CC BY
20
UDC: 615.12:615.012(669.1) DOI: 10.15587/2313-8416.2016.62439
CONTEMPORARY CHALLENGES OF PHARMACEUTICAL COMPOUNDING IN SOUTHERN NIGERIA: RESULTS OF SURVEY
© D. Alfred-Ugbenbo, O. Zdoryk, V. Georgiyants
In the past decade the pharmacy practice worldwide has witness a trend shift from product-orientation to patient-orientation. This and other reasons encouraged the Nigerian government and its institutions to systematically de-emphasized through its budget, funding for the development of compounding unit.
Aim: The aim of given article was to examine the challenges facing compounding pharmacists in hospital pharmacies, cost estimating of extemporaneous preparations and searching of solutions.
Methods: A closed and open-ended format questionnaire was distributed to 50 compounding pharmacists in Rivers State of Nigeria. The questionnaire comprised of a cover letter and 10 items which cut across personnel training, staffing, premise and equipment, logistics, cost of compounding, national reference standards on compounding, in-pharmacy control.
Results: From the survey results, challenges of compounding pharmacies in southern Nigeria such as inadequate manpower, absence of electronic documentation, facilities and funding; lack of national formulary on extemporaneous formulations and locally conducted stability tests were revealed. Cost of extemporaneous preparations ranged from 1-15 US dollars.
Conclusions: Development and implementation of easily accessible national formulary on extemporaneous formulations and their stability study, development of standard operating procedures for all activities in the pharmacy and staff training on recent technologies in compounding preparations are recommended Keywords: compounded preparations, hospital pharmacy, questionnaire, standard operating procedure, national formulary, stability
За останне десятилття в фармацевтичнш практиц в усьому ceimi спостер^аеться тенден^я переходу eid продуктовой орiенmацii на орiенmацiю на пацiенmа. Через дану та iншi причини уряд Шгери та його iн-ституци систематично скорочують бюджеты кошти на розвиток блоку аптечного виготовлення. Метою даноi cmаmmi було визначення проблем, що постають перед фармацевтичними працiвниками госттальних аптек, оцтка варmоcmi екстемпоральних лтарських заcобiв та пошукрШень. Mamepimu i методи: Анкета, що включала в себе закриmi i вiдкриmi питання, була поширена серед 50 фар-мацевmiв виробничих аптек в шmаmi Рiверc, Нiгерiя. Анкета складалася з пояснювально'1' записки i 10 питань, яю стосувалися навчання персоналу, кадрового забезпечення, примщення та обладнання, логктики, вартос-mi виготовлення, нацюнальних cmандарmiв виготовлення, внутршньоаптечного контролю якоcmi. Результати: Виходячи з резульmаmiв анкетування, проблемами виробничих аптек у пiвденнiй Шгери е неналежна юльюсть персоналу, вiдcуmнicmь електронного документування, обладнання i фтансування; було виявлено вiдcуmнicmь нацiонального формуляру екстемпоральних лтарських заcобiв та проведених доcлiджень на стабшьнкть. Варткть екстемпоральних лтарських заcобiв коливаеться в межах вiд 115 доларiв США.
Висновки: Рекомендуються розробка та впровадження легко доступного нацiонального формуляру на екcmемпоральнi лЫарсьт засоби i 1'х вивчення cmабiльноcmi, розробка стандартних операцтних процедур для вах видiв дiяльноcmi в апmецi i пiдвищення квалiфiкацii персоналу про новтш технологи виготовлення лтарських заcобiв в аптеках
Ключовi слова: лЫарсьт засоби аптечного виготовлення, госттальна аптека, анкета, стандартна операцтна процедура, нацюнальний формуляр, стабшьтсть
1. Introduction
In the past decade the pharmacy practice worldwide has experienced a shift from product-orientation to patient-orientation [1-3]. Compounding is the preparation (mixing, altering, assembling), under the supervision of a licenced pharmacist, of a medication that is not commercially available in the concentration or form needed for a specific patient pursuant to a prescription [4]. Products of compounding are called compounded preparations, extemporaneous formulations and compounded medications. The British pharmacopoeia refers to them as unlicensed medicines [5].
2. Formulation of the problem in a general way, the relevance of the theme and its connection with important scientific and practical issues
At the present stage of development of pharmaceutical industry there is a need to preserve the compounding of medicines in pharmacies. The Nigerian government and its institutions also have over the years, systematically de-emphasized through its budget, funding for the compounding unit. Today the compounding of medicines usually involves a small number of state and hospital pharmacies. In this regard, the majority of the population is limited acquisition opportunities in extemporaneous preparations.
3. Analysis of recent studies and publications in which a solution of the problem and which draws on the author
Organizational and economic problems of pharmaceutical compounding and its preservation for a long time are discussed by the pharmaceutical community [6-9]. Usually these problems are due to insufficient development of the pharmaceutical legislation in the absence of adequate funding.
in southern Nigeria, cost of extemporaneous preparations and proffer solutions.
4. Allocation of unsolved parts of the general problem, which is dedicated to the article
Study of problems of pharmaceutical compounding and dynamics of main economic indicators are relevant today. These include compliance to good compounding and pharmacy practices such as standard operating procedures, accessible harmonized national formulary and updates on local stability tests for extemporaneous formulations, quality control, and cost of extemporaneous preparations, logistics and adequate facilities.
5. Formulation of goals (tasks) of article
The aim of this study is to examine challenges facing compounding pharmacists in hospital pharmacies
6. Statement of the basic material of the study (methods and objects) with the justification of the results
A closed and open-ended format questionnaire was distributed to 50 compounding pharmacists. The survey was conducted in River State (southern Nigeria) within the period of October - December 2015. The questionnaire comprised of a cover letter and 10 items which cut across personnel training, staffing, premise and equipment, logistics, cost of compounding, national reference standards on compounding, in-pharmacy control. The statement was considered accepted if it is affirmed by 50 % of the respondents. Data from questionnaire were analysed into Microsoft Excel 2010 and summarized below.
Out of the 50 distributed questionnaires, a total of 48 were returned, representing a 96 % response rate of the sample size. Mean scores were determined for each item and the summarized data presented below.
Table 1
Relevant responses from administered questionnaire
# Questions Scales (responses)
1 Do you believe a biennial seminar/workshop for compounding pharmacists on recent scientific research is necessary? Yes No
100 % 0%
2 Type of API used during compounding Pure API, as part of commercial drug (tablet, capsule, injection etc)
7.1 % 92.9 %
3 Vehicles/bases used Import-ed(ORA-Plus, ORA-Sweet etc) Locally available (Vit C, Vit BCo etc) Both Abstained from answering question
47.6 % 38.1 % 11.9 % 2.4 %
4 What determines the cost of a Rx API Base/V ehicle Both Abstained from answering question
16.7 % 23.8 % 52.4 % 7.1 %
Abstained
5 Possible high cost for a compounded preparation ($) 1 USD 1-3 USD 3-5 USD 5-15 USD >15 USD from answering question
2.4 % 16.7 % 61.9 % 4.8 % 7.1 % 7.1 %
6 Possible low cost for a compounded preparation ($) <0.5 USD <1 USD 1-3 USD 3-5 USD Abstained from answering question
9.6 % 14.3 % 61.9 % 7.1 % 7.1 %
7 Awareness/existence of Nig. Ref. standards on compounding or quality control Aware Not aware Abstained from answering question
2.4 % 95.2 % 2.4 %
8 Existence/awareness of stability tests conducted in/for the country Aware Not aware Abstained from answering question
35.7 % 61.9 % 2.4 %
9 Adequacy of quality control lab Adequate Inadequate Abstained from answering question
21.4 % 76.2 % 2.4 %
10 Who should equip the Q.C. Lab? Hospital Government Private firms H+G All stakeholders
33.3 % 42.9 % - 11.9 % 11.9 %
Cost: Compounding in Nigeria is done mainly in government-owned hospital pharmacies, where the cost of extemporaneous preparations is highly subsidized. Whilst 61.9 % of respondents pegged the possible high cost of a compounded prescription to be in the range of 3-5 USD, extemporaneous formulations in the pharmacy could go for as high as 15 USD. 61.9 % of respondents pegged the lowest possible cost of a compounded prescription to be in the range of 3-5 USD. 52.4 % of respondents agree that the cost of both APIs and vehicles/bases determine the final cost of the extemporaneous medication. The cost of APIs is subsidized if they are included in the National health insurance scheme (NHIS) drug list [10]. A fee (maybe fixed) for compounding service as proposed and obtainable in some countries should be stipulated to enable the pharmacist place the patient as the primary focus and the cost of the product as a secondary in priority [11].
Personnel and training: 100.0 % of the respondents approved a biennial seminar/workshop on recent scientific development on compounding; the curriculum should include the course of quality assurance of compounding preparations [12].
Staffing: The ratio of compounding pharmacists to population is very low [13]. This poses a threat of wear-out, prescription errors and less time devoted to patient counselling on medications. Compounding is done mainly by pharmacists.
Documentation: Thanks to routine preparation of monthly reports the practice of documentation has being strong. However, only 30.9 % of respondents had switched to electronic (computer-based) documentation of compounded formulations. Their reasons bothered on time constraint as a result of understaffing.
Logistics: availability of required APIs and excipients (vehicle/bases) is an important aspect of compounding. Although use of pure substances is preferable, 92.9 % use commercial drugs (tablet, capsules etc.) as APIs for compounding. Vehicles/bases utilised include ORA-Plus, ORA-Sweet, cherry syrup, simple syrup USP. A staggering 50 % of the respondents said there was difficulty accessing required ingredients for compounding. The problem of logistics is being tackled by both the Nigerian government and the Pharmaceutical Society of Nigeria through a proposed Mega drug distribution System [14, 15].
Premises and equipment: Until recently, the pharmacy unit as a whole was planned and designed by doctors. Pharmacists made no input. As a result compounding units are poorly planned. Head of Hospitals and clinics (doctors) are forced to make readjustments of the pharmacy premises to meet a required specification recommended by the NHIS [16], when they apply for accreditation to join the scheme. Since compounding units is not a compulsory requirement for registration of hospital pharmacies with the scheme, pharmacists are forced to make a strong case for its inclusion. Compounding unit specifications should be stipulated and included in the requirements for setup of a hospital.
Quality Control: 76.2 % complain of inadequately equipped compounding units. 33.3 % and 42.9 % ascribe responsibility of an adequately equipped compounding unit on the hospital itself and government respectively. 11.9 % place the responsibility on both while the same percentage believes all (including private firms) stakeholders share the responsibility. All respondents (100 %) acceded to the need for development and implementation of standard operating procedures (SOP) for all activities in the pharmacy, including all stages of compounding, routine cleaning procedures, compounding equipment and environmental conditions under which products are prepared to enhance quality assurance [17].
In-pharmacy control: 100 % of the participants (respondents) confirmed in-pharmacy control. Prescriptions are vetted before compounding. Calculations and technology of production are checked by the supervising pharmacist before compounding. The compounded formulation is checked by another pharmacist before dispensing. Stocks are checked monthly. Erring pharmacists are retrained on the job. Raw materials are examined on reception, before storage and before use. Inspection of compounding by regulatory bodies is less frequent.
Reference standard: the reference standards used within the pharmacy include the British Pharmaceutical Codex, British Pharmacopoeia, United States Pharmacopoeia, the American Society of Health System Pharmacists Drug Information, Information from the International Journal of Pharmaceutical Compounding and other available sources that provide information on stability studies or recent updates relating to drug compounding. From the survey, 95.2 % of respondents are not aware of the existence of a national reference standard. Neither is 61.9 % aware of any stability tests being conducted in/for the country (Nigeria). A template for national formulary for compounded drugs is therefore proposed in Fig. 1, similar to existing/proposed formats in other countries [18-20].
This should be in a database form, containing readily accessible formulary to pharmacists nationwide. The formulary should include formula magistrals and medicines prepared by a hospital or community pharmacy in accordance with instructions in a compendium, pharmacopoeia or a formulary and dispensed by a pharmacy to patients [21, 22].
It should be subject to regular updates and a channel (or forum) [23] be created for inputs on new formulas/recipe. The advantages include access to locally usable information, increased quality assurance, inputs from academic and practicing pharmacists, and a harmonised national formulary of suitable formulations [24]. Stability tests should be made using products readily available in the country. Since generics of the same drug may produce different stability results due to the use of different excipients, it becomes necessary that the specific company producing the generic be mentioned.
Formulation Record
Name/Strength/Dosage form: Propranolol 1 mg/ml Suspension Route of Administration: Oral
Ingredients Strength Quantity
Propranolol Tablets 40 mg 6 tablets
Distilled water(wetting 4.8 ml
agent)
Citric acid Solution 25% 1 ml
Simple Syrup qs 240 ml
Procedure:
1. Crush tablets in a mortar to a fine powder.
2. Levigate the powder with distilled water until a smooth paste.
3. Add a small amount of simple syrup to form a smooth paste. Add more syrup until a liquid is formed and transfer the contents into a graduated cylinder. Use additional simple syrup to rinse the remaining drug from the mortar.
4. Add citric acid to the suspension in the graduate. Mix well.
5. QS to final volume with simple syrup.
6. Transfer the suspension into amber bottle
7. Shake well and label
Storage requirements: Refrigerate. Keep in amber bottle. Protect from light.
Stability: 45 days
Reference:
1. Pharmacy Compounding Manual May 2011, Alberta Health Services Calgary and Area ,p. 179
2. Milap C. Nahata, Vinita B.Pai, Thomas F.Hippie. Peadiatric Drug Formulation, 5th Edition, 2004 p. 233.
Fig. 1. Proposed format for compounding preparation formulary
7. Conclusion
The survey reveals challenges of compounding pharmacists in southern Nigeria such as inadequate manpower, electronic documentation, facilities and funding, access to a comprehensive national formulary on extemporaneous formulations and locally conducted stability tests.
Full electronic documentation, increased government funding for quality assurance conditions, logistics, adequate equipment of the compounding and quality control units, recruitment of more pharmacists is advocated.
An easily accessible national formulary on extemporaneous formulations and their stability study, development and implementation of SOP for all activities in the pharmacy and staff training on recent technologies in compounding preparation are recommended.
References
1. Martin, S. Hospital Pharmacy [Text] / S. Martin. -2-nd ed. - UK: Pharmaceutical Press, 2011. - P. 140-141.
2. Karin, W. Developing pharmacy practice - a focus on patient care [Text] / W. Karin, R. S. Summers, C. A. Mack-ie, A. G. S. Gous, M. Everard // World Health Organization and International Pharmaceutical Federation. - 2006. - P. 9-12.
3. Okhamafe, A. O. A review of B.Pharm degree pharmaceutics and pharmaceutical technology curriculum component [Text]: conference / A. O. Okhamafe; P. I. Akubue, B. A. Fred (Eds.). - Nigeria, 2001. - P. 56-63.
4. Pharmaceutical Compounding - Nonsterile Preparations <795> [Text]. - Revision bulletin. - 2014. - P. 1-7. -Available at: http://www.usp.org/sites/default/files/usp_pdf/EN/ gc795.pdf
5. General notices part II- Unlicensed medicines. British Pharmacopoeia [Text]. - 7-th ed. - London: The Stationary Office, 2013.
6. Managing Access to Medicines and Health Technologies [Text] / E. Martha, R. Marian (Eds.). - 3-rd ed. - Arlington, VA: Management Sciences for Health, 2012. - P. 29-178.
7. Aldo, M. Compounding in Argentina [Text] / M. Aldo // International Journal of Pharmaceutical Compounding. -2008. - Vol. 12, Issue 2. - P. 104.
8. Marisol, L. Compounding in Puerto Rico [Text] / L. Marisol // International Journal of Pharmaceutical Compounding. - 2008. - Vol. 12, Issue 2. - P. 110-111.
9. Diego, M. Compounding in Spain [Text] / M. Diego // International Journal of Pharmaceutical Compounding. -2008. - Vol. 12, Issue 2. - P. 112-113.
10. Drug price list [Text]. - 2-nd ed. - National Health Insurance Scheme. - Abuja, 2013. - P. 2-32.
11. Fink, J. F. Student Sketches [Text] / J. F. Fink // Journal of the American Pharmaceutical Association (1961). - 1969. -Vol. 9, Issue 3. - P. 140. doi: 10.1016/s0003-0465(15)31817-6
12. Zdoryk, O. A. Organization of the quality assurance system of compounding pharmacies in Ukraine: results of the survey [Text] / O. A. Zdoryk // News of Pharmacy. - 2014. -Vol. 4, Issue 80. - P. 64-67.
13. FIP Global Pharmacy Workforce Report [Electronic resource]. - 2012. - Available at: http://www.fip.org/files/ members/library/FIP_workforce_Report_2012. pdf
14. Ojo, L. A closer look at the new national drug distribution guidelines [Text] / L. Ojo // Pharmanews. - 2014. -Available at: http://www.pharmanewsonline.com/a-closer-look-at-the-new-national-drug-distribution-guidelines/
15. Nigerian government to enforce drug distribution guidelines from July 1 [Electronic resource]. - Health news. -2015. - Available at: http://healthnewsng.com/nigerian-govern-ment-to-enforce-drug-distribution-guidelines-from-july-1/
16. Operational guidelines [Text]. - National Health Insurance Scheme. - Abuja, 2012. - P. 58-60.
17. Kastango, E. S. Quality assurance for sterile products [Text] / E. S. Kastango, K. Douglass // Int. J. Pharm. Compd. - 2001. - Vol. 5, Issue 4. - P. 246-253.
18. Pharmacy Compounding Manual [Text]. - Calgary Health Region Pharmacy. - 2008. - P. 204.
19. Pharmaceutical Division Service [Text]. - Ministry of Health Extemporaneous formulary. - Malaysia, 2011. -P. 1-57.
20. Evans, A. Development of a standardized intranet database of formulation records for nonsterile compounding, part 1 [Text] / A. Evans, M. Haile, K. Anderson // Int. J. Pharm. Compd. - 2010. - Vol. 14, Issue 5. - P. 401-405.
21. Ministério da Saúde. Decreto-Lei n. ° 95/2004, de 22 de Abril, Artigo 1° [Text] // Diário da República. - 2004. -I Série-A 95. - P. 2440.
22. CETMED. Formulário Galénico Portugués [Text]. -2-nd ed. - Lisboa: Associajao Nacional das Farmácias, 2005.
23. European cooperation and synergy in quality standards beyond the European pharmacopoeia [Text]. - National experiences of formularies. - EDQM Symposium Strasbourg, France, 2007.
24. Expert Advisory Group ULM 14 [Text]. - British Pharmacopoeia Commission: Unlicensed Medicines. - London, 2014. - Available at: https://www.pharmacopoeia. com/file/ ULM—November-2014.pdf
References
1. Martin, S. (2011). Hospital Pharmacy. UK: Pharmaceutical Press, 140-141.
2. Karin, W., Summers, R. S., Mackie, C. A., Gous, A. G. S., Everard, M. (2006). Developing pharmacy practice - a focus on patient care. World Health Organization and International Pharmaceutical Federation, 9-12.
3. Okhamafe, A. O.; Akubue, P. I., Fred, B. A. (Eds.) (2001). A review of B.Pharm degree pharmaceutics and
pharmaceutical technology curriculum component. Nigeria, 56-63.
4. Pharmaceutical Compounding - Nonsterile Preparations <795> (2014). - Revision bulletin, 1-7. Available at: http://www.usp.org/sites/default/files/usp_pdf/EN/gc795.pdf
5. General notices part II- Unlicensed medicines. British Pharmacopoeia (2013). London: The Stationary Office.
6. Martha, E., Marian, R. (Eds.) (2012). Managing Access to Medicines and Health Technologies. Arlington, VA: Management Sciences for Health, 29-178.
7. Aldo, M. (2008). Compounding in Argentina. International Journal of Pharmaceutical Compounding, 12 (2), 104.
8. Marisol, L. (2008). Compounding in Puerto Rico. International Journal of Pharmaceutical Compounding, 12 (2), 110-111.
9. Diego, M. (2008). Compounding in Spain. International Journal of Pharmaceutical Compounding, 12 (2), 112-113.
10. Drug price list (2013). National Health Insurance Scheme. Abuja, 2-32.
11. Fink, J. F. (1969). Student Sketches. Journal of the American Pharmaceutical Association (1961), 9 (3), 140. doi: 10.1016/s0003-0465(15)31817-6
12. Zdoryk, O. A. (2014). Organization of the quality assurance system of compounding pharmacies in Ukraine: results of the survey. News of Pharmacy, 4 (80), 64-67.
13. FIP Global Pharmacy Workforce Report (2012). Available at: http://www.fip.org/files/members/library/FIP_ workforce_Report_2012.pdf
14. Ojo, L. (2014). A closer look at the new national drug distribution guidelines. Pharmanews. Available at: http:// www.pharmanewsonline.com/a-closer-look-at-the-new-national-drug-distribution-guidelines/
15. Nigerian government to enforce drug distribution guidelines from July 1 (2015). Health news. Available at: http://healthnewsng.com/nigerian-government-to-enforce-drug-distribution-guidelines-from-july-1/
16. Operational guidelines (2012). National Health Insurance Scheme. Abuja, 58-60.
17. Kastango, E. S., Douglass, K. (2001). Quality assurance for sterile products. Int. J. Pharm. Compd., 5 (4), 246-253.
18. Pharmacy Compounding Manual (2008). Calgary Health Region Pharmacy, 204.
19. Pharmaceutical Division Service (2011). Ministry of Health Extemporaneous formulary. Malaysia, 1-57.
20. Evans, A., Haile, M., Anderson, K. (2010). Development of a standardized intranet database of formulation records for nonsterile compounding, part 1. Int. J. Pharm. Compd., 14 (5), 401-405.
21. Ministério da Saúde. Decreto-Lei n. ° 95/2004, de 22 de Abril, Artigo 1° (2004). Diário da República, I Série-A 95, 2440.
22. CETMED. Formulário Galénico Portugués (2005). Lisboa: Associajao Nacional das Farmácias.
23. European cooperation and synergy in quality standards beyond the European pharmacopoeia (2007). National experiences of formularies. EDQM Symposium Strasbourg, France.
24. Expert Advisory Group ULM 14 (2014). British Pharmacopoeia Commission: Unlicensed Medicines. London. Available at: https://www.pharmacopoeia.com/file/ULM---November-2014.pdf
Дата надходженнярукопису 24.02.2016
Deghinmotei Alfred-Ugbenbo, Postgraduate student, Department of Pharmaceutical chemistry, National University of Pharmacy, Pushkinska str., 53, Kharkiv, Ukraine, 61002 E-mail: audeghinmotei@gmail.com
Zdoryk Oleksandr, Candidate of pharmaceutical science, Associate professor, Pharmaceutical chemistry department, National University of Pharmacy, Pushkinska str., 53, Kharkiv, Ukraine, 61002 E-mail: oleksandr_zdoryk@ukr.net
Georgiyants Viktoria, Doctor of pharmaceutical sciences, Professor, head of the department, Pharmaceutical chemistry department, National University of Pharmacy, Pushkinska str., 53, Kharkiv, Ukraine, 61002 E-mail: vgeorg@ukr.net
УДК 615.322
DOI: 10.15587/2313-8416.2016.61495
DEVELOPMENT OF METHODS FOR DETERMINATION OF PHENOLIC ACIDS AND FLAVONOIDS IN CAPSULES CONTAINING CORYLUS AVELLANA L. DRY EXTRACT
© N. Blyznyuk, Yu. Prokopenko, V. Georgiyants
The questions of standardization and quality control of both herbs and herbal remedies remain relevant, because it is well-known that product quality standards are essential, whether consumer using herbs or drugs. The necessity of the standardization methods development for the initial herbal material and capsule dosage form for the further quality control under manufacturing conditions remains relevant.
Aim. The aim of our research was to develop simple, specific, accurate and reproducible methods for identification offlavonoids and phenolic acids in capsule dosage form containing Corylus avellana L. dry extract. Methods. The samples of gelatine capsules containing Corylus avellana L. dry extract for oral administration were analyzed. The analysis was carried out using Camag HPTLC system.
The absorption spectroscopy determination of the sum offlavonoids was carried out using THERMO Scientific Evolution 60S Spectroscope in wavelength range of300-600 nm.
Results. As a result of HPTLC research rutine and quercitrine have been identified in capsule dosage form containing Corylus avellana L. dry extract. Among phenolic acids, neochlorogenic and chlorogenic acids have been identified.
Under the given conditions, the spectrum of the test solution had a maximum absorption at wavelength 406 nm. The analysis of flavonoids total content in gelatine capsules containing Corylus avellana L. dry extract calculated as rutine has shown the content of 1,7 %.
Conclusion. Effective HPTLC and absorption spectroscopy methods for determination offlavonoids and phenolic acids in capsule dosage form containing Corylus avellana L. dry extract have been developed. It has been found that described methods are promising enough for standardization of capsules with Corylus avellana L. dry extract and may be suggested for the quality control of the dosage form under manufacturing conditions Keywords: capsules, Corylus avellana L., extract, HPTLC, absorption spectroscopy, phenolic acids, flavonoids
Питання стандартизаци та контролю якоcmi якрослин, так i лтарських заcобiв рослинного походжен-ня набувае акmуальноcmi, враховуючи той факт, що стандарти якоcmi продукци е вкрай важливими, не-залежно вiд того, чи вживае споживач лЫарсьт рослини або лжарсьт засоби. Необхiднicmь розробки методик стандартизаци для вихiдноi рослинно'1' сировини та капсульовано лiкарcькоi форми для пода-льшого контролю якоcmi в умовах виробництва залишаеться актуальною.
Мета. Метою нашого до^дження була розробка просто'1', cпецифiчноi, точно'1' та вiдmворюваноi методики iденmифiкацii флавоноiдiв та фенольних кислот у капсульовант лiкарcькiй формi з сухим екст-рактом Corylus avellana L.
Методи. Для до^дження використовували зразки желатинових капсул з сухим екстрактом Corylus avellana L. для орального застосування. Аналiз проводили з використанням системи Camag для ВЕТСХ. Визначення вмicmу суми флавоноiдiв методом абcорбцiйноi спектроскопа здтснювали за допомогою спектрометра THERMO Scientific Evolution 60S у дiапазонi хвиль 300-600 нм.
Результати. В резульmаmi ВЕТСХ аналiзу у капсульовант лкарськт формi з сухим екстрактом Corylus avellana L. були iденmифiкованi рутин та кверцитрин. Серед фенольних кислот були iденmифiкованi не-охлорогенова та хлорогенова кислоти.
В умовах проведення спектрофотометричного до^дження спектр випробовуваного розчину мав максимум поглинання за довжини хвилi 406 нм. Вмicm суми флавоноiдiв у желатинових капсулах з сухим екстрактом Corylus avellana L. у перерахунку на рутин становив 1,7 %.
