and 5.50, oral liquid is relatively stable. Finally, the technological parameters of "kought oral liquid" are determined. This method is convenient, stable and feasible. On the basis of the above study, three batch magnification studies have been carried out. The results showed that the technology was stable and feasible. In the study of quality standards, the TLC identification method of ephedra, Papaver shell, licorice and HPLC method for the detection of ephedrine hydrochloride and morphine in oral liquid were established, and the quality standard of "kought oral liquid" was set up according to the provisions of the general principles of Chinese Pharmacopoeia >2010. The "kought oral liquid" was successfully prepared, and its quality standard was preliminarily studied. It was developed into oral liquid, which brought new choice of drug for the patients, and provided scientific basis for the promotion of long-term clinical medication and laid the foundation for the application of the next product.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：TQ460.6;R286.0

【參考文獻(xiàn)】

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1 周曉玲;高艷;賈秋穎;李q阽，

本文編號：1973340